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eHealth Weight Loss Program in African American Breast Cancer Survivors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02699983
Recruitment Status : Completed
First Posted : March 7, 2016
Results First Posted : August 6, 2019
Last Update Posted : August 6, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jeanne M. Ferrante, MD, MPH, Rutgers, The State University of New Jersey

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Conditions Cancer Survivor
Stage IA Breast Cancer
Stage IB Breast Cancer
Stage IIA Breast Cancer
Stage IIB Breast Cancer
Stage IIIA Breast Cancer
Stage IIIB Breast Cancer
Stage IIIC Breast Cancer
Stage 0 Breast Cancer
Interventions Behavioral: Behavioral Dietary Intervention
Behavioral: Exercise Intervention
Device: Activity Monitoring Device
Enrollment 35
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Group I (SparkPeople Program) Group II (Wait List)
Hide Arm/Group Description

Participants receive training on how to use the SparkPeople website, self-monitor their diet using the SparkPeople tool, and to self-monitor their activity daily using the Fitbit monitoring device.

Participants receive weekly motivational reminders to log into the website for 3 months via email, text, or phone, based on patient preference (active phase). Participants then enter the maintenance phase for 3 months without reminders.

Behavioral Dietary Intervention: Use SparkPeople web-based program

Exercise Intervention: Use Fitbit monitor and SparkPeople web-based program

Activity Monitoring Device: Wear Fitbit activity monitoring device

Participants receive the weight loss handout and a Fitbit activity monitoring device and proceed with their usual life. After 6 months, patients receive the SparkPeople treatment as in Group I.

Activity Monitoring Device: Wear Fitbit activity monitoring device

Period Title: Overall Study
Started 18 17
Completed 17 17
Not Completed 1 0
Reason Not Completed
Withdrawal by Subject             1             0
Arm/Group Title Group I (SparkPeople Program) Group II (Wait List) Total
Hide Arm/Group Description

Participants receive training on how to use the SparkPeople website, self-monitor their diet using the SparkPeople tool, and to self-monitor their activity daily using the Fitbit monitoring device.

Participants receive weekly motivational reminders to log into the website for 3 months via email, text, or phone, based on patient preference (active phase). Participants then enter the maintenance phase for 3 months without reminders.

Behavioral Dietary Intervention: Use SparkPeople web-based program

Exercise Intervention: Use Fitbit monitor and SparkPeople web-based program

Activity Monitoring Device: Wear Fitbit activity monitoring device

Participants receive the weight loss handout and a Fitbit activity monitoring device and proceed with their usual life. After 6 months, patients receive the SparkPeople treatment as in Group I. Total of all reporting groups
Overall Number of Baseline Participants 18 17 35
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants 17 participants 35 participants
61.20  (10.26) 62.25  (6.66) 61.67  (8.74)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 17 participants 35 participants
Female
18
 100.0%
17
 100.0%
35
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 17 participants 35 participants
Hispanic or Latino
4
  22.2%
0
   0.0%
4
  11.4%
Not Hispanic or Latino
14
  77.8%
17
 100.0%
31
  88.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 17 participants 35 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
18
 100.0%
17
 100.0%
35
 100.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 18 participants 17 participants 35 participants
18 17 35
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 18 participants 17 participants 35 participants
35.51  (6.98) 38.40  (6.94) 36.73  (6.84)
1.Primary Outcome
Title Recruitment Rate
Hide Description Number of eligible participants who were enrolled and randomly assigned. Feasibility is defined as >= 75% recruitment rate.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The overall number of participants is the number that were eligible for the study, hence it is greater than the number with results.
Arm/Group Title Group I (SparkPeople Program) Group II (Wait List)
Hide Arm/Group Description:

Participants receive training on how to use the SparkPeople website, self-monitor their diet using the SparkPeople tool, and to self-monitor their activity daily using the Fitbit monitoring device.

Participants receive weekly motivational reminders to log into the website for 3 months via email, text, or phone, based on patient preference (active phase). Participants then enter the maintenance phase for 3 months without reminders.

Behavioral Dietary Intervention: Use SparkPeople web-based program

Exercise Intervention: Use Fitbit monitor and SparkPeople web-based program

Activity Monitoring Device: Wear Fitbit activity monitoring device

Participants receive the weight loss handout and a Fitbit activity monitor. After 6 months, participants receive the SparkPeople treatment.

Exercise Intervention: Use Fitbit monitor

Activity Monitoring Device: Wear Fitbit activity monitoring device

Overall Number of Participants Analyzed 23 22
Measure Type: Count of Participants
Unit of Measure: Participants
18
  78.3%
17
  77.3%
2.Primary Outcome
Title Retention Rate
Hide Description Number of participants completing study. Feasibility will be defined as >= 80% retention rate.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group I (SparkPeople Program) Group II (Wait List)
Hide Arm/Group Description:

Participants receive training on how to use the SparkPeople website, self-monitor their diet using the SparkPeople tool, and to self-monitor their activity daily using the Fitbit monitoring device.

Participants receive weekly motivational reminders to log into the website for 3 months via email, text, or phone, based on patient preference (active phase). Participants then enter the maintenance phase for 3 months without reminders.

Behavioral Dietary Intervention: Use SparkPeople web-based program

Exercise Intervention: Use Fitbit monitor and SparkPeople web-based program

Activity Monitoring Device: Wear Fitbit activity monitoring device

Participants receive a weight loss handout and a Fitbit activity monitoring device and proceed with their usual life. After 6 months, patients receive the SparkPeople treatment as in Group I.

Exercise Intervention: Use Fitbit monitor

Activity Monitoring Device: Wear Fitbit activity monitoring device

Overall Number of Participants Analyzed 18 17
Measure Type: Count of Participants
Unit of Measure: Participants
17
  94.4%
17
 100.0%
3.Primary Outcome
Title Adherence to SparkPeople- Logged in
Hide Description average number of days logged per week in to SparkPeople website
Time Frame 0-3 months after intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group I (SparkPeople Program) Group II (Wait List)
Hide Arm/Group Description:

Participants receive training on how to use the SparkPeople website, self-monitor their diet using the SparkPeople tool, and to self-monitor their activity daily using the Fitbit monitoring device.

Participants receive weekly motivational reminders to log into the website for 3 months via email, text, or phone, based on patient preference (active phase). Participants then enter the maintenance phase for 3 months without reminders.

Behavioral Dietary Intervention: Use SparkPeople web-based program

Exercise Intervention: Use Fitbit monitor and SparkPeople web-based program

Activity Monitoring Device: Wear Fitbit activity monitoring device

Participants receive the weight loss handout and a Fitbit activity monitoring device and proceed with their usual life. After 6 months, patients receive the SparkPeople treatment as in Group I.
Overall Number of Participants Analyzed 18 17
Mean (Standard Deviation)
Unit of Measure: days/week
3.01  (2.07) 2.30  (2.27)
4.Primary Outcome
Title Adherence to SparkPeople- Logged in
Hide Description Average number of days per week logged in to SparkPeople website
Time Frame 4-6 months after intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group I (SparkPeople Program) Group II (Wait List)
Hide Arm/Group Description:

Participants receive training on how to use the SparkPeople website, self-monitor their diet using the SparkPeople tool, and to self-monitor their activity daily using the Fitbit monitoring device.

Participants receive weekly motivational reminders to log into the website for 3 months via email, text, or phone, based on patient preference (active phase). Participants then enter the maintenance phase for 3 months without reminders.

Behavioral Dietary Intervention: Use SparkPeople web-based program

Exercise Intervention: Use Fitbit monitor and SparkPeople web-based program

Activity Monitoring Device: Wear Fitbit activity monitoring device

Participants receive the weight loss handout and a Fitbit activity monitoring device and proceed with their usual life. After 6 months, patients receive the SparkPeople treatment as in Group I.
Overall Number of Participants Analyzed 18 17
Mean (Standard Deviation)
Unit of Measure: days/week
2.30  (2.30) 1.14  (1.64)
5.Primary Outcome
Title Adherence to SparkPeople- Logged Food
Hide Description Average number of days per week logged food into SparkPeople
Time Frame 0-3 months after intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group I (SparkPeople Program) Group II (Wait List)
Hide Arm/Group Description:

Participants receive training on how to use the SparkPeople website, self-monitor their diet using the SparkPeople tool, and to self-monitor their activity daily using the Fitbit monitoring device.

Participants receive weekly motivational reminders to log into the website for 3 months via email, text, or phone, based on patient preference (active phase). Participants then enter the maintenance phase for 3 months without reminders.

Behavioral Dietary Intervention: Use SparkPeople web-based program

Exercise Intervention: Use Fitbit monitor and SparkPeople web-based program

Activity Monitoring Device: Wear Fitbit activity monitoring device

Participants receive the weight loss handout and a Fitbit activity monitoring device and proceed with their usual life. After 6 months, patients receive the SparkPeople treatment as in Group I.
Overall Number of Participants Analyzed 18 17
Mean (Standard Deviation)
Unit of Measure: days/week
1.69  (1.84) 1.50  (1.85)
6.Primary Outcome
Title Adherence to SparkPeople- Logged Food
Hide Description Average number of days per week logged food into SparkPeople
Time Frame 4-6 months after intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group I (SparkPeople Program) Group II (Wait List)
Hide Arm/Group Description:

Participants receive training on how to use the SparkPeople website, self-monitor their diet using the SparkPeople tool, and to self-monitor their activity daily using the Fitbit monitoring device.

Participants receive weekly motivational reminders to log into the website for 3 months via email, text, or phone, based on patient preference (active phase). Participants then enter the maintenance phase for 3 months without reminders.

Behavioral Dietary Intervention: Use SparkPeople web-based program

Exercise Intervention: Use Fitbit monitor and SparkPeople web-based program

Activity Monitoring Device: Wear Fitbit activity monitoring device

Participants receive the weight loss handout and a Fitbit activity monitoring device and proceed with their usual life. After 6 months, patients receive the SparkPeople treatment as in Group I.
Overall Number of Participants Analyzed 18 17
Mean (Standard Deviation)
Unit of Measure: days/week
0.6  (0.87) 0.71  (1.17)
7.Primary Outcome
Title Acceptability of SparkPeople
Hide Description Usefulness of SparkPeople website on 1 (not useful at all) to 4 (very useful) scale
Time Frame 0-3 months after intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group I (SparkPeople Program) Group II (Wait List)
Hide Arm/Group Description:

Participants receive training on how to use the SparkPeople website, self-monitor their diet using the SparkPeople tool, and to self-monitor their activity daily using the Fitbit monitoring device.

Participants receive weekly motivational reminders to log into the website for 3 months via email, text, or phone, based on patient preference (active phase). Participants then enter the maintenance phase for 3 months without reminders.

Behavioral Dietary Intervention: Use SparkPeople web-based program

Exercise Intervention: Use Fitbit monitor and SparkPeople web-based program

Activity Monitoring Device: Wear Fitbit activity monitoring device

Participants receive the weight loss handout and a Fitbit activity monitoring device and proceed with their usual life. After 6 months, patients receive the SparkPeople treatment as in Group I.
Overall Number of Participants Analyzed 18 17
Mean (Standard Deviation)
Unit of Measure: score on a scale
3.53  (0.83) 3.60  (0.52)
8.Primary Outcome
Title Acceptability of SparkPeople
Hide Description Usefulness of SparkPeople website on 1 (not useful at all) to 4 (very useful) scale
Time Frame 4-6 months after intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group I (SparkPeople Program) Group II (Wait List)
Hide Arm/Group Description:

Participants receive training on how to use the SparkPeople website, self-monitor their diet using the SparkPeople tool, and to self-monitor their activity daily using the Fitbit monitoring device.

Participants receive weekly motivational reminders to log into the website for 3 months via email, text, or phone, based on patient preference (active phase). Participants then enter the maintenance phase for 3 months without reminders.

Behavioral Dietary Intervention: Use SparkPeople web-based program

Exercise Intervention: Use Fitbit monitor and SparkPeople web-based program

Activity Monitoring Device: Wear Fitbit activity monitoring device

Participants receive the weight loss handout and a Fitbit activity monitoring device and proceed with their usual life. After 6 months, patients receive the SparkPeople treatment as in Group I.
Overall Number of Participants Analyzed 18 17
Mean (Standard Deviation)
Unit of Measure: score on a scale
3.53  (0.80) 3.42  (0.79)
9.Primary Outcome
Title Adherence to Fitbit
Hide Description average days used Fitbit per week
Time Frame 0-3 months after intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group I (SparkPeople Program) Group II (Wait List)
Hide Arm/Group Description:

Participants receive training on how to use the SparkPeople website, self-monitor their diet using the SparkPeople tool, and to self-monitor their activity daily using the Fitbit monitoring device.

Participants receive weekly motivational reminders to log into the website for 3 months via email, text, or phone, based on patient preference (active phase). Participants then enter the maintenance phase for 3 months without reminders.

Behavioral Dietary Intervention: Use SparkPeople web-based program

Exercise Intervention: Use Fitbit monitor and SparkPeople web-based program

Activity Monitoring Device: Wear Fitbit activity monitoring device

Participants receive the weight loss handout and a Fitbit activity monitoring device and proceed with their usual life. After 6 months, patients receive the SparkPeople treatment as in Group I.
Overall Number of Participants Analyzed 18 17
Mean (Standard Deviation)
Unit of Measure: days/week
6.24  (0.84) 5.96  (1.63)
10.Primary Outcome
Title Adherence to Fitbit
Hide Description average days used Fitbit per week
Time Frame 4-6 months after intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group I (SparkPeople Program) Group II (Wait List)
Hide Arm/Group Description:

Participants receive training on how to use the SparkPeople website, self-monitor their diet using the SparkPeople tool, and to self-monitor their activity daily using the Fitbit monitoring device.

Participants receive weekly motivational reminders to log into the website for 3 months via email, text, or phone, based on patient preference (active phase). Participants then enter the maintenance phase for 3 months without reminders.

Behavioral Dietary Intervention: Use SparkPeople web-based program

Exercise Intervention: Use Fitbit monitor and SparkPeople web-based program

Activity Monitoring Device: Wear Fitbit activity monitoring device

Participants receive the weight loss handout and a Fitbit activity monitoring device and proceed with their usual life. After 6 months, patients receive the SparkPeople treatment as in Group I.
Overall Number of Participants Analyzed 18 17
Mean (Standard Deviation)
Unit of Measure: days/week
5.57  (1.83) 5.61  (1.77)
11.Primary Outcome
Title Acceptability of Fitbit
Hide Description Usefulness of Fitbit, rated on 1 (not useful at all) to 4 (very useful) scale
Time Frame 0-3 months after intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group I (SparkPeople Program) Group II (Wait List)
Hide Arm/Group Description:

Participants receive training on how to use the SparkPeople website, self-monitor their diet using the SparkPeople tool, and to self-monitor their activity daily using the Fitbit monitoring device.

Participants receive weekly motivational reminders to log into the website for 3 months via email, text, or phone, based on patient preference (active phase). Participants then enter the maintenance phase for 3 months without reminders.

Behavioral Dietary Intervention: Use SparkPeople web-based program

Exercise Intervention: Use Fitbit monitor and SparkPeople web-based program

Activity Monitoring Device: Wear Fitbit activity monitoring device

Participants receive the weight loss handout and a Fitbit activity monitoring device and proceed with their usual life. After 6 months, patients receive the SparkPeople treatment as in Group I.
Overall Number of Participants Analyzed 18 17
Mean (Standard Deviation)
Unit of Measure: score on a scale
3.93  (0.26) 3.93  (0.26)
12.Primary Outcome
Title Acceptability of Fitbit
Hide Description Usefulness of Fitbit, rated on 1 (not useful at all) to 4 (very useful) scale
Time Frame 4-6 months after intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group I (SparkPeople Program) Group II (Wait List)
Hide Arm/Group Description:

Participants receive training on how to use the SparkPeople website, self-monitor their diet using the SparkPeople tool, and to self-monitor their activity daily using the Fitbit monitoring device.

Participants receive weekly motivational reminders to log into the website for 3 months via email, text, or phone, based on patient preference (active phase). Participants then enter the maintenance phase for 3 months without reminders.

Behavioral Dietary Intervention: Use SparkPeople web-based program

Exercise Intervention: Use Fitbit monitor and SparkPeople web-based program

Activity Monitoring Device: Wear Fitbit activity monitoring device

Participants receive the weight loss handout and a Fitbit activity monitoring device and proceed with their usual life. After 6 months, patients receive the SparkPeople treatment as in Group I.
Overall Number of Participants Analyzed 18 17
Mean (Standard Deviation)
Unit of Measure: score on a scale
4.00  (0) 4.00  (0)
13.Secondary Outcome
Title Change in Weight
Hide Description Change in weight from baseline
Time Frame baseline and 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group I (SparkPeople Program) Group II (Wait List)
Hide Arm/Group Description:

Participants receive training on how to use the SparkPeople website, self-monitor their diet using the SparkPeople tool, and to self-monitor their activity daily using the Fitbit monitoring device.

Participants receive weekly motivational reminders to log into the website for 3 months via email, text, or phone, based on patient preference (active phase). Participants then enter the maintenance phase for 3 months without reminders.

Behavioral Dietary Intervention: Use SparkPeople web-based program

Exercise Intervention: Use Fitbit monitor and SparkPeople web-based program

Activity Monitoring Device: Wear Fitbit activity monitoring device

Participants receive the weight loss handout and a Fitbit activity monitoring device and proceed with their usual life. After 6 months, patients receive the SparkPeople treatment as in Group I.
Overall Number of Participants Analyzed 18 17
Mean (Standard Deviation)
Unit of Measure: kg
-2.10  (2.64) -2.26  (2.16)
14.Secondary Outcome
Title Change in Weight
Hide Description Change in weight from baseline
Time Frame baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group I (SparkPeople Program) Group II (Wait List)
Hide Arm/Group Description:

Participants receive training on how to use the SparkPeople website, self-monitor their diet using the SparkPeople tool, and to self-monitor their activity daily using the Fitbit monitoring device.

Participants receive weekly motivational reminders to log into the website for 3 months via email, text, or phone, based on patient preference (active phase). Participants then enter the maintenance phase for 3 months without reminders.

Behavioral Dietary Intervention: Use SparkPeople web-based program

Exercise Intervention: Use Fitbit monitor and SparkPeople web-based program

Activity Monitoring Device: Wear Fitbit activity monitoring device

Participants receive the weight loss handout and a Fitbit activity monitoring device and proceed with their usual life. After 6 months, patients receive the SparkPeople treatment as in Group I.
Overall Number of Participants Analyzed 18 17
Mean (Standard Deviation)
Unit of Measure: kg
-1.71  (1.88) -2.53  (4.00)
15.Secondary Outcome
Title Change in Waist Circumference
Hide Description Change in waist circumference from baseline
Time Frame baseline and 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group I (SparkPeople Program) Group II (Wait List)
Hide Arm/Group Description:

Participants receive training on how to use the SparkPeople website, self-monitor their diet using the SparkPeople tool, and to self-monitor their activity daily using the Fitbit monitoring device.

Participants receive weekly motivational reminders to log into the website for 3 months via email, text, or phone, based on patient preference (active phase). Participants then enter the maintenance phase for 3 months without reminders.

Behavioral Dietary Intervention: Use SparkPeople web-based program

Exercise Intervention: Use Fitbit monitor and SparkPeople web-based program

Activity Monitoring Device: Wear Fitbit activity monitoring device

Participants receive the weight loss handout and a Fitbit activity monitoring device and proceed with their usual life. After 6 months, patients receive the SparkPeople treatment as in Group I.
Overall Number of Participants Analyzed 18 17
Mean (Standard Deviation)
Unit of Measure: cm
-1.98  (5.39) -0.05  (5.56)
16.Secondary Outcome
Title Change in Waist Circumference
Hide Description Change in waist circumference from baseline
Time Frame baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group I (SparkPeople Program) Group II (Wait List)
Hide Arm/Group Description:

Participants receive training on how to use the SparkPeople website, self-monitor their diet using the SparkPeople tool, and to self-monitor their activity daily using the Fitbit monitoring device.

Participants receive weekly motivational reminders to log into the website for 3 months via email, text, or phone, based on patient preference (active phase). Participants then enter the maintenance phase for 3 months without reminders.

Behavioral Dietary Intervention: Use SparkPeople web-based program

Exercise Intervention: Use Fitbit monitor and SparkPeople web-based program

Activity Monitoring Device: Wear Fitbit activity monitoring device

Participants receive the weight loss handout and a Fitbit activity monitoring device and proceed with their usual life. After 6 months, patients receive the SparkPeople treatment as in Group I.
Overall Number of Participants Analyzed 18 17
Mean (Standard Deviation)
Unit of Measure: cm
-3.56  (4.70) -0.84  (5.21)
17.Secondary Outcome
Title Change in Caloric Intake
Hide Description Changes in caloric intake per day, measured by 24-hour recall
Time Frame baseline and 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group I (SparkPeople Program) Group II (Wait List)
Hide Arm/Group Description:

Participants receive training on how to use the SparkPeople website, self-monitor their diet using the SparkPeople tool, and to self-monitor their activity daily using the Fitbit monitoring device.

Participants receive weekly motivational reminders to log into the website for 3 months via email, text, or phone, based on patient preference (active phase). Participants then enter the maintenance phase for 3 months without reminders.

Behavioral Dietary Intervention: Use SparkPeople web-based program

Exercise Intervention: Use Fitbit monitor and SparkPeople web-based program

Activity Monitoring Device: Wear Fitbit activity monitoring device

Participants receive the weight loss handout and a Fitbit activity monitoring device and proceed with their usual life. After 6 months, patients receive the SparkPeople treatment as in Group I.
Overall Number of Participants Analyzed 18 17
Mean (Standard Deviation)
Unit of Measure: kcal/day
-62.06  (589.27) -386.38  (514.95)
18.Secondary Outcome
Title Change in Caloric Intake
Hide Description Changes in caloric intake per day, measured by 24-hour recall
Time Frame baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group I (SparkPeople Program) Group II (Wait List)
Hide Arm/Group Description:

Participants receive training on how to use the SparkPeople website, self-monitor their diet using the SparkPeople tool, and to self-monitor their activity daily using the Fitbit monitoring device.

Participants receive weekly motivational reminders to log into the website for 3 months via email, text, or phone, based on patient preference (active phase). Participants then enter the maintenance phase for 3 months without reminders.

Behavioral Dietary Intervention: Use SparkPeople web-based program

Exercise Intervention: Use Fitbit monitor and SparkPeople web-based program

Activity Monitoring Device: Wear Fitbit activity monitoring device

Participants receive the weight loss handout and a Fitbit activity monitoring device and proceed with their usual life. After 6 months, patients receive the SparkPeople treatment as in Group I.
Overall Number of Participants Analyzed 18 17
Mean (Standard Deviation)
Unit of Measure: kcal/day
-216.65  (606.09) -173.06  (805.40)
19.Secondary Outcome
Title Change in Physical Activity
Hide Description change in average number of steps per day measured using Fitbit monitor
Time Frame baseline and 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group I (SparkPeople Program) Group II (Wait List)
Hide Arm/Group Description:

Participants receive training on how to use the SparkPeople website, self-monitor their diet using the SparkPeople tool, and to self-monitor their activity daily using the Fitbit monitoring device.

Participants receive weekly motivational reminders to log into the website for 3 months via email, text, or phone, based on patient preference (active phase). Participants then enter the maintenance phase for 3 months without reminders.

Behavioral Dietary Intervention: Use SparkPeople web-based program

Exercise Intervention: Use Fitbit monitor and SparkPeople web-based program

Activity Monitoring Device: Wear Fitbit activity monitoring device

Participants receive the weight loss handout and a Fitbit activity monitoring device and proceed with their usual life. After 6 months, patients receive the SparkPeople treatment as in Group I.
Overall Number of Participants Analyzed 18 17
Mean (Standard Deviation)
Unit of Measure: steps per day
466.36  (2203.49) -609.83  (2898.36)
20.Secondary Outcome
Title Change in Physical Activity
Hide Description change in average number of steps per day measured using Fitbit monitor
Time Frame baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group I (SparkPeople Program) Group II (Wait List)
Hide Arm/Group Description:

Participants receive training on how to use the SparkPeople website, self-monitor their diet using the SparkPeople tool, and to self-monitor their activity daily using the Fitbit monitoring device.

Participants receive weekly motivational reminders to log into the website for 3 months via email, text, or phone, based on patient preference (active phase). Participants then enter the maintenance phase for 3 months without reminders.

Behavioral Dietary Intervention: Use SparkPeople web-based program

Exercise Intervention: Use Fitbit monitor and SparkPeople web-based program

Activity Monitoring Device: Wear Fitbit activity monitoring device

Participants receive the weight loss handout and a Fitbit activity monitoring device and proceed with their usual life. After 6 months, patients receive the SparkPeople treatment as in Group I.
Overall Number of Participants Analyzed 18 17
Mean (Standard Deviation)
Unit of Measure: steps per day
-107.07  (2184.94) -205.47  (2147.79)
21.Secondary Outcome
Title Cardiopulmonary Fitness
Hide Description change in fitness, measured by the 6-minute walk test
Time Frame baseline and 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group I (SparkPeople Program) Group II (Wait List)
Hide Arm/Group Description:

Participants receive training on how to use the SparkPeople website, self-monitor their diet using the SparkPeople tool, and to self-monitor their activity daily using the Fitbit monitoring device.

Participants receive weekly motivational reminders to log into the website for 3 months via email, text, or phone, based on patient preference (active phase). Participants then enter the maintenance phase for 3 months without reminders.

Behavioral Dietary Intervention: Use SparkPeople web-based program

Exercise Intervention: Use Fitbit monitor and SparkPeople web-based program

Activity Monitoring Device: Wear Fitbit activity monitoring device

Participants receive the weight loss handout and a Fitbit activity monitoring device and proceed with their usual life. After 6 months, patients receive the SparkPeople treatment as in Group I.
Overall Number of Participants Analyzed 18 17
Mean (Standard Deviation)
Unit of Measure: meters
0.81  (51.13) 20.07  (52.81)
22.Secondary Outcome
Title Cardiopulmonary Fitness
Hide Description change in fitness, measured by the 6-minute walk test
Time Frame baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group I (SparkPeople Program) Group II (Wait List)
Hide Arm/Group Description:

Participants receive training on how to use the SparkPeople website, self-monitor their diet using the SparkPeople tool, and to self-monitor their activity daily using the Fitbit monitoring device.

Participants receive weekly motivational reminders to log into the website for 3 months via email, text, or phone, based on patient preference (active phase). Participants then enter the maintenance phase for 3 months without reminders.

Behavioral Dietary Intervention: Use SparkPeople web-based program

Exercise Intervention: Use Fitbit monitor and SparkPeople web-based program

Activity Monitoring Device: Wear Fitbit activity monitoring device

Participants receive the weight loss handout and a Fitbit activity monitoring device and proceed with their usual life. After 6 months, patients receive the SparkPeople treatment as in Group I.
Overall Number of Participants Analyzed 18 17
Mean (Standard Deviation)
Unit of Measure: meters
26.64  (35.88) 31.97  (26.27)
23.Secondary Outcome
Title Change in Quality of Life
Hide Description measured using Quality of Life in Adult Cancer Survivors Scale (minimum 65, maximum 257); higher scores mean worse quality of life
Time Frame baseline and 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group I (SparkPeople Program) Group II (Wait List)
Hide Arm/Group Description:

Participants receive training on how to use the SparkPeople website, self-monitor their diet using the SparkPeople tool, and to self-monitor their activity daily using the Fitbit monitoring device.

Participants receive weekly motivational reminders to log into the website for 3 months via email, text, or phone, based on patient preference (active phase). Participants then enter the maintenance phase for 3 months without reminders.

Behavioral Dietary Intervention: Use SparkPeople web-based program

Exercise Intervention: Use Fitbit monitor and SparkPeople web-based program

Activity Monitoring Device: Wear Fitbit activity monitoring device

Participants receive the weight loss handout and a Fitbit activity monitoring device and proceed with their usual life. After 6 months, patients receive the SparkPeople treatment as in Group I.
Overall Number of Participants Analyzed 18 17
Mean (Standard Deviation)
Unit of Measure: units on a scale
-5.44  (18.11) -4.35  (16.69)
24.Secondary Outcome
Title Change in Quality of Life
Hide Description measured using Quality of Life in Adult Cancer Survivors Scale (minimum 65, maximum 257); higher scores mean worse quality of life
Time Frame baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group I (SparkPeople Program) Group II (Wait List)
Hide Arm/Group Description:

Participants receive training on how to use the SparkPeople website, self-monitor their diet using the SparkPeople tool, and to self-monitor their activity daily using the Fitbit monitoring device.

Participants receive weekly motivational reminders to log into the website for 3 months via email, text, or phone, based on patient preference (active phase). Participants then enter the maintenance phase for 3 months without reminders.

Behavioral Dietary Intervention: Use SparkPeople web-based program

Exercise Intervention: Use Fitbit monitor and SparkPeople web-based program

Activity Monitoring Device: Wear Fitbit activity monitoring device

Participants receive the weight loss handout and a Fitbit activity monitoring device and proceed with their usual life. After 6 months, patients receive the SparkPeople treatment as in Group I.
Overall Number of Participants Analyzed 18 17
Mean (Standard Deviation)
Unit of Measure: units on a scale
-9.44  (16.97) -4.65  (24.21)
25.Secondary Outcome
Title Self-efficacy, Eating Healthy Foods
Hide Description change in self-efficacy, eating healthy foods, measured with Health Beliefs Survey, scale range 0 (certain I cannot) to 100 (certain I can)
Time Frame baseline and 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group I (SparkPeople Program) Group II (Wait List)
Hide Arm/Group Description:

Participants receive training on how to use the SparkPeople website, self-monitor their diet using the SparkPeople tool, and to self-monitor their activity daily using the Fitbit monitoring device.

Participants receive weekly motivational reminders to log into the website for 3 months via email, text, or phone, based on patient preference (active phase). Participants then enter the maintenance phase for 3 months without reminders.

All participants have follow-up visits at 3, 6, 9, and 12 months to answer survey questions on quality of life and social cognitive theory variables and undergo anthropometric measurements.

Participants receive the weight loss handout and a Fitbit activity monitoring device and proceed with their usual life. After 6 months, patients receive the SparkPeople treatment as in Group I. All participants have follow-up visits at 3, 6, 9, and 12 months to answer survey questions on quality of life and social cognitive theory variables and undergo anthropometric measurements.
Overall Number of Participants Analyzed 18 17
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.14  (8.17) -0.41  (13.47)
26.Secondary Outcome
Title Self-efficacy, Eating Healthy Foods
Hide Description change in self-efficacy, eating healthy foods, measured with Health Beliefs Survey, scale range 0 (certain I cannot) to 100 (certain I can)
Time Frame baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group I (SparkPeople Program) Group II (Wait List)
Hide Arm/Group Description:

Participants receive training on how to use the SparkPeople website, self-monitor their diet using the SparkPeople tool, and to self-monitor their activity daily using the Fitbit monitoring device.

Participants receive weekly motivational reminders to log into the website for 3 months via email, text, or phone, based on patient preference (active phase). Participants then enter the maintenance phase for 3 months without reminders.

Behavioral Dietary Intervention: Use SparkPeople web-based program

Exercise Intervention: Use Fitbit monitor and SparkPeople web-based program

Activity Monitoring Device: Wear Fitbit activity monitoring device

Participants receive the weight loss handout and a Fitbit activity monitoring device and proceed with their usual life. After 6 months, patients receive the SparkPeople treatment as in Group I.
Overall Number of Participants Analyzed 18 17
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.59  (12.63) -6.59  (15.36)
27.Secondary Outcome
Title Social Support for Healthy Nutrition
Hide Description change in social support for healthy nutrition, measured by Health Beliefs Survey, scale range 1 (strongly disagree) to 5 (strongly agree); a higher number, e.g., 5 (strongly agree) is the more favorable outcome
Time Frame baseline and 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group I (SparkPeople Program) Group II (Wait List)
Hide Arm/Group Description:

Participants receive training on how to use the SparkPeople website, self-monitor their diet using the SparkPeople tool, and to self-monitor their activity daily using the Fitbit monitoring device.

Participants receive weekly motivational reminders to log into the website for 3 months via email, text, or phone, based on patient preference (active phase). Participants then enter the maintenance phase for 3 months without reminders.

Behavioral Dietary Intervention: Use SparkPeople web-based program

Exercise Intervention: Use Fitbit monitor and SparkPeople web-based program

Activity Monitoring Device: Wear Fitbit activity monitoring device

Participants receive the weight loss handout and a Fitbit activity monitoring device and proceed with their usual life. After 6 months, patients receive the SparkPeople treatment as in Group I.
Overall Number of Participants Analyzed 18 17
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.40  (0.58) 0.11  (0.56)
28.Secondary Outcome
Title Social Support for Healthy Nutrition
Hide Description change in social support for healthy nutrition, measured by Health Beliefs Survey, scale range 1 (strongly disagree) to 5 (strongly agree); a higher number, e.g., 5 (strongly agree) is the more favorable outcome
Time Frame baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group I (SparkPeople Program) Group II (Wait List)
Hide Arm/Group Description:

Participants receive training on how to use the SparkPeople website, self-monitor their diet using the SparkPeople tool, and to self-monitor their activity daily using the Fitbit monitoring device.

Participants receive weekly motivational reminders to log into the website for 3 months via email, text, or phone, based on patient preference (active phase). Participants then enter the maintenance phase for 3 months without reminders.

Behavioral Dietary Intervention: Use SparkPeople web-based program

Exercise Intervention: Use Fitbit monitor and SparkPeople web-based program

Activity Monitoring Device: Wear Fitbit activity monitoring device

Participants receive the weight loss handout and a Fitbit activity monitoring device and proceed with their usual life. After 6 months, patients receive the SparkPeople treatment as in Group I.
Overall Number of Participants Analyzed 18 17
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.39  (0.85) 0.11  (0.71)
Time Frame 6 months
Adverse Event Reporting Description This is a minimal risk study. The lifestyle behavioral modification intervention did not place participants at risk for any serious adverse events or death.
 
Arm/Group Title Group I (SparkPeople Program) Group II (Wait List)
Hide Arm/Group Description

Participants receive training on how to use the SparkPeople website, self-monitor their diet using the SparkPeople tool, and to self-monitor their activity daily using the Fitbit monitoring device.

Participants receive weekly motivational reminders to log into the website for 3 months via email, text, or phone, based on patient preference (active phase). Participants then enter the maintenance phase for 3 months without reminders.

All participants have follow-up visits at 3, 6, 9, and 12 months to answer survey questions on quality of life and social cognitive theory variables and undergo anthropometric measurements.

Participants receive the weight loss handout and a Fitbit activity monitoring device and proceed with their usual life. After 6 months, patients receive the SparkPeople treatment as in Group I. All participants have follow-up visits at 3, 6, 9, and 12 months to answer survey questions on quality of life and social cognitive theory variables and undergo anthropometric measurements.
All-Cause Mortality
Group I (SparkPeople Program) Group II (Wait List)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/17 (0.00%) 
Hide Serious Adverse Events
Group I (SparkPeople Program) Group II (Wait List)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/17 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Group I (SparkPeople Program) Group II (Wait List)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/17 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jeanne Ferrante
Organization: Rutgers Robert Wood Johnson Medical School
Phone: 848-932-5252
EMail: jeanne.ferrante@rutgers.edu
Layout table for additonal information
Responsible Party: Jeanne M. Ferrante, MD, MPH, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT02699983    
Other Study ID Numbers: 131404
NCI-2015-02137 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
Pro20150001595 ( Other Identifier: Rutgers University eIRB )
131404 ( Other Identifier: Rutgers Cancer Institute of New Jersey )
R21CA191431 ( U.S. NIH Grant/Contract )
First Submitted: March 1, 2016
First Posted: March 7, 2016
Results First Submitted: March 6, 2019
Results First Posted: August 6, 2019
Last Update Posted: August 6, 2019