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Trial record 1 of 1 for:    1R01HL122302-01A1
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RELAX: A Mobile Application Suite Targeting Obesity and Stress

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ClinicalTrials.gov Identifier: NCT02615171
Recruitment Status : Completed
First Posted : November 26, 2015
Results First Posted : March 11, 2021
Last Update Posted : April 13, 2021
Sponsor:
Collaborators:
Worcester Polytechnic Institute
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Sherry Pagoto, University of Connecticut

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Stress
Weight
Interventions Behavioral: Comprehensive Dietary Self-Monitoring; Device: smartphone; Other: physical activity
Behavioral: Simple Dietary Self-Monitoring; Device: smartphone; Other: physical activity
Enrollment 64
Recruitment Details  
Pre-assignment Details After participants were initially screened, a telephone screening, webinar orientation and baseline survey was required prior to being randomized.
Arm/Group Title Comprehensive Dietary Self-Monitoring Simple Dietary Self-Monitoring
Hide Arm/Group Description The intervention includes Facebook-delivered weight loss counseling and the use of MyFitnessPal, a comprehensive diet and exercise self-monitoring app. The intervention will last for 12 weeks. In addition to weight loss counseling in a private Facebook group, participants will be encouraged to use the self-monitoring app to enter everything they eat and do for exercise during the intervention period (12 weeks). Participants will receive a daily calorie goal directly from the app. Participants will receive a Fitbit scale to take their weight weekly and at assessments. The intervention includes Facebook-delivered weight loss counseling and the use of Slip Buddy, an app created by the investigative team that only requires users to record instances of overeating by hitting a single button and then indicate the overeating trigger and stress and hunger levels. The intervention will last for 12 weeks. In addition to the weight loss counseling, participants will be asked to use the Slip Buddy app during the intervention period (12 weeks). Participants will receive a Fitbit scale to take their weight weekly and at assessments.
Period Title: Overall Study
Started 32 32
Completed 30 31
Not Completed 2 1
Reason Not Completed
Lost to Follow-up             2             1
Arm/Group Title Comprehensive Dietary Self-Monitoring Simple Dietary Self-Monitoring Total
Hide Arm/Group Description The intervention includes Facebook-delivered weight loss counseling and the use of MyFitnessPal, a comprehensive diet and exercise self-monitoring app. The intervention will last for 12 weeks. In addition to weight loss counseling in a private Facebook group, participants will be encouraged to use the self-monitoring app to enter everything they eat and do for exercise during the intervention period (12 weeks). Participants will receive a daily calorie goal directly from the app. Participants will receive a Fitbit scale to take their weight weekly and at assessments. The intervention includes Facebook-delivered weight loss counseling and the use of Slip Buddy, an app created by the investigative team that only requires users to record instances of overeating by hitting a single button and then indicate the overeating trigger and stress and hunger levels. The intervention will last for 12 weeks. In addition to the weight loss counseling, participants will be asked to use the Slip Buddy app during the intervention period (12 weeks). Participants will receive a Fitbit scale to take their weight weekly and at assessments. Total of all reporting groups
Overall Number of Baseline Participants 32 32 64
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 32 participants 32 participants 64 participants
40.2  (12.3) 39.5  (9.6) 39.8  (11.0)
Sex/Gender, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Selection of Gender Number Analyzed 32 participants 32 participants 64 participants
Male
7
  21.9%
8
  25.0%
15
  23.4%
Female
24
  75.0%
24
  75.0%
48
  75.0%
Transmasculine Nonbinary
1
   3.1%
0
   0.0%
1
   1.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 32 participants 64 participants
Hispanic or Latino
4
  12.5%
1
   3.1%
5
   7.8%
Not Hispanic or Latino
28
  87.5%
31
  96.9%
59
  92.2%
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 32 participants 32 participants 64 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   3.1%
0
   0.0%
1
   1.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   3.1%
3
   9.4%
4
   6.3%
White
28
  87.5%
27
  84.4%
55
  85.9%
More than one race
2
   6.3%
2
   6.3%
4
   6.3%
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 32 participants 32 participants 64 participants
32 32 64
1.Primary Outcome
Title Percentage of Days App Used Over 12 Weeks
Hide Description App use was measured for each condition using either backend data from Slip Buddy or reviewing MyFitnessPal entries indicating use over each 24-hour period.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Comprehensive Dietary Self-Monitoring Simple Dietary Self-Monitoring
Hide Arm/Group Description:
The intervention includes Facebook-delivered weight loss counseling and the use of MyFitnessPal, a comprehensive diet and exercise self-monitoring app. The intervention will last for 12 weeks. In addition to weight loss counseling in a private Facebook group, participants will be encouraged to use the self-monitoring app to enter everything they eat and do for exercise during the intervention period (12 weeks). Participants will receive a daily calorie goal directly from the app. Participants will receive a Fitbit scale to take their weight weekly and at assessments.
The intervention includes Facebook-delivered weight loss counseling and the use of Slip Buddy, an app created by the investigative team that only requires users to record instances of overeating by hitting a single button and then indicate the overeating trigger and stress and hunger levels. The intervention will last for 12 weeks. In addition to the weight loss counseling, participants will be asked to use the Slip Buddy app during the intervention period (12 weeks). Participants will receive a Fitbit scale to take their weight weekly and at assessments.
Overall Number of Participants Analyzed 32 32
Mean (Standard Deviation)
Unit of Measure: percent of days app used
57.5  (28.4) 53.8  (31.3)
2.Primary Outcome
Title Usability
Hide Description Usability will be assessed using the System Usability Scale (SUS), a 10-item measure with 5-point Likert scale response options (Strongly Agree to Strongly Disagree). Scores are summed (0-40) then converted to a 0-100 scale, with higher scores indicating higher usability. Scores above 58 are considered above average, and scores above 80 are considered to indicate high usability where participants are likely to recommend the product to friends.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Comprehensive Dietary Self-Monitoring Simple Dietary Self-Monitoring
Hide Arm/Group Description:
The intervention includes Facebook-delivered weight loss counseling and the use of MyFitnessPal, a comprehensive diet and exercise self-monitoring app. The intervention will last for 12 weeks. In addition to weight loss counseling in a private Facebook group, participants will be encouraged to use the self-monitoring app to enter everything they eat and do for exercise during the intervention period (12 weeks). Participants will receive a daily calorie goal directly from the app. Participants will receive a Fitbit scale to take their weight weekly and at assessments.
The intervention includes Facebook-delivered weight loss counseling and the use of Slip Buddy, an app created by the investigative team that only requires users to record instances of overeating by hitting a single button and then indicate the overeating trigger and stress and hunger levels. The intervention will last for 12 weeks. In addition to the weight loss counseling, participants will be asked to use the Slip Buddy app during the intervention period (12 weeks). Participants will receive a Fitbit scale to take their weight weekly and at assessments.
Overall Number of Participants Analyzed 30 31
Mean (Standard Deviation)
Unit of Measure: score on a scale
76.3  (17.6) 64.8  (16.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Comprehensive Dietary Self-Monitoring, Simple Dietary Self-Monitoring
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0106
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Primary Outcome
Title Acceptability
Hide Description Acceptability was assessed with a single item at 12 weeks assessing perceived helpfulness of the assigned app: "Tracking my diet and exercise with MFP/slips with Slip Buddy was helpful" (responses on a 5-point Likert scale from strongly disagree to strongly agree). Acceptability was indicated by responses of agree or strongly agree.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Comprehensive Dietary Self-Monitoring Simple Dietary Self-Monitoring
Hide Arm/Group Description:
The intervention includes Facebook-delivered weight loss counseling and the use of MyFitnessPal, a comprehensive diet and exercise self-monitoring app. The intervention will last for 12 weeks. In addition to weight loss counseling in a private Facebook group, participants will be encouraged to use the self-monitoring app to enter everything they eat and do for exercise during the intervention period (12 weeks). Participants will receive a daily calorie goal directly from the app. Participants will receive a Fitbit scale to take their weight weekly and at assessments.
The intervention includes Facebook-delivered weight loss counseling and the use of Slip Buddy, an app created by the investigative team that only requires users to record instances of overeating by hitting a single button and then indicate the overeating trigger and stress and hunger levels. The intervention will last for 12 weeks. In addition to the weight loss counseling, participants will be asked to use the Slip Buddy app during the intervention period (12 weeks). Participants will receive a Fitbit scale to take their weight weekly and at assessments.
Overall Number of Participants Analyzed 30 31
Measure Type: Number
Unit of Measure: percentage of participants
77 39
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Comprehensive Dietary Self-Monitoring, Simple Dietary Self-Monitoring
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0027
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
4.Primary Outcome
Title Burden
Hide Description At 12 weeks, participants were asked how burdensome the task of using their assigned application was on a scale of 0-100, 0 being not at all burdensome and 100 being very burdensome.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Comprehensive Dietary Self-Monitoring Simple Dietary Self-Monitoring
Hide Arm/Group Description:
The intervention includes Facebook-delivered weight loss counseling and the use of MyFitnessPal, a comprehensive diet and exercise self-monitoring app. The intervention will last for 12 weeks. In addition to weight loss counseling in a private Facebook group, participants will be encouraged to use the self-monitoring app to enter everything they eat and do for exercise during the intervention period (12 weeks). Participants will receive a daily calorie goal directly from the app. Participants will receive a Fitbit scale to take their weight weekly and at assessments.
The intervention includes Facebook-delivered weight loss counseling and the use of Slip Buddy, an app created by the investigative team that only requires users to record instances of overeating by hitting a single button and then indicate the overeating trigger and stress and hunger levels. The intervention will last for 12 weeks. In addition to the weight loss counseling, participants will be asked to use the Slip Buddy app during the intervention period (12 weeks). Participants will receive a Fitbit scale to take their weight weekly and at assessments.
Overall Number of Participants Analyzed 30 31
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
45.0
(10.0 to 60.0)
30.0
(15.0 to 50.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Comprehensive Dietary Self-Monitoring, Simple Dietary Self-Monitoring
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7829
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
5.Secondary Outcome
Title Percent Weight Change From Baseline to 12-Week Follow-Up
Hide Description A digital scale (Fitbit Aria) will be used to record weight. Percent weight change was calculated using weight at baseline and weight at 12-week follow-up. Missing values were calculated using last carry forward (LOCF).
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Comprehensive Dietary Self-Monitoring Simple Dietary Self-Monitoring
Hide Arm/Group Description:
The intervention includes Facebook-delivered weight loss counseling and the use of MyFitnessPal, a comprehensive diet and exercise self-monitoring app. The intervention will last for 12 weeks. In addition to weight loss counseling in a private Facebook group, participants will be encouraged to use the self-monitoring app to enter everything they eat and do for exercise during the intervention period (12 weeks). Participants will receive a daily calorie goal directly from the app. Participants will receive a Fitbit scale to take their weight weekly and at assessments.
The intervention includes Facebook-delivered weight loss counseling and the use of Slip Buddy, an app created by the investigative team that only requires users to record instances of overeating by hitting a single button and then indicate the overeating trigger and stress and hunger levels. The intervention will last for 12 weeks. In addition to the weight loss counseling, participants will be asked to use the Slip Buddy app during the intervention period (12 weeks). Participants will receive a Fitbit scale to take their weight weekly and at assessments.
Overall Number of Participants Analyzed 32 32
Mean (Standard Deviation)
Unit of Measure: percent weight
-3.6  (4.9) -3.0  (4.5)
6.Secondary Outcome
Title Change in Perceived Stress From Baseline to 12-Week Follow-Up
Hide Description The Perceived Stress Scale is a 14-item measure of perceived stress. Scores range from 0-56, higher scores indicate higher perceived stress.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Comprehensive Dietary Self-Monitoring Simple Dietary Self-Monitoring
Hide Arm/Group Description:
The intervention includes Facebook-delivered weight loss counseling and the use of MyFitnessPal, a comprehensive diet and exercise self-monitoring app. The intervention will last for 12 weeks. In addition to weight loss counseling in a private Facebook group, participants will be encouraged to use the self-monitoring app to enter everything they eat and do for exercise during the intervention period (12 weeks). Participants will receive a daily calorie goal directly from the app. Participants will receive a Fitbit scale to take their weight weekly and at assessments.
The intervention includes Facebook-delivered weight loss counseling and the use of Slip Buddy, an app created by the investigative team that only requires users to record instances of overeating by hitting a single button and then indicate the overeating trigger and stress and hunger levels. The intervention will last for 12 weeks. In addition to the weight loss counseling, participants will be asked to use the Slip Buddy app during the intervention period (12 weeks). Participants will receive a Fitbit scale to take their weight weekly and at assessments.
Overall Number of Participants Analyzed 30 31
Mean (Standard Deviation)
Unit of Measure: score on a scale
2.8  (9.1) 2.5  (6.8)
7.Secondary Outcome
Title Change in Emotional Eating From Baseline to 12-Week Follow-Up
Hide Description Three-Factory Eating Inventory is an 18-item measure and the emotional eating subscale consists of 3 items on a 4-point Likert scale. The score is derived by a multi-step equation. The range of scores for this subscale is 0-100, higher scores indicate higher emotional eating.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Comprehensive Dietary Self-Monitoring Simple Dietary Self-Monitoring
Hide Arm/Group Description:
The intervention includes Facebook-delivered weight loss counseling and the use of MyFitnessPal, a comprehensive diet and exercise self-monitoring app. The intervention will last for 12 weeks. In addition to weight loss counseling in a private Facebook group, participants will be encouraged to use the self-monitoring app to enter everything they eat and do for exercise during the intervention period (12 weeks). Participants will receive a daily calorie goal directly from the app. Participants will receive a Fitbit scale to take their weight weekly and at assessments.
The intervention includes Facebook-delivered weight loss counseling and the use of Slip Buddy, an app created by the investigative team that only requires users to record instances of overeating by hitting a single button and then indicate the overeating trigger and stress and hunger levels. The intervention will last for 12 weeks. In addition to the weight loss counseling, participants will be asked to use the Slip Buddy app during the intervention period (12 weeks). Participants will receive a Fitbit scale to take their weight weekly and at assessments.
Overall Number of Participants Analyzed 30 31
Mean (Standard Deviation)
Unit of Measure: change in score from baseline 12 weeks
-1.1  (25.5) -9.9  (25.1)
Time Frame Adverse events were collected over the period of 12 weeks.
Adverse Event Reporting Description Adverse events were assessed during follow-up as well as documented when participants reported them during the intervention. Pregnancy was only assessed with female participants.
 
Arm/Group Title Comprehensive Dietary Self-Monitoring Simple Dietary Self-Monitoring
Hide Arm/Group Description The intervention includes Facebook-delivered weight loss counseling and the use of MyFitnessPal, a comprehensive diet and exercise self-monitoring app. The intervention will last for 12 weeks. In addition to weight loss counseling in a private Facebook group, participants will be encouraged to use the self-monitoring app to enter everything they eat and do for exercise during the intervention period (12 weeks). Participants will receive a daily calorie goal directly from the app. Participants will receive a Fitbit scale to take their weight weekly and at assessments. The intervention includes Facebook-delivered weight loss counseling and the use of Slip Buddy, an app created by the investigative team that only requires users to record instances of overeating by hitting a single button and then indicate the overeating trigger and stress and hunger levels. The intervention will last for 12 weeks. In addition to the weight loss counseling, participants will be asked to use the Slip Buddy app during the intervention period (12 weeks). Participants will receive a Fitbit scale to take their weight weekly and at assessments.
All-Cause Mortality
Comprehensive Dietary Self-Monitoring Simple Dietary Self-Monitoring
Affected / at Risk (%) Affected / at Risk (%)
Total   0/32 (0.00%)      0/32 (0.00%)    
Hide Serious Adverse Events
Comprehensive Dietary Self-Monitoring Simple Dietary Self-Monitoring
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/32 (0.00%)      0/32 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Comprehensive Dietary Self-Monitoring Simple Dietary Self-Monitoring
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/32 (15.63%)      5/32 (15.63%)    
General disorders     
Weight Gain   1/32 (3.13%)  1 1/32 (3.13%)  1
Immune system disorders     
Flu *  1/32 (3.13%)  1 0/32 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Injury unrelated to exercise *  2/32 (6.25%)  2 2/32 (6.25%)  2
Pulled Muscle During Exercise   0/32 (0.00%)  0 1/32 (3.13%)  1
Pregnancy, puerperium and perinatal conditions     
Pregnancy  [1]  1/24 (4.17%)  1 1/24 (4.17%)  1
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
[1]
Assessed in females only
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: Dr. Sherry Pagoto
Organization: University of Connecticut
Phone: 8604868979
EMail: Sherry.Pagoto@uconn.edu
Layout table for additonal information
Responsible Party: Sherry Pagoto, University of Connecticut
ClinicalTrials.gov Identifier: NCT02615171    
Other Study ID Numbers: H17-217
1R01HL122302-01A1 ( U.S. NIH Grant/Contract )
First Submitted: November 19, 2015
First Posted: November 26, 2015
Results First Submitted: October 30, 2020
Results First Posted: March 11, 2021
Last Update Posted: April 13, 2021