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Trial record 1 of 1 for:    1K24HL124366-01A1
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Facebook and Friends: Developing an Effective Online Social Network for Weight Loss

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ClinicalTrials.gov Identifier: NCT02656680
Recruitment Status : Completed
First Posted : January 15, 2016
Results First Posted : March 16, 2021
Last Update Posted : April 15, 2021
Sponsor:
Collaborator:
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
Condition Weight Loss
Interventions Behavioral: FB + Friends
Behavioral: FB Only
Enrollment 134
Recruitment Details  
Pre-assignment Details At the start of the 16-week trial, we randomized participants (n=80) to two groups: 'FB+Friends' (n=40) or 'FB Only' (n=40). For the first 8 weeks of the trial, we continued to add new participants (n=54) into the 'FB+Friends' group. Our total enrollment (n=134) includes these 54 post-randomized participants. We did not include the post-randomized sample in the analysis for this record.
Arm/Group Title FB+Friends FB Only
Hide Arm/Group Description

FB+Friends is a Facebook-delivered weight loss intervention. The study team will keep recruitment open for this condition to allow enrollment through week 8.

Participants will receive a weight loss intervention delivered in an online context. The online coaches will post daily content, respond to questions, address concerns, and encourage engagement. The weight loss intervention is based on the Diabetes Prevention Program (DPP), an evidence-based weight loss program focused on lifestyle changes. The goals for the intervention are 175 minutes of moderate physical activity per week and an overall weight loss of 7%. Each participant will get an individualized calorie goal that would facilitate a 1-2 lbs. weight loss weekly. Participants will also be encouraged to use an app such as MyFitnessPal to track daily diet. For this arm, the study team will keep recruitment open for this condition to allow enrollment of new participants through week 8.

FB Only Facebook-delivered weight loss intervention including only study participants.

FB Only: Participants will receive a weight loss intervention delivered in an online context. The online coaches will post daily content, respond to questions, address concerns, and encourage engagement. The weight loss intervention is based on the Diabetes Prevention Program (DPP), an evidence-based weight loss program focused on lifestyle changes. The goals for the intervention are 175 minutes of moderate physical activity per week and an overall weight loss of 7%. Each participant will get an individualized calorie goal that would facilitate a 1-2 lbs. weight loss weekly. Participants will also be encouraged to use an app such as MyFitnessPal to track daily diet.

Period Title: Overall Study
Started 40 40
Completed 40 39
Not Completed 0 1
Reason Not Completed
Lost to Follow-up             0             1
Arm/Group Title FB+Friends FB Only Total
Hide Arm/Group Description

FB+Friends is a Facebook-delivered weight loss intervention. For this group, the study team continued to enroll participants through week 8.

FB + Friends: Participants will receive a weight loss intervention delivered in an online context. The online coaches will post daily content, respond to questions, address concerns, and encourage engagement. The weight loss intervention is based on the Diabetes Prevention Program (DPP), an evidence-based weight loss program focused on lifestyle changes. The goals for the intervention are 175 minutes of moderate physical activity per week and an overall weight loss of 7%. Each participant will get an individualized calorie goal that would facilitate a 1-2 lbs. weight loss weekly. Participants will also be encouraged to use an app such as MyFitnessPal to track daily diet. For this arm, the study team will keep recruitment open for this condition to allow enrollment of new participants through week 8.

FB Only Facebook-delivered weight loss intervention including only study participants.

FB Only: Participants will receive a weight loss intervention delivered in an online context. The online coaches will post daily content, respond to questions, address concerns, and encourage engagement. The weight loss intervention is based on the Diabetes Prevention Program (DPP), an evidence-based weight loss program focused on lifestyle changes. The goals for the intervention are 175 minutes of moderate physical activity per week and an overall weight loss of 7%. Each participant will get an individualized calorie goal that would facilitate a 1-2 lbs. weight loss weekly. Participants will also be encouraged to use an app such as MyFitnessPal to track daily diet.

Total of all reporting groups
Overall Number of Baseline Participants 40 40 80
Hide Baseline Analysis Population Description
Wave 2 Randomized Sample
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants 40 participants 80 participants
40.0  (10.6) 40.4  (11.8) 40.2  (11.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 40 participants 80 participants
Female
34
  85.0%
34
  85.0%
68
  85.0%
Male
6
  15.0%
6
  15.0%
12
  15.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 40 participants 80 participants
Hispanic or Latino
1
   2.5%
3
   7.5%
4
   5.0%
Not Hispanic or Latino
39
  97.5%
36
  90.0%
75
  93.8%
Unknown or Not Reported
0
   0.0%
1
   2.5%
1
   1.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 40 participants 80 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
3
   7.5%
3
   7.5%
6
   7.5%
White
36
  90.0%
36
  90.0%
72
  90.0%
More than one race
1
   2.5%
0
   0.0%
1
   1.3%
Unknown or Not Reported
0
   0.0%
1
   2.5%
1
   1.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 40 participants 40 participants 80 participants
40 40 80
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 40 participants 40 participants 80 participants
34.0  (4.6) 34.8  (5.4) 34.4  (5.0)
1.Primary Outcome
Title Engagement
Hide Description Number of Facebook "likes" and other reactions, replies, posts, and polls per participant during the 16 week program.
Time Frame 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
Wave 2 All Randomized
Arm/Group Title FB+Friends FB Only
Hide Arm/Group Description:
FB+Friends is a Facebook-delivered weight loss intervention. The study team will keep recruitment open for this condition to allow enrollment through week 8.
FB Only Facebook-delivered weight loss intervention including only study participants.
Overall Number of Participants Analyzed 40 40
Median (Inter-Quartile Range)
Unit of Measure: Total Engagements
77.00
(29.25 to 271.50)
116.50
(28.50 to 174.00)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FB+Friends, FB Only
Comments Mann-Whitney U Test
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.72
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Primary Outcome
Title Retention
Hide Description The number of participants who complete the follow-up assessment in each condition.
Time Frame 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
Wave 2 Only
Arm/Group Title FB+Friends FB Only
Hide Arm/Group Description:
FB+Friends is a Facebook-delivered weight loss intervention. The study team will keep recruitment open for this condition to allow enrollment through week 8.
FB Only Facebook-delivered weight loss intervention including only study participants.
Overall Number of Participants Analyzed 40 40
Measure Type: Count of Participants
Unit of Measure: Participants
40
 100.0%
39
  97.5%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FB+Friends, FB Only
Comments Chi square test comparing proportion retained in each condition.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.31
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
3.Primary Outcome
Title Number of Participants Rating the Intervention 'Acceptable
Hide Description Participants will rate acceptability of the online intervention. Acceptability was assessed with a single item during the follow-up survey: "How likely are you to recommend the program to a friend?" (responses on a 5-point Likert scale from not at all likely to very likely). Acceptability was categorized into acceptable, defined as responses of a little bit likely, somewhat likely, likely, and very likely, and unacceptable was defined as response of not at all likely.
Time Frame 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
Wave 2 Participants Who Completed Acceptability Survey Question
Arm/Group Title FB+Friends FB Only
Hide Arm/Group Description:
FB+Friends is a Facebook-delivered weight loss intervention. The study team will keep recruitment open for this condition to allow enrollment through week 8.
FB Only Facebook-delivered weight loss intervention including only study participants.
Overall Number of Participants Analyzed 35 39
Measure Type: Count of Participants
Unit of Measure: Participants
31
  88.6%
36
  92.3%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FB+Friends, FB Only
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.69
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
4.Secondary Outcome
Title Percent Weight Loss
Hide Description We calculated percent weight loss from baseline to 4 months.
Time Frame Baseline to 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized Sample; FB Only condition excludes 1 participant for pregnancy
Arm/Group Title FB+Friends FB Only
Hide Arm/Group Description:
FB+Friends is a Facebook-delivered weight loss intervention. For this group, the study team continued to enroll participants through week 8.
FB Only Facebook-delivered weight loss intervention including only study participants.
Overall Number of Participants Analyzed 40 39
Mean (Standard Deviation)
Unit of Measure: percent change
-3.0844  (4.28) -1.8713  (4.41)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FB+Friends, FB Only
Comments We compared mean percent weight loss from baseline across groups with a one-way ANOVA. One participant became pregnant and thus removed from the analysis. This analysis is exploratory given that this pilot study was not powered to detect weight loss differences between groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.218
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
5.Secondary Outcome
Title Diet
Hide Description The number of intervention days that a participant tracked diet and/or exercise in MyFitnessPal app. Any entry was counted as a day of tracking.
Time Frame 4 Months
Hide Outcome Measure Data
Hide Analysis Population Description
randomized wave 2 sample
Arm/Group Title FB+Friends FB Only
Hide Arm/Group Description:
FB+Friends is a Facebook-delivered weight loss intervention. The study team will keep recruitment open for this condition to allow enrollment through week 8.
FB Only is a Facebook-delivered weight loss intervention including only study participants.
Overall Number of Participants Analyzed 40 40
Mean (Standard Deviation)
Unit of Measure: days
37.88  (29.49) 32.41  (31.01)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FB+Friends, FB Only
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.421
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Time Frame Adverse events were collected over the period of 16 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 FB+Friends FB Only
Hide Arm/Group Description

FB+Friends is a Facebook-delivered weight loss intervention. The study team will keep recruitment open for this condition to allow enrollment through week 8.

Participants will receive a weight loss intervention delivered in an online context. The online coaches will post daily content, respond to questions, address concerns, and encourage engagement. The weight loss intervention is based on the Diabetes Prevention Program (DPP), an evidence-based weight loss program focused on lifestyle changes. The goals for the intervention are 175 minutes of moderate physical activity per week and an overall weight loss of 7%. Each participant will get an individualized calorie goal that would facilitate a 1-2 lbs. weight loss weekly. Participants will also be encouraged to use an app such as MyFitnessPal to track daily diet. For this arm, the study team will keep recruitment open for this condition to allow enrollment of new participants through week 8.

FB Only Facebook-delivered weight loss intervention including only study participants.

FB Only: Participants will receive a weight loss intervention delivered in an online context. The online coaches will post daily content, respond to questions, address concerns, and encourage engagement. The weight loss intervention is based on the Diabetes Prevention Program (DPP), an evidence-based weight loss program focused on lifestyle changes. The goals for the intervention are 175 minutes of moderate physical activity per week and an overall weight loss of 7%. Each participant will get an individualized calorie goal that would facilitate a 1-2 lbs. weight loss weekly. Participants will also be encouraged to use an app such as MyFitnessPal to track daily diet.

All-Cause Mortality
FB+Friends FB Only
Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/40 (0.00%) 
Hide Serious Adverse Events
FB+Friends FB Only
Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/40 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
FB+Friends FB Only
Affected / at Risk (%) Affected / at Risk (%)
Total   13/40 (32.50%)   6/40 (15.00%) 
Congenital, familial and genetic disorders     
Losing Vision Due to Genetic Disorder *  0/40 (0.00%)  1/40 (2.50%) 
Gastrointestinal disorders     
Gastrointestinal Illness *  1/40 (2.50%)  0/40 (0.00%) 
General disorders     
Weight Gain  [1]  0/40 (0.00%)  2/40 (5.00%) 
Began Taking Medication Affecting Weight   2/40 (5.00%)  0/40 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthritis *  2/40 (5.00%)  0/40 (0.00%) 
Pregnancy, puerperium and perinatal conditions     
Pregnancy  [2]  0/34 (0.00%)  1/34 (2.94%) 
Psychiatric disorders     
Binge Eating Disorder   1/40 (2.50%)  0/40 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Respiratory Illness *  3/40 (7.50%)  0/40 (0.00%) 
Surgical and medical procedures     
Had Surgery or Procedure *  4/40 (10.00%)  2/40 (5.00%) 
*
Indicates events were collected by non-systematic assessment
Indicates events were collected by systematic assessment
[1]
Pts gained 5% or more of baseline weight during intervention
[2]
Only Assessed in Females
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: NCT02656680    
Other Study ID Numbers: H17-215
1K24HL124366-01A1 ( U.S. NIH Grant/Contract )
First Submitted: January 7, 2016
First Posted: January 15, 2016
Results First Submitted: February 22, 2021
Results First Posted: March 16, 2021
Last Update Posted: April 15, 2021