- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02656680
Facebook and Friends: Developing an Effective Online Social Network for Weight Loss
Developing an Effective Online Social Network for Weight Loss
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The overarching goal of the research plan is to test ways to leverage mobile technologies and social media to increase the impact, scalability, cost-effectiveness, and dissemination potential of lifestyle interventions that reduce cardiovascular disease (CVD) risk. Mobile technology and social media have the potential to reduce the intensity of traditional prevention interventions and enhance outcome by delivering behavioral strategies in-the-moment and by connecting patients other patients to generate better communication and a social support system for lifestyle changes.
This study includes a behavioral weight loss program delivered entirely via on online social network. 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 be connected to one another via Facebook and receive behavioral counseling via posts from coaches who are present on the network daily. Participants will track their diet and exercise via a free commercial mobile app. Participants will be assigned to either a Facebook group allowing the invite of friends (wave 1), a Facebook group with open enrollment through week 8 (wave 2) or a Facebook group including only study participants. If they are assigned to the group including their friends, they have the opportunity to invite their friends to participate in the weight loss group if they are interested in losing weight as well. They will not have a limit as to how many friends they can invite. The friends that are invited will not undergo the same procedures as the Facebook (FB)+friends study participants, but we will provide them with a factsheet and collect minimal information from them. If they are assigned to the group with open enrollment through week 8, additional people will be recruited into that group. Those participants being enrolled between week 1-8 will undergo the same procedures as others besides randomization. The goal of both of these studies is to explore how to build the size of online weight loss groups in such a way that increases participant engagement. Feasibility outcomes include engagement (frequency of posts, likes, and comments and number of completed days of tracking posted) retention, acceptability, and weight loss. Post intervention focus groups will gather feedback on the program.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Connecticut
-
Storrs, Connecticut, United States, 06269
- University of Connecticut
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Participants must be:
- 18-65 years of age;
- Have a BMI 27-45 kg/m²;
- Lives in the United States; and
- Have daily internet access;
Exclusion Criteria:
- Does not post on Facebook at least once per week
- Comments on someone else's post on Facebook less than once per week
- Does not currently use a smartphone;
- Is not familiar with using phone apps;
- Pregnant and/or lactating;
- Meets criteria for severe depression on the Patient Health Questionnaire (PHQ-9) (score of >20);
- Had bariatric surgery, plans to during the study;
- Has had a weight loss of 5% or greater within previous 3 months;
- Meets criteria for Binge Eating Disorder;
- Condition that precludes lifestyle changes (i.e. a condition that prevents physical activity increase or dietary changes);
- Medications affecting weight;
- Incapable of walking ¼ mile without stopping;
- Type 1 or 2 diabetes;
- Participated in previous weight loss studies under the PI;
- Has concerns about being in a Facebook group with other faculty, staff, or students from the University of Connecticut;
- Has concerns about being audiotaped;
- Inability to provide consent;
- Prisoners; and
- Non-English speaking
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Continuous Enrollment (Randomized)
The Continuous Enrollment is a Facebook-delivered weight loss intervention.
Participants in this arm were randomized to this Facebook group and started the intervention together.
For this group, the study team continued to enroll participants 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.
Other Names:
|
Active Comparator: Closed Enrollment (Randomized)
Closed Enrollment is a Facebook-delivered weight loss intervention.
Participants in this arm were randomized to this Facebook group and started the intervention together.
No additional participants were added to this group during the study.
|
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.
Other Names:
|
Other: Continuous Enrollment (Non-Randomized)
The Continuous Enrollment is a Facebook-delivered weight loss intervention.
For this group, the study team continued to enroll participants through week 8.
This arm captures only those participants that were added to the group during these 8 weeks.
They were enrolled in the study after the original 80 participants were randomized.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Engagement
Time Frame: 4 months
|
Number of Facebook "likes" and other reactions, replies, posts, and polls per participant during the 16 week program.
|
4 months
|
Retention
Time Frame: 4 months
|
The number of participants who complete the follow-up assessment in each condition.
|
4 months
|
Number of Participants Rating the Intervention 'Acceptable
Time Frame: 4 months
|
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.
|
4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent Weight Loss
Time Frame: Baseline to 4 months
|
We calculated percent weight loss from baseline to 4 months.
|
Baseline to 4 months
|
Diet
Time Frame: 4 Months
|
The percentage of intervention days that a participant tracked diet and/or exercise in MyFitnessPal app.
Any entry was counted as a day of tracking.
|
4 Months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Sherry Pagoto, PhD, University of Connecticut
Publications and helpful links
General Publications
- Xu R, Divito J, Bannor R, Schroeder M, Pagoto S. Predicting Participant Engagement in a Social Media-Delivered Lifestyle Intervention Using Microlevel Conversational Data: Secondary Analysis of Data From a Pilot Randomized Controlled Trial. JMIR Form Res. 2022 Jul 28;6(7):e38068. doi: 10.2196/38068.
- Pagoto SL, Schroeder MW, Xu R, Waring ME, Groshon L, Goetz JM, Idiong C, Troy H, DiVito J, Bannor R. A Facebook-Delivered Weight Loss Intervention Using Open Enrollment: Randomized Pilot Feasibility Trial. JMIR Form Res. 2022 May 6;6(5):e33663. doi: 10.2196/33663.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H17-215
- 1K24HL124366-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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