Weight Loss Clinical Trial
Official title:
Developing an Effective Online Social Network for Weight Loss
| Verified date | March 2024 |
| Source | University of Connecticut |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
In a pilot randomized trial of 160 obese participants, investigators will test the feasibility of a behavioral weight loss program delivered entirely via Facebook. We will recruit in 2 separate waves of 80 participants each. Participants will be randomized to: 1) a condition with study participants only or 2) to a condition they will be able to invite their friends into (wave 1) or one in which the study team keeps recruitment open to allow enrollment through week 8 (wave 2). All participants will receive behavioral counseling via the private Facebook group from the coaches who are present on the network daily. Participants will track their diet and exercise via a free commercial mobile app.
| Status | Completed |
| Enrollment | 134 |
| Est. completion date | March 31, 2020 |
| Est. primary completion date | February 20, 2020 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility | Inclusion Criteria: Participants must be: 1. 18-65 years of age; 2. Have a BMI 27-45 kg/m²; 3. Lives in the United States; and 4. Have daily internet access; Exclusion Criteria: 1. Does not post on Facebook at least once per week 2. Comments on someone else's post on Facebook less than once per week 3. Does not currently use a smartphone; 4. Is not familiar with using phone apps; 5. Pregnant and/or lactating; 6. Meets criteria for severe depression on the Patient Health Questionnaire (PHQ-9) (score of >20); 7. Had bariatric surgery, plans to during the study; 8. Has had a weight loss of 5% or greater within previous 3 months; 9. Meets criteria for Binge Eating Disorder; 10. Condition that precludes lifestyle changes (i.e. a condition that prevents physical activity increase or dietary changes); 11. Medications affecting weight; 12. Incapable of walking ¼ mile without stopping; 13. Type 1 or 2 diabetes; 14. Participated in previous weight loss studies under the PI; 15. Has concerns about being in a Facebook group with other faculty, staff, or students from the University of Connecticut; 16. Has concerns about being audiotaped; 17. Inability to provide consent; 18. Prisoners; and 19. Non-English speaking |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Connecticut | Storrs | Connecticut |
| Lead Sponsor | Collaborator |
|---|---|
| University of Connecticut | National Heart, Lung, and Blood Institute (NHLBI) |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Engagement | Number of Facebook "likes" and other reactions, replies, posts, and polls per participant during the 16 week program. | 4 months | |
| Primary | Retention | The number of participants who complete the follow-up assessment in each condition. | 4 months | |
| Primary | Number of Participants Rating the Intervention 'Acceptable | 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 | Percent Weight Loss | We calculated percent weight loss from baseline to 4 months. | Baseline to 4 months | |
| Secondary | Diet | 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 |
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