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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02656680
Other study ID # H17-215
Secondary ID 1K24HL124366-01A
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2018
Est. completion date March 31, 2020

Study information

Verified date March 2024
Source University of Connecticut
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Continuous Enrollment
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.
Closed Enrollment
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.

Locations

Country Name City State
United States University of Connecticut Storrs Connecticut

Sponsors (2)

Lead Sponsor Collaborator
University of Connecticut National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

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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