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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 : March 16, 2021
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Sherry Pagoto, University of Connecticut

Tracking Information
First Submitted Date  ICMJE January 7, 2016
First Posted Date  ICMJE January 15, 2016
Results First Submitted Date  ICMJE February 22, 2021
Results First Posted Date  ICMJE March 16, 2021
Last Update Posted Date March 16, 2021
Actual Study Start Date  ICMJE February 1, 2018
Actual Primary Completion Date February 20, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 22, 2021)
  • Engagement [ Time Frame: 4 months ]
    Number of Facebook "likes" and other reactions, replies, posts, and polls per participant during the 16 week program.
  • Retention [ Time Frame: 4 months ]
    The proportion of participants who complete the follow-up assessment in each condition.
  • Acceptability [ 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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 13, 2016)
  • Weight Loss [ Time Frame: Baseline ]
    Weight measured using at digital scale
  • Weight Loss [ Time Frame: 3 months ]
    Weight measured using at digital scale
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 22, 2021)
  • Percent Weight Loss [ Time Frame: 4 months ]
    We calculated percent weight loss from baseline to 4 months.
  • Diet [ Time Frame: 4 Months ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 13, 2016)
  • Retention [ Time Frame: 3 months ]
    The proportion of participants who complete the follow-up assessment in each condition
  • Pew Internet & American Life Project Poll [ Time Frame: Baseline ]
    This will evaluate use of online social networks and experience using social media
  • Pew Internet & American Life Project Poll [ Time Frame: 3 months ]
    This will evaluate use of online social networks and experience using social media
  • Group engagement measured by calculation of likes, posts, and comments [ Time Frame: 3 months ]
    Participant's activity in the online group
  • Intervention Engagement [ Time Frame: 3 months ]
    Intervention materials will be evaluated at 3-months by asking participants to put a check next to the titles of any blog posts or videos they viewed and to give each post/video ratings for informative and enjoyable
  • Acceptability [ Time Frame: 3 months ]
    Participants will rate acceptability of the online intervention on visual analogue scales
  • Social network size [ Time Frame: Baseline ]
    The number of users each participant follows will be recorded
  • Social network size [ Time Frame: 3 months ]
    The number of users each participants follows will be recorded
  • Weight Management Support Inventory [ Time Frame: Baseline ]
    Measures social support for weight loss from friends and family
  • Weight Management Support Inventory [ Time Frame: 3 months ]
    Measures social support for weight loss from friends and family
  • Ball and Crawford Survey [ Time Frame: Baseline ]
    Measures social support for weight-related behaviors
  • Ball and Crawford Survey [ Time Frame: 3 months ]
    Measures social support for weight-related behaviors
  • Social Norms for Weight Loss Scale [ Time Frame: Baseline ]
    Items assess how often social contacts encouraged them to lose weight, how much they offered advice or help, and how much contacts would approve/disapprove if the participant lost weight.
  • Social Norms for Weight Loss Scale [ Time Frame: 3 months ]
    Items assess how often social contacts encouraged them to lose weight, how much they offered advice or help, and how much contacts would approve/disapprove if the participant lost weight.
  • Social Control Scale [ Time Frame: Baseline ]
    This scale measures social control for health enhancing behaviors and health-compromising behaviors, number of social network members attempting social control for these behaviors, intensity of social control, and positive and negative social control strategies
  • Social Control Scale [ Time Frame: 3 months ]
    This scale measures social control for health enhancing behaviors and health-compromising behaviors, number of social network members attempting social control for these behaviors, intensity of social control, and positive and negative social control strategies
  • Sense of Belonging Scale [ Time Frame: Baseline ]
    Measures sense of belonging and desire/ability to develop a sense of belonging
  • Sense of Belonging Scale [ Time Frame: 3 months ]
    Measures sense of belonging and desire/ability to develop a sense of belonging
  • Liebowitz Social Anxiety Scale [ Time Frame: Baseline ]
    Measures social anxiety symptoms
  • Perceived Stress Scale [ Time Frame: Baseline ]
    Measures perceived stress
  • Beck Depression Inventory [ Time Frame: Baseline ]
    Measures depression symptoms
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Facebook and Friends: Developing an Effective Online Social Network for Weight Loss
Official Title  ICMJE Developing an Effective Online Social Network for Weight Loss
Brief 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.
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 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Weight Loss
Intervention  ICMJE
  • Behavioral: 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.
    Other Name: Continuous Enrollment
  • Behavioral: 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.
    Other Name: Closed Enrollment
Study Arms  ICMJE
  • Experimental: FB+Friends
    FB+Friends is a Facebook-delivered weight loss intervention. For this group, the study team continued to enroll participants through week 8.
    Intervention: Behavioral: FB + Friends
  • Active Comparator: FB Only
    FB Only Facebook-delivered weight loss intervention including only study participants.
    Intervention: Behavioral: FB Only
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 2, 2020)
134
Original Estimated Enrollment  ICMJE
 (submitted: January 13, 2016)
80
Actual Study Completion Date  ICMJE March 31, 2020
Actual Primary Completion Date February 20, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Participants must be:

  1. 18-65 years of age;
  2. have a BMI 30-45 kg/m²;
  3. have written clearance from their primary care provider to participate; and
  4. have daily internet access;

Exclusion Criteria:

  1. Age under 18 or over 65;
  2. BMI under 25 or over 45;
  3. No medical clearance from primary care provider;
  4. Inactive on Facebook;
  5. Does not currently use a smartphone;
  6. Is not familiar with using phone apps;
  7. Plans to move during study;
  8. Pregnant/lactating;
  9. Had bariatric surgery, plans to during the study, or had recent weight loss;
  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. Is a UMass/UConn employee and is uncomfortable participating in a Facebook group with other UMass/UConn employees
  16. Unable to attend the orientation visit;
  17. Inability to provide consent;
  18. Prisoners; and
  19. Has concerns about being audiotaped

Friends of the subjects participating in the FB+friends and FB w/o friends conditions:

  1. Must be: at least 18 years old;
  2. BMI of 25 or over; and
  3. Have an interest in losing weight.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02656680
Other Study ID Numbers  ICMJE H17-215
1K24HL124366-01A1 ( U.S. NIH Grant/Contract )" onClick="openNewWindow('https://projectreporter.nih.gov/reporterapi.cfm?PROJECTNUM=1K24HL124366-01A1&Fy=all'); return false">1K24HL124366-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Sherry Pagoto, University of Connecticut
Study Sponsor  ICMJE University of Connecticut
Collaborators  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE Not Provided
PRS Account University of Connecticut
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP