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Mentoring in mHealth and Social Networking Interventions for CVD Risk Reduction

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ClinicalTrials.gov Identifier: NCT02656680
Recruitment Status : Recruiting
First Posted : January 15, 2016
Last Update Posted : May 29, 2019
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Sherry Pagoto, University of Connecticut

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.

Condition or disease Intervention/treatment Phase
Weight Loss Behavioral: FB + Friends Behavioral: FB Only Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mentoring in mHealth and Social Networking Interventions for CVD Risk Reduction
Actual Study Start Date : February 1, 2018
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: FB+Friends
FB+Friends is a Facebook-delivered weight loss intervention. In wave 1, participants will be able to invite their friends who are also interested in losing weight. In wave 2, the study team will keep recruitment open for this condition to allow enrollment through week 8.
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. In wave 1, participants will be able to invite their friends who are also interested in losing weight. In wave 2, the study team will keep recruitment open for this condition to allow enrollment through week 8.

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




Primary Outcome Measures :
  1. Engagement [ Time Frame: 4 months ]
    Data on "likes" and other reactions, replies, and posts

  2. Retention [ Time Frame: 4 months ]
    The proportion of participants who complete the follow-up assessment in each condition

  3. Acceptability [ Time Frame: 4 months ]
    Participants will rate acceptability of the online intervention on visual analogue scales


Secondary Outcome Measures :
  1. Percent weight loss [ Time Frame: 4 months ]
    percent weight loss from baseline to 4 months

  2. Diet [ Time Frame: Change from baseline to 4 months ]
    Measure that assesses dietary behavior

  3. Friends invited [ Time Frame: 4 months ]
    The number of friends each participant invited to the Facebook group



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02656680


Contacts
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Contact: Jessica Oleski, MA 860-486-8979 mhealthstudy@uconn.edu
Contact: Jared Goetz 860-486-8772 mhealthstudy@uconn.edu

Locations
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United States, Connecticut
University of Connecticut Recruiting
Storrs, Connecticut, United States, 06269
Contact: Sherry Pagoto, PhD    860-486-2313    sherry.pagoto@uconn.edu   
Principal Investigator: Sherry Pagoto, PhD         
Sponsors and Collaborators
University of Connecticut
National Heart, Lung, and Blood Institute (NHLBI)

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Responsible Party: Sherry Pagoto, Professor, University of Connecticut
ClinicalTrials.gov Identifier: NCT02656680     History of Changes
Other Study ID Numbers: H17-215
1K24HL124366-01A1 ( U.S. NIH Grant/Contract )
First Posted: January 15, 2016    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms