Mentoring in mHealth and Social Networking Interventions for CVD Risk Reduction

• ClinicalTrials.gov Identifier: NCT02656680
• Recruitment Status: Recruiting
• First Posted: January 15, 2016
• Last Update Posted: November 4, 2019
• Sponsor: University of Connecticut
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Information provided by (Responsible Party): Sherry Pagoto, University of Connecticut

Study Description

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.

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Engagement [ Time Frame: 4 months ]
   Number of "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

Eligibility Criteria

• 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.

Contacts and Locations

Contacts

Contact: Jessica Oleski, MA; 860-486-8979; mhealthstudy@uconn.edu

Contact: Jared Goetz; 860-486-8772; mhealthstudy@uconn.edu

Locations

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)

More Information

• Responsible Party: Sherry Pagoto, Professor, University of Connecticut
• ClinicalTrials.gov Identifier: NCT02656680
• Other Study ID Numbers: H17-215; 1K24HL124366-01A1 ( U.S. NIH Grant/Contract )
• First Posted: January 15, 2016
• Last Update Posted: November 4, 2019
• Last Verified: October 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

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

Additional relevant MeSH terms:

Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms