Mentoring in mHealth and Social Networking Interventions for CVD Risk Reduction
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02656680 |
Recruitment Status :
Completed
First Posted : January 15, 2016
Last Update Posted : April 3, 2020
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Condition or disease | Intervention/treatment | Phase |
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Weight Loss | Behavioral: FB + Friends Behavioral: FB Only | Not Applicable |
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 : | Interventional (Clinical Trial) |
Actual Enrollment : | 134 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 |
Actual Primary Completion Date : | February 10, 2020 |
Actual Study Completion Date : | March 31, 2020 |

Arm | Intervention/treatment |
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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.
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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.
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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. |
- Engagement [ Time Frame: 4 months ]Number of "likes" and other reactions, replies, and posts
- 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 on visual analogue scales
- Percent weight loss [ Time Frame: 4 months ]percent weight loss from baseline to 4 months
- Diet [ Time Frame: Change from baseline to 4 months ]Measure that assesses dietary behavior
- Friends invited [ Time Frame: 4 months ]The number of friends each participant invited to the Facebook group

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.
Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Participants must be:
- 18-65 years of age;
- have a BMI 30-45 kg/m²;
- have written clearance from their primary care provider to participate; and
- have daily internet access;
Exclusion Criteria:
- Age under 18 or over 65;
- BMI under 25 or over 45;
- No medical clearance from primary care provider;
- Inactive on Facebook;
- Does not currently use a smartphone;
- Is not familiar with using phone apps;
- Plans to move during study;
- Pregnant/lactating;
- Had bariatric surgery, plans to during the study, or had recent weight loss;
- Condition that precludes lifestyle changes (i.e. a condition that prevents physical activity increase or dietary changes);
- Medications affecting weight;
- Incapable of walking ¼ mile without stopping;
- Type 1 or 2 diabetes;
- Participated in previous weight loss studies under the PI;
- Is a UMass/UConn employee and is uncomfortable participating in a Facebook group with other UMass/UConn employees
- Unable to attend the orientation visit;
- Inability to provide consent;
- Prisoners; and
- Has concerns about being audiotaped
Friends of the subjects participating in the FB+friends and FB w/o friends conditions:
- Must be: at least 18 years old;
- BMI of 25 or over; and
- Have an interest in losing weight.

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
United States, Connecticut | |
University of Connecticut | |
Storrs, Connecticut, United States, 06269 |
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 Key Record Dates |
Last Update Posted: | April 3, 2020 |
Last Verified: | April 2020 |
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 |
Weight Loss Body Weight Changes Body Weight |