Proof-of-Concept Study of an Integrated Mobile and Social Network Weight Loss Intervention

NCT ID: NCT05295849

Last Updated: 2024-11-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-18
• Study Completion Date: 2022-08-31

Brief Summary

The purpose of this 6 week single-arm pilot is to evaluate the feasibility of the Habit app plus Facebook group intervention in 20 adults with obesity. Participants will participate in a 6-week version of the intervention which involves receiving a feed based on the Diabetes Prevention Program in a private Facebook group, access to a professional weight loss counselor in the Facebook group, MyFitnessPal, and the Habit app.

Detailed Description

The purpose of this single-arm pilot is to evaluate the feasibility of the intervention in 20 adults with obesity. We define feasibility as use of the mobile app features (dietary self-monitoring, slip tracker, and problem sharing/solving), retention, engagement (overall, problem solving), acceptability, and burden. This study will give us information that we can use to modify the intervention and our procedures before the larger pilot study. We will enroll 20 adults with obesity to participate in the 6-week pilot. Eligible participants will receive a link to complete surveys, mailed a wifi scale, and asked to provide staff with login information for the scale so weight can be recorded during assessments. They will then have a 60-minute call with a counselor to 1) download and receive training on program technology (MyFitnessPal, Habit app, and Fitbit scale) and 2) be entered into the Facebook group. Participants will participate in a 6-week version of the intervention which involves receiving a feed based on the Diabetes Prevention Program in a private Facebook group, access to a professional weight loss counselor in the Facebook group, MyFitnessPal, and the Habit app. Every Monday in the group, participants will be given one diet and one exercise goal for the week and every Sunday they will be asked to share their progress on those goals. Every Friday they will participate in a "weigh in" thread in the group. In addition to the group, for the first two weeks, participants will be asked to use MyFitnessPal; for the second two weeks, they will be asked to use the Temptation/Slip Tracker and Exercise Planner; and for the final two weeks they will be asked to use the Problem Solver. We will ask each participant to share at least one diet or exercise problem with the group over the 6 weeks and to participate in each other's problem solving posts. Participants may attend optional weekly breakout sessions where weight loss related problems will be discussed. On the final day of the intervention, a post will go up in the group asking for a volunteer who used the app enough to brainstorm how to improve it to participate in a team meeting to discuss how to improve the program. If more than one participant volunteers, one will be randomly selected to participate. After the 6-week intervention, participants will complete the weight loss problem solving skills survey, provide a final weight, and complete individual phone interviews to discuss their experience. We will convene a team meeting with the investigators, interventionists, and a participant to discuss the results and any modifications that should be made to the program before progressing to the pilot study.

Conditions

Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Habit App

Habit Mobile App

Group Type: EXPERIMENTAL

Building Habits Together Online Weight Loss 6-Week Usability Trial

Intervention Type: BEHAVIORAL

The intervention includes: the Facebook-delivered Diabetes Prevention Program (DPP) Lifestyle Intervention, MyFitnessPal and the Habit app. The DPP will be delivered within a counselor-led private Facebook group. It uses behavioral strategies to help participants 1) achieve a program assigned calorie goal based on amount needed to lose 1-2 pounds per week, 2) develop a healthy diet, and 3) engage in 150-300 minutes per week of moderate intensity exercise. Participants will be instructed to use MyFitnessPal for the first two weeks, the Habit app slip tracker and exercise planner for two weeks, and the Habit app problem solver for two weeks.

Interventions

Building Habits Together Online Weight Loss 6-Week Usability Trial

The intervention includes: the Facebook-delivered Diabetes Prevention Program (DPP) Lifestyle Intervention, MyFitnessPal and the Habit app. The DPP will be delivered within a counselor-led private Facebook group. It uses behavioral strategies to help participants 1) achieve a program assigned calorie goal based on amount needed to lose 1-2 pounds per week, 2) develop a healthy diet, and 3) engage in 150-300 minutes per week of moderate intensity exercise. Participants will be instructed to use MyFitnessPal for the first two weeks, the Habit app slip tracker and exercise planner for two weeks, and the Habit app problem solver for two weeks.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. 18-65 years old

2. BMI 30-45 kg/m2

3. has wifi connectivity at home (for wifi scale)

4. logs into Facebook at least 5 days per week over the past 2 weeks, and has posted/replied at least once a week in the past 2 weeks

5. able to participate in the study in English.

Exclusion Criteria

1. Pregnant/lactating or plans to become pregnant during study period

2. bipolar disorder, substance abuse, psychosis, bulimia, binge eating disorder, or severe depression

3. had bariatric surgery or plans to have surgery during the study

4. currently taking medication affecting weight

5. has lost ≥10% of weight in past year

6. is participating or intends to participate in another weight loss program during the study that provides coaching or problem solving

7. chronic pain that interferes with the ability to exercise

8. Type 1 or 2 Diabetes

9. unable to make dietary changes or increase physical activity

10. unable to walk ¼ mile unaided without stopping

11. currently smokes or vapes nicotine

12. does not live in the United States

13. had major surgery in past 6 months

14. hospitalized for psychiatric reasons in past 12 months

15. has concerns about being audiotaped during the focus groups

16. does not have or not willing to create Fitbit account for study

17. unable to access smartphone at home and at work

18. does not have FB

19. has done a study with this PI before

20. has concerns about being in FB group with faculty/students of same university in which they work/attend

21. does not have smartphone

22. smartphone type/version not meeting app requirements

23. prisoner

24. unable to provide consent

25. does not complete onboarding steps for the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Worcester Polytechnic Institute

OTHER

Sponsor Role: collaborator

University of Connecticut

OTHER

Sponsor Role: lead

Responsible Party

Sherry Pagoto

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sherry Pagoto, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Connecticut

Locations

University of Connecticut

Storrs, Connecticut, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1R34HL145439-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H20-0060

Identifier Type: -

Identifier Source: org_study_id