Clinical trial NCT05295849: Proof-of-Concept Study of an Integrated Mobile and Social Network Weight Loss Intervention
Official title: Building Habits Together: Feasibility Trial of an Integrated Mobile and Social Network Weight Loss Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: obesity
lifestyle intervention
mobile app
Lead sponsor: University of Connecticut
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: Worcester Polytechnic Institute
First posted: 2022-03-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: single-arm usability pilot
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Mean Number of Uses of the Temptation Tracker
timeFrame: 2 weeks
measure: Mean Number of Slips Reported
timeFrame: 2 weeks
measure: Mean Number of Temptations Resisted
timeFrame: 2 weeks
measure: Mean Number of Exercises Planned
timeFrame: 2 weeks
measure: Mean Number of Total Problems Solved
timeFrame: 2 weeks
measure: Mean Number of Diet Problems Solved
timeFrame: 2 weeks
measure: Mean Number of Exercise Problems Solved
timeFrame: 2 weeks
measure: Number of Participants Saying They Agree or Strongly Agree They Would Continue to Use the Habit App if Given the Chance
timeFrame: 6 weeks
measure: Number of Participants Saying They Agree or Strongly Agree That They Would Recommend the Habit App to a Friend
timeFrame: 6 weeks
measure: Number of Participants Rating the Temptation and Slip Tracker as Time-consuming
timeFrame: 6 weeks
measure: Number of Participants Rating the Problem Solver as Time-consuming
timeFrame: 6 weeks
measure: Number of Participants Rating the Exercise Planner as Time-consuming
timeFrame: 6 weeks
measure: Median Total Engagements in the Facebook Group
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Storrs
country: United States
facility: University of Connecticut
state: Connecticut
Study officials:
affiliation: University of Connecticut
name: Sherry Pagoto, PhD
role: PRINCIPAL_INVESTIGATOR
References: