Habit App Pre-Pilot

Obesity Clinical Trial

— BHT-OWL  

Official title:

Building Habits Together: Feasibility Trial of an Integrated Mobile and Social Network Weight Loss Intervention

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05295849
• Other study ID #: H20-0060
• Secondary ID: 1R34HL145439-01A
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 18, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: July 2022
• Source: University of Connecticut
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	University of Connecticut	Storrs	Connecticut

Sponsors (3)

Lead Sponsor	Collaborator
University of Connecticut	National Heart, Lung, and Blood Institute (NHLBI), Worcester Polytechnic Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean total days Habit app was used	A backend server for Habit will capture data on total uses of the app, including the use of each feature (diet slip tracker, exercise planner, and problem solver.	6 weeks
Primary	Number of participants saying they would be likely or very likely to continue to use the Habit app if given the chance	Participants will rate how likely they would be to continue to use the Habit app (very unlikely to very likely) on 5-point Likert scales.	6 weeks
Primary	Number of participants saying they would be likely or very likely to recommend the Habit to a friend	Participants will rate how likely they would be to recommend the Habit app to a friend (very unlikely to very likely) on 5-point Likert scales.	6 weeks
Primary	Number of participants rating the slip tracker as time-consuming	Participants will rate their agreement with statements about how time-consuming participation in the program and use of each component (slip tracker, problem solver, and Facebook group) is on 5-point Likert scales. This outcome counts number of participants that Strongly Agree or Agree.	6 weeks
Primary	Number of participants rating the problem solver as time-consuming	Participants will rate their agreement with statements about how time-consuming participation in the program and use of each component (slip tracker, problem solver, and Facebook group) is on 5-point Likert scales. This outcome counts number of participants that Strongly Agree or Agree.	6 weeks
Primary	Number of participants rating the Facebook group as time-consuming	Participants will rate their agreement with statements about how time-consuming participation in the program and use of each component (slip tracker, problem solver, and Facebook group) is on 5-point Likert scales. This outcome counts number of participants that Strongly Agree or Agree.	6 weeks
Primary	Mean total engagements in the Facebook group	Using Grytics, we will retrieve objective engagement data from the Facebook group, including the date and content of all posts, replies, reactions, and poll votes. We will calculate the total number of posts, replies, reactions, and poll votes per participant.	6 weeks
Secondary	Mean number of exercises planned using the exercise planner	A backend server for Habit will capture data on participant use of exercise planner feature in Habit app	6 weeks
Secondary	Mean number of problem-solving attempts created using the problem solver	A backend server for Habit will capture data on participant use of problem solver feature in Habit app	6 weeks
Secondary	Mean total uses of diet slip tracker	A backend server for Habit will capture data on participant use of diet slip tracker feature in the Habit app	6 weeks
Secondary	Mean number of problem sharing Facebook posts	All posts and comments in the Facebook group will be qualitatively coded to determine if a participant is sharing a problem they are having with the group either via the app or as an original post.	6 weeks
Secondary	Mean number of problem solving Facebook comments	All posts and comments in the Facebook group will be qualitatively coded for problem solving if a comment is directed toward another participant (or anonymous post) that serve to help the OP brainstorm ideas on how to solve the problem.	6 weeks
Secondary	Number of participants that attended at least one breakout session	Participants can attend optional breakout sessions during the intervention to discuss problems related to weight loss and receive peer feedback. We will track attendance and report the number of participants that attended at least one breakout session during the 6-week intervention.	6 weeks