Proof-of-Concept Study of an Integrated Mobile and Social Network Weight Loss Intervention (BHT-OWL)

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Building Habits Together Online Weight Loss 6-Week Usability Trial

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Storrs, Connecticut, United States, 06269
      • University of Connecticut

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Habit App; Habit Mobile App

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Number of Uses of the Temptation Tracker	Participants were asked to use the temptation tracker on weeks 3 and 4 of the intervention. Uses were extracted from the app's backend server.	2 weeks
Mean Number of Slips Reported	Participants were asked to report whether a temptation led to a slip or if they resisted on weeks 3 and 4 of the intervention. Uses were extracted from the app's backend server.	2 weeks
Mean Number of Temptations Resisted	Participants were asked to report whether a temptation led to a slip or if they resisted on weeks 3 and 4 of the intervention. Uses were extracted from the app's backend server.	2 weeks
Mean Number of Exercises Planned	Participants were asked to plan their exercise in advance on weeks 3 and 4 of the intervention. Uses were extracted from the app's backend server.	2 weeks
Mean Number of Total Problems Solved	Participants were asked to use the app problem solver on weeks 5 and 6 of the intervention. Uses were extracted from the app's backend server.	2 weeks
Mean Number of Diet Problems Solved	Participants were asked to use the app problem solver on weeks 5 and 6 of the intervention. Uses were extracted from the app's backend server.	2 weeks
Mean Number of Exercise Problems Solved	Participants were asked to use the app problem solver on weeks 5 and 6 of the intervention. Uses were extracted from the app's backend server.	2 weeks
Number of Participants Saying They Agree or Strongly Agree They Would Continue to Use the Habit App if Given the Chance	Participants will rate how much they agree with the statement "I would continue to use the Habit app after the study if given the chance" on 5-point Likert scales.	6 weeks
Number of Participants Saying They Agree or Strongly Agree That They Would Recommend the Habit App to a Friend	Participants will rate how much they agree with the following statement "I would recommend the Habit app to a friend who is trying to lose weight" on a 5-point Likert scale.	6 weeks
Number of Participants Rating the Temptation and 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 (temptation/slip tracker, problem solver, etc) is on 5-point Likert scales. This outcome counts number of participants that Strongly Agree or Agree.	6 weeks
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, etc) is on 5-point Likert scales. This outcome counts number of participants that Strongly Agree or Agree.	6 weeks
Number of Participants Rating the Exercise Planner 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, etc) is on 5-point Likert scales. This outcome counts number of participants that Strongly Agree or Agree.	6 weeks
Median 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Connecticut
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); Worcester Polytechnic Institute
• Investigators: Principal Investigator: Sherry Pagoto, PhD, University of Connecticut

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2022
• Primary Completion (Actual): August 31, 2022
• Study Completion (Actual): August 31, 2022

Study Registration Dates

• First Submitted: July 23, 2021
• First Submitted That Met QC Criteria: March 15, 2022
• First Posted (Actual): March 25, 2022

Study Record Updates

• Last Update Posted (Estimated): November 26, 2024
• Last Update Submitted That Met QC Criteria: November 15, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: obesity; lifestyle intervention; mobile app
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss
• Other Study ID Numbers: H20-0060; 1R34HL145439-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

We will adhere to the NIH Grant Policy on Sharing of Unique Research Resources. Any unique resources will be made available immediately after publication.

Procedures to protect the privacy of health data of individuals will be implemented to ensure NHLBI and HIPPA privacy standards are met. After the publication of outcome data, it will be made available to individuals who have IRB approval. The final dataset will be de-identified prior to sharing. Facebook participant engagement data is difficult to de-identify thus we do not intend to share it, unless we can be completely confident that participants cannot be identified.

We will insure that data and associated documentation is available to users only under a data sharing agreement that states a commitment to: 1) using the data only for research purposes, 2) securing the data using appropriate computer protection technology; and 3) destroying the data after analyses are completed. Datasets will be stored with encryption.

• IPD Sharing Time Frame: Immediately after publication
• IPD Sharing Access Criteria: After the publication of outcome data, data will be made available to individuals who have IRB approval.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No