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Habit App Pre-Pilot (BHT-OWL)

Primary Purpose

Obesity

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Building Habits Together Online Weight Loss 6-Week Usability Trial
Sponsored by
University of Connecticut
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Obesity focused on measuring obesity, lifestyle intervention, mobile app

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Connecticut

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Habit App

Arm Description

Habit Mobile App

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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
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
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
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.
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.
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.

Full Information

First Posted
July 23, 2021
Last Updated
July 29, 2022
Sponsor
University of Connecticut
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), Worcester Polytechnic Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05295849
Brief Title
Habit App Pre-Pilot
Acronym
BHT-OWL
Official Title
Building Habits Together: Feasibility Trial of an Integrated Mobile and Social Network Weight Loss Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 18, 2022 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Connecticut
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), Worcester Polytechnic Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
obesity, lifestyle intervention, mobile app

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
single-arm usability pilot
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Habit App
Arm Type
Experimental
Arm Description
Habit Mobile App
Intervention Type
Behavioral
Intervention Name(s)
Building Habits Together Online Weight Loss 6-Week Usability Trial
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean total days Habit app was used
Description
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.
Time Frame
6 weeks
Title
Number of participants saying they would be likely or very likely to continue to use the Habit app if given the chance
Description
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.
Time Frame
6 weeks
Title
Number of participants saying they would be likely or very likely to recommend the Habit to a friend
Description
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.
Time Frame
6 weeks
Title
Number of participants rating the slip tracker as time-consuming
Description
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.
Time Frame
6 weeks
Title
Number of participants rating the problem solver as time-consuming
Description
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.
Time Frame
6 weeks
Title
Number of participants rating the Facebook group as time-consuming
Description
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.
Time Frame
6 weeks
Title
Mean total engagements in the Facebook group
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Mean number of exercises planned using the exercise planner
Description
A backend server for Habit will capture data on participant use of exercise planner feature in Habit app
Time Frame
6 weeks
Title
Mean number of problem-solving attempts created using the problem solver
Description
A backend server for Habit will capture data on participant use of problem solver feature in Habit app
Time Frame
6 weeks
Title
Mean total uses of diet slip tracker
Description
A backend server for Habit will capture data on participant use of diet slip tracker feature in the Habit app
Time Frame
6 weeks
Title
Mean number of problem sharing Facebook posts
Description
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.
Time Frame
6 weeks
Title
Mean number of problem solving Facebook comments
Description
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.
Time Frame
6 weeks
Title
Number of participants that attended at least one breakout session
Description
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.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18-65 years old BMI 30-45 kg/m2 has wifi connectivity at home (for wifi scale) 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 able to participate in the study in English. Exclusion Criteria: Pregnant/lactating or plans to become pregnant during study period bipolar disorder, substance abuse, psychosis, bulimia, binge eating disorder, or severe depression had bariatric surgery or plans to have surgery during the study currently taking medication affecting weight has lost ≥10% of weight in past year is participating or intends to participate in another weight loss program during the study that provides coaching or problem solving chronic pain that interferes with the ability to exercise Type 1 or 2 Diabetes unable to make dietary changes or increase physical activity unable to walk ¼ mile unaided without stopping currently smokes or vapes nicotine does not live in the United States had major surgery in past 6 months hospitalized for psychiatric reasons in past 12 months has concerns about being audiotaped during the focus groups does not have or not willing to create Fitbit account for study unable to access smartphone at home and at work does not have FB has done a study with this PI before has concerns about being in FB group with faculty/students of same university in which they work/attend does not have smartphone smartphone type/version not meeting app requirements prisoner unable to provide consent does not complete onboarding steps for the study
Facility Information:
Facility Name
University of Connecticut
City
Storrs
State/Province
Connecticut
ZIP/Postal Code
06269
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Habit App Pre-Pilot

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