Feasibility Trial of a Problem-Solving Weight Loss Mobile Application

Study Overview
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Brief Summary
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The purpose of this research was to develop and test the feasibility of Habit, a weight loss mobile application that was designed to coach patients through their weight loss challenges. In a pilot trial in 43 obese participants, investigators tested the feasibility of the Smart Coach mobile application when paired with a shortened online-delivered (8-week) behavioral weight loss intervention. Feasibility outcomes included frequency and duration of usage of the mobile app and each feature, recruitment, and retention. Post-intervention focus groups discussed the feasibility and acceptability of the intervention. The investigators also performed exploratory analyses comparing conditions on problem solving skills and weight loss at 8 and 16 weeks, which will inform a subsequent randomized controlled efficacy trial.

Detailed Description
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The investigators developed and tested the feasibility of Habit, a weight loss mobile app that includes common features such as self-monitoring, goal setting, and a social network, but even more importantly, an avatar-facilitated, idiographic problem solving feature that processes information intelligently to help patients identify solutions to their weight loss problems. In a pilot trial in 43 obese participants, investigators tested the feasibility of the Habit mobile application when paired with a shortened (8 week) behavioral weight loss intervention. Feasibility outcomes included frequency and duration of usage of the mobile app and each feature, recruitment, and retention. The investigators also performed analyses on problem solving skills and weight loss at 8 and 16 weeks, which will inform a subsequent randomized controlled efficacy trial. Data will support an efficacy trial of a Habit-assisted brief behavioral weight loss intervention relative to a brief behavioral weight loss intervention alone with 1 year follow-up. The investigators overarching goal is to develop mobile technology that reduces the intensity of lifestyle interventions as far as possible while preserving weight loss outcomes, to ultimately broaden reach.

Official Title
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Feasibility Trial of a Problem-Solving Weight Loss Mobile Application

Conditions
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Obesity, Weight Loss

Intervention / Treatment
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* Behavioral: Diabetes Prevention Program Lifestyle Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion: Participants must 1) have a BMI between 30 and 45, 2) currently uses a smartphone with Android software, 3) have connectivity to the internet at home and work, 4) have PCP written clearance, and 5) age 18 or older. Exclusion: Ages <18 BMI <30 and >45 Does not currently use a smart phone with Android software version 4.4 or later Does not use a smartphone supported by the app (will assess model and type of phone for each participant) Does not have connectivity to the internet at home and work; or wifi access at home Does not use smart phone regularly throughout the day Has not used Android smartphone for at least a year Has not used a weight loss mobile app in the last 6 months Does not have a Facebook account, uses it infrequently, or does not actively engage on Facebook Does not have a gmail account or is unwilling to create one Does not have PCP written clearance Bipolar disorder, substance abuse, psychosis, bulimia, or severe depression Pregnant or lactating Had bariatric surgery Medication affecting weight Adults unwilling to provide consent Prisoners Unable to read or understand English Has type 1 or 2 diabetes Have concerns about being audiotaped Unable to walk unaided Has any medical condition that precludes lifestyle changes

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Behavioral Weight Loss + Habit<br>Participants will receive 8 week of an online-delivered weight loss intervention adapted from the Diabetes Prevention Program Lifestyle Intervention and will use the Habit mobile app during the study. | Behavioral: Diabetes Prevention Program Lifestyle Intervention<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility (Total Uses) | Mean total uses of the problem solving function of the mobile application | 8-week follow-up | 
| Feasibility (Total Habits Attempted) | Total amount of new habits attempted during the study | 8-week follow-up | 
| Feasibility (Recruitment Rates) | Recruitment rates include the total number of participants contacting us to participate, which includes the intervention participants plus those screened out prior to starting the intervention (Total screened = 559; Total intervention participants = 43) | Baseline | 
| Feasibility (Retention Rates) | Total attendance at groups and total withdrawn from the study | 8-weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Problem Solving Inventory | The social problem solving inventory measures strengths and weaknesses in ability to solve problems in all areas of life. The measure includes sub scales (positive problem orientation, rational problem-solving, negative problem orientation, impulsivity/carelessness style, and avoidance style). The means of the subscales are summed and then matched against an age chart to achieve the total score for the age being studied. This is done for each participant. The scoring range is 28 to 140. The higher the score the higher the problem solving ability.The change from baseline to 8-weeks is calculated by subtracting the baseline score from the 8 week score and then doing a 1-sample t-test of whether or not the change was different than 0. | 8-week follow-up | 
| % Weight Change | Measured in pounds with a digital scale | 8-week follow-up | 
| % Weight Change | Measured in pounds with a digital scale | 16 week follow-up | 
| Social Problem Solving Inventory | The social problem solving inventory measures strengths and weaknesses in ability to solve problems in all areas of life. The measure includes sub scales (positive problem orientation, rational problem-solving, negative problem orientation, impulsivity/carelessness style, and avoidance style). The means of the subscales are summed and then matched against an age chart to achieve the total score for the age being studied. This is done for each participant. The scoring range is 28 to 140. The higher the score the higher the problem solving ability. The change from baseline to 16-weeks is calculated by subtracting the baseline score from the 16 week score and then doing a 1-sample t-test of whether or not the change was different than 0. | 16-week follow-up |