Building Habits Together Online Weight Loss Program

Study Overview
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Brief Summary
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The purpose of this pilot trial is to evaluate the feasibility of a lifestyle intervention where participants will all receive online weight loss counseling delivered via a private Facebook group, but be randomized to the Habit app (developed by the investigators) or MyFitnessPal, a commercial calorie tracking app.

Detailed Description
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The purpose of this pilot trial is to evaluate the feasibility of a program where 70 adults with overweight or obesity will receive online weight loss counseling delivered via a private Facebook group, but be randomized to the Habit app (developed by the investigators) or MyFitnessPal, a commercial calorie tracking app. Participants randomized to the Habit app will be asked to record their weight daily, monitor their dietary temptations, plan their exercise, and solve diet and exercise related problems. The temptation tracker helps users identify triggers and track when and why those triggers lead to dietary lapses. The exercise planner allows users to plan their exercise for the week and track whether they completed or missed the exercise and why they missed it. The Habit app provides insights to users about the patterns of their dietary lapses and exercise habits. The problem solver feature helps users identify their biggest problem with diet/exercise and then asks a series of questions to help the app provide tailored solutions to the participant to work on. Participants randomized to MyFitnessPal will track their calorie intake and exercise daily during the intervention.

Official Title
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Building Habits Together Online Weight Loss Program: Pilot Trial

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Building Habits Together
* Behavioral: Getting Healthy Together


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-65 years old Body mass index (BMI) 27-45 kg/m2 Wi-Fi connectivity at home Logs into Facebook at least 5 days per week over the past 2 weeks Has posted/replied on Facebook at least once a week in the past 2 weeks Able to participate in the study in English Interested in losing weight Exclusion Criteria: Under the age of 18 and over the age of 65 BMI under 27 or over 45 at screening; then under 27 at the point of the first weight on scale Does not have Wi-Fi connectivity at home Does not have a Facebook account Does not log into Facebook at least 5 days per week over the past 2 weeks Did not post/reply on Facebook once a week over the past 2 weeks Not able to participate in the study in English Does not live in the United States Not interested in losing weight Pregnant/lactating or plans to become pregnant during study period Reports having bipolar disorder, substance abuse, psychosis, an eating disorder, or severe depression Had bariatric surgery or plans to have surgery during the study Currently taking medication affecting weight Has lost ≥5% of weight in past 3 months 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 Has Type 1 Diabetes Has Type 2 Diabetes Unable to make dietary changes or increase physical activity Unable to walk ¼ mile unaided without stopping Currently smokes or vapes nicotine No phone connectivity at home and work Has a digestive disorder/condition that precludes dietary changes Meets criteria for severe depression on the Patient Health Questionnaire (PHQ)-8 (score of >19) Does not currently own a smartphone Smartphone type and/or version not meeting app requirements Participated in previous weight loss studies under the PI Unable to attend the orientation webinar If University of Connecticut (UConn) employee/student has concerns about being in a Facebook group with other UConn faculty, staff, and students Had major surgery in past 6 months and have not been cleared by their doctor to resume physical activity and diet changes Plans to have major surgery in the next 6-months Has an implanted cardiac defibrillator or pacemaker Did not complete screening and on-board processes of study (screening survey, webinar, e-consent, baseline survey, app set-up, scale set-up, etc.) Not willing to be audiotaped for focus groups Prisoner; or Unable to provide consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Building Habits Together<br>The Building Habits Together arm includes the 24-week, Facebook-delivered lifestyle intervention based on the Diabetes Prevention Program and use of the Habit app (temptation tracking, exercise planning, and problem solving features). | Behavioral: Building Habits Together<br>* Private, hidden Facebook group Building Habits Together includes 24 weeks on content based on the Diabetes Prevention Program and the Habit app.<br>|
| Active Comparator: Getting Healthy Together<br>The Getting Healthy Together arm includes the 24-week, Facebook-delivered lifestyle intervention based on the Diabetes Prevention Program and use of the MyFitnessPal app (daily calorie tracking, exercise tracking). | Behavioral: Getting Healthy Together<br>* Private, hidden Facebook group Getting Healthy Together includes 24 weeks on content based on the Diabetes Prevention Program and the MyFitnessPal app.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mobile app use | Investigators will calculate the number of uses for each app feature for each participant | 24 weeks | 
| Retention | Investigators will calculate retention as the proportion of participants who provide weight data at the 24 week follow-up | 24 weeks | 
| Engagement per participant in the Facebook group | For each participant, investigators will calculate total engagement in the Facebook group as defined as reactions (e.g., like, care, wow, etc.), replies, posts, and poll votes during the 24-week program. Then we will calculate mean or median engagement per participant over 24 weeks. | 24 weeks | 
| Intervention Satisfaction | Participants will rate how easy it was to use their assigned app (% who strongly agree/agree versus neutral/disagree/strongly disagree) | 24 weeks | 
| Contamination | Investigators will report the percent of participants in the Habit condition that used MyFitnessPal or other calorie tracking apps during the program. | 24 weeks | 
| Burden | Participants will rate their assigned app in terms of whether they felt it took too much time out of their day (% who strongly agree/agree versus neutral/disagree/strongly disagree) | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent weight change | Investigators will calculate percent weight change from baseline at 24 weeks | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, lifestyle intervention, mobile app