Elements Vital to Treat Obesity Study

Study Overview
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Brief Summary
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The overall objective of this study is to evaluate the first rigorously optimized, remotely delivered treatment for obesity against the current gold standard treatment in a head-to-head randomized controlled trial. The investigators will be comparing the previously developed and optimized behavioral weight loss intervention (APP) to the Diabetes Prevention Program (DPP), to evaluate program weight-loss success and cost-effectiveness.

Detailed Description
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The proposed study seeks to determine if the APP program is an effective, resource-sensitive strategy to manage weight for obesity, as compared to the DPP program. During the 24-week active intervention phase, participants will be randomized to one of two treatments: 1) APP, wherein participants receive calorie, fat, and physical activity goals via a Smartphone application for self-monitoring, online educational readings, and biweekly sessions with a Health Promotionist; or 2) DPP, wherein participants are guided to self-monitor their physical activity, food intake, and weight via a participant log, and are guided through 16 sessions by a Health Promotionist. Assessments to track progress will occur remotely at the 3-month, 6-month, and 12-month time points of the program.

Official Title
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Evaluating the EVO Treatment Optimized for Resource Constraints: Elements Vital to Treat Obesity.

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Smartphone App Participants (APP)
* Behavioral: Diabetes Prevention Program Participants (DPP)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI 30-45 Weight stable Own a Smartphone and be willing to install our Smartphone app Willing to conduct video conference calls with study staff Exclusion Criteria: Enrolled in any formal weight loss program Taking anti-obesity medications Not taking medications that may cause weight gain Unstable medical conditions Diabetes requiring insulin supplementation Crohn's Disease Diagnosis of obstructive sleep apnea requiring intervention (i.e., CPAP) Assistive devices for mobility Hospitalizations for a psychiatric disorder within the past 5 years Cardiovascular disease symptoms while performing moderate intensity exercise Pregnancy, trying to get pregnant, or lactating. Bulimia or binge eating disorder Reports of active suicidal ideation Current substance abuse or dependence besides nicotine dependence

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Smartphone App Participants (APP)<br>Smartphone application, diet and activity goals, online lessons, brief remote sessions with a Health Promotionist | Behavioral: Smartphone App Participants (APP)<br>* Participants will receive calorie, fat, and physical activity goals, a Smartphone application for self-monitoring their diet, activity and weight, online educational readings, and brief bi-weekly remote health sessions with a Health Promotionist. They will also be provided with a wireless bluetooth scale and portable blood pressure machine.<br>|
| Experimental: Diabetes Prevention Program Participants (DPP)<br>Participant program manual, diet and activity logs, hour long remote sessions with a Health Promotionist | Behavioral: Diabetes Prevention Program Participants (DPP)<br>* In accordance with the Center for Disease Control curriculum, participants will receive a participant log for tracking physical activity, food intake, and weight, a paper participant guide with worksheets, logs, and psycho-educational materials, and 16 hour long remote sessions with a Health Promotionist. They will also be provided with a wireless bluetooth scale and portable blood pressure machine.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight | Participant change in weight, in kilograms, from baseline to 6-months. | Baseline to 6-Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Costs of treatment | Costs of EVO versus DPP implementation | 12 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Weight Loss, Diet, Physical Activity, Self Monitoring, Mobile Health