State-wide Health Approach to Increase Reach and Effectiveness: Study 2

Study Overview
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Brief Summary
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Behavioral weight loss programs can successfully reduce body weight, but these programs are available to limited numbers of overweight and obese individuals. This project evaluates a unique weight loss approach that combines a self-sustaining weight loss campaign (for outreach) with training in behavioral weight loss strategies and tests the efficacy of adding components designed to enhance accountability and increase motivation for weight loss.

Detailed Description
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This is a randomized trial. Participants will be randomly assigned to 1 of 3 treatment arms: (1) Shape Up Rhode Island (a community-based weight loss campaign) plus and Internet-based behavioral weight loss program (SURI+IBWL), (2) SURI + IBWL + optional group sessions (SURI+IBWL+Group), or (3) SURI+IBWL + monetary incentives for submitting self-monitoring information and achieving clinically significant weight loss. The primary outcome is weight loss at 12 weeks.

Official Title
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Using a State-wide Initiative to Disseminate Effective Behavioral Weight Loss Strategies

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Shape Up Rhode Island + Online weight loss program
* Behavioral: Shape Up Rhode Island + Online weight loss program + Groups
* Behavioral: Shape Up Rhode Island + Online weight loss + Incentives


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body mass index >=25 kg/m2 English speaking Exclusion Criteria: Health problems that make weight loss or unsupervised exercise unsafe Current pregnancy or plan to become pregnant in the next 12 months Planned relocation Previous participation in Shape Up Rhode Island research studies

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 |
| --- | --- |
| Active Comparator: Shape Up Rhode Island + Online Weight Loss + Incentives<br> | Behavioral: Shape Up Rhode Island + Online weight loss + Incentives<br>* Participants assigned to this arm will receive the standard Shape Up Rhode Island statewide intervention, an Internet-based behavioral weight loss program, and monetary incentives for submitting self-monitoring information and for achieving clinically significant weight loss.<br>|
| Active Comparator: Shape Up Rhode Island + Online weight loss program<br> | Behavioral: Shape Up Rhode Island + Online weight loss program<br>* Participants assigned to this arm will receive the standard Shape Up Rhode Island statewide intervention and an Internet-based behavioral weight loss program.<br>|
| Active Comparator: Shape Up Rhode Island + Online weight loss program + groups<br> | Behavioral: Shape Up Rhode Island + Online weight loss program + Groups<br>* Participants assigned to this arm will receive the standard Shape Up Rhode Island statewide intervention, an Internet-based behavioral weight loss program, and the option to attend group sessions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight change from the initial assessment to the 3-month follow-up assessment measured on a digital scale to the nearest 0.1-kilogram |  | 0 to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight change from the initial assessment to the 6-month assessment measured on a digital scale to the nearest 0.1-kilogram |  | 0 to 6 months | 
| Weight change from the initial assessment to the 12-month assessment measured on a digital scale to the nearest 0.1-kilogram |  | 0 to 12-months |