State-wide Health Approach to Increase Reach and Effectiveness: Study 1

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 strategies to increase accountability (to improve weight loss success). This innovative combination has the potential to be a cost-effective model for disseminating weight control interventions.

Detailed Description
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Participants will be randomly assigned to 1 of 3 treatment arms: Shape Up Rhode Island (SURI; a community-based weight loss campaign), SURI plus an Internet-based behavioral weight loss program (SURI + IBWL), or SURI + IBWL + optional group sessions (SURI + IBWL + Group). 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 Resources
* Behavioral: Shape Up Rhode Island + Online Weight Loss Program
* Behavioral: Shape Up Rhode Island + Online Weight Loss Program + Group sessions


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18-70 years Body Mass Index >25 kg/m2 Both genders will be recruited; it is estimated that 70% of participants will be women. All ethnic groups will be recruited, with a goal of recruiting 33% minorities (see below for specific recruitment plans) No health problems that make weight loss or unsupervised exercise unsafe English speaking Exclusion criteria: report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire (PAR-Q; items 1-4). Individuals endorsing joint problems, prescription medication use or other medical conditions that could limit exercise will be required to obtain written physician consent to participate. are currently pregnant or intend to become pregnant in the next 12 months are planning to move outside of the state within the next 12 months have previously participated in the Shape Up Rhode Island 2008 pilot study

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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No

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 program + groups<br>Participants assigned to this arm will receive the standard Shape Up Rhode Island statewide intervention, an internet-based weight loss program, and the option of attending face-to-face group sessions | Behavioral: Shape Up Rhode Island + Online Weight Loss Program + Group sessions<br>* Participants will receive Shape Up Rhode Island, a 12-week statewide physical activity and weight loss campaign in addition to an online weight loss program and the option of attending group sessions<br>|
| Active Comparator: Shape Up Rhode Island + Online Weight Loss Program<br>Participants assigned to this arm will receive the standard Shape Up Rhode Island statewide intervention in addition to an internet-based weight loss program | Behavioral: Shape Up Rhode Island + Online Weight Loss Program<br>* Participants will receive Shape Up Rhode Island, a 12-week statewide physical activity and weight loss campaign in addition to an online weight loss program<br>|
| Active Comparator: Shape Up Rhode Island + Internet Resources<br>Participants in this arm will receive the Standard Shape Up Rhode Island statewide intervention plus access to internet resources | Behavioral: Shape Up Rhode Island + Online Resources<br>* Participants will receive Shape Up Rhode Island, which is a 12-week statewide physical activity and weight loss campaign in addition to online weight loss resources<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 follow-up 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 follow-up assessment measured on a digital scale to the nearest 0.1-kilogram. |  | 0 to 12-months |