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

Phase 3

Completed

• Conditions: Obesity

• Registration Number: NCT01264393
• Lead Sponsor: The Miriam Hospital

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2010-12-17
• Study First Submitted QC: 2010-12-20
• Study First Posted: 2010-12-21
• Study Start: 2011-01
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-23
• Last Update Posted: 2013-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

1. age 18-70 years
2. Body Mass Index >25 kg/m2
3. Both genders will be recruited; it is estimated that 70% of participants will be women.
4. All ethnic groups will be recruited, with a goal of recruiting 33% minorities (see below for specific recruitment plans)
5. No health problems that make weight loss or unsupervised exercise unsafe
6. English speaking

Exclusion criteria:

1. 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.
2. are currently pregnant or intend to become pregnant in the next 12 months
3. are planning to move outside of the state within the next 12 months
4. have previously participated in the Shape Up Rhode Island 2008 pilot study

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

The Miriam Hospital's Weight Control and Diabetes Research Center; 🇺🇸 Providence, Rhode Island, United States