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

Phase 3

Completed

• Conditions: Obesity
• Interventions: Behavioral: Shape Up Rhode Island + Online weight loss + Incentives; Behavioral: Shape Up Rhode Island + Online weight loss program; Behavioral: Shape Up Rhode Island + Online weight loss program + Groups

• Registration Number: NCT01560130
• 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 tests the efficacy of adding components designed to enhance accountability and increase motivation for weight loss.

Detailed Description

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.

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-03-20
• Study First Submitted QC: 2012-03-21
• Study First Posted: 2012-03-22
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-23
• Last Update Posted: 2013-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. Body mass index >=25 kg/m2
2. English speaking

Exclusion Criteria

1. Health problems that make weight loss or unsupervised exercise unsafe
2. Current pregnancy or plan to become pregnant in the next 12 months
3. Planned relocation
4. Previous participation in Shape Up Rhode Island research studies

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Shape Up Rhode Island + Online Weight Loss + Incentives	Shape Up Rhode Island + Online weight loss + Incentives	-
Shape Up Rhode Island + Online weight loss program	Shape Up Rhode Island + Online weight loss program	-
Shape Up Rhode Island + Online weight loss program + groups	Shape Up Rhode Island + Online weight loss program + Groups	-

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 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

Trial Locations

Locations (1)

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