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

Lifespan

Status and phase: Completed; Phase 3

Conditions: Obesity

Treatments: 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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01560130

211699-7

R18DK083248 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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300 participants in 3 patient groups

Shape Up Rhode Island + Online Weight Loss + Incentives

Active Comparator group

Treatment:

Behavioral: Shape Up Rhode Island + Online weight loss + Incentives

Shape Up Rhode Island + Online weight loss program

Active Comparator group

Treatment:

Behavioral: Shape Up Rhode Island + Online weight loss program

Shape Up Rhode Island + Online weight loss program + groups

Active Comparator group

Treatment:

Behavioral: Shape Up Rhode Island + Online weight loss program + Groups