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

April 23, 2013 updated by: Rena R. Wing, The Miriam Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

300

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • The Miriam Hospital's Weight Control and Diabetes Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Shape Up Rhode Island + Online Weight Loss + Incentives
Behavioral: Shape Up Rhode Island + Online weight loss + Incentives
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.
Active Comparator: Shape Up Rhode Island + Online weight loss program
Behavioral: Shape Up Rhode Island + Online weight loss program
Participants assigned to this arm will receive the standard Shape Up Rhode Island statewide intervention and an Internet-based behavioral weight loss program.
Active Comparator: Shape Up Rhode Island + Online weight loss program + groups
Behavioral: Shape Up Rhode Island + Online weight loss program + Groups
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
Time Frame: 0 to 3 months
0 to 3 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Miriam Hospital

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

March 20, 2012

First Submitted That Met QC Criteria

March 21, 2012

First Posted (Estimate)

March 22, 2012

Study Record Updates

Last Update Posted (Estimate)

April 24, 2013

Last Update Submitted That Met QC Criteria

April 23, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • 211699-7
  • R18DK083248 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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