State-wide Health Approach to Increase Reach and Effectiveness: Study 2 (SHARE)
This study has been completed.
Sponsor:
The Miriam Hospital
Collaborator:
Information provided by (Responsible Party):
Rena R. Wing, The Miriam Hospital
ClinicalTrials.gov Identifier:
NCT01560130
First received: March 20, 2012
Last updated: April 23, 2013
Last verified: April 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Obesity |
Behavioral: Shape Up Rhode Island + Online weight loss program Behavioral: Shape Up Rhode Island + Online weight loss program + Groups Behavioral: Shape Up Rhode Island + Online weight loss + Incentives |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Using a State-wide Initiative to Disseminate Effective Behavioral Weight Loss Strategies |
Resource links provided by NLM:
Further study details as provided by The Miriam Hospital:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Enrollment: | 300 |
| Study Start Date: | January 2012 |
| Study Completion Date: | February 2013 |
| Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Body mass index >=25 kg/m2
- English speaking
Exclusion Criteria:
- Health problems that make weight loss or unsupervised exercise unsafe
- Current pregnancy or plan to become pregnant in the next 12 months
- Planned relocation
- Previous participation in Shape Up Rhode Island research studies
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01560130
Locations
| United States, Rhode Island | |
| The Miriam Hospital's Weight Control and Diabetes Research Center | |
| Providence, Rhode Island, United States, 02903 | |
Sponsors and Collaborators
The Miriam Hospital
Investigators
| Principal Investigator: | Rena R Wing, PhD | The Miriam Hospital |
More Information
No publications provided
| Responsible Party: | Rena R. Wing, Professor, The Miriam Hospital |
| ClinicalTrials.gov Identifier: | NCT01560130 History of Changes |
| Other Study ID Numbers: | 211699-7, R18DK083248 |
| Study First Received: | March 20, 2012 |
| Last Updated: | April 23, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Obesity Overnutrition Nutrition Disorders |
Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013