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State-wide Health Approach to Increase Reach and Effectiveness: Study 1 (SHARE)
This study has been completed.
Sponsor:
The Miriam Hospital
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Rena R. Wing, The Miriam Hospital
ClinicalTrials.gov Identifier:
NCT01264393
First received: December 17, 2010
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 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.
| Condition | Intervention | Phase |
|---|---|---|
| Obesity | Behavioral: Shape Up Rhode Island + Online Resources Behavioral: Shape Up Rhode Island + Online Weight Loss Program Behavioral: Shape Up Rhode Island + Online Weight Loss Program + Group sessions | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized 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 Rena R. Wing, 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 ]
Secondary Outcome Measures:
- Weight change from the initial assessment to the 6-month follow-up assessment measured on a digital scale to the nearest 0.1-kilogram. [ Time Frame: 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. [ Time Frame: 0 to 12-months ]
| Enrollment: | 500 |
| Study Start Date: | January 2011 |
| Study Completion Date: | March 2013 |
| Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 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 weight loss program, and the option of attending face-to-face group sessions
|
Behavioral: Shape Up Rhode Island + Online Weight Loss Program + Group sessions
Participants will receive Shape Up Rhode Island, a 12-week statewide physical activity and weight loss campaign in addition to an online weight loss program and the option of attending group sessions
|
|
Active Comparator: Shape Up Rhode Island + Online Weight Loss Program
Participants assigned to this arm will receive the standard Shape Up Rhode Island statewide intervention in addition to an internet-based weight loss program
|
Behavioral: Shape Up Rhode Island + Online Weight Loss Program
Participants will receive Shape Up Rhode Island, a 12-week statewide physical activity and weight loss campaign in addition to an online weight loss program
|
|
Active Comparator: Shape Up Rhode Island + Internet Resources
Participants in this arm will receive the Standard Shape Up Rhode Island statewide intervention plus access to internet resources
|
Behavioral: Shape Up Rhode Island + Online Resources
Participants will receive Shape Up Rhode Island, which is a 12-week statewide physical activity and weight loss campaign in addition to online weight loss resources
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- age 18-70 years
- Body Mass Index >25 kg/m2
- Both genders will be recruited; it is estimated that 70% of participants will be women.
- All ethnic groups will be recruited, with a goal of recruiting 33% minorities (see below for specific recruitment plans)
- No health problems that make weight loss or unsupervised exercise unsafe
- English speaking
Exclusion criteria:
- 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.
- are currently pregnant or intend to become pregnant in the next 12 months
- are planning to move outside of the state within the next 12 months
- have previously participated in the Shape Up Rhode Island 2008 pilot study
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01264393
Please refer to this study by its ClinicalTrials.gov identifier: NCT01264393
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
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
| Principal Investigator: | Rena R. Wing, PhD | The Miriam Hospital |
More Information
Publications:
| Responsible Party: | Rena R. Wing, Professor, The Miriam Hospital |
| ClinicalTrials.gov Identifier: | NCT01264393 History of Changes |
| Other Study ID Numbers: |
2054-10 R18DK083248 ( U.S. NIH Grant/Contract ) |
| Study First Received: | December 17, 2010 |
| Last Updated: | April 23, 2013 |
ClinicalTrials.gov processed this record on July 21, 2017