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State-wide Health Approach to Increase Reach and Effectiveness: Study 3 (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):
The Miriam Hospital
ClinicalTrials.gov Identifier:
NCT01760486
First received: January 2, 2013
Last updated: January 11, 2016
Last verified: December 2013
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Purpose
The investigators have shown that adding an internet behavioral weight loss program to a statewide campaign improves weight loss outcomes. However, our follow-up data suggest that once the intervention is stopped, participants begin to experience weight regain. Thus, the purpose of this project is extend this line of work and pilot test health coaches and monetary incentives for weight loss maintenance. The investigators hypothesize that coaching and incentives will improve longer-term weight outcomes.
| Condition | Intervention |
|---|---|
| Obesity | Behavioral: Shape Up Rhode Island Behavioral: Shape Up Rhode Island + Professional Coach + Incentives Behavioral: Shape Up Rhode Island + Peer Coach + Incentives |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (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 month 2 (i.e. immediately following the weight loss phase) to the 12 month follow-up assessment measured on a digital scale to the nearest 0.1 kilogram [ Time Frame: 2 to 12 months ]
| Estimated Enrollment: | 300 |
| Study Start Date: | January 2013 |
| Study Completion Date: | November 2015 |
| Primary Completion Date: | November 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Shape Up Rhode Island
Individuals who join Shape Up Rhode Island 2013, enter our research study, and lose 5% of their initial body weight during the first two months of Shape Up will be randomized to one of the three maintenance interventions. If randomized to this treatment arm, participants will receive periodic newsletters throughout the 12 month trial.
|
Behavioral: Shape Up Rhode Island |
|
Experimental: Shape Up Rhode Island + Professional Coach + Incentives
Individuals who join Shape Up Rhode Island 2013, enter our research study, and lose 5% of their initial body weight during the first two months of Shape Up will be randomized to one of the three maintenance interventions. If randomized to this treatment arm, participants will receive a professional weight loss coach and will be incentivized for submitting information to their coach and meeting weight goals.
|
Behavioral: Shape Up Rhode Island + Professional Coach + Incentives |
|
Experimental: Shape Up Rhode Island + Peer Coach + Incentives
Individuals who join Shape Up Rhode Island 2013, enter our research study, and lose 5% of their initial body weight during the first two months of Shape Up will be randomized to one of the three maintenance interventions. If randomized to this treatment arm, participants will receive a peer coach and will be incentivized for reporting to their coach and meeting weight goals.
|
Behavioral: Shape Up Rhode Island + Peer Coach + Incentives |
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Body Mass Index >=25kg/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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
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: NCT01760486
Please refer to this study by its ClinicalTrials.gov identifier: NCT01760486
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
| Responsible Party: | The Miriam Hospital |
| ClinicalTrials.gov Identifier: | NCT01760486 History of Changes |
| Other Study ID Numbers: |
211699-11 R18DK083248 ( U.S. NIH Grant/Contract ) |
| Study First Received: | January 2, 2013 |
| Last Updated: | January 11, 2016 |
ClinicalTrials.gov processed this record on September 19, 2017