State-wide Health Approach to Increase Reach and Effectiveness: Study 1 (SHARE)
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ClinicalTrials.gov Identifier: NCT01264393 |
Recruitment Status
:
Completed
First Posted
: December 21, 2010
Last Update Posted
: April 24, 2013
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Condition or disease | Intervention/treatment | 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 (Clinical Trial) |
Actual Enrollment : | 500 participants |
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 |
Study Start Date : | January 2011 |
Actual Primary Completion Date : | March 2013 |
Actual Study Completion Date : | March 2013 |
Arm | Intervention/treatment |
---|---|
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
|
- 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 ]
- 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 ]

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01264393
United States, Rhode Island | |
The Miriam Hospital's Weight Control and Diabetes Research Center | |
Providence, Rhode Island, United States, 02903 |
Principal Investigator: | Rena R. Wing, PhD | The Miriam Hospital |
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 ) |
First Posted: | December 21, 2010 Key Record Dates |
Last Update Posted: | April 24, 2013 |
Last Verified: | April 2013 |