State-wide Health Approach to Increase Reach and Effectiveness: Study 2
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Using a State-wide Initiative to Disseminate Effective Behavioral Weight Loss Strategies
2 other identifiers
interventional
300
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 obesity
Started Jan 2012
Shorter than P25 for phase_3 obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 20, 2012
CompletedFirst Posted
Study publicly available on registry
March 22, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedApril 24, 2013
April 1, 2013
1.1 years
March 20, 2012
April 23, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Weight change from the initial assessment to the 3-month follow-up assessment measured on a digital scale to the nearest 0.1-kilogram
0 to 3 months
Secondary Outcomes (2)
Weight change from the initial assessment to the 6-month assessment measured on a digital scale to the nearest 0.1-kilogram
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
0 to 12-months
Study Arms (3)
Shape Up Rhode Island + Online Weight Loss + Incentives
ACTIVE COMPARATORShape Up Rhode Island + Online weight loss program
ACTIVE COMPARATORShape Up Rhode Island + Online weight loss program + groups
ACTIVE COMPARATORInterventions
Participants assigned to this arm will receive the standard Shape Up Rhode Island statewide intervention and an Internet-based behavioral weight loss program.
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.
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.
Eligibility Criteria
You may qualify if:
- Body mass index \>=25 kg/m2
- English speaking
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Miriam Hospital's Weight Control and Diabetes Research Center
Providence, Rhode Island, 02903, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rena R Wing, PhD
The Miriam Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 20, 2012
First Posted
March 22, 2012
Study Start
January 1, 2012
Primary Completion
February 1, 2013
Study Completion
February 1, 2013
Last Updated
April 24, 2013
Record last verified: 2013-04