State-wide Health Approach to Increase Reach and Effectiveness: Study 2 (SHARE)

This study has been completed.
Sponsor:
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
  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:

  1. Body mass index >=25 kg/m2
  2. English speaking

Exclusion Criteria:

  1. Health problems that make weight loss or unsupervised exercise unsafe
  2. Current pregnancy or plan to become pregnant in the next 12 months
  3. Planned relocation
  4. 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 April 22, 2014