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Completed

NCT Number: NCT01560130

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

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The Miriam Hospital's Weight Control and Diabetes Research Center

Providence, Rhode Island, 02903, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Body mass index >=25 kg/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

Treatment and study plan

Shape Up Rhode Island + Online weight loss program

Behavioral

Participants assigned to this arm will receive the standard Shape Up Rhode Island statewide intervention and an Internet-based behavioral weight loss program.

Shape Up Rhode Island + Online weight loss program + Groups

Behavioral

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.

Shape Up Rhode Island + Online weight loss + Incentives

Behavioral

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.

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

    Time frame: 0 to 3 months

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

The Miriam Hospital

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

Using a State-wide Initiative to Disseminate Effective Behavioral Weight Loss Strategies

Acronym: SHARE

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 22, 2012
Registry last updated
Apr 24, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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