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Completed

NCT Number: NCT01264393

State-wide Health Approach to Increase Reach and Effectiveness: Study 1

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 strategies to increase accountability (to improve weight loss success). This innovative combination has the potential to be a cost-effective model for disseminating weight control interventions.

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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

Participants will be randomly assigned to 1 of 3 treatment arms: Shape Up Rhode Island (SURI; a community-based weight loss campaign), SURI plus an Internet-based behavioral weight loss program (SURI + IBWL), or SURI + IBWL + optional group sessions (SURI + IBWL + Group). Primary outcome is weight loss at 12-weeks.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Shape Up Rhode Island + Online Resources

Behavioral

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

Shape Up Rhode Island + Online weight loss program

Behavioral

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

Shape Up Rhode Island + Online Weight Loss Program + Group sessions

Behavioral

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

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 follow-up 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 follow-up 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
2011
Primary completion
2013
Study completion
2013
First posted
Dec 21, 2010
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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