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Completed

NCT Number: NCT00749606

Study to Promote Weight Loss in Primary Care Practices

The purpose of this study is to determine if primary care based, telephone-delivered weight loss interventions are effective.

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Key information

Conditions

Obesity Body Weight Body Weight Changes Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Obesity is related to the rising incidence of type 2 diabetes. Cost-effective interventions leading to sustained weight loss are needed to improve the public health and reverse the alarming rise in diabetes, its cardiovascular complications and other obesity-related illnesses. The Diabetes Prevention Program is identified as a model for a successful weight loss intervention. The proposed study is a randomized controlled trial of 2 active telephone-based interventions based on the Diabetes Prevention Model that will be delivered at primary care sites.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Obese
  • Metabolic syndrome
  • Read and write English
  • Planning to stay in treatment with their PCP for the next 3 years
  • On stable doses of medications for chronic diseases such as hypothyroidism for 3 years

Exclusion criteria

  • Unstable health
  • Diabetes mellitus
  • Severe medical comorbidities that might interfere with their ability to participate in intervention such as severe psychiatric disease or significant heart disease.

Treatment and study plan

Individual telephone intervention

Behavioral

Individually administered telephone-based weight loss intervention based on the Diabetes Prevention Program (weekly nurse calls for the first 5 weeks, then monthly, to cover the 16 topics from the Diabetes Prevention Program). In year 1 (after the first 5 weeks), the "coach" will have 3 weekly calls per month with participants. Contact will decrease to monthly in year 2. In year 3 there will be no contact arranged by study staff.

Group telephone intervention

Behavioral

Group education conference calls administered weight loss intervention based on the Diabetes Prevention Program (weekly nurse calls for the first 5 weeks, then monthly, to cover the 16 topics from the Diabetes Prevention Program). In year 1 (after the first 5 weeks), the "coach" will have 3 weekly calls per month with participants. Contact will decrease to monthly in year 2. In year 3 there will be no contact arranged by study staff.

Primary outcomes

  1. Weight

    Time frame: baseline, 1, 2, 3 years

    Weight (kg)

Secondary outcomes

  1. Blood Pressure

    Time frame: baseline, 1, 2, 3 years

    Systolic blood pressure (mm Hg) / Diastolic blood pressure (mm Hg)

  2. Fasting Lipid Panel

    Time frame: baseline, 1, 2, 3 years

    LDL-cholesterol (mg/dL)

  3. Fasting Glucose Level

    Time frame: baseline, 1, 2, 3 years

    Fasting glucose (mg/dL)

  4. Health Behaviors (Diet, Physical Activity)

    Time frame: baseline, 6 months, 1 and 2 years

    National Cancer Institute Fat screener

  5. SF-12 Physical Summary Score

    Time frame: baseline, 6 months, 1 and 2 years

    The impact of physical health on overall quality of life; higher score reflects better quality of life. Range 0-100 (0 indicates the lowest level and 100 the highest level of health).

  6. International Physical Activity Questionnaire

    Time frame: baseline, 6 months, 1 and 2 years

    Measure of physical activity is calculated as in mets/week

Sponsors and collaborators

Lead sponsor

State University of New York - Upstate Medical University

Other

Collaborators

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

Registry information

Official study title

Weight Loss in Primary Care: a Translation of the Diabetes Prevention Program

Important dates

Study start
2009
Primary completion
2012
Study completion
2014
First posted
Sep 9, 2008
Registry last updated
Feb 12, 2018

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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