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Study to Promote Weight Loss in Primary Care Practices

Not Applicable
Completed
Conditions
Obesity
Registration Number
NCT00749606
Lead Sponsor
State University of New York - Upstate Medical University
Brief Summary

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

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
257
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Weightbaseline, 1, 2, 3 years

Weight (kg)

Secondary Outcome Measures
NameTimeMethod
Fasting Lipid Panelbaseline, 1, 2, 3 years

LDL-cholesterol (mg/dL)

Blood Pressurebaseline, 1, 2, 3 years

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

SF-12 Physical Summary Scorebaseline, 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).

Fasting Glucose Levelbaseline, 1, 2, 3 years

Fasting glucose (mg/dL)

Health Behaviors (Diet, Physical Activity)baseline, 6 months, 1 and 2 years

National Cancer Institute Fat screener

International Physical Activity Questionnairebaseline, 6 months, 1 and 2 years

Measure of physical activity is calculated as in mets/week

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