Assessing the Effectiveness of a Weight Watchers-based Lifestyle Intervention for the Primary Prevention of Type 2 Diabetes

Completed · Not applicable

Conditions studied: Prediabetes, Gestational Diabetes Mellitus, Obesity

In brief

This study is a randomized pilot study to assess the applicability of the Weight Watchers model for lifestyle modification to the primary prevention of type 2 diabetes. The approach developed by Weight Watchers to achieve weight loss is based on similar nutritional principals and techniques used in the Diabetes Prevention Program (DPP) lifestyle intervention; monitoring food intake, exercising calorie control, setting modest weight loss goals and using physical activity.

Key facts

Study ID

NCT02000024

Run by

Indiana University

People needed

225

Starts

2011-12-01

Expected to finish

2016-03-01

Last updated by the study team

2016-04-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Persons age 18 and over
• Determination of BMI ≥ 24 kg/m2; persons of Asian Descent BMI ≥ 23 kg/m2
• Completion of the 7-item ADA Diabetes Risk Assessment and an ADA risk score ≥ 5
• Persons with a value of 100mg/dl or greater will confer eligibility from a single drop of whole blood obtained by finger stick to assess casual capillary blood glucose (CCBG) concentration using One-Touch Ultra handheld glucometer.
• Persons at high-risk for Impaired Glucose Tolerance (IGT), having an ADA Risk Score ≥5 and CCBG 110-199 mg/dl or an A1c ≥5.7%and < 6.5%.
• Women with a self-reported history of gestational diabetes with an A1c <6.5% and/or CCBG <199 mg/dl

You may not qualify if…

• Persons under the age of 18
• Persons with no evidence of pre-diabetes.
• Persons who are pregnant or planning to become pregnant.
• Person unable or unwilling to provide consent.
• Screening attendees who have a known condition that could alter glucose metabolism (e.g. pregnancy; known diabetes; antipsychotic or steroid medications; certain diseases or other conditions including Cushing's syndrome, acromegaly, pheochromocytoma, chronic pancreatitis, or HIV.)
• Heart attack, stroke or transient ischemic attack (TIA) in the past 6 months.
• Uncontrolled hypertension: systolic > 180 mm Hg or diastolic >105 mm Hg.
• Persons receiving treatment for cancer (excluding surgery alone) within the last 2 years(excluding skin cancer).
• Chest pain.
• Shortness of breath with minimal activity or at rest.
• Unexplained dizziness or fainting with physical activity (exercise).
• Chronic lung disease: Chronic Obstructive Pulmonary Disease (COPD) or asthma requiring home oxygen therapy (excluding sole use of a continuous positive airway pressure (CPAP) machine).
• Current use of anti-diabetes medications for the treatment of diagnosed diabetes
• Unable to communicate with research staff (including intervention staff).
• Unable to read written English.

Where it is running

• Indiana University School of Medicine — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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