A Novel Diet-Phenotype Interaction Affecting Body Weight

Completed · Not applicable

Conditions studied: Obesity, Metabolic Syndrome

In brief

The primary aim of the study is to examine insulin secretion as an effect modifier of the efficacy of a low-fat vs. low-glycemic load diet for weight loss among overweight/obese young adults in an 18-month, prospectively stratified, multi-center randomized controlled trial.

Key facts

Study ID

NCT01303757

Run by

Boston Children's Hospital

People needed

155

Starts

2011-02-01

Expected to finish

2015-12-01

Last updated by the study team

2016-02-09

Who can join

Age: 18 and older, up to 40. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Aged 18 to 40 years.
• Body mass index (BMI) ≥ 27 kg/m2.
• Body weight ≤ 300 lb.
• Access to a working telephone.
• Clearance in writing from a primary care provider (i.e., physician or nurse practitioner) to rule out pre-existing medical conditions.
• Willing and able to attend group workshops (for dietary intervention) on specified evenings.

You may not qualify if…

• Physician diagnosis of a major medical illness or eating disorder.
• Chronic use of any medication that may affect study outcomes (e.g., insulin-sensitizing agents).
• Current smoking (i.e., 1 cigarette in the past week).
• Physical, mental, or cognitive handicaps that prevent participation.
• Another member of the family (i.e., first degree relative) or household participating in the study.
• Planning to relocate from current area of residence during the proposed timeframe for study participation.
• If female, planning to become pregnant during the 18 months of the study.

Where it is running

• Children's Hospital Boston — Boston, Massachusetts, United States
• University of North Carolina, Chapel Hill — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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