Evaluating the Effects Two Diets Combined With Exercise in Persons With Abdominal Obesity (The SHAPE5 Study)

Completed · Phase 3

Conditions studied: Overweight, Obese, Sedentary, Abdominal Obesity

In brief

Abdominal obesity, which is affected by a lack of physical activity and excess weight, put people at an increased risk of cardiovascular disease. This study will compare the effects of two different dietary approaches to weight loss, each combined with exercise, for their effects on cardiovascular factors that are early predictors of future cardiovascular disease in overweight and obese people with excessive weight around their waist. The two diets are a low-carbohydrate versus a more traditional low-fat, low calorie diet.

Key facts

Study ID

NCT00990457

Run by

Johns Hopkins University

People needed

77

Starts

2009-10-01

Expected to finish

2011-09-01

Last updated by the study team

2013-04-04

Who can join

Age: 30 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Ages 30-65 years old
• Body mass index (BMI) of 25-42 kg/m\^2
• Waist of 35 inches or greater in women and 40 inches or greater in men; or, a
• Waist-hip ratio greater than 1.

You may not qualify if…

• Currently smokes
• History or evidence of cardiovascular disease or other major chronic illness
• Currently exercising regularly or following a weight loss diet
• Diabetes
• Uncontrolled high blood pressure
• Any illness that would prevent participation in a moderate-intense exercise program
• Pregnant
• Substance abuse

Where it is running

• Johns Hopkins Bayview Medical Center — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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