Overweight Clinical Trial
— SHAPE5Official title:
Two Diets With Exercise in Abdominal Obesity: Cardiovascular Effects
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.
Status | Completed |
Enrollment | 77 |
Est. completion date | September 2011 |
Est. primary completion date | September 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 30 Years to 65 Years |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins Bayview Medical Center | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University | National Heart, Lung, and Blood Institute (NHLBI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cardiovascular structure and function | Measured at 6 months | No | |
Secondary | Body composition | Measured at 6 months | No |
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