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Grain Exercise Trial - Whole Grain Versus no Grain With or Without Physiotherapy-promoted Exercise for Waist Loss

Lund University · 2010
ClinicalTrials.gov · Datasets · License: Public Domain · 2010
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abdominal-obesityblood-pressurecardiovascular-diseasesdiabetes-type-2exercise-therapyfoodhypertensionoverweight
The main purpose of this 2-year lifestyle experiment for waist loss is twofold: 1. to compare whole grains and no grains as part of a healthy diet, 2. to determine if an 8-week exercise program, led by physiotherapists, is more efficient than brief counseling and follow-up. People with abdominal overweight (≥84 cm in women and ≥98 cm in men) and at least one additional cardiovascular risk factor, (typically hypertension, diabetes type 2 or prior cardiovascular disease) are randomly assigned to receive Diet A or Diet B, with or without a structured exercise program at the department of physiotherapy, or to a control group receiving usual care. Diet A and B both include fruit, vegetables, fish, meat, and low-fat dairy products, and differ only in that Diet A recommends exchange of cereal grains for more potatoes, root vegetables, fruit and other carbohydrate-rich foods, while Diet B recommends exchange of regular cereal grains for whole grains. The primary outcome (most important follow-up variable) is change in waist circumference during 2 years. Secondary outcome measures include blood pressure, blood lipids, level of physical activity and, in subjects with diabetes, glycated hemoglobin and fasting blood sugar.
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