Obesity Clinical Trial
Official title:
Benefits & Risks of Popular Weight Loss Diets
This study will compare the safety and effectiveness of three popular weight loss plans. These plans will be compared with the USDA Dietary Guidelines.
Obesity is the single most significant, nutrition-related health issue of the new
millennium. Several “medical experts” have designed and promoted weight loss diets that
dramatically differ from one another and from the USDA Dietary Guidelines. These diets have
gained surprisingly widespread and persistent popularity among Americans despite the lack of
evidence supporting their claims. This clinical trial will provide preliminary feasibility
data for a full-scale study that will examine health outcomes (e.g., benefits, risks,
success) of three popular weight loss diets. The study will investigate behavioral and
physiological factors that influence adherence and retention to these diet plans.
Overweight women will be randomly assigned to one of four diets for 1 year: Atkins
(extremely low carbohydrate), Zone (low carbohydrate, high protein), Ornish (very low fat),
or USDA/Food Pyramid (high carbohydrate/moderate-low fat). Behavioral and physiological data
will be collected. Participants attend study visits at baseline, 8 weeks, 6 months, and 1
year. At these visits, measurements will include that will include weight and blood pressure
measurements and blood tests. Participants will be asked to complete ten questionnaires over
the course of the study to assess behavior and appetite. Participants will also undergo a
DEXA scan to assess body composition.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment
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