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Comparison of Popular Weight Loss Diets
This study has been completed.
Study NCT00079573   Information provided by National Center for Complementary and Alternative Medicine (NCCAM)
First Received: March 9, 2004   Last Updated: August 16, 2006   History of Changes

March 9, 2004
August 16, 2006
July 2002
 
  • Weight; measured at each study visit
  • Percent body fat; measured at each study visit
  • Weight
  • Percent body fat
Complete list of historical versions of study NCT00079573 on ClinicalTrials.gov Archive Site
  • Blood lipids (cholesterol, triglycerides); measured at each study visit
  • Fasting insulin and glucose; measured at each study visit
  • Behavioral variables; measured at each study visit
  • Blood lipids (cholesterol, triglycerides)
  • Fasting insulin and glucose
  • Behavioral variables
 
Comparison of Popular Weight Loss Diets
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.

Phase II
Interventional
Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Obesity
  • Behavioral: Atkins diet (extremely low carbohydrate)
  • Behavioral: Zone diet (low carbohydrate, high protein)
  • Behavioral: Ornish diet (very low fat)
 
Gardner CD, Kiazand A, Alhassan S, Kim S, Stafford RS, Balise RR, Kraemer HC, King AC. Comparison of the Atkins, Zone, Ornish, and LEARN diets for change in weight and related risk factors among overweight premenopausal women: the A TO Z Weight Loss Study: a randomized trial. JAMA. 2007 Mar 7;297(9):969-77.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
300
June 2004
 

Inclusion Criteria

  • Body mass index (BMI) between 27 and 40 kg/m2
  • Weight stable for last 2 months
  • Not actively on a weight loss plan
  • No plans to move from the area over the next 2 years
  • Willing to accept random assignment

Exclusion Criteria

  • Pregnant or breastfeeding
  • Within 6 months of giving birth or planning to become pregnant in the next 2 years
  • Diabetes (type 1 or 2) or history of gestational diabetes
  • Renal or liver disease, active neoplasms, or recent myocardial infarction
  • Hyper- or hypothyroidism
  • Lipid lowering medications or medications known to affect weight/energy expenditure
  • Excessive alcohol intake (self-reported, > 3 drinks/day)
  • Postmenopausal, including surgical menopause
  • Currently under psychiatric care or severely clinically depressed (> 17 on Beck Inventory)
Female
30 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00079573
 
R21 AT001098-01A1
National Center for Complementary and Alternative Medicine (NCCAM)
Community Foundation of Southeastern Michigan
Principal Investigator: Christopher D. Gardner, PhD Stanford University
National Center for Complementary and Alternative Medicine (NCCAM)
August 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP