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Comparison of Popular Weight Loss Diets

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00079573
Recruitment Status : Completed
First Posted : March 10, 2004
Last Update Posted : August 18, 2006
Sponsor:
Collaborator:
Community Foundation of Southeastern Michigan
Information provided by:
National Center for Complementary and Integrative Health (NCCIH)

Study Description
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Brief Summary:
This study will compare the safety and effectiveness of three popular weight loss plans. These plans will be compared with the USDA Dietary Guidelines.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: Atkins diet (extremely low carbohydrate) Behavioral: Zone diet (low carbohydrate, high protein) Behavioral: Ornish diet (very low fat) Phase 2

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Benefits & Risks of Popular Weight Loss Diets
Study Start Date : July 2002
Study Completion Date : June 2004

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Weight; measured at each study visit
  2. Percent body fat; measured at each study visit

Secondary Outcome Measures :
  1. Blood lipids (cholesterol, triglycerides); measured at each study visit
  2. Fasting insulin and glucose; measured at each study visit
  3. Behavioral variables; measured at each study visit

Eligibility Criteria
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Ages Eligible for Study:   30 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00079573


Locations
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United States, California
Stanford Prevention Research Center
Stanford, California, United States, 94305
Sponsors and Collaborators
National Center for Complementary and Integrative Health (NCCIH)
Community Foundation of Southeastern Michigan
Investigators
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Principal Investigator: Christopher D. Gardner, PhD Stanford University
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00079573    
Other Study ID Numbers: R21AT001098-01A1 ( U.S. NIH Grant/Contract )
First Posted: March 10, 2004    Key Record Dates
Last Update Posted: August 18, 2006
Last Verified: August 2006
Keywords provided by National Center for Complementary and Integrative Health (NCCIH):
Weight Loss
Obesity
Overweight
Premenopausal women
Diet
Additional relevant MeSH terms:
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Weight Loss
Body Weight
Body Weight Changes