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Comparison of Popular Weight Loss Diets

Primary Purpose

Obesity

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Atkins diet (extremely low carbohydrate)
Zone diet (low carbohydrate, high protein)
Ornish diet (very low fat)
Sponsored by
National Center for Complementary and Integrative Health (NCCIH)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Weight Loss, Obesity, Overweight, Premenopausal women, Diet

Eligibility Criteria

30 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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)

Sites / Locations

  • Stanford Prevention Research Center

Outcomes

Primary Outcome Measures

Weight; measured at each study visit
Percent body fat; measured at each study visit

Secondary Outcome Measures

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

Full Information

First Posted
March 9, 2004
Last Updated
August 16, 2006
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborators
Community Foundation of Southeastern Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT00079573
Brief Title
Comparison of Popular Weight Loss Diets
Official Title
Benefits & Risks of Popular Weight Loss Diets
Study Type
Interventional

2. Study Status

Record Verification Date
August 2006
Overall Recruitment Status
Completed
Study Start Date
July 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborators
Community Foundation of Southeastern Michigan

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Weight Loss, Obesity, Overweight, Premenopausal women, Diet

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
300 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Atkins diet (extremely low carbohydrate)
Intervention Type
Behavioral
Intervention Name(s)
Zone diet (low carbohydrate, high protein)
Intervention Type
Behavioral
Intervention Name(s)
Ornish diet (very low fat)
Primary Outcome Measure Information:
Title
Weight; measured at each study visit
Title
Percent body fat; measured at each study visit
Secondary Outcome Measure Information:
Title
Blood lipids (cholesterol, triglycerides); measured at each study visit
Title
Fasting insulin and glucose; measured at each study visit
Title
Behavioral variables; measured at each study visit

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher D. Gardner, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford Prevention Research Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17341711
Citation
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. doi: 10.1001/jama.297.9.969. Erratum In: JAMA. 2007 Jul 11;298(2):178.
Results Reference
derived
Links:
URL
http://prevention.stanford.edu/
Description
Stanford Center for Research in Disease Prevention

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Comparison of Popular Weight Loss Diets

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