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Comparison of Popular Weight Loss Diets

NCT ID: NCT00079573

Last Updated: 2006-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-07-31

Study Completion Date

2004-06-30

Brief Summary

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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

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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.

Conditions

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Obesity

Keywords

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Weight Loss Obesity Overweight Premenopausal women Diet

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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Atkins diet (extremely low carbohydrate)

Intervention Type BEHAVIORAL

Zone diet (low carbohydrate, high protein)

Intervention Type BEHAVIORAL

Ornish diet (very low fat)

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

30 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Community Foundation of Southeastern Michigan

UNKNOWN

Sponsor Role collaborator

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role lead

Principal Investigators

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Christopher D. Gardner, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford Prevention Research Center

Stanford, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 17341711 (View on PubMed)

Related Links

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http://prevention.stanford.edu/

Stanford Center for Research in Disease Prevention

Other Identifiers

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R21AT001098-01A1

Identifier Type: NIH

Identifier Source: org_study_id

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