NCT00079573

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for phase_2 obesity

Timeline
Completed

Started Jul 2002

Typical duration for phase_2 obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2002

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

March 9, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 10, 2004

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2004

Completed
Last Updated

August 18, 2006

Status Verified

August 1, 2006

First QC Date

March 9, 2004

Last Update Submit

August 16, 2006

Conditions

Keywords

Weight LossObesityOverweightPremenopausal womenDiet

Outcome Measures

Primary Outcomes (2)

  • Weight; measured at each study visit

  • Percent body fat; measured at each study visit

Secondary Outcomes (3)

  • 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

Interventions

Eligibility Criteria

Age30 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford Prevention Research Center

Stanford, California, 94305, United States

Location

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

ObesityWeight LossOverweight

Interventions

Diet, High-Protein Low-Carbohydrate

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-RestrictedDiet TherapyNutrition TherapyTherapeuticsDiet, High-ProteinDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Christopher D. Gardner, PhD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

March 9, 2004

First Posted

March 10, 2004

Study Start

July 1, 2002

Study Completion

June 1, 2004

Last Updated

August 18, 2006

Record last verified: 2006-08

Locations