Comparison of Two Approaches to Weight Loss Follow-Up Study

NCT ID: NCT00143962

Last Updated: 2016-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-07-31
• Study Completion Date: 2006-03-31

Brief Summary

This is a follow-up research study to determine if there are any differences in the long-term maintenance of two diet groups, the Atkins' diet (low-carbohydrate) or the LEARN program (low-fat). The Atkins' diet continues to get a significant amount of popular attention and very little scientific evaluation. Due to the small amount of scientific data to support a low-carbohydrate diet and given the wide spread use of this type of diet, it is important to evaluate the long-term safety and effectiveness of the Atkins' diet.

We will evaluate whether there are any differences between these two groups 3-years after participation in the initial 1-year study period. We will specifically assess weight, cholesterol levels, glucose and insulin levels, and eating habits and mood as we did originally.

Detailed Description

***PLEASE NOTE: Only those who participated in the original study of low carbohydrate and low fat diets are eligable for enrollment in this follow-up study***

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Low Carbohydrate Diet

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Body mass index between 30 and 40
• Live and work within 1 hour of the study site

Exclusion Criteria

• History of heart disease, heart attack, or stroke
• Blood pressure >140/90 mmHg
• Abnormal cholesterol levels
• Significant psychiatric illness
• Any medication that affects weight or metabolic rate
• Presence or history of a chronic disease that is known to affect appetite, food intake, or metabolism (i.e., diabetes, thyroid disease, or cancer)
• Currently using antidepressants, steroids, tobacco, or illegal drugs
• Pregnant, breastfeeding, or planning pregnancy
• 10 lb change in weight within 6 months of study entry
• History of malignant arrhythmias or cerebrovascular, renal, or hepatic disease
• History of protein wasting diseases or gout
• Severe arthritis
• Osteoporosis
• Certain types of hormone replacement therapy
• Currently following a vegetarian diet

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Principal Investigators

Gary Foster, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Holly Wyatt, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

James Hill, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Samuel Klein, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

University of Colorado

Denver, Colorado, United States

Washington University

St Louis, Missouri, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

References

Foster GD, Wyatt HR, Hill JO, McGuckin BG, Brill C, Mohammed BS, Szapary PO, Rader DJ, Edman JS, Klein S. A randomized trial of a low-carbohydrate diet for obesity. N Engl J Med. 2003 May 22;348(21):2082-90. doi: 10.1056/NEJMoa022207.

Reference Type: BACKGROUND

PMID: 12761365 (View on PubMed)

Other Identifiers

801787

Identifier Type: -

Identifier Source: org_study_id

NCT00200811

Identifier Type: -

Identifier Source: nct_alias