Comparison of Two Approaches to Weight Loss Follow-Up Study

This study is currently recruiting participants.

Verified by University of Pennsylvania, December 2005

First Received: September 1, 2005 Last Updated: December 16, 2005 History of Changes

Sponsor:	University of Pennsylvania
Collaborator:	National Institutes of Health (NIH)
Information provided by:	University of Pennsylvania
ClinicalTrials.gov Identifier:	NCT00143962

Purpose

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.

Condition	Intervention	Phase
Obesity	Behavioral: Low Carbohydrate Diet	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:	Comparison of Two Approaches to Weight Loss Follow-Up Study

Resource links provided by NLM:

MedlinePlus related topics: Diets Obesity Weight Control

U.S. FDA Resources

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:

Obesity

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***

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00143962

Contacts

Contact: Diane Rosenbaum

rdiane@mail.med.upenn.edu

Locations

United States, Colorado
University of Colorado	Recruiting
Denver, Colorado, United States
Contact: Carrie Brill carrie.brill@uchsc.edu
United States, Missouri
Washington University	Active, not recruiting
St. Louis, Missouri, United States
United States, Pennsylvania
University of Pennsylvania	Recruiting
Philadelphia, Pennsylvania, United States
Contact: Diane Rosenbaum rdiane@mail.med.upenn.edu

Sponsors and Collaborators

University of Pennsylvania

National Institutes of Health (NIH)

Investigators

Principal Investigator:	Gary Foster, PhD	University of Pennsylvania
Principal Investigator:	Holly Wyatt, MD	University of Colorado at Denver and Health Sciences Center
Principal Investigator:	James Hill, PhD	University of Colorado at Denver and Health Sciences Center
Principal Investigator:	Samuel Klein, MD	Washington University School of Medicine

More Information

Publications:

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.

Study ID Numbers:	801787
Study First Received:	September 1, 2005
Last Updated:	December 16, 2005
ClinicalTrials.gov Identifier:	NCT00143962 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Pennsylvania:

Weight Loss

Additional relevant MeSH terms:

Body Weight
Signs and Symptoms
Obesity
Weight Loss

Body Weight Changes
Nutrition Disorders
Overweight
Overnutrition

ClinicalTrials.gov processed this record on November 22, 2009