Comparison of Two Approaches to Weight Loss Follow-Up Study - Tabular View

Tracking Information

First Received Date ^ICMJE

September 1, 2005

Last Updated Date

December 16, 2005

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Obesity

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00143962 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Comparison of Two Approaches to Weight Loss Follow-Up Study

Official Title ^ICMJE

Comparison of Two Approaches to Weight Loss Follow-Up Study

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***

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Obesity

Intervention ^ICMJE

Behavioral: Low Carbohydrate Diet

Study Arms / Comparison Groups

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Diane Rosenbaum

rdiane@mail.med.upenn.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00143962

Responsible Party

Study ID Numbers ^ICMJE

801787

Study Sponsor ^ICMJE

University of Pennsylvania

Collaborators ^ICMJE

National Institutes of Health (NIH)

Investigators ^ICMJE

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

Information Provided By

University of Pennsylvania

Verification Date

December 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP