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Comparison of Two Approaches to Weight Loss Follow-Up Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2005 by University of Pennsylvania.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00143962
First received: September 1, 2005
Last updated: December 16, 2005
Last verified: December 2005
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Two Approaches to Weight Loss Follow-Up Study

Resource links provided by NLM:

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, Denver
Principal Investigator: James Hill, PhD University of Colorado, Denver
Principal Investigator: Samuel Klein, MD Washington University School of Medicine
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00143962     History of Changes
Obsolete Identifiers: NCT00200811
Other Study ID Numbers: 801787
Study First Received: September 1, 2005
Last Updated: December 16, 2005
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
Weight Loss

Additional relevant MeSH terms:
Obesity
Weight Loss
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on June 18, 2013