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:
Information provided by:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00143962
First received: September 1, 2005
Last updated: December 16, 2005
Last verified: December 2005
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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 Early Recognition Center
  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:
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 29, 2014