Comparison of Two Approaches to Weight Loss Follow-Up Study

• Sponsor: University of Pennsylvania (Other)
• Overall Status: Completed
• CT.gov ID: NCT00143962
• Collaborator: National Institutes of Health (NIH) (NIH)
• Enrollment: 6
• Locations: 3
• Duration (Months): 20
• Patients Per Site: 2
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Behavioral: Low Carbohydrate Diet	Phase 4

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 Design

• Study Type: Interventional
• Actual Enrollment: 6 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Comparison of Two Approaches to Weight Loss Follow-Up Study
• Study Start Date: Jul 1, 2004
• Actual Primary Completion Date: Mar 1, 2006
• Actual Study Completion Date: Mar 1, 2006

Outcome Measures

Primary Outcome Measures

1. Obesity []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	University of Colorado	Denver	Colorado	United States
2	Washington University	St. Louis	Missouri	United States
3	University of Pennsylvania	Philadelphia	Pennsylvania	United States

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

Study Documents (Full-Text)

None provided.

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.

• ClinicalTrials.gov Identifier: NCT00143962
• Other Study ID Numbers: 801787; NCT00200811
• First Posted: Sep 2, 2005
• Last Update Posted: Aug 17, 2016
• Last Verified: Aug 1, 2016

• Keywords provided by , ,: Weight Loss
• Additional relevant MeSH terms: Weight Loss

Study Results

No Results Posted as of Aug 17, 2016