Comparison of Two Approaches to Weight Loss Follow-Up Study

Obesity Clinical Trial

Official title:

Comparison of Two Approaches to Weight Loss Follow-Up Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00143962
• Other study ID #: 801787
• Status: Completed
• Phase: Phase 4
• First received: September 1, 2005
• Last updated: August 15, 2016
• Start date: July 2004
• Est. completion date: March 2006

Study information

• Verified date: August 2016
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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***

Other known NCT identifiers

• NCT00200811

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: March 2006
• Est. primary completion date: March 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

Behavioral:
• Low Carbohydrate Diet

Locations

Country	Name	City	State
United States	University of Colorado	Denver	Colorado
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Washington University	St. Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Obesity