Comparison of Two Approaches to Weight Loss Follow-Up Study

Completed · Phase 4

Conditions studied: Obesity

In brief

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.

Key facts

Study ID

NCT00143962

Run by

University of Pennsylvania

People needed

6

Starts

2004-07-01

Expected to finish

2006-03-01

Last updated by the study team

2016-08-17

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

Where it is running

• University of Colorado — Denver, Colorado, United States
• Washington University — St Louis, Missouri, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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