Comparison of Two Approaches to Weight Loss Follow-Up Study

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.

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Key information

Conditions

Obesity Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Colorado, Denver, Colorado, United States

About this study

***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***

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

low carbohydrate diet

Behavioral

Primary outcomes

Obesity

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

National Institutes of Health (NIH)

Registry information

Important dates

Study start: 2004
Primary completion: 2006
Study completion: 2006
First posted: Sep 2, 2005
Registry last updated: Aug 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed