Comparison of Two Approaches to Weight Loss Follow-Up Study

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00143962

Enrollment

Registered

2005-09-02

Start date

2004-07-31

Completion date

2006-03-31

Last updated

2016-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

Weight Loss

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.

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\*\*\*

Interventions

BEHAVIORALLow Carbohydrate Diet

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
Obesity	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026