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Comparison of Two Approaches to Weight Loss Follow-Up Study

Primary Purpose

Obesity

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Low Carbohydrate Diet
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Weight Loss

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Colorado
  • Washington University
  • University of Pennsylvania

Outcomes

Primary Outcome Measures

Obesity

Secondary Outcome Measures

Full Information

First Posted
September 1, 2005
Last Updated
August 15, 2016
Sponsor
University of Pennsylvania
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00143962
Brief Title
Comparison of Two Approaches to Weight Loss Follow-Up Study
Official Title
Comparison of Two Approaches to Weight Loss Follow-Up Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
March 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Pennsylvania
Collaborators
National Institutes of Health (NIH)

4. Oversight

5. 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.
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***

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Weight Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Low Carbohydrate Diet
Primary Outcome Measure Information:
Title
Obesity

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary Foster, PhD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Holly Wyatt, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
James Hill, PhD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Samuel Klein, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado
City
Denver
State/Province
Colorado
Country
United States
Facility Name
Washington University
City
St. Louis
State/Province
Missouri
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
12761365
Citation
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. doi: 10.1056/NEJMoa022207.
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Comparison of Two Approaches to Weight Loss Follow-Up Study

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