Effectiveness of Four Popular Diet Strategies for Weight Loss and Cardiac Risk Reduction
Effectiveness of Four Dietary Treatment Strategies for Metabolic Syndrome: a Prospective Randomized Trial
1 other identifier
interventional
160
0 countries
N/A
Brief Summary
A single-center randomized trial at an academic medical center in Boston, Mass, of overweight or obese adults with known hypertension, dyslipidemia, or fasting hyperglycemia. Participants were enrolled starting July 18, 2000, and randomized to 4 popular diet groups until January 24, 2002.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable obesity
Started Jul 2000
Typical duration for not_applicable obesity
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2004
CompletedFirst Submitted
Initial submission to the registry
May 20, 2015
CompletedFirst Posted
Study publicly available on registry
May 27, 2015
CompletedResults Posted
Study results publicly available
October 31, 2016
CompletedOctober 31, 2016
September 1, 2016
2.5 years
May 20, 2015
May 28, 2015
September 13, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Weight Loss
Change from baseline body weight at 1 year, measured in kilograms
1 year
Secondary Outcomes (7)
Total Cholesterol
1 year
LDL Cholesterol
1 year
HDL Cholesterol
1 year
Triglycerides
1 year
Glucose
1 year
- +2 more secondary outcomes
Study Arms (4)
Atkins Diet
ACTIVE COMPARATORAtkins Diet (dietary counseling)
Zone Diet
ACTIVE COMPARATORZone Diet (dietary counseling)
Weight Watchers Diet
ACTIVE COMPARATORWeight Watchers Diet (dietary counseling)
Ornish Diet
ACTIVE COMPARATOROrnish Diet (dietary counseling)
Interventions
Eligibility Criteria
You may qualify if:
- BMI 27-42;
- At least one metabolic cardiac risk factor
You may not qualify if:
- Age under 18 years;
- Insulin therapy;
- Unstable chronic illness;
- Unwilling to follow dietary advice
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Dansinger ML, Gleason JA, Griffith JL, Selker HP, Schaefer EJ. Comparison of the Atkins, Ornish, Weight Watchers, and Zone diets for weight loss and heart disease risk reduction: a randomized trial. JAMA. 2005 Jan 5;293(1):43-53. doi: 10.1001/jama.293.1.43.
PMID: 15632335RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The protocol provided dietary advice rather than food. The attrition rate was 35% to 50% in each group. Missing data were replaced with baseline data for intent-to-treat analysis. Long-term safety beyond 1-year was not assessed.
Results Point of Contact
- Title
- Michael Dansinger, MD
- Organization
- Tufts Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Michael L Dansinger, MD
Tufts Medical Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 20, 2015
First Posted
May 27, 2015
Study Start
July 1, 2000
Primary Completion
January 1, 2003
Study Completion
January 1, 2004
Last Updated
October 31, 2016
Results First Posted
October 31, 2016
Record last verified: 2016-09
Data Sharing
- IPD Sharing
- Will share
Peer-reviewed publication