Effectiveness of Four Popular Diet Strategies for Weight Loss and Cardiac Risk Reduction

Obesity Clinical Trial

Official title:

Effectiveness of Four Dietary Treatment Strategies for Metabolic Syndrome: a Prospective Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02454127
• Other study ID #: DANS0001
• Status: Completed
• Phase: N/A
• First received: May 20, 2015
• Last updated: May 26, 2015
• Start date: July 2000
• Est. completion date: January 2004

Study information

• Verified date: May 2015
• Source: Tufts Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

A single-center randomized trial at an academic medical center in Boston, Mass, of overweight or obese (body mass index: mean, 35; range, 27-42) adults aged 22 to 72 years 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.

Description:

Objective: To assess adherence rates and the effectiveness of 4 popular diets (Atkins, Zone, Weight Watchers, and Ornish) for weight loss and cardiac risk factor reduction.

Design, Setting, and Participants: A single-center randomized trial at an academic medical center in Boston, Mass, of overweight or obese (body mass index: mean, 35; range, 27-42) adults aged 22 to 72 years 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.

Intervention: A total of 160 participants were randomly assigned to either Atkins (carbohydrate restriction, n=40), Zone (macronutrient balance, n=40), Weight Watchers (calorie restriction, n=40), or Ornish (fat restriction, n=40) diet groups. After 2 months of maximum effort, participants selected their own levels of dietary adherence.

Main Outcome Measures: One-year changes in baseline weight and cardiac risk factors, and self-selected dietary adherence rates per self-report.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: January 2004
• Est. primary completion date: January 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• BMI 27-42;

• At least one metabolic cardiac risk factor

Exclusion Criteria:

• Age under 18 years;

• Insulin therapy;

• Unstable chronic illness;

• Unwilling to follow dietary advice

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Metabolic Syndrome
• Metabolic Syndrome X
• Obesity

Intervention

Behavioral:
• Atkins Diet
Dietary counseling for 1 year
• Zone Diet
Dietary counseling for 1 year
• Weight Watchers Diet
Dietary counseling for 1 year
• Ornish Diet
Dietary counseling for 1 year

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tufts Medical Center

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight loss	Change from baseline body weight at 1 year	1 year	No
Secondary	Cardiovascular risk factor reduction	Changes from baseline metabolic cardiac risk markers at 1 year	1 year	No