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

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ClinicalTrials.gov Identifier: NCT02454127
Recruitment Status : Completed
First Posted : May 27, 2015
Results First Posted : October 31, 2016
Last Update Posted : October 31, 2016
Sponsor:
Information provided by (Responsible Party):
Tufts Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Obesity Cardiovascular Disease Metabolic Syndrome Behavioral: Atkins Diet Behavioral: Zone Diet Behavioral: Weight Watchers Diet Behavioral: Ornish Diet Not Applicable

Detailed 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 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.

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. Outcome measures included body weight, total cholesterol, LDL-C, HDL-C, triglycerides, hsCRP, insulin, glucose.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Four Dietary Treatment Strategies for Metabolic Syndrome: a Prospective Randomized Trial
Study Start Date : July 2000
Actual Primary Completion Date : January 2003
Actual Study Completion Date : January 2004

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Atkins Diet
Atkins Diet (dietary counseling)
 Behavioral: Atkins Diet
Dietary counseling for 1 year
Active Comparator: Zone Diet
Zone Diet (dietary counseling)
 Behavioral: Zone Diet
Dietary counseling for 1 year
Active Comparator: Weight Watchers Diet
Weight Watchers Diet (dietary counseling)
 Behavioral: Weight Watchers Diet
Dietary counseling for 1 year
Active Comparator: Ornish Diet
Ornish Diet (dietary counseling)
 Behavioral: Ornish Diet
Dietary counseling for 1 year


Outcome Measures
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Primary Outcome Measures :
  1. Weight Loss [ Time Frame: 1 year ]
    Change from baseline body weight at 1 year, measured in kilograms


Secondary Outcome Measures :
  1. Total Cholesterol [ Time Frame: 1 year ]
    Change in total cholesterol from baseline at 1 year, measured in mg/dL

  2. LDL Cholesterol [ Time Frame: 1 year ]
    Change from baseline LDL cholesterol at 1 year, measured in mg/dL

  3. HDL Cholesterol [ Time Frame: 1 year ]
    Change from baseline HDL cholesterol at 1 year, measured in mg/dL

  4. Triglycerides [ Time Frame: 1 year ]
    Change from baseline triglycerides at 1 year, measured in mg/dL

  5. Glucose [ Time Frame: 1 year ]
    Change from baseline glucose at 1 year, measured in mg/dL

  6. Insulin [ Time Frame: 1 year ]
    Change from baseline insulin at 1 year, measured in microIU/mL

  7. C-reactive Protein [ Time Frame: 1 year ]
    Change from baseline high-sensitivity CRP at 1 year, measured in mg/L


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02454127


Sponsors and Collaborators
Tufts Medical Center
Investigators
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Principal Investigator: Michael L Dansinger, MD Tufts Medical Center
More Information
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Publications of Results:

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Responsible Party: Tufts Medical Center
ClinicalTrials.gov Identifier: NCT02454127    
Other Study ID Numbers: DANS0001
First Posted: May 27, 2015    Key Record Dates
Results First Posted: October 31, 2016
Last Update Posted: October 31, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Peer-reviewed publication
Keywords provided by Tufts Medical Center:
nutrition
popular diets
weight loss
lifestyle
counseling
Additional relevant MeSH terms:
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Cardiovascular Diseases
Metabolic Syndrome
Syndrome
Disease
Pathologic Processes
 Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases