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Completed

NCT Number: NCT02454127

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

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.

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Key information

Conditions

Obesity Body Weight Body Weight Changes Cardiovascular Disease Cardiovascular Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Atkins Diet

Behavioral

Dietary counseling for 1 year

Zone Diet

Behavioral

Dietary counseling for 1 year

Weight Watchers Diet

Behavioral

Dietary counseling for 1 year

Ornish Diet

Behavioral

Dietary counseling for 1 year

Primary outcomes

  1. Weight Loss

    Time frame: 1 year

    Change from baseline body weight at 1 year, measured in kilograms

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Tufts Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2000
Primary completion
2003
Study completion
2004
First posted
May 27, 2015
Registry last updated
Oct 31, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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