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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atkins Diet | Active Comparator | Atkins Diet (dietary counseling) |
|
| Zone Diet | Active Comparator | Zone Diet (dietary counseling) |
|
| Weight Watchers Diet | Active Comparator | Weight Watchers Diet (dietary counseling) |
|
| Ornish Diet | Active Comparator | Ornish Diet (dietary counseling) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atkins Diet | Behavioral | Dietary counseling for 1 year |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Weight Loss | Change from baseline body weight at 1 year, measured in kilograms | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Total Cholesterol | Change in total cholesterol from baseline at 1 year, measured in mg/dL | 1 year |
| LDL Cholesterol | Change from baseline LDL cholesterol at 1 year, measured in mg/dL |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael L Dansinger, MD | Tufts Medical Center | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15632335 | Result | 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. |
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Peer-reviewed publication
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| ID | Title | Description |
|---|---|---|
| FG000 | Atkins Diet | Atkins Diet (dietary counseling) Atkins Diet: Dietary counseling for 1 year |
| FG001 | Zone Diet | Zone Diet (dietary counseling) Zone Diet: Dietary counseling for 1 year |
| FG002 | Weight Watchers Diet | Weight Watchers Diet (dietary counseling) Weight Watchers Diet: Dietary counseling for 1 year |
| FG003 | Ornish Diet | Ornish Diet (dietary counseling) Ornish Diet: Dietary counseling for 1 year |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Atkins Diet | Atkins Diet (dietary counseling) Atkins Diet: Dietary counseling for 1 year |
| BG001 | Zone Diet | Zone Diet (dietary counseling) Zone Diet: Dietary counseling for 1 year |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Weight Loss | Change from baseline body weight at 1 year, measured in kilograms | Intent-to-treat analysis. Missing data were replaced with baseline values. | Posted | Mean | Standard Deviation | kg | 1 year |
|
1 year
Clinically significant adverse events likely related to dietary adherence
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Atkins Diet | Atkins Diet (dietary counseling) Atkins Diet: Dietary counseling for 1 year |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Dansinger, MD | Tufts Medical Center | 617-636-5000 | mdansinger@tuftsmedicalcenter.org |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D002318 | Cardiovascular Diseases |
| D024821 | Metabolic Syndrome |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000076107 | Diet, High-Protein Low-Carbohydrate |
| ID | Term |
|---|---|
| D050528 | Diet, Carbohydrate-Restricted |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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| 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 |
|
| 1 year |
| HDL Cholesterol | Change from baseline HDL cholesterol at 1 year, measured in mg/dL | 1 year |
| Triglycerides | Change from baseline triglycerides at 1 year, measured in mg/dL | 1 year |
| Glucose | Change from baseline glucose at 1 year, measured in mg/dL | 1 year |
| Insulin | Change from baseline insulin at 1 year, measured in microIU/mL | 1 year |
| C-reactive Protein | Change from baseline high-sensitivity CRP at 1 year, measured in mg/L | 1 year |
| BG002 | Weight Watchers Diet | Weight Watchers Diet (dietary counseling) Weight Watchers Diet: Dietary counseling for 1 year |
| BG003 | Ornish Diet | Ornish Diet (dietary counseling) Ornish Diet: Dietary counseling for 1 year |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Weight Watchers Diet (dietary counseling)
Weight Watchers Diet: Dietary counseling for 1 year
| OG003 | Ornish Diet | Ornish Diet (dietary counseling) Ornish Diet: Dietary counseling for 1 year |
|
|
| Secondary | Total Cholesterol | Change in total cholesterol from baseline at 1 year, measured in mg/dL | Intent-to-treat analysis. Missing data were replaced with baseline data. | Posted | Mean | Standard Deviation | mg/dL | 1 year |
|
|
|
| Secondary | LDL Cholesterol | Change from baseline LDL cholesterol at 1 year, measured in mg/dL | Intent-to-treat analysis. Missing data were replaced with baseline values | Posted | Mean | Standard Deviation | mg/dL | 1 year |
|
|
|
| Secondary | HDL Cholesterol | Change from baseline HDL cholesterol at 1 year, measured in mg/dL | Intent-to-treat analysis. Missing data were replaced with baseline values. | Posted | Mean | Standard Deviation | mg/dL | 1 year |
|
|
|
| Secondary | Triglycerides | Change from baseline triglycerides at 1 year, measured in mg/dL | Intent-to-treat analysis. Missing data were replaced with baseline values | Posted | Mean | Standard Deviation | mg/dL | 1 year |
|
|
|
| Secondary | Glucose | Change from baseline glucose at 1 year, measured in mg/dL | Intent-to-treat analysis. Missing data were replaced with baseline values. | Posted | Mean | Standard Deviation | mg/dL | 1 year |
|
|
|
| Secondary | Insulin | Change from baseline insulin at 1 year, measured in microIU/mL | Intent-to-treat analysis. Missing data were replaced with baseline values | Posted | Mean | Standard Deviation | microIU/ml | 1 year |
|
|
|
| Secondary | C-reactive Protein | Change from baseline high-sensitivity CRP at 1 year, measured in mg/L | Intent-to-treat analysis. Missing data were replaced with baseline values. | Posted | Mean | Standard Deviation | mg/L | 1 year |
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | Zone Diet | Zone Diet (dietary counseling) Zone Diet: Dietary counseling for 1 year | 0 | 40 | 0 | 40 |
| EG002 | Weight Watchers Diet | Weight Watchers Diet (dietary counseling) Weight Watchers Diet: Dietary counseling for 1 year | 0 | 40 | 0 | 40 |
| EG003 | Ornish Diet | Ornish Diet (dietary counseling) Ornish Diet: Dietary counseling for 1 year | 0 | 40 | 0 | 40 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D001836 | Body Weight Changes |
| D000073600 |
| Diet, High-Protein |
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |