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

Primary Purpose

Obesity, Cardiovascular Disease, Metabolic Syndrome

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Atkins Diet

Zone Diet

Weight Watchers Diet

Ornish Diet

About this trial

This is an interventional treatment trial for Obesity focused on measuring nutrition, popular diets, weight loss, lifestyle, counseling

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Arm Label

Atkins Diet

Zone Diet

Weight Watchers Diet

Ornish Diet

Arm Description

Atkins Diet (dietary counseling)

Zone Diet (dietary counseling)

Weight Watchers Diet (dietary counseling)

Ornish Diet (dietary counseling)

Outcomes

Primary Outcome Measures

Weight Loss

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

Secondary Outcome Measures

Total Cholesterol

Change in total cholesterol from baseline at 1 year, measured in mg/dL

LDL Cholesterol

Change from baseline LDL cholesterol at 1 year, measured in mg/dL

HDL Cholesterol

Change from baseline HDL cholesterol at 1 year, measured in mg/dL

Triglycerides

Change from baseline triglycerides at 1 year, measured in mg/dL

Glucose

Change from baseline glucose at 1 year, measured in mg/dL

Insulin

Change from baseline insulin at 1 year, measured in microIU/mL

C-reactive Protein

Change from baseline high-sensitivity CRP at 1 year, measured in mg/L

Full Information

NCT ID

NCT02454127

First Posted

May 20, 2015

Last Updated

September 13, 2016

Sponsor

Tufts Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT02454127

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Completed

Study Start Date

July 2000 (undefined)

Primary Completion Date

January 2003 (Actual)

Study Completion Date

January 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tufts Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, Cardiovascular Disease, Metabolic Syndrome

Keywords

nutrition, popular diets, weight loss, lifestyle, counseling

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

160 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Atkins Diet

Arm Type

Active Comparator

Arm Description

Atkins Diet (dietary counseling)

Arm Title

Zone Diet

Arm Type

Active Comparator

Arm Description

Zone Diet (dietary counseling)

Arm Title

Weight Watchers Diet

Arm Type

Active Comparator

Arm Description

Weight Watchers Diet (dietary counseling)

Arm Title

Ornish Diet

Arm Type

Active Comparator

Arm Description

Ornish Diet (dietary counseling)

Intervention Type

Behavioral

Intervention Name(s)

Atkins Diet

Intervention Description

Dietary counseling for 1 year

Intervention Type

Behavioral

Intervention Name(s)

Zone Diet

Intervention Description

Dietary counseling for 1 year

Intervention Type

Behavioral

Intervention Name(s)

Weight Watchers Diet

Intervention Description

Dietary counseling for 1 year

Intervention Type

Behavioral

Intervention Name(s)

Ornish Diet

Intervention Description

Dietary counseling for 1 year

Primary Outcome Measure Information:

Title

Weight Loss

Description

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

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Total Cholesterol

Description

Change in total cholesterol from baseline at 1 year, measured in mg/dL

Time Frame

1 year

Title

LDL Cholesterol

Description

Change from baseline LDL cholesterol at 1 year, measured in mg/dL

Time Frame

1 year

Title

HDL Cholesterol

Description

Change from baseline HDL cholesterol at 1 year, measured in mg/dL

Time Frame

1 year

Title

Triglycerides

Description

Change from baseline triglycerides at 1 year, measured in mg/dL

Time Frame

1 year

Title

Glucose

Description

Change from baseline glucose at 1 year, measured in mg/dL

Time Frame

1 year

Title

Insulin

Description

Change from baseline insulin at 1 year, measured in microIU/mL

Time Frame

1 year

Title

C-reactive Protein

Description

Change from baseline high-sensitivity CRP at 1 year, measured in mg/L

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael L Dansinger, MD

Organizational Affiliation

Tufts Medical Center

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Peer-reviewed publication

Citations:

PubMed Identifier

15632335

Citation

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.

Results Reference

result

Learn more about this trial

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

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