ObesityNCT02454127
Effectiveness of Four Popular Diet Strategies for Weight Loss and Cardiac Risk Reduction
A study testing Atkins Diet, Zone Diet and Weight Watchers Diet in people with Obesity and Cardiovascular Disease, run by Tufts Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Cardiovascular Disease, Metabolic Syndrome
- What is being tested?
- Atkins Diet, Zone Diet and Weight Watchers Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- Jul 2000to Jan 2004
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI 27-42;
- At least one metabolic cardiac risk factor
Who cannot join
- Age under 18 years;
- Insulin therapy;
- Unstable chronic illness;
- Unwilling to follow dietary advice
About this study
Official title: Effectiveness of Four Dietary Treatment Strategies for Metabolic Syndrome: a Prospective Randomized Trial
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.
Read the 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.
- Conditions
- Obesity, Cardiovascular Disease, Metabolic Syndrome
- Being tested
- Atkins Diet, Zone Diet, Weight Watchers Diet, Ornish Diet
- Keywords
- nutrition, popular diets, weight loss, lifestyle, counseling
- Medical subject headings
- Obesity, Cardiovascular Diseases, Metabolic Syndrome, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atkins DietBehavioural
Dietary counseling for 1 year
Zone DietBehavioural
Dietary counseling for 1 year
Weight Watchers DietBehavioural
Dietary counseling for 1 year
Ornish DietBehavioural
Dietary counseling for 1 year
| Study group | Role | What they receive |
|---|---|---|
| Atkins Diet | Active comparator | Atkins Diet (dietary counseling) Receives: Behavioral: Atkins Diet |
| Zone Diet | Active comparator | Zone Diet (dietary counseling) Receives: Behavioral: Zone Diet |
| Weight Watchers Diet | Active comparator | Weight Watchers Diet (dietary counseling) Receives: Behavioral: Weight Watchers Diet |
| Ornish Diet | Active comparator | Ornish Diet (dietary counseling) Receives: Behavioral: Ornish Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Loss
Change from baseline body weight at 1 year, measured in kilograms
Measured: 1 year
Secondary outcomes (7)
Total Cholesterol
Change in total cholesterol from baseline at 1 year, measured in mg/dL
Measured: 1 year
LDL Cholesterol
Change from baseline LDL cholesterol at 1 year, measured in mg/dL
Measured: 1 year
HDL Cholesterol
Change from baseline HDL cholesterol at 1 year, measured in mg/dL
Measured: 1 year
Triglycerides
Change from baseline triglycerides at 1 year, measured in mg/dL
Measured: 1 year
Glucose
Change from baseline glucose at 1 year, measured in mg/dL
Measured: 1 year
Insulin
Change from baseline insulin at 1 year, measured in microIU/mL
Measured: 1 year
C-reactive Protein
Change from baseline high-sensitivity CRP at 1 year, measured in mg/L
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2015 (estimated)
- Study startJul 2000
- Primary completionJan 2003
- Study completionJan 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael L Dansinger, MD, Principal investigator, Tufts Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02454127
- Sponsor's protocol ID
- DANS0001
- Status last verified
- Sep 2016
- First submitted
- 20 May 2015
- Last updated
- 31 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Peer-reviewed publication
Publications
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.
PubMed 15632335
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Four Dietary Treatment Strategies for Metabolic Syndrome: a Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT02454127
- Acronym / sponsor ID
- DANS0001
- Conditions
- Obesity, Cardiovascular Disease, Metabolic Syndrome
- Keywords
- nutrition, popular diets, weight loss, lifestyle, counseling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Study start
- Jul 2000
- Primary completion
- Jan 2003 (actual)
- Study completion
- Jan 2004 (actual)
- First posted
- 27 May 2015 (estimated)
- Results
- Posted 31 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Atkins Diet | Active comparator | Behavioral: Atkins DietAtkins Diet (dietary counseling) |
| Zone Diet | Active comparator | Behavioral: Zone DietZone Diet (dietary counseling) |
| Weight Watchers Diet | Active comparator | Behavioral: Weight Watchers DietWeight Watchers Diet (dietary counseling) |
| Ornish Diet | Active comparator | Behavioral: Ornish DietOrnish Diet (dietary counseling) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMI 27-42;
- At least one metabolic cardiac risk factor
Key exclusion criteria (4 listed)
- Age under 18 years;
- Insulin therapy;
- Unstable chronic illness;
- Unwilling to follow dietary advice
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atkins DietDietary counseling for 1 year | Behavioural | Atkins Diet |
| Zone DietDietary counseling for 1 year | Behavioural | Zone Diet |
| Weight Watchers DietDietary counseling for 1 year | Behavioural | Weight Watchers Diet |
| Ornish DietDietary counseling for 1 year | Behavioural | Ornish Diet |
Primary outcome
Weight Loss
Time frame: 1 year
Change from baseline body weight at 1 year, measured in kilograms
7 secondary outcomes
Total Cholesterol
Time frame: 1 year
LDL Cholesterol
Time frame: 1 year
HDL Cholesterol
Time frame: 1 year
Triglycerides
Time frame: 1 year
Glucose
Time frame: 1 year
Insulin
Time frame: 1 year
C-reactive Protein
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 15632335Dansinger 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.
- Individual participant dataSharing planned: Yes. Peer-reviewed publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael L Dansinger, MD principal investigator
Tufts Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Atkins Diet, Zone Diet and Weight Watchers Diet in people with Obesity and Cardiovascular Disease, run by Tufts Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight Loss (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02454127, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2016.