Metabolic SyndromePrit-TNNCT03929198
Translation of Pritikin Program to the Community
A study testing Healthy Lifestyle in people with Metabolic Syndrome and Obesity, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The broad, long-term aims of this scope of work are to investigate the effects of the Pritikin Program to the general population. The study will test the effects on individuals from the community with dysfunctional lipids, blood pressure and glycemic control. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metabolic Syndrome, Obesity, Weight Loss
- What is being tested?
- Healthy Lifestyle
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Sep 2018to 1 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Dysfunctional lipids, blood pressure and glycemic control determined at a screening visit:
- Triglycerides > 150 mg/dL OR HDL <50 in females, <40 mg/dL in males
- Systolic blood pressure ≥130 mmHg OR diastolic blood pressure ≥80 mmHg (or on hypertension medication)
- HbA1c ≥5.7% or higher
- No diagnosis or treatment for cancer in the past year
- No diagnosis of mild cognitive impairment or dementia in the past year
- Ability to perform daily exercise, including aerobic activity and resistance exercise
- Non-smoker in the past year
Who cannot join
- Positive exercise stress test
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University in St. Louis
St Louis, Missouri, 63110
About this study
Official title: Population-Based Lifestyle Intervention: Translation of the Pritikin Program to the Community- Pilot Study Protocol
The broad, long-term aims of this scope of work are to investigate the effects of the Pritikin Program to the general population. The study will test the effects on individuals from the community with dysfunctional lipids, blood pressure and glycemic control. To assess the effectiveness of the Pritikin Program in the community, the effects of Pritikin lifestyle intervention on overall health will be investigated.
- Conditions
- Metabolic Syndrome, Obesity, Weight Loss, Hypertension, Hypercholesterolemia, Hypertriglyceridemia
- Being tested
- Healthy Lifestyle
- Keywords
- metabolic syndrome, obesity
- Medical subject headings
- Metabolic Syndrome, Obesity, Weight Loss, Hypertension, Hypercholesterolemia, Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy LifestyleOther
6 week Diet, Exercise training, Behavioral modification
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention group participated in a 6-week Pritikin diet, exercise program, and behavioral modification. Receives: Other: Healthy Lifestyle |
| Control | No intervention | This group did not receive any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Weight
Measured: 6 weeks
Blood Pressure
Measured: 6 weeks
Cholesterol
Measured: 6 weeks
Triglycerides
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2019
- Study start27 Sep 2018
- Primary completion20 Nov 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Pritikin Longevity Center, Wellmont Health System
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03929198
- Sponsor's protocol ID
- 1204508
- Acronym
- Prit-TN
- Status last verified
- May 2019
- First submitted
- 24 Apr 2019
- Last updated
- 8 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Population-Based Lifestyle Intervention: Translation of the Pritikin Program to the Community- Pilot Study Protocol
- ClinicalTrials.gov ID
- NCT03929198
- Acronym / sponsor ID
- Prit-TN / 1204508
- Conditions
- Metabolic Syndrome, Obesity, Weight Loss, Hypertension, Hypercholesterolemia, Hypertriglyceridemia
- Keywords
- metabolic syndrome, obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Pritikin Longevity Center, Wellmont Health System
- Study start
- 27 Sep 2018 (actual)
- Primary completion
- 20 Nov 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 26 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The broad, long-term aims of this scope of work are to investigate the effects of the Pritikin Program to the general population. The study will test the effects on individuals from the community with dysfunctional lipids, blood pressure and glycemic control. To assess the effectiveness of the Pritikin Program in the community, the effects of Pritikin lifestyle intervention on overall health will be investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Healthy LifestyleThe intervention group participated in a 6-week Pritikin diet, exercise program, and behavioral modification. |
| Control | No intervention | –This group did not receive any intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Dysfunctional lipids, blood pressure and glycemic control determined at a screening visit:
- No diagnosis or treatment for cancer in the past year
- No diagnosis of mild cognitive impairment or dementia in the past year
- Ability to perform daily exercise, including aerobic activity and resistance exercise
- Non-smoker in the past year
Key exclusion criteria (1 listed)
- Positive exercise stress test
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 |
|---|---|---|
| Healthy Lifestyle6 week Diet, Exercise training, Behavioral modification | Other | Intervention |
Primary outcome
Body Weight
Time frame: 6 weeks
Blood Pressure
Time frame: 6 weeks
Cholesterol
Time frame: 6 weeks
Triglycerides
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Lifestyle in people with Metabolic Syndrome and Obesity, run by Washington University School of Medicine at 1 site in United States.
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 8 inclusion and 1 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 8 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Body Weight (time frame: 6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 May 2019.