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Translation of Pritikin Program to the Community (Prit-TN)

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ClinicalTrials.gov Identifier: NCT03929198
Recruitment Status : Completed
First Posted : April 26, 2019
Last Update Posted : May 8, 2019
Sponsor:
Collaborators:
Pritikin Longevity Center
Wellmont Health System
Information provided by (Responsible Party):
Washington University School of Medicine

Brief 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. To assess the effectiveness of the Pritikin Program in the community, the effects of Pritikin lifestyle intervention on overall health will be investigated.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Obesity Weight Loss Hypertension Hypercholesterolemia Hypertriglyceridemia Other: Healthy Lifestyle Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Population-Based Lifestyle Intervention: Translation of the Pritikin Program to the Community- Pilot Study Protocol
Actual Study Start Date : September 27, 2018
Actual Primary Completion Date : November 20, 2018
Actual Study Completion Date : December 1, 2018

Arm Intervention/treatment
Experimental: Intervention
The intervention group participated in a 6-week Pritikin diet, exercise program, and behavioral modification.
Other: Healthy Lifestyle
6 week Diet, Exercise training, Behavioral modification

No Intervention: Control
This group did not receive any intervention.



Primary Outcome Measures :
  1. Body Weight [ Time Frame: 6 weeks ]
  2. Blood Pressure [ Time Frame: 6 weeks ]
  3. Cholesterol [ Time Frame: 6 weeks ]
  4. Triglycerides [ Time Frame: 6 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Positive exercise stress test

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03929198


Locations
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United States, Missouri
Washington University in St. Louis
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Pritikin Longevity Center
Wellmont Health System

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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03929198     History of Changes
Other Study ID Numbers: 1204508
First Posted: April 26, 2019    Key Record Dates
Last Update Posted: May 8, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Washington University School of Medicine:
metabolic syndrome
obesity

Additional relevant MeSH terms:
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Weight Loss
Metabolic Syndrome
Hypercholesterolemia
Hypertriglyceridemia
Body Weight Changes
Body Weight
Signs and Symptoms
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders