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

May 6, 2019 updated by: Washington University School of Medicine

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University in St. Louis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Body Weight
Time Frame: 6 weeks
6 weeks
Blood Pressure
Time Frame: 6 weeks
6 weeks
Cholesterol
Time Frame: 6 weeks
6 weeks
Triglycerides
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Collaborators

Pritikin Longevity Center
Wellmont Health System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 27, 2018

Primary Completion (Actual)

November 20, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

April 24, 2019

First Submitted That Met QC Criteria

April 24, 2019

First Posted (Actual)

April 26, 2019

Study Record Updates

Last Update Posted (Actual)

May 8, 2019

Last Update Submitted That Met QC Criteria

May 6, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1204508

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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