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

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: Hypertension; Obesity; Metabolic Syndrome; Weight Loss; Hypercholesterolemia; Hypertriglyceridemia
• Intervention / Treatment: Other: Healthy Lifestyle

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	6 weeks
Blood Pressure	6 weeks
Cholesterol	6 weeks
Triglycerides	6 weeks

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: Pritikin Longevity Center; Wellmont Health System

Study record dates

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: obesity; metabolic syndrome
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Body Weight; Insulin Resistance; Hyperinsulinism; Body Weight Changes; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Metabolic Syndrome; Weight Loss; Hypercholesterolemia; Hypertriglyceridemia
• 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