Translation of Pritikin Program to the Community

Obesity Clinical Trial

— Prit-TN  

Official title:

Population-Based Lifestyle Intervention: Translation of the Pritikin Program to the Community- Pilot Study Protocol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03929198
• Other study ID #: 1204508
• Status: Completed
• Phase: N/A
• Start date: September 27, 2018
• Est. completion date: December 1, 2018

Study information

• Verified date: May 2019
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: December 1, 2018
• Est. primary completion date: November 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypercholesterolemia
• Hypertension
• Hypertriglyceridemia
• Metabolic Syndrome
• Obesity
• Weight Loss

Intervention

Other:
• Healthy Lifestyle
6 week Diet, Exercise training, Behavioral modification

Locations

Country	Name	City	State
United States	Washington University in St. Louis	Saint Louis	Missouri

Sponsors (3)

Lead Sponsor	Collaborator
Washington University School of Medicine	Pritikin Longevity Center, Wellmont Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Weight		6 weeks
Primary	Blood Pressure		6 weeks
Primary	Cholesterol		6 weeks
Primary	Triglycerides		6 weeks