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

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The Washington University

Status

Completed

Conditions

Weight Loss
Hypertension
Hypertriglyceridemia
Hypercholesterolemia
Obesity
Metabolic Syndrome

Treatments

Other: Healthy Lifestyle

Study type

Interventional

Funder types

Other

Identifiers

NCT03929198
1204508

Details and patient eligibility

About

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.

Enrollment

54 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

54 participants in 2 patient groups

Intervention
Experimental group
Description:
The intervention group participated in a 6-week Pritikin diet, exercise program, and behavioral modification.
Treatment:
Other: Healthy Lifestyle
Control
No Intervention group
Description:
This group did not receive any intervention.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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