Population-Based Lifestyle Intervention: Translation of the Pritikin Program to the Community- Pilot Study Protocol
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 54
- Locations
- 1
- Primary Endpoint
- Blood Pressure
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Intervention
The intervention group participated in a 6-week Pritikin diet, exercise program, and behavioral modification.
Intervention: Healthy Lifestyle (Other)
Control
This group did not receive any intervention.
Outcomes
Primary Outcomes
Blood Pressure
Time Frame: 6 weeks
Cholesterol
Time Frame: 6 weeks
Triglycerides
Time Frame: 6 weeks
Body Weight
Time Frame: 6 weeks
Secondary Outcomes
No secondary outcomes reported