Back to resultsTranslation of Pritikin Program to the Community (Prit-TN)
Primary Purpose
Metabolic Syndrome, Obesity, Weight Loss
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Healthy Lifestyle
Sponsored by
About this trial
This is an interventional treatment trial for Metabolic Syndrome focused on measuring metabolic syndrome, obesity
Eligibility Criteria
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
Sites / Locations
- Washington University in St. Louis
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
The intervention group participated in a 6-week Pritikin diet, exercise program, and behavioral modification.
This group did not receive any intervention.
Outcomes
Primary Outcome Measures
Body Weight
Blood Pressure
Cholesterol
Triglycerides
Secondary Outcome Measures
Full Information
NCT ID
NCT03929198
First Posted
April 24, 2019
Last Updated
May 6, 2019
Sponsor
Washington University School of Medicine
Collaborators
Pritikin Longevity Center, Wellmont Health System
1. Study Identification
Unique Protocol Identification Number
NCT03929198
Brief Title
Translation of Pritikin Program to the Community
Acronym
Prit-TN
Official Title
Population-Based Lifestyle Intervention: Translation of the Pritikin Program to the Community- Pilot Study Protocol
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
September 27, 2018 (Actual)
Primary Completion Date
November 20, 2018 (Actual)
Study Completion Date
December 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
Pritikin Longevity Center, Wellmont Health System
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Obesity, Weight Loss, Hypertension, Hypercholesterolemia, Hypertriglyceridemia
Keywords
metabolic syndrome, obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
The intervention group participated in a 6-week Pritikin diet, exercise program, and behavioral modification.
Arm Title
Control
Arm Type
No Intervention
Arm Description
This group did not receive any intervention.
Intervention Type
Other
Intervention Name(s)
Healthy Lifestyle
Intervention Description
6 week Diet, Exercise training, Behavioral modification
Primary Outcome Measure Information:
Title
Body Weight
Time Frame
6 weeks
Title
Blood Pressure
Time Frame
6 weeks
Title
Cholesterol
Time Frame
6 weeks
Title
Triglycerides
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Washington University in St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Translation of Pritikin Program to the Community
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