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出境医 / 临床实验 / Translation of Pritikin Program to the Community (Prit-TN)

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

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.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Obesity Weight Loss Hypertension Hypercholesterolemia Hypertriglyceridemia Other: Healthy Lifestyle Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Population-Based Lifestyle Intervention: Translation of the Pritikin Program to the Community- Pilot Study Protocol
Actual Study Start Date : September 27, 2018
Actual Primary Completion Date : November 20, 2018
Actual Study Completion Date : December 1, 2018
Arms and Interventions
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.
Outcome Measures
Primary Outcome Measures :
  1. Body Weight [ Time Frame: 6 weeks ]
  2. Blood Pressure [ Time Frame: 6 weeks ]
  3. Cholesterol [ Time Frame: 6 weeks ]
  4. Triglycerides [ Time Frame: 6 weeks ]

Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Locations
Layout table for location information
United States, Missouri
Washington University in St. Louis
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Pritikin Longevity Center
Wellmont Health System
Tracking Information
First Submitted Date  ICMJE April 24, 2019
First Posted Date  ICMJE April 26, 2019
Last Update Posted Date May 8, 2019
Actual Study Start Date  ICMJE September 27, 2018
Actual Primary Completion Date November 20, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 24, 2019)
  • Body Weight [ Time Frame: 6 weeks ]
  • Blood Pressure [ Time Frame: 6 weeks ]
  • Cholesterol [ Time Frame: 6 weeks ]
  • Triglycerides [ Time Frame: 6 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Translation of Pritikin Program to the Community
Official Title  ICMJE Population-Based Lifestyle Intervention: Translation of the Pritikin Program to the Community- Pilot Study Protocol
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Metabolic Syndrome
  • Obesity
  • Weight Loss
  • Hypertension
  • Hypercholesterolemia
  • Hypertriglyceridemia
Intervention  ICMJE Other: Healthy Lifestyle
6 week Diet, Exercise training, Behavioral modification
Study Arms  ICMJE
  • Experimental: Intervention
    The intervention group participated in a 6-week Pritikin diet, exercise program, and behavioral modification.
    Intervention: Other: Healthy Lifestyle
  • No Intervention: Control
    This group did not receive any intervention.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 24, 2019) 		54
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 1, 2018
Actual Primary Completion Date November 20, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03929198
Other Study ID Numbers  ICMJE 1204508
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Washington University School of Medicine
Study Sponsor  ICMJE Washington University School of Medicine
Collaborators  ICMJE
  • Pritikin Longevity Center
  • Wellmont Health System
Investigators  ICMJE Not Provided
PRS Account Washington University School of Medicine
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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