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Total Health Improvement Program Research Project

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ClinicalTrials.gov Identifier: NCT04082585
Recruitment Status : Active, not recruiting
First Posted : September 9, 2019
Last Update Posted : September 9, 2019
Sponsor:
Collaborators:
Health Resources and Services Administration (HRSA)
Better Living Center
Information provided by (Responsible Party):
Heidi Beery, Pacific Northwest University of Health Sciences

Tracking Information
First Submitted Date August 28, 2019
First Posted Date September 9, 2019
Last Update Posted Date September 9, 2019
Actual Study Start Date September 4, 2019
Estimated Primary Completion Date November 22, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 6, 2019)
  • Change from Baseline - Global Health Score [ Time Frame: 12 weeks ]
    Change in global health score as measured by the validated SF-20 survey. The survey is scored for limitations in physical and role functioning (a higher score value indicates better functioning, for mental health (a higher score value indicates better health) and for pain (a higher score value indicates more pain).
  • Correlation of Global Health Scores to Social Determinants of Health [ Time Frame: 12 weeks ]
    The primary analysis will be to determine if changes in SF-20 score are correlated with scores from the PCS3 Socioeconomic Survey to determine the relationship, if any, between socioeconomic status and changes in global health.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: September 6, 2019)
  • Change from Baseline - Weight [ Time Frame: 12 Weeks ]
    The participants will be weighed at week 2 (baseline) and week 12. The data will be analyzed to determine effectiveness of the Total Health Improvement Program.
  • Change from Baseline - Abdominal Circumference [ Time Frame: 12 Weeks ]
    The participants will have there abdominal circumference measured at week 2 (baseline) and week 12. The data will be analyzed to determine effectiveness of the Total Health Improvement Program.
  • Change from Baseline - HbA1C [ Time Frame: 12 Weeks ]
    The participants will have blood draws at week 2 (baseline) and week 12 and results will be compared to determine effectiveness of the Total Health Improvement Program. .
  • Change from Baseline - Total Cholesterol [ Time Frame: 12 Weeks ]
    The participants will have blood draws at week 2 (baseline) and week 12 and results will be compared to determine effectiveness of the Total Health Improvement Program. .
  • Change from Baseline - Triglycerides [ Time Frame: 12 Weeks ]
    The participants will have blood draws at week 2 (baseline) and week 12 and results will be compared to determine effectiveness of the Total Health Improvement Program. .
  • Change from Baseline - LDL Cholesterol [ Time Frame: 12 Weeks ]
    The participants will have blood draws at week 2 (baseline) and week 12 and results will be compared to determine effectiveness of the Total Health Improvement Program. .
  • Change from Baseline - HDL Cholesterol Ratio [ Time Frame: 12 Weeks ]
    The participants will have blood draws at week 2 (baseline) and week 12 and results will be compared to determine effectiveness of the Total Health Improvement Program. .
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Total Health Improvement Program Research Project
Official Title Total Health Improvement Program Research Project (A Community Lifestyle Medicine Course and Ability to Improve Health in All Classes of Socioeconomic Status)
Brief Summary The purpose of this study is to assess the effectiveness a 13-week community based nutrition education program to assist participants program in improving in physical and emotional well being and to assess if there are differences in outcomes based on a participant's socioeconomic status.
Detailed Description

Little is known about effective strategies to reduce inequalities in non-communicable diseases (NCDs) and their underlying behaviors. McGill et al did a systematic review of the socioeconomic inequalities in promoting healthy eating. They found that upstream interventions with policy changes on price (fiscal measures such as taxes, subsidies, or economic incentives) reduced socioeconomic inequalities compared to downstream interventions such as cooking lessons, tailored nutritional education/counseling or nutrition education in the school curriculum appear likely to widen inequalities.

Douglas County's average income is $44,023 (compared to the median annual income of $60,336 across the entire United States) and the 5th poorest county in the state. 17% of the population is in poverty, higher than the national average of 13.4%.

The Complete Health Improvement Program (CHIP) is a premier lifestyle intervention that has been offered for more than 25 years and has been shown in over 25 peer-reviewed publications to benefit chronic disease. The Complete Health Improvement Program (CHIP) is a premier lifestyle intervention that has been offered for more than 25 years and has been shown in over 25 peer-reviewed publications to benefit chronic disease. CHIP was initially offered in Douglas County 5 years ago and found to benefit participants but there were concerns that it was widening inequalities due to the cost of the class. A similar program named Total Health Improvement Program (THIP) was designed and offered to the community for free through the partnership of a non-profit organization called UC-VEG.

The purpose of this study is to determine the effectiveness of the 13-week community-based nutrition education THIP program to assist participants with the adoption of a plant-based diet, increase physical activity and increase positive psychology. Research has shown plant-based diets to be safe and effective for weight management or reduction, cholesterol management, hypertension and diabetes management, and overall health and longevity. The primary objectives are to assess the effectiveness of the program in improving physical and emotional well-being and to assess if there are differences in outcomes based on a participant's socioeconomic status.

Study Type Observational
Study Design Observational Model: Ecologic or Community
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Adults who have at least one chronic disease and may or maynot be economically or educationally disadvantaged.
Condition
  • Chronic Disease
  • Cardiovascular Diseases
  • Hypertension
  • Diabetes
  • Pre-diabetes
  • Obesity
Intervention Behavioral: Total Health Improvement Program
The Total Health Improvement program is a 13 week community based nutrition program designed to assist participants in improving their physical and emotional well being. The program focuses on a plant based diet and increased physical activity.
Study Groups/Cohorts Not Provided
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 Active, not recruiting
Estimated Enrollment
 (submitted: September 6, 2019)
50
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 1, 2020
Estimated Primary Completion Date November 22, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Speak English
  • 18 years of age or older
  • Prepared to engage in the Total health Improvement Program (THIP) weekly educational classes (13 weeks)
  • Willing to participate in the pre and post questionnaire
  • Able to participate in the lab work at weeks 2 and 12
  • Have at least one chronic disease including cardiovascular disease, hyperlipidemia, hypertension, obesity (BMI >30), diabetes, or pre-diabetes (A1C>5.7%)
  • Able to provide their own meals (whole foods diet)
  • Has not attended the THIP program in the last year

Exclusion Criteria:

  • Non English Speakers
  • Less than 18 years of age
  • Unwilling to engage in the Total health Improvement Program (THIP) weekly educational classes (13 weeks)
  • Unwilling to participate in the pre and post questionnaire
  • Not able to participate in the lab work at weeks 2 and 12
  • Do not have at least one chronic disease including cardiovascular disease, hypertension, diabetes or pre-diabetes (A1C>5.7%)
  • Unable to provide their own meals (whole foods diet)
  • Has attended the THIP program in the last year
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04082585
Other Study ID Numbers 2019-019
Has Data Monitoring Committee No
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
Plan to Share IPD: No
Responsible Party Heidi Beery, Pacific Northwest University of Health Sciences
Study Sponsor Pacific Northwest University of Health Sciences
Collaborators
  • Health Resources and Services Administration (HRSA)
  • Better Living Center
Investigators
Principal Investigator: Heidi Beery, MD Pacific Northwest University of Health Science
PRS Account Pacific Northwest University of Health Sciences
Verification Date September 2019