Total Health Improvement Program Research Project

Total Health Improvement Program Research Project (A Community Lifestyle Medicine Course and Ability to Improve Health in All Classes of Socioeconomic Status)

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Hypertension; Obesity; Diabetes; Chronic Disease; Pre-diabetes
• Intervention / Treatment: Behavioral: Total Health Improvement Program

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
• Enrollment (Actual): 45

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Roseburg, Oregon, United States, 97471
      • Better Living Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adults who have at least one chronic disease and may or maynot be economically or educationally disadvantaged.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline - Global Health Score	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).	12 weeks
Correlation of Global Health Scores to Social Determinants of Health	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.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline - Weight	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.	12 Weeks
Change from Baseline - Abdominal Circumference	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.	12 Weeks
Change from Baseline - HbA1C	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. .	12 Weeks
Change from Baseline - Total Cholesterol	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. .	12 Weeks
Change from Baseline - Triglycerides	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. .	12 Weeks
Change from Baseline - LDL Cholesterol	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. .	12 Weeks
Change from Baseline - HDL Cholesterol Ratio	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. .	12 Weeks

Collaborators and Investigators

• 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

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2019
• Primary Completion (Actual): June 1, 2020
• Study Completion (Actual): August 12, 2021

Study Registration Dates

• First Submitted: August 28, 2019
• First Submitted That Met QC Criteria: September 6, 2019
• First Posted (Actual): September 9, 2019

Study Record Updates

• Last Update Posted (Actual): May 9, 2022
• Last Update Submitted That Met QC Criteria: May 5, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Disease Attributes; Cardiovascular Diseases; Diabetes Mellitus; Prediabetic State; Chronic Disease
• Other Study ID Numbers: 2019-019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No