Clinical trial NCT04082585: 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Disease
Cardiovascular Diseases
Hypertension
Diabetes
Pre-diabetes
Obesity
Lead sponsor: Pacific Northwest University of Health Sciences
Sponsor class: OTHER
Collaborators: name: Health Resources and Services Administration (HRSA)
name: Better Living Center
First posted: 2019-09-09
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults who have at least one chronic disease and may or maynot be economically or educationally disadvantaged.

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.

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

Primary outcomes:
measure: Change from Baseline - Global Health Score
timeFrame: 12 weeks
measure: Correlation of Global Health Scores to Social Determinants of Health
timeFrame: 12 weeks
Secondary outcomes:
measure: Change from Baseline - Weight
timeFrame: 12 Weeks
measure: Change from Baseline - Abdominal Circumference
timeFrame: 12 Weeks
measure: Change from Baseline - HbA1C
timeFrame: 12 Weeks
measure: Change from Baseline - Total Cholesterol
timeFrame: 12 Weeks
measure: Change from Baseline - Triglycerides
timeFrame: 12 Weeks
measure: Change from Baseline - LDL Cholesterol
timeFrame: 12 Weeks
measure: Change from Baseline - HDL Cholesterol Ratio
timeFrame: 12 Weeks
Other outcomes:
Locations:
city: Roseburg
country: United States
facility: Better Living Center
state: Oregon
Study officials:
affiliation: Pacific Northwest University of Health Science
name: Heidi Beery, MD
role: PRINCIPAL_INVESTIGATOR
References: