Total Health Improvement Program Research Project

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04082585
• Other study ID #: 2019-019
• Status: Completed
• Start date: September 4, 2019
• Est. completion date: August 12, 2021

Study information

• Verified date: May 2022
• Source: Pacific Northwest University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: August 12, 2021
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Chronic Disease
• Diabetes
• Diabetes Mellitus
• Hypertension
• Obesity
• Pre-diabetes
• Prediabetic State

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.

Locations

Country	Name	City	State
United States	Better Living Center	Roseburg	Oregon

Sponsors (3)

Lead Sponsor	Collaborator
Pacific Northwest University of Health Sciences	Better Living Center, Health Resources and Services Administration (HRSA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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