Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04082585
Other study ID # 2019-019
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Recruiting NCT04243317 - Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults N/A
Recruiting NCT04101669 - EndoBarrier System Pivotal Trial(Rev E v2) N/A
Terminated NCT03772886 - Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball N/A
Completed NCT03640442 - Modified Ramped Position for Intubation of Obese Females. N/A
Completed NCT04506996 - Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2 N/A
Recruiting NCT06019832 - Analysis of Stem and Non-Stem Tibial Component N/A
Active, not recruiting NCT05891834 - Study of INV-202 in Patients With Obesity and Metabolic Syndrome Phase 2
Active, not recruiting NCT05275959 - Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI) N/A
Recruiting NCT04575194 - Study of the Cardiometabolic Effects of Obesity Pharmacotherapy Phase 4
Completed NCT04513769 - Nutritious Eating With Soul at Rare Variety Cafe N/A
Withdrawn NCT03042897 - Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer N/A
Completed NCT03644524 - Heat Therapy and Cardiometabolic Health in Obese Women N/A
Recruiting NCT05917873 - Metabolic Effects of Four-week Lactate-ketone Ester Supplementation N/A
Active, not recruiting NCT04353258 - Research Intervention to Support Healthy Eating and Exercise N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Recruiting NCT03227575 - Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control N/A
Completed NCT01870947 - Assisted Exercise in Obese Endometrial Cancer Patients N/A
Recruiting NCT06007404 - Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
Recruiting NCT05972564 - The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function Phase 1/Phase 2
Recruiting NCT05371496 - Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction Phase 2