Total Health Improvement Program Research Project

NCT ID: NCT04082585

Last Updated: 2022-05-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 45 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-09-04
• Study Completion Date: 2021-08-12

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.

Conditions

Chronic Disease; Cardiovascular Diseases; Hypertension; Diabetes; Pre-diabetes; Obesity

Study Design

• Observational Model Type: ECOLOGIC_OR_COMMUNITY
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Health Resources and Services Administration (HRSA)

FED

Sponsor Role: collaborator

Better Living Center

UNKNOWN

Sponsor Role: collaborator

Pacific Northwest University of Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Heidi Beery

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Heidi Beery, MD

Role: PRINCIPAL_INVESTIGATOR

Pacific Northwest University of Health Science

Locations

Better Living Center

Roseburg, Oregon, United States

Countries

United States

Other Identifiers

2019-019

Identifier Type: -

Identifier Source: org_study_id