Total Health Improvement Program Research Project

NCT04082585 | Completed

• 1 other identifier: 2019-019
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Change from Baseline - Weight

  12 Weeks

• Change from Baseline - Abdominal Circumference

  12 Weeks

• Change from Baseline - HbA1C

  12 Weeks

• Change from Baseline - Total Cholesterol

  12 Weeks

• Change from Baseline - Triglycerides

  12 Weeks

Interventions

Total Health Improvement Program BEHAVIORAL

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Speak English
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pacific Northwest University of Health Sciences: lead
• Health Resources and Services Administration (HRSA): collaborator
• Better Living Center: collaborator

Study Sites (1)

Better Living Center

Roseburg, Oregon, 97471, United States

Location

MeSH Terms

Conditions

Chronic Disease; Cardiovascular Diseases; Hypertension; Diabetes Mellitus; Glucose Intolerance; Obesity

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperglycemia; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms

Study Officials

• Heidi Beery, MD

  Pacific Northwest University of Health Science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 28, 2019
• First Posted: September 9, 2019
• Study Start: September 4, 2019
• Primary Completion: June 1, 2020
• Study Completion: August 12, 2021
• Last Updated: May 9, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)