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)
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 |
Verified date | May 2022 |
Source | Pacific Northwest University of Health Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Better Living Center | Roseburg | Oregon |
Lead Sponsor | Collaborator |
---|---|
Pacific Northwest University of Health Sciences | Better Living Center, Health Resources and Services Administration (HRSA) |
United States,
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 |
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