Chronic DiseaseNCT04082585
Total Health Improvement Program Research Project
An observational study of Chronic Disease and Cardiovascular Diseases, run by Pacific Northwest University of Health Sciences at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Disease, Cardiovascular Diseases, Hypertension
- What is being tested?
- Total Health Improvement Program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Sep 2019to 12 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults who have at least one chronic disease and may or maynot be economically or educationally disadvantaged.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Total Health Improvement Program Research Project (A Community Lifestyle Medicine Course and Ability to Improve Health in All Classes of Socioeconomic Status)
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.
Read the 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
- Being tested
- Total Health Improvement Program
- Medical subject headings
- Chronic Disease, Cardiovascular Diseases, Hypertension, Diabetes Mellitus, Glucose Intolerance, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Health Improvement ProgramBehavioural
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 12 weeks
Secondary outcomes (7)
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.
Measured: 12 Weeks
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.
Measured: 12 Weeks
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. .
Measured: 12 Weeks
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. .
Measured: 12 Weeks
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. .
Measured: 12 Weeks
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. .
Measured: 12 Weeks
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. .
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2019
- Study start4 Sep 2019
- Primary completion1 Jun 2020
- Study completion12 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pacific Northwest University of Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Health Resources and Services Administration (HRSA), Better Living Center
- Responsible party
- Principal investigator, Heidi Beery, Pacific Northwest University of Health Sciences
- Investigators
- Heidi Beery, MD, Principal investigator, Pacific Northwest University of Health Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04082585
- Sponsor's protocol ID
- 2019-019
- Status last verified
- May 2022
- First submitted
- 28 Aug 2019
- Last updated
- 9 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Health Improvement Program Research Project (A Community Lifestyle Medicine Course and Ability to Improve Health in All Classes of Socioeconomic Status)
- ClinicalTrials.gov ID
- NCT04082585
- Acronym / sponsor ID
- 2019-019
- Conditions
- Chronic Disease, Cardiovascular Diseases, Hypertension, Diabetes, Pre-diabetes, Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Pacific Northwest University of Health SciencesUniversity, hospital or other
- Collaborators
- Health Resources and Services Administration (HRSA), Better Living Center
- Study start
- 4 Sep 2019 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 12 Aug 2021 (actual)
- First posted
- 9 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults who have at least one chronic disease and may or maynot be economically or educationally disadvantaged.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total Health Improvement ProgramThe 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. | Behavioural | – |
Primary outcome
Change from Baseline - Global Health Score
Time frame: 12 weeks
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).
Correlation of Global Health Scores to Social Determinants of Health
Time frame: 12 weeks
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.
7 secondary outcomes
Change from Baseline - Weight
Time frame: 12 Weeks
Change from Baseline - Abdominal Circumference
Time frame: 12 Weeks
Change from Baseline - HbA1C
Time frame: 12 Weeks
Change from Baseline - Total Cholesterol
Time frame: 12 Weeks
Change from Baseline - Triglycerides
Time frame: 12 Weeks
Change from Baseline - LDL Cholesterol
Time frame: 12 Weeks
Change from Baseline - HDL Cholesterol Ratio
Time frame: 12 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heidi Beery, MD principal investigator
Pacific Northwest University of Health Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Disease and Cardiovascular Diseases, run by Pacific Northwest University of Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline - Global Health Score (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2022.