Chronic DiseaseNCT03731481
Virtual Lifestyle Medicine Comparative Effectiveness Research
A study testing Lifestyle Medicine in people with Chronic Disease and Obesity, run by Ohio University at 1 site in United States.
Trial summary
This study evaluates the effectiveness of two online Lifestyle Medicine programs. Participants will be randomized by residence, urban vs. rural, into one of two Lifestyle Medicine programs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Disease, Obesity, Sleep Disorder
- What is being tested?
- Lifestyle Medicine
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 31 May 2017to 1 Jul 2018
- Phase
- Interventional
- 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
Who may be able to join
- 18 years of age or older
- Able to read and write English
- Access to high-speed Internet
- Taking medication for at least one chronic disease condition such as high blood pressure, OR are overweight (BMI of 25 or greater)
- Willing to provide blood samples at three time points
- Willing to complete online surveys at three time points
Who cannot join
- Advised by physician to limit physical activity
- Previous experience with lifestyle medicine programs, specifically Lifestyle Medicine Clinic, Complete Health Improvement Program, Full Plate Diet
- Household includes someone who has previous experience with a Lifestyle Medicine program
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing the Effectiveness of Two Virtual Lifestyle Medicine Interventions Across Urban and Rural Settings
This study evaluates the effectiveness of two online Lifestyle Medicine programs. Participants will be randomized by residence, urban vs. rural, into one of two Lifestyle Medicine programs.
Read the detailed description
This study compares the effectiveness of two virtual Lifestyle Medicine programs across two settings: urban and rural. Program materials include nutritional education, methods to reduce personal stress, and incorporation of physical activity in daily routine. Bio-marker and subjective/self-reported survey measures will be collected at baseline, 5-weeks and six-months from baseline. Study seeks to measure variations in participant outcomes across two lifestyle interventions, participant engagement and level of adherence.
- Conditions
- Chronic Disease, Obesity, Sleep Disorder, Depression
- Being tested
- Lifestyle Medicine
- Medical subject headings
- Chronic Disease, Obesity, Sleep Wake Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle MedicineBehavioural
Lifestyle Medicine programs provide instruction in plant-based nutrition, food preparation, methods of stress reduction and incorporation of physical activity into daily routine.
| Study group | Role | What they receive |
|---|---|---|
| CHIP - Urban | Experimental | Participants randomized by urban location of residence to receive CHIP Lifestyle Medicine program intervention. Receives: Behavioral: Lifestyle Medicine |
| CHIP - Rural | Experimental | Participants randomized by rural location of residence to receive CHIP Lifestyle Medicine program intervention. Receives: Behavioral: Lifestyle Medicine |
| FPD2- Urban | Experimental | Participants randomized by urban location of residence to receive FPD2 Lifestyle Medicine program intervention. Receives: Behavioral: Lifestyle Medicine |
| FPD2 - Rural | Experimental | Participants randomized by rural location of residence to receive FPD2 Lifestyle Medicine program intervention. Receives: Behavioral: Lifestyle Medicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of participant engagement
Measure of number of sign-ins and class attendance
Measured: 6 months
Secondary outcomes (2)
Chronic disease status
Change in medication dosage for chronic disease conditions
Measured: Baseline, 5-weeks, and 6-months from baseline
Psychological status
Change in psychological state from self-reported, validated surveys
Measured: Baseline, 5-weeks, and 6-months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2018
- Study start31 May 2017
- Primary completion28 Feb 2018
- Study completion1 Jul 2018
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Comparative effectiveness research of two interventions across four cohorts
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio University
- Sponsor type
- University, hospital or other
- Collaborators
- Live Healthy Appalachia, Ardmore Institute of Health, OhioHealth, Lifestyle Medicine Institute
- Responsible party
- Principal investigator, David Drozek, Ohio University
- Investigators
- David Drozek, DO, Principal investigator, Ohio University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03731481
- Sponsor's protocol ID
- 17-X-166
- Status last verified
- Nov 2019
- First submitted
- 31 Oct 2018
- Last updated
- 15 Nov 2019
- 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 15 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Effectiveness of Two Virtual Lifestyle Medicine Interventions Across Urban and Rural Settings
- ClinicalTrials.gov ID
- NCT03731481
- Acronym / sponsor ID
- 17-X-166
- Conditions
- Chronic Disease, Obesity, Sleep Disorder, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Ohio UniversityUniversity, hospital or other
- Collaborators
- Live Healthy Appalachia, Ardmore Institute of Health, OhioHealth, Lifestyle Medicine Institute
- Study start
- 31 May 2017 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 6 Nov 2018 (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.
This study evaluates the effectiveness of two online Lifestyle Medicine programs. Participants will be randomized by residence, urban vs. rural, into one of two Lifestyle Medicine programs.
Detailed description
This study compares the effectiveness of two virtual Lifestyle Medicine programs across two settings: urban and rural. Program materials include nutritional education, methods to reduce personal stress, and incorporation of physical activity in daily routine. Bio-marker and subjective/self-reported survey measures will be collected at baseline, 5-weeks and six-months from baseline. Study seeks to measure variations in participant outcomes across two lifestyle interventions, participant engagement and level of adherence.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Comparative effectiveness research of two interventions across four cohorts
| Arm | Type | Receives |
|---|---|---|
| CHIP - Urban | Experimental | Behavioral: Lifestyle MedicineParticipants randomized by urban location of residence to receive CHIP Lifestyle Medicine program intervention. |
| CHIP - Rural | Experimental | Behavioral: Lifestyle MedicineParticipants randomized by rural location of residence to receive CHIP Lifestyle Medicine program intervention. |
| FPD2- Urban | Experimental | Behavioral: Lifestyle MedicineParticipants randomized by urban location of residence to receive FPD2 Lifestyle Medicine program intervention. |
| FPD2 - Rural | Experimental | Behavioral: Lifestyle MedicineParticipants randomized by rural location of residence to receive FPD2 Lifestyle Medicine program intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years of age or older
- Able to read and write English
- Access to high-speed Internet
- Taking medication for at least one chronic disease condition such as high blood pressure, OR are overweight (BMI of 25 or greater)
- Willing to provide blood samples at three time points
Key exclusion criteria (3 listed)
- Advised by physician to limit physical activity
- Previous experience with lifestyle medicine programs, specifically Lifestyle Medicine Clinic, Complete Health Improvement Program, Full Plate Diet
- Household includes someone who has previous experience with a Lifestyle Medicine program
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 |
|---|---|---|
| Lifestyle MedicineLifestyle Medicine programs provide instruction in plant-based nutrition, food preparation, methods of stress reduction and incorporation of physical activity into daily routine. | Behavioural | CHIP - Rural, CHIP - Urban, FPD2 - Rural, FPD2- Urban |
Primary outcome
Level of participant engagement
Time frame: 6 months
Measure of number of sign-ins and class attendance
2 secondary outcomes
Chronic disease status
Time frame: Baseline, 5-weeks, and 6-months from baseline
Psychological status
Time frame: Baseline, 5-weeks, and 6-months from baseline
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 15 Nov 2019.
- Individual participant dataSharing planned: No
Related trials for Chronic Disease
Recruiting
Dietary Intervention for Migraine Relief
Migraine
RecruitingPhase 2
Neurovascular Regulation During Exercise in Humans With Chronic Kidney Disease: Sympatholysis in CKD
Chronic Kidney Disease
Not yet recruiting
Combined Versus Multicomponent Training in People With Chronic Kidney Disease Stages 3a and 3b
Chronic Kidney Disease Stage 3A, Chronic Kidney Disease Stage 3B
RecruitingPhase 3
A Follow-up Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia
Immune Thrombocytopenic Purpura (ITP)
Active, not recruitingPhase 3
Efficacy and Safety of Tezepelumab in Patients With Eosinophilic Esophagitis
Eosinophilic Esophagitis
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.
David Drozek, DO principal investigator
Ohio University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle Medicine in people with Chronic Disease and Obesity, run by Ohio University 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 6 inclusion and 3 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 15 Nov 2019. 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?
Level of participant engagement (time frame: 6 months). 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 15 Nov 2019.