Coronary DiseaseNCT03392350
Randomized Trial of the Impact of Body Scanning and Intensive Behavioral Intervention on Behavioral Change and Health Outcomes
A study testing Physician Body Scan Consultation with Behavioral Intervention in people with Coronary Disease and Behavior and Behavior Mechanisms, run by Reengineering Healthcare Inc..
Trial summary
We evaluated the effectiveness of a combination of a comprehensive health assessment consisting of the combination of a screening full body scan employing graphic patient education and motivational techniques followed by intensive, individualized behavioral training and management program on improved adherence to… Read more about this study
- Who is it for?
- Ages 35 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronary Disease, Behavior and Behavior Mechanisms, Hypertension
- What is being tested?
- Physician Body Scan Consultation with Behavioral Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 267 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2012to 20 Nov 2015
- 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 35 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men or women aged 35 and over who provide informed consent to participate including the baseline, interim, and follow-up clinic visits, as well as willingness to participate in the on-line intervention (if selected to be in that group) -
Who cannot join
- Known cardiovascular disease, cancer, or any life-threatening or debilitating illness, including psychiatric illnesses, or significant difficulty with the English language that would preclude successful participation in the program
- -
About this study
We evaluated the effectiveness of a combination of a comprehensive health assessment consisting of the combination of a screening full body scan employing graphic patient education and motivational techniques followed by intensive, individualized behavioral training and management program on improved adherence to beneficial lifestyle behaviors, as well as possibly reduced risk of disease.
Read the detailed description
We initially enrolled 267 volunteer asymptomatic adults consisting of firefighters/police workers (n= 173), active military personnel (n= 57) and community college staff (n= 37). Subjects were randomized either to an intervention group or to usual care. The intervention group received The RENEW™ Program (www.therenewprogram.net) of lifestyle intervention as described below. A whole body CT scan was performed using a multidetector CT scan on all participants at baseline with the results discussed by a physician only in the intervention group, and after 2 years of follow-up a repeat scan was performed with a detailed evaluation of the results discussed by a physician with all participants (in part as a motivation to complete thestudy). This study was carried out in accordance with the recommendations of the Western Institutional Review Board with written informed consent from all subjects. All subjects gavewritten informed consent in accordance with the Declaration of Helsinki. The protocol wasapproved by the Western Institutional Review Board.
- Being tested
- Physician Body Scan Consultation with Behavioral Intervention
- Medical subject headings
- Coronary Disease, Behavior, Hypertension, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physician Body Scan Consultation with Behavioral InterventionBehavioural
The RENEW™ program consisted of 7 bi-monthly face-to-face web sessions over 16-18 weeks followed by an average of 15 monthly check-in sessions (maintenance) over 80 weeks.This included modules on responding to stress, enhancing effects of relaxation, nourishing theimmune system, physical activity, and social support.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Intervention arm | Active comparator | A behavioral intervention consisting of a physician body scan consultation with a radiologist which included viewing self imagery followed by an 18 month behavioral intervention which included educational modules covering:
Responding to Stress More Effectively Enhancing the effects of Relaxation Nourishing your immune system Energizing your Body Welcoming Others and Strengthening Relationships Receives: Behavioral: Physician Body Scan Consultation with Behavioral Intervention |
| Control Group | Active comparator | No Intervention Receives: Behavioral: Physician Body Scan Consultation with Behavioral Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression of Coronary Artery Calcium
Coronary artery calcium (CAC) was assessed by a trained technologist with the Agatston score measured and volume score calculated, summed among the four major coronary arteries using conventional methods.
Measured: 2 years
Secondary outcomes (1)
Epicardial and Thoracic fat volume (in cm3)
The QFAT™ software was utilized to provide measures of epicardial and thoracic fat volume (in cm3) as described previously (20) in a subset of participants who had the required Dicom-archived CT scan data both pre and post intervention
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2018
- Study start15 Jun 2012
- Primary completion15 Sep 2015
- Study completion20 Nov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- One Control group one Intervention arm. The intervention group are the only subjects receiving a body scan consultation and behavioral intervention.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 267 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reengineering Healthcare Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03392350
- Sponsor's protocol ID
- 20111268
- Status last verified
- Dec 2017
- First submitted
- 29 Dec 2017
- Last updated
- 5 Jan 2018
- 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 5 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of the Impact of Body Scanning and Intensive Behavioral Intervention on Behavioral Change and Health Outcomes
- ClinicalTrials.gov ID
- NCT03392350
- Acronym / sponsor ID
- 20111268
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 267 participants (actual)
- Lead sponsor
- Reengineering Healthcare Inc.University, hospital or other
- Study start
- 15 Jun 2012 (actual)
- Primary completion
- 15 Sep 2015 (actual)
- Study completion
- 20 Nov 2015 (actual)
- First posted
- 5 Jan 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.
We evaluated the effectiveness of a combination of a comprehensive health assessment consisting of the combination of a screening full body scan employing graphic patient education and motivational techniques followed by intensive, individualized behavioral training and management program on improved adherence to beneficial lifestyle behaviors, as well as possibly reduced risk of disease.
Detailed description
We initially enrolled 267 volunteer asymptomatic adults consisting of firefighters/police workers (n= 173), active military personnel (n= 57) and community college staff (n= 37). Subjects were randomized either to an intervention group or to usual care. The intervention group received The RENEW™ Program (www.therenewprogram.net) of lifestyle intervention as described below. A whole body CT scan was performed using a multidetector CT scan on all participants at baseline with the results discussed by a physician only in the intervention group, and after 2 years of follow-up a repeat scan was performed with a detailed evaluation of the results discussed by a physician with all participants (in part as a motivation to complete thestudy). This study was carried out in accordance with the recommendations of the Western Institutional Review Board with written informed consent from all subjects. All subjects gavewritten informed consent in accordance with the Declaration of Helsinki. The protocol wasapproved by the Western Institutional Review Board.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- One Control group one Intervention arm. The intervention group are the only subjects receiving a body scan consultation and behavioral intervention.
| Arm | Type | Receives |
|---|---|---|
| Behavioral Intervention arm | Active comparator | Behavioral: Physician Body Scan Consultation with Behavioral InterventionA behavioral intervention consisting of a physician body scan consultation with a radiologist which included viewing self imagery followed by an 18 month behavioral intervention which included educational modules covering: Responding to Stress More Effectively Enhancing the effects of Relaxation Nourishing your immune system Energizing your Body Welcoming Others and Strengthening Relationships |
| Control Group | Active comparator | Behavioral: Physician Body Scan Consultation with Behavioral InterventionNo Intervention |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Men or women aged 35 and over who provide informed consent to participate including the baseline, interim, and follow-up clinic visits, as well as willingness to participate in the on-line intervention (if selected to be in that group) -
Key exclusion criteria (2 listed)
- Known cardiovascular disease, cancer, or any life-threatening or debilitating illness, including psychiatric illnesses, or significant difficulty with the English language that would preclude successful participation in the 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 |
|---|---|---|
| Physician Body Scan Consultation with Behavioral InterventionThe RENEW™ program consisted of 7 bi-monthly face-to-face web sessions over 16-18 weeks followed by an average of 15 monthly check-in sessions (maintenance) over 80 weeks.This included modules on responding to stress, enhancing effects of relaxation, nourishing theimmune system, physical activity, and social support. | Behavioural | Behavioral Intervention arm, Control Group |
Primary outcome
Progression of Coronary Artery Calcium
Time frame: 2 years
Coronary artery calcium (CAC) was assessed by a trained technologist with the Agatston score measured and volume score calculated, summed among the four major coronary arteries using conventional methods.
1 secondary outcome
Epicardial and Thoracic fat volume (in cm3)
Time frame: 2 years
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 5 Jan 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Physician Body Scan Consultation with Behavioral Intervention in people with Coronary Disease and Behavior and Behavior Mechanisms, run by Reengineering Healthcare Inc..
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 1 inclusion and 2 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 5 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Progression of Coronary Artery Calcium (time frame: 2 years). 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 5 Jan 2018.