Randomized Trial of the Impact of Body Scanning and Intensive Behavioral Intervention on Behavioral Change and Health Outcomes
1 other identifier
interventional
267
0 countries
N/A
Brief 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 beneficial lifestyle behaviors, as well as possibly reduced risk of disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2012
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 15, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 20, 2015
CompletedFirst Submitted
Initial submission to the registry
December 29, 2017
CompletedFirst Posted
Study publicly available on registry
January 5, 2018
CompletedJanuary 5, 2018
December 1, 2017
3.3 years
December 29, 2017
December 29, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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.
2 years
Secondary Outcomes (1)
Epicardial and Thoracic fat volume (in cm3)
2 years
Study Arms (2)
Behavioral Intervention arm
ACTIVE COMPARATORA 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 COMPARATORNo Intervention
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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) -
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Masking Details
- The staff doing the end point assessment were blinded as to treatment assignment.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 29, 2017
First Posted
January 5, 2018
Study Start
June 15, 2012
Primary Completion
September 15, 2015
Study Completion
November 20, 2015
Last Updated
January 5, 2018
Record last verified: 2017-12
Data Sharing
- IPD Sharing
- Will not share