The Impact of Portion Plates for Weight Loss on Cardiac Rehabilitation Patients
1 other identifier
interventional
90
1 country
1
Brief Summary
The study will involve cardiac rehabilitation clients and will measure their weight, height, waist circumference and blood pressure comparisons between first and final visit (after 8 weeks). A control group will receive usual care and an experimental group will receive usual care plus a portion control plate for their meals. Patients currently have their waist circumference, weight, height and blood pressure measured at their first visit (week 0) and at their final visit (week 8). This study would compare these three parameters at these same times (week 0 and week 8) between the control and experimental groups. The control group would receive the usual care while the experimental group would receive usual care plus be given a portion control plate at week 0. The hypothesis of this study is that subjects from the experimental group will have an average reduction in: (a) waist circumference by \> 5%, (b) weight or BMI by \> 5%, and (c) systolic and diastolic blood pressure by \>10%. The subjects in the control group are hypothesized to show an average less than these targets for the experimental group.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 20, 2010
CompletedFirst Posted
Study publicly available on registry
January 22, 2010
CompletedStudy Start
First participant enrolled
February 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedJanuary 22, 2010
January 1, 2010
1 year
January 20, 2010
January 20, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reduce waist circumference by 5% or more in intervention group
8 weeks
Secondary Outcomes (2)
Reduce weight or BMI by 5% or more in intervention group
8 weeks
Reduce diastolic and systolic blood pressure by 10% or more in intervention group
8 weeks
Study Arms (1)
Standard nutrition cardiac care
NO INTERVENTIONPatients will receive standard care of group nutrition counselling and individual counselling if requested
Interventions
Patients in the experimental group will be provided with standard care (group and individual nutrition counselling) plus be provided a portion control plate
Eligibility Criteria
You may qualify if:
- patients attending the cardiac rehab program who have a waist circumference of more than 102 cm (males) and 89 cm (females)
You may not qualify if:
- any patients with a waist circumference below the above levels
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Richmond Health Services, Cardiac Rehabilitation
Richmond, British Columbia, V6X 1A2, Canada
MeSH Terms
Conditions
Study Officials
- STUDY DIRECTOR
Monica Redekopp, BSN, PhD
Richmond Health Services
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
January 20, 2010
First Posted
January 22, 2010
Study Start
February 1, 2010
Primary Completion
February 1, 2011
Study Completion
February 1, 2011
Last Updated
January 22, 2010
Record last verified: 2010-01