Text Size

The Impact of Portion Plates for Weight Loss on Cardiac Rehabilitation Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Richmond Health Services.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Richmond Health Services
ClinicalTrials.gov Identifier:
NCT01054040
First received: January 20, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted
  Purpose

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.


Condition Intervention
Cardiovascular Disease
 Other: Portion plate given to cardiac rehabilitation patients

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: The Impact of Portion Plates for Weight Loss on Cardiac Rehabilitation Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Richmond Health Services:

Primary Outcome Measures:
  • Reduce waist circumference by 5% or more in intervention group [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reduce weight or BMI by 5% or more in intervention group [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Reduce diastolic and systolic blood pressure by 10% or more in intervention group [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: February 2010
Estimated Study Completion Date: February 2011
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Standard nutrition cardiac care
Patients will receive standard care of group nutrition counselling and individual counselling if requested
 Other: Portion plate given to cardiac rehabilitation patients
Patients in the experimental group will be provided with standard care (group and individual nutrition counselling) plus be provided a portion control plate
Other Name: Divided portion control plate from StepsCount

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients attending the cardiac rehab program who have a waist circumference of more than 102 cm (males) and 89 cm (females)

Exclusion Criteria:

  • any patients with a waist circumference below the above levels
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01054040

Contacts
Contact: Mary Flesher, BSc(Diet) MA 604-278-9711 ext 4125 mary.flesher@vch.ca
Contact: Jessica Begg, BSc (Diet) 604-278-9711 ext 4111 jessica.begg@vch.ca

Locations
Canada, British Columbia
Richmond Health Services, Cardiac Rehabilitation Not yet recruiting
Richmond, British Columbia, Canada, V6X 1A2
Contact: Mary Flesher, BSc(Diet) MA     604-278-9711 ext 4125     mary.flesher@vch.ca    
Contact: Jessica Begg, BSc(Diet)     604-278-9711 ext 4111     jessica.begg@vch.ca    
Sub-Investigator: Joan Prescesky, BSN            
Sub-Investigator: Ronda Field, PT            
Sponsors and Collaborators
Richmond Health Services
Investigators
Study Director: Monica Redekopp, BSN, PhD Richmond Health Services
  More Information

No publications provided

Responsible Party: Mary Flesher, Richmond Health Services
ClinicalTrials.gov Identifier: NCT01054040     History of Changes
Other Study ID Numbers: H09-03467 (UBC Ethics Board)
Study First Received: January 20, 2010
Last Updated: January 20, 2010
Health Authority: Canada: Ethics Review Committee

Keywords provided by Richmond Health Services:
cardiovascular disease, portion plate

Additional relevant MeSH terms:
Cardiovascular Diseases
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013