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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01262768
Other study ID # 00010835
Secondary ID
Status Completed
Phase N/A
First received December 16, 2010
Last updated February 19, 2014
Start date April 2010
Est. completion date January 2014

Study information

Verified date February 2014
Source University of Alberta
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Interventional

Clinical Trial Summary

Portion size measurement aids (PSMAs) are tools that facilitate the estimation of food servings. The objectives of this study are to determine (a) if food portion size estimation accuracy differs when using a two dimensional (2D) PSMA (actual-size photos called Portion Size Cards) compared to a 3D PSMA (Portion Size Kit) and (b) whether differences exist in the short-term usefulness of and satisfaction with these PSMAs in a sample of parents of overweight children and youth. We hypothesize that the group that receives the 3D PSMAs will be more accurate in food portion size estimation and will be more satisfied with the tool compared to the group that receives the 2D PSMAs.


Description:

Forty primary caregivers of overweight children and youth attending the Pediatric Centre for Weight and Health (Edmonton, AB) will be recruited. Participants will be randomly assigned to one of the two groups (2D PSMAs versus 3D PSMAs). After a brief explanation of the respective tool, participants will estimate the volumes of pre-measured rubber food portion models on a test plate. Participants will then be given the 2D or 3D PSMAs to take home with them to use in the real-world. After 2-4 weeks, participants will be telephoned by the research team to complete a brief survey to evaluate their usefulness of and satisfaction with the 2D or 3D PSMAs at home.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date January 2014
Est. primary completion date September 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Participants must be primary caregivers of children or youth attending a clinical appointment for weight management (clients must have a BMI greater or equal to the 85th percentile at this clinic)

- Participants must be literate and fluent in English

Exclusion Criteria:

- Any participant who does not meet the above criteria

- Participants must not have had any previous education or resources on food portion sizes at this clinic

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Portion Size Measurement Aids (PSMAs)
Subjects are randomly assigned to receive either 2D or 3D PSMAs to examine accuracy, acceptability and usefulness of the models. Both groups receive brief instructions on the use of the respective PSMAs, complete an accuracy estimation task, and are given the 2D or 3D PSMAs to take home with them to use for 2-4 weeks, after which the researchers telephone parents to complete a brief satisfaction and usefulness survey.

Locations

Country Name City State
Canada Pediatric Centre for Weight and Health- Edmonton General Continuing Care Centre Edmonton Alberta

Sponsors (1)

Lead Sponsor Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Accuracy of food portion size estimation During the initial interview, the subject receives a brief description of the task and is shown pre-estimated rubber food models. The subject then estimates the portion sizes (volumes) of the rubber food models using either 2D or 3D PSMAs. At the time of subject interview (single time point) No
Secondary Acceptability (satisfaction and usefulness) of 2D and 3D PSMAs After the intial interview, subjects are given either 2D or 3D PSMAs to take home with them to use in a real-world setting. After 2-4 weeks, the researcher team contacts the subjects to complete a brief telephone interview to determine parental satisfaction and usefulness regarding the 2D or 3D PSMAs. 2-4 weeks following the accuracy assessment No
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