Nutrition AssessmentPSMANCT01262768
Efficacy of Portion Size Measurement Aids
A study testing Portion Size Measurement Aids (PSMAs) in people with Nutrition Assessment and Obesity, run by University of Alberta at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Nutrition Assessment, Obesity
- What is being tested?
- Portion Size Measurement Aids (PSMAs)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2010to Jan 2014
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Pediatric Centre for Weight and Health- Edmonton General Continuing Care Centre
Edmonton, Alberta, T6K 0L4
About this study
Official title: Exploring the Accuracy and Acceptability of Portion Size Measurement Aids in Parents of Overweight Children
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.
Read the detailed 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.
- Conditions
- Nutrition Assessment, Obesity
- Being tested
- Portion Size Measurement Aids (PSMAs)
- Keywords
- Nutrition, Obesity, Parent, Portion Size Estimation, Accuracy
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Portion Size Measurement Aids (PSMAs)Behavioural
Also called 2D Portion Size Measurement Aids (PSMAs), 3D 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.
| Study group | Role | What they receive |
|---|---|---|
| 2D Portion Size Measurment Aids (PSMAs) | Experimental | The 2D PSMAs are life-size photographs of the 3D PSMAs. Receives: Behavioral: Portion Size Measurement Aids (PSMAs) |
| 3D Portion Size Measurement Aids (PSMAs) | Experimental | The 3D PSMAs include foam rubber replicas of a golf ball, a hockey puck, a tennis ball and a baseball. Receives: Behavioral: Portion Size Measurement Aids (PSMAs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the time of subject interview (single time point)
Secondary outcomes (1)
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.
Measured: 2-4 weeks following the accuracy assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2010 (estimated)
- Study startApr 2010
- Primary completionSep 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrition AssessmentStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Geoff Ball, University of Alberta
- Investigators
- Geoff DC Ball, PhD, RD, Principal investigator, Department of Pediatrics, University of Alberta; Director, Pediatric Centre for Weight and Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01262768
- Sponsor's protocol ID
- 00010835
- Acronym
- PSMA
- Status last verified
- Feb 2014
- First submitted
- 16 Dec 2010
- Last updated
- 20 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Accuracy and Acceptability of Portion Size Measurement Aids in Parents of Overweight Children
- ClinicalTrials.gov ID
- NCT01262768
- Acronym / sponsor ID
- PSMA / 00010835
- Conditions
- Nutrition Assessment, Obesity
- Keywords
- Nutrition, Obesity, Parent, Portion Size Estimation, Accuracy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Sep 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 17 Dec 2010 (estimated)
- 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.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2D Portion Size Measurment Aids (PSMAs) | Experimental | Behavioral: Portion Size Measurement Aids (PSMAs)The 2D PSMAs are life-size photographs of the 3D PSMAs. |
| 3D Portion Size Measurement Aids (PSMAs) | Experimental | Behavioral: Portion Size Measurement Aids (PSMAs)The 3D PSMAs include foam rubber replicas of a golf ball, a hockey puck, a tennis ball and a baseball. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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
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 |
|---|---|---|
| Portion Size Measurement Aids (PSMAs)Also: 2D Portion Size Measurement Aids (PSMAs), 3D 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. | Behavioural | 2D Portion Size Measurment Aids (PSMAs), 3D Portion Size Measurement Aids (PSMAs) |
Primary outcome
Accuracy of food portion size estimation
Time frame: At the time of subject interview (single time point)
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.
1 secondary outcome
Acceptability (satisfaction and usefulness) of 2D and 3D PSMAs
Time frame: 2-4 weeks following the accuracy assessment
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 20 Feb 2014.
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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.
Geoff DC Ball, PhD, RD principal investigator
Department of Pediatrics, University of Alberta; Director, Pediatric Centre for Weight and Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Portion Size Measurement Aids (PSMAs) in people with Nutrition Assessment and Obesity, run by University of Alberta at 1 site in Canada.
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 2 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 20 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Accuracy of food portion size estimation (time frame: At the time of subject interview (single time point)). 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 20 Feb 2014.