Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001091392
Ethics application status
Approved
Date submitted
21/07/2017
Date registered
27/07/2017
Date last updated
21/01/2022
Date data sharing statement initially provided
21/01/2022
Date results provided
21/01/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Using cognitive interviews with parents to improve the design of short food questions measuring young children’s food intake
Scientific title
Using cognitive interviews with parents to improve the design of short food questions measuring young children’s food intake
Secondary ID [1] 292432 0
Centre of Research Excellence in the Early Prevention of Obesity in Childhood
NHMRC CRE 1101675
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dietary intake 304027 0
Childhood obesity 304028 0
Condition category
Condition code
Diet and Nutrition 303357 303357 0 0
Obesity

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study will use semi-structured cognitive interviews, combining think-aloud and retrospective probing question approaches to evaluate question comprehension and recall strategies used by parents of 3-7 year old children when responding to questions about their child’s dietary intake. The length of the interview will be approximately 60 minutes.

The measurement of four food groups will be evaluated: discretionary foods, grains and cereals, meat and vegetables. To reduce interview length and participant burden, not all food groups will be evaluated in all interviews. All participants will answer questions about discretionary foods. The remaining food groups will be randomised, so that each participant will answer a question about two of the three other food groups. The order in which the food groups are presented will also be randomised.

Firstly, participants will ‘think-aloud’ as they answer a selection of short food questions for one food group. They will be encouraged by the interviewer to vocalise all of their thoughts as they complete the questions about their child’s dietary intake. Secondly, retrospective probing questions will be asked to gain further understanding of areas of interest, for example:
- Was the question understood as intended?
- What recall strategies were employed to come to an answer?
- What specific foods, meal occasions, other factors were considered?
- Were portion size and/or serving size considered, and if so how?
This process will be repeated for the other two food groups allocated to the participant.
At the completion of the think-aloud and probing for all three food groups, the participant will be presented with different approaches for asking questions about one food group and asked to indicate their preference and provide feedback.

Selected questions from three dietary instruments will be evaluated: (1) Short Food Survey (38-item questionnaire measuring usual food intake, variety and behaviours), (2) Child Diet Questionnaire (28-item questionnaire measuring obesity-related food intake over the previous 7-days), and (3) Pre-schooler dietary questionnaire (19-item questionnaire measuring dietary intake over the previous seven days). The format of questions from these instruments differs according to whether portion size is included in the question, completeness of foods listed within questions for each food group, and time frame (usual intake versus specified 7-day period). The ‘type’ of question presented will also be randomised, so that the interviewee receives one question from each of the food groups from each of the questionnaires.
Intervention code [1] 298606 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 302751 0
Comprehension of short food questions, assessed by analysis of transcribed semi-structured interviews
Timepoint [1] 302751 0
At time of interview
Primary outcome [2] 302752 0
Recall strategies used to arrive at answer, assessed by analysis of transcribed semi-structured interviews
Timepoint [2] 302752 0
At time of interview
Primary outcome [3] 302754 0
Consideration of portion size and/or serving size, assessed by analysis of transcribed semi-structured interviews
Timepoint [3] 302754 0
At time of interview
Secondary outcome [1] 336904 0
Recall of foods consumed in mixed meals, assessed by analysis of transcribed semi-structured interviews
Timepoint [1] 336904 0
At time of interview
Secondary outcome [2] 336905 0
Preferred short food question format, assessed by analysis of transcribed semi-structured interviews
Timepoint [2] 336905 0
At time of interview
Secondary outcome [3] 337188 0
Suitability of response options, assessed by analysis of transcribed semi-structured interviews
Timepoint [3] 337188 0
At time of interview
Secondary outcome [4] 337189 0
Problems encountered when completing short food questions, assessed by analysis of transcribed semi-structured interviews
Timepoint [4] 337189 0
At time of interview

Eligibility
Key inclusion criteria
- Parents or primary caregiver (responsible for child feeding) with one or more children aged 3-7 years.
- Parents of vegetarians/vegans will be included, and will not be asked questions about meat intake.
- Sufficient English fluency to undertake an interview.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Parents of children with conditions which effect their eating will be excluded. For example food intolerances or allergies, Coeliac Disease, Type 1 Diabetes, Cystic Fibrosis.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
A sample size of 30-60 participants is required based on cognitive interviewing recommendations of 5-15 participants per interviewing round (each of the 4 food groups evaluated is considered as one interviewing round) and the sample size of existing studies (n=23-4) using cognitive interviewing techniques to evaluate dietary questionnaires. Interviews will be conducted until data saturation, not exceeding 60 interviews in total.

All interviews will be transcribed verbatim. A combined deductive and inductive approach will be used to manually code interview data. A preliminary list of themes for coding will be determined from the semi-structured interview questions. Initially, two interviews will be coded separately by two researchers, and coding will be compared and discussed by the research team to reach a consensus for a list of themes against which the remaining interviews will be coded. Throughout coding of the remaining interviews, additional emerging themes will be identified.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
23/06/2017
Date of last participant enrolment
Anticipated
30/11/2017
Actual
23/11/2017
Date of last data collection
Anticipated
22/12/2017
Actual
23/11/2017
Sample size
Target
30
Accrual to date
Final
21
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 296991 0
Government body
Name [1] 296991 0
NHMRC Centre of Research Excellence - Centre of Research Excellence in the Early Prevention of Obesity in Childhood
Country [1] 296991 0
Australia
Funding source category [2] 297059 0
University
Name [2] 297059 0
University of South Australia
Country [2] 297059 0
Australia
Primary sponsor type
Individual
Name
Dr Dorota Zarnowiecki
Address
School of Pharmacy and Medical Sciences,
University of South Australia,
City East Campus, Frome Road,
Adelaide, SA, 5000.
Postal address: GPO Box 2471, Adelaide, SA, 5001
Country
Australia
Secondary sponsor category [1] 296064 0
Individual
Name [1] 296064 0
Dr Rebecca Golley
Address [1] 296064 0
School of Pharmacy and Medical Sciences,
University of South Australia,
City East Campus, Frome Road,
Adelaide, SA, 5000.
Postal address: GPO Box 2471, Adelaide, SA, 5001
Country [1] 296064 0
Australia
Other collaborator category [1] 279651 0
Individual
Name [1] 279651 0
Dr Lucy Bell
Address [1] 279651 0
School of Pharmacy and Medical Sciences,
University of South Australia,
City East Campus, Frome Road,
Adelaide, SA, 5000.
Postal address: GPO Box 2471, Adelaide, SA, 5001
Country [1] 279651 0
Australia
Other collaborator category [2] 279652 0
Individual
Name [2] 279652 0
Dr Rebecca Byrne
Address [2] 279652 0
School of Exercise and Nutrition Sciences
Queensland University of Technology
Level 6, Centre for Children’s Health Research (LCCH)
62 Graham St, South Brisbane, QLD 4010
Country [2] 279652 0
Australia
Other collaborator category [3] 279653 0
Individual
Name [3] 279653 0
Professor Stewart Trost
Address [3] 279653 0
School of Exercise and Nutrition Sciences
Queensland University of Technology
Level 6, Centre for Children’s Health Research (LCCH)
62 Graham St, South Brisbane, QLD 4010
Country [3] 279653 0
Australia
Other collaborator category [4] 279654 0
Other Collaborative groups
Name [4] 279654 0
The Centre of Research Excellence in the Early Prevention of Obesity in Childhood (EPOCH CRE)
Address [4] 279654 0
Prevention Research Collaboration
School of Public Health
Level 6, Charles Perkins Centre
University of Sydney
Sydney, NSW 2006
Country [4] 279654 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298189 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 298189 0
Ethics committee country [1] 298189 0
Australia
Date submitted for ethics approval [1] 298189 0
21/05/2017
Approval date [1] 298189 0
16/06/2017
Ethics approval number [1] 298189 0
200014

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 76270 0
Dr Dorota Zarnowiecki
Address 76270 0
School of Pharmacy and Medical Science
University of South Australia
GPO Box 2471
Adelaide SA 5001
Country 76270 0
Australia
Phone 76270 0
+61 8 8302 2501
Fax 76270 0
Email 76270 0
[email protected]
Contact person for public queries
Name 76271 0
Dorota Zarnowiecki
Address 76271 0
School of Pharmacy and Medical Science
University of South Australia
GPO Box 2471
Adelaide SA 5001
Country 76271 0
Australia
Phone 76271 0
+61 8 8302 2501
Fax 76271 0
Email 76271 0
[email protected]
Contact person for scientific queries
Name 76272 0
Dorota Zarnowiecki
Address 76272 0
School of Pharmacy and Medical Science
University of South Australia
GPO Box 2471
Adelaide SA 5001
Country 76272 0
Australia
Phone 76272 0
+61 8 8302 2501
Fax 76272 0
Email 76272 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.