Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000774921
Ethics application status
Approved
Date submitted
18/05/2020
Date registered
28/07/2020
Date last updated
28/07/2020
Date data sharing statement initially provided
28/07/2020
Date results provided
28/07/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pictorial calendar for adherence to complementary feeding (PiC-Feed)
Scientific title
Acceptability and validity of pictorial calendar for reporting adherence to recommended complementary feeding practices among mothers with low literacy in Bangladesh slums
Secondary ID [1] 301306 0
None
Universal Trial Number (UTN)
Trial acronym
PiC-Feed
Linked study record
NCT04067284
This record was a pilot study of one of the intervention components (pictorial calendar) of NCT04067284.

Health condition
Health condition(s) or problem(s) studied:
Complementary feeding 317492 0
Child malnutrition 317493 0
Condition category
Condition code
Diet and Nutrition 315594 315594 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Education Session: Control and Intervention Arms
The education session was conducted by the Research Assistant (RA), which was about an hour in duration. We adapted behavioural recommendations from previous successful intervention in this population, the WASH Benefits Bangladesh trial and UNICEF’s complementary feeding guidelines. The nutrition education messages were delivered at households using illustrative flip charts, in one face to face meeting with both parents.
Messages emphasized the following:
• Continued breastfeeding until two years of age
• Food groups
• Balanced diet
• Introduction to locally available nutritious and low-cost foods
• Amount and frequency of complementary feeding
• Safe water, and
• Handwashing with soap before feeding

Pictorial calendar: Intervention Arm
Following the one hour nutrition education session mothers were supplied with a pictorial calendar kit. It took another 15-30 minutes to explain the calendar to the mothers.
The calendar itself had two parts: first part was a usual calendar. The second part of it was the pictures of different food groups, which we added to the calendar. The second component of this kit was the colored dots. There were four colored stickers that the mothers had to add to the calendar every day.
The colors represented food groups that were illustrated in the calendar:
• Yellow=energy yielding foods (rice, bread, oil, potato)
• Red=body building foods (fish, meat, egg, milk, lentil)
• Green=protective foods and (fruits and vegetables)
• Blue=breastfeeding
The RA described to the mothers how and when to fill out the calendar. The RA made sure that the mothers felt confident about filling out the calendar. Mothers were asked to start filling out the calendar in the morning. One particular day in the pictorial calendar started in the morning and ended up on the next morning. Mothers were encouraged to check for completeness of the calendar next morning before starting a new day.
The RA made an informal visit to the households within a day or two after the household meeting to check if they were comfortable filling out the calendar. The mothers were to fill out the calendar everyday for 4 weeks.
Intervention code [1] 317608 0
Behaviour
Comparator / control treatment
Control: This group of mothers received only the one-hour educational session as described above but no pictorial calendar. At the end of the study that is after 4 weeks of intervention period, control mothers also received the calendar kit and were demonstrated how to fill it out.
Control group
Active

Outcomes
Primary outcome [1] 323828 0
Minimum dietary diversity (MDD) score
According to WHO guidelines, we created 7 food groups using the infant food frequency (FFQ) questionnaire. Minimum dietary diversity (MDD) score for children 6-23 months old was calculated by summing all the seven food groups: grains, legumes and nuts, dairy products, flesh foods, eggs, vitamin-A rich fruits and vegetables and other fruits and vegetables. Adequate MDD was coded as 1 if children aged 6-23 months old consumed 4 or more different food groups in past 24 hours and inadequate MDD was classified as 0 if children aged 6-23 months old consumed less than 4 different food groups.
Timepoint [1] 323828 0
Dietary diversity was measured twice at random days during the 4-weeks study period.
Primary outcome [2] 324114 0
Minimum Meal Frequency (MMF)
MMF was measured using the WHO guideline for infant feeding. MMF is the proportion of breastfed and non-breastfed children 6-23.9 months of age who receive solid, semi-solid, or soft foods or milk feeds the minimum number of times or more.
Minimum meal frequency is defined:
2 times for breastfed infants 6–8 months
3 times for breastfed children 9–23 months
4 times for non-breastfed children 6–23 months
We used WHO Infant Food Frequency Questionnaire to assess the breastfeeding status of the children and dietary diversity. According to the questionnaire, mother was asked if the child was completely wined or still breastfeeding. Dietary diversity was measured using 24-hour recall and 7-days recall.
Timepoint [2] 324114 0
Dietary diversity was measured twice at random days during the 4-weeks study period along with MDD.
Secondary outcome [1] 383002 0
Knowledge assessment
Knowledge assessment: at the end of the study, after one month of the initial nutrition education session, mothers in both the study arms were asked to identify pictures of foods from different food groups presented in the printed questionnaire. Knowledge regarding food groups was assessed by the average number of right or wrong answers for each food groups at post intervention only.
Food groups presented in the nutrition education session was adopted from a large scale randomized control trial, the WASH Benefits study (http://www.washbenefits.net/). The specific questionnaire used in this study was designed for this study only.
Timepoint [1] 383002 0
At the end of 4 weeks.
Secondary outcome [2] 383795 0
Completeness of the calendar:
Was assessed by estimating proportion of number of blank dates on the calendar.
Timepoint [2] 383795 0
At the end of 4 weeks.
Secondary outcome [3] 383796 0
Agreement of the calendar with the FFQ data:
We calculated percent agreement between infant FFQ and pictorial calendar. Kappa statistics could not be estimated due to absence of variability in FFQ data.
Timepoint [3] 383796 0
At the end of 4 weeks.
Secondary outcome [4] 383797 0
In-depth interview (IDI):
We interviewed mothers to assess their experiences about the pictorial calendar through a semi-structured in-depth interview (IDI). The interview was conducted in a face-to-face session at the participant's household. The interviews were within 30-minutes duration and were audio recorded.
Timepoint [4] 383797 0
At the end of 4 weeks.

Eligibility
Key inclusion criteria
Inclusion criteria for both groups:
1. Mothers with child aged 6-23 months irrespective of gender of the child
2. All religion, language and ethnicity
3. Mothers with child born through normal delivery or caesarean section
4. Mothers with breastfeeding or non-breastfeeding child
5. Mothers with no or low educational attainment (less than or up to 5 years of completed education)
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Infants with any major congenital abnormality
2. Infants with any chronic conditions

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
allocation involved contacting the holder of the allocation schedule who was "off-site" or at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using the excel random number procedure
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Quantitative
According to World Bank, poverty level was calculated using monthly household income and number of household members. The bank defined extreme poverty as living on less than USD 1.90/day in terms of 2011 purchasing power parity. Descriptive statistics was done to present the demographic characteristics of the participants.
According to WHO guidelines, we created 7 food groups using the infant food frequency (FFQ) questionnaire. Minimum dietary diversity (MDD) score for children 6-23 months old was calculated by summing all the seven food items: grains, legumes and nuts, dairy products, flesh foods, eggs, vitamin-A rich fruits and vegetables and other fruits and vegetables. Adequate MDD was coded as 1 if children aged 6-23 months old consumed 4 or more different food groups in past 24 hours and inadequate MDD was classified as 0 if children aged 6-23 months old consumed less than 4 different food groups. MDD for 7-days was defined as proportion of index children who consumed foods from 4 or more groups at all days in past 7-days. In addition to the MDD, we measured consumption of animal source protein in past 24-hours and all days in past 7-days. Animal source protein included all kind of meat including organ meat, fresh or dry fish, eggs, milk and milk products.
Initially, we created frequency tabulations of all characteristic variables followed by descriptive analyses that summarised the participant characteristics at week 2 and week 4 using chi-squared and t-test to test the significance of associations with p<0.05 considered significant. We used generalised estimation equations (GEE) with a log link and binomial family that adjusted for within-person correlation and the effects of time.
Knowledge regarding food groups was assessed by the average number of right or wrong answers for each food groups at post intervention only. Intervention arm was compared to control using independent sample t-test. Completeness of the calendar was assessed by estimating proportion of number of blank dates on the calendar. We calculated percent agreement between infant FFQ and pictorial calendar. Kappa statistics could not be estimated due to absence of variability in FFQ data.
Qualitative
We interviewed mothers to assess their experiences about the pictorial calendar through a semi-structured in-depth interview (IDI). We interviewed mothers until we reached a state of data saturation. All interviews were summarized thematically.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
10/04/2018
Date of last participant enrolment
Anticipated
Actual
28/04/2018
Date of last data collection
Anticipated
Actual
14/06/2018
Sample size
Target
30
Accrual to date
Final
34
Recruitment outside Australia
Country [1] 22562 0
Bangladesh
State/province [1] 22562 0
Dhaka

Funding & Sponsors
Funding source category [1] 305745 0
University
Name [1] 305745 0
Merom Dafna Research Account, Western Sydney University
Country [1] 305745 0
Australia
Primary sponsor type
Individual
Name
Professor Dafna Merom
Address
Western Sydney University
24.2.33
Narellan Rd & Gilchrist Dr, Campbelltown NSW 2560, Australia
Country
Australia
Secondary sponsor category [1] 306175 0
None
Name [1] 306175 0
Address [1] 306175 0
Country [1] 306175 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306020 0
Western Sydney University Human Research Ethics Committee
Ethics committee address [1] 306020 0
Ethics committee country [1] 306020 0
Australia
Date submitted for ethics approval [1] 306020 0
Approval date [1] 306020 0
09/04/2018
Ethics approval number [1] 306020 0
H12630

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

Contacts
Principal investigator
Name 40014 0
Prof Dafna Merom
Address 40014 0
School of Health Sciences
Western Sydney University
Narellan Rd & Gilchrist Dr, Campbelltown NSW 2560
Country 40014 0
Australia
Phone 40014 0
+61 2 4620 3796
Fax 40014 0
Email 40014 0
[email protected]
Contact person for public queries
Name 40015 0
Dafna Merom
Address 40015 0
School of Health Sciences
Western Sydney University
Narellan Rd & Gilchrist Dr, Campbelltown NSW 2560
Country 40015 0
Australia
Phone 40015 0
+61 2 4620 3796
Fax 40015 0
Email 40015 0
[email protected]
Contact person for scientific queries
Name 40016 0
Dafna Merom
Address 40016 0
School of Health Sciences
Western Sydney University
Narellan Road & Gilchrist Drive, Campbelltown NSW 2560
Country 40016 0
Australia
Phone 40016 0
+61 2 4620 3796
Fax 40016 0
Email 40016 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial.
When will data be available (start and end dates)?
Immediately following publication, no end date.
Available to whom?
Only researchers who provide a methodologically sound proposal.
Available for what types of analyses?
Any purpose.
How or where can data be obtained?
Access subject to approvals by Principal Investigator.
Professor Dafna Merom
Professor In Physical Activity and Health,
Dean's Unit School of Health Sciences
Western Sydney University
24.2.33
Campbelltown, NSW
Australia
Email: [email protected]


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.