Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001975280
Ethics application status
Approved
Date submitted
23/05/2018
Date registered
7/12/2018
Date last updated
7/12/2018
Date data sharing statement initially provided
7/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of unconditional Cash transfers and mobile behaviour change communications to reduce child under nutrition in rural Bangladesh
Scientific title
A community based cluster randomised controlled trial to determine the effectiveness of unconditional Cash transfers and mobile behaviour change communications to reduce child under nutrition in rural Bangladesh
Secondary ID [1] 293615 0
APP1120507
Universal Trial Number (UTN)
Trial acronym
SCC ( Shonjibon Cash and Counselling)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chilld hood Stunting 305877 0
Low Birth Weight 307977 0
Condition category
Condition code
Public Health 307014 307014 0 0
Epidemiology
Diet and Nutrition 307020 307020 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention plan
Pregnancy Surveillance: Our surveillance worker will then conduct door-to-door bi monthly visits to identify women missing two menstrual periods in a row. All such woman will undergo pregnancy test with a sensitive pregnancy urine test kit (Excel®). Women tested positive will be invited to participate in the study with appropriate informed written consent. We will conduct recruitment during the pre-monsoon season (January to June) to enrol pregnant women during the hungry season. Based on experience with our previous study with similar design and settings, we expect at least 95% of mothers will consent.

Mobile platform
Once registered, each woman will receive a mobile phone with standard connection and limited credit (2-3 calls/month). We will provide mobile credit till the end of the study. However the family will retain the mobile phone after the study. The efficiency of using mobile phones for cash transfers and delivering counselling provides the rationale for this additional non-cash transfer to these poor families. Each phone will be preinstalled with a cash transfer application, and we will assist participants to open a mobile bank account with bKash, the largest mobile bank in Bangladesh. We will train the women about basic phone maintenance, using the phone for cash transfers, receiving & listening to voice messages, and about collecting their cash from mobile bank agents.

Mobile nutrition behaviour change communication
The mobile phone nutrition BCC intervention will consist of 2 main components: voice messages about nutrition; and nutrition counselling by phone. Life cycle stage-appropriate, pre-scheduled, voice messages will be sent to the women every week. These messages were developed and tested in the pilot and cover; diet and care during pregnancy, breastfeeding, complementary feeding, care in child illness, and basic hygiene. They aim to increase both caloric intake and dietary diversity. They will be transmitted using an interactive voice response (IVR) system and a mobile application. Mobile phone, biweekly nutrition counselling will be conducted with trained nutrition counsellors from a call centre set up at icddrb. The counsellor listens to the woman’s experiences with her own diet and feeding her child, and offers suggestions and support. She will check if the woman has been listening to and understands the voice messages, and repeats them if needed. Each session will be around 5-15 minutes depending on the need of the women. We will measure and monitor the adherence to the intervention by regular analysis of built in analytics in the mobile app and call centre register.

Unconditional cash transfer with mobile phones
A cash transfer of US$12.5 per month will be made through the participants’ mobile phone, which is approximately 20% of average monthly income of the poorest 40% of rural households (~US$60/m). The well-developed food markets in rural Bangladesh will ensure food products are available for households to purchase. We will use a soft conditional approach with mothers being asked to listen to the messages and participate in counselling, but the cash transfers will be made irrespective of the participant’s compliance. Project staff will follow up with mothers who do not participate to explore the reasons & reinforce the importance of the messages & counselling. Cash will be transferred directly to woman’s mobile bank accounts using bKash mobile

Social marketing brand & strategy
A social marketing brand platform will be developed to provide an appealing overall identity for the intervention. Our understanding of the audience’s concerns, aspirations and desires from formative research will drive our social marketing approach, which will be based on an emotional connection rather than a factual communication. We will consider benefits such as convenience, social status, feel-good experience and economic gains, to position nutrition as the overall ‘smart choice’ for mothers and their families. Our communications plan will include social media, posters & leaflets, and be consistent with voice messages & counselling.

We will provide the behaviour change communication intervention for 30 months starting from 1st trimester till the child is 24 months of age. The total duration of the study period is 40 months.
Intervention code [1] 301300 0
Prevention
Comparator / control treatment
Comparison arm
Routine nutrition counselling for pregnant women and mothers of under-five children by BRAC and Government programs will continue with the same schedule as in the intervention group at antenatal clinics, delivery, and immunization clinics. We will provide mobile phones to the control arm to balance out any non-specific beneficial effects from the family having a mobile phone. We will provide limited mobile credit (2-3 calls/month). till the end of the study. However the family will retain the mobile phone after the study. We will contact the family by phone to minimize differential loss to follow up, although experience with our previous such trials indicates it will not likely be a problem as poor families’ value repeated examinations conducted as part of the trial evaluations.

The total duration of the study period is 40 months.
Control group
Active

Outcomes
Primary outcome [1] 305994 0
The primary trial outcome will be changes in the percentage of stunted children (height-for-age <-2 Z) assessed by the study staff using seca height measuring tape monthly for 6 months from birth and then at 9th month of age, 12th month of age, 18th months of age and 24 months of age(primary endpoint)
Timepoint [1] 305994 0
Monthly for 6 months from birth and then at 9th month of age, 12th month of age, 18th months of age and 24 months of age(primary endpoint)
Secondary outcome [1] 347249 0
Mean birthweight, percentage with low birthweight & percentage with small for gestational age assessed by the study staff using seca weight measuring scale.
Timepoint [1] 347249 0
At birth
Secondary outcome [2] 347252 0
Changes in the percentage of wasted children (Weight-for-length Z scores) by the study staff using seca height measuring tape and seca weight measuring scale.
Timepoint [2] 347252 0
Monthly for 6 months from birth and then at 9th month of age, 12th month of age and 18th months of age
Secondary outcome [3] 347254 0
Percentage of women exclusively breastfeeding their infants assessed by study staff using standard questionnaire ( Demographic and Health Survey questionaire)
Timepoint [3] 347254 0
Monthly for 6 months from birth
Secondary outcome [4] 347255 0
Mean duration of exclusive breastfeeding, and any breastfeeding assessed by study staff using standard questionnaire ( Demographic and Health Survey questionaire)
Timepoint [4] 347255 0
Monthly till 6 months post birth
Secondary outcome [5] 347256 0
Percentage of children consuming >4 food groups assessed by study staff using standard questionnaire (Adapted from household and Individual food diversity questionnaire of food and agriculture organisation)
Timepoint [5] 347256 0
At 9th months, 12 months, 18th months and 24 months post birth
Secondary outcome [6] 347257 0
Mean child intake of energy assessed by study staff using standard questionnaire (designed specifically for this study)
Timepoint [6] 347257 0
At 9th months, 12 months, 18th months and 24 months post birth
Secondary outcome [7] 347258 0
Percentage of women at risk of inadequate nutrient intakes assessed by study staff using standard questionnaire (designed specifically for this study)
Timepoint [7] 347258 0
At enrolment and 3rd trimester of pregnancy
Secondary outcome [8] 347259 0
Household food security at baseline and at 6th months, 12 months, 18th months and 24 months post birth assessed by study staff by standard questionnaire (Household food Insecurity Access scale - FANTA)
Timepoint [8] 347259 0
At 6th months, 12 months, 18th months and 24 months post birth
Secondary outcome [9] 347261 0
Average cost per stunted child prevented (Data for the cost-effectiveness analysis will be based on costs and outcomes observed in the trial. The perspective to be adopted will be that of the health sector. Average costs per individual in each treatment group will be estimated over the period of follow-up. Costs of delivering the intervention (start-up costs, staff, training, mobile phone service, cash transfers) will be collected via facility and project records. Also, a sub-sample of participants will be asked to record use and costs of health services at each follow-up interview).
Timepoint [9] 347261 0
At 30 month post enrolment
Secondary outcome [10] 347275 0
Percentage of women initiating Breastfeeding within 1 hr assessed by the study staff using standard questionnaire (Demographic and Health Survey questionaire)
Timepoint [10] 347275 0
Within 1 month post birth
Secondary outcome [11] 349422 0
Mean days with diarrhoea among children assessed by study staff with standard questionnaire adopted from Bangladesh Demographic and Health Survey
Timepoint [11] 349422 0
At 24 months post birth
Secondary outcome [12] 349423 0
Mean days with acute respiratory illness among children assessed by study staff with standard questionnaire adopted from Bangladesh Demographic and Health Survey
Timepoint [12] 349423 0
At 24 months post birth
Secondary outcome [13] 349424 0
Mean days with fever among children assessed by study staff with standard questionnaire adopted from Bangladesh Demographic and Health Survey
Timepoint [13] 349424 0
At 24 months post birth
Secondary outcome [14] 354611 0
Mean child intake of protein assessed by study staff using standard questionnaire (designed specifically for this study)
Timepoint [14] 354611 0
At 9th months, 12 months, 18th months and 24 months post birth
Secondary outcome [15] 354612 0
Mean child intake of carbohydrate assessed by study staff using standard questionnaire (designed specifically for this study)
Timepoint [15] 354612 0
At 9th months, 12 months, 18th months and 24 months post birth
Secondary outcome [16] 354619 0
Mean child intake of fat assessed by study staff using standard questionnaire (designed specifically for this study)
Timepoint [16] 354619 0
At 9th months, 12 months, 18th months and 24 months post birth
Secondary outcome [17] 354620 0
Mean child intake of micro nutrients assessed by study staff using standard questionnaire (designed specifically for this study)
Timepoint [17] 354620 0
At 9th months, 12 months, 18th months and 24 months post birth

Eligibility
Key inclusion criteria
Eligibility criteria to participate in surveillance
• All married women between 15-49 years
• Currently not using any family planning methods,
• Have not had any permanent method of contraception (either women or their husbands)
• Permanent residents of the study area

Eligibility criteria to participate in study
• Women tested positive with pregnancy urine test kit (Excel®).
Minimum age
No limit
Maximum age
49 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Not willing to stay in the study area through out the study period

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The treatments will be assigned to eligible clusters using a fixed randomization scheme with uniform allocation ratio of treatments. The random allocation sequence will be generated using Stata® software.
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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2019
Actual
Date of last participant enrolment
Anticipated
1/10/2019
Actual
Date of last data collection
Anticipated
30/10/2021
Actual
Sample size
Target
2850
Accrual to date
Final
Recruitment outside Australia
Country [1] 10503 0
Bangladesh
State/province [1] 10503 0
Jamalpur

Funding & Sponsors
Funding source category [1] 298227 0
Government body
Name [1] 298227 0
National Health and Medical Research Council (NHMRC)
Country [1] 298227 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney
NSW 2006
Australia
Country
Australia
Secondary sponsor category [1] 297343 0
Other
Name [1] 297343 0
International Centre for Diarrhoeal Disease Research, Bangladesh (icddrb)
Address [1] 297343 0
68, Shaheed Tajuddin Ahmed Sarani
Mohakhali, Dhaka 1212, Bangladesh
Country [1] 297343 0
Bangladesh

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299236 0
Ethical Review Committee of international centre for diarrhoeal disease research, Bangladesh (icddr,b)
Ethics committee address [1] 299236 0
Ethics committee country [1] 299236 0
Bangladesh
Date submitted for ethics approval [1] 299236 0
07/12/2017
Approval date [1] 299236 0
08/01/2018
Ethics approval number [1] 299236 0
PR#17106

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

Contacts
Principal investigator
Name 79754 0
Prof Michael J Dibley
Address 79754 0
The University of Sydney
Rm 328, Edward Ford Building (A27) |
The University of Sydney | NSW | 2006 | AUSTRALIA
Country 79754 0
Australia
Phone 79754 0
+61 2 9351 5203
Fax 79754 0
+61 2 9351 5049
Email 79754 0
[email protected]
Contact person for public queries
Name 79755 0
Tanvir Huda
Address 79755 0
The University of Sydney
Rm 301a, Edward Ford Building (A27) |
The University of Sydney | NSW | 2006 | AUSTRALIA
Country 79755 0
Australia
Phone 79755 0
+61 2 9351 3299
Fax 79755 0
Email 79755 0
[email protected]
Contact person for scientific queries
Name 79756 0
Michael J Dibley
Address 79756 0
The University of Sydney
Rm 328, Edward Ford Building (A27) |
The University of Sydney | NSW | 2006 | AUSTRALIA
Country 79756 0
Australia
Phone 79756 0
+61 2 9351 5203
Fax 79756 0
+61 2 9351 5049
Email 79756 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Due to ethical restrictions related to protecting study participants privacy, data access is subject to icddr,b data policy (http://www.icddrb.org/policies). Interested parties may contact Ms. Armana Ahmed (gro.brddci@demhaa) with further inquiries related to data access.


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.