Improving Pre-school Anthropometric StatusTMRINCT02237144

Transfer Modality Research Initiative - Bangladesh

A study testing Cash transfer, Food transfer and Food and cash transfer in people with Improving Pre-school Anthropometric Status and Improving Household Food Security, run by International Food Policy Research Institute at 1 site in Bangladesh.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 15 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for: Improving Pre-school Anthropometric Status, Improving Household Food Security, Improving Maternal Nutrition Knowledge
What is being tested?: Cash transfer, Food transfer and Food and cash transfer
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 5,000 participants
Where: 1 siteBangladesh
Study dates: Apr 2012to Jul 2018
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 15 to 65 years
Women only
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

Child age < 60 months

Who cannot join

None

Trial locations and contacts

1 site in 1 country.

Bangladesh1 site

International Food Policy Research Institute
Dhaka

Other trials in Bangladesh

About this study

This is a randomized control trial in two zones of Bangladesh (north and south). Treatment is assigned at the village level where treatments are: cash transfers (north and south); cash transfers + nutrition behavior communication change (north only); food transfers (north and south); food transfers + nutrition behavior communication change (south only); food-cash split (north and south); and controls (north and south). Within treatment localities, women living in very poor households are targeted to receive benefits for two years.

Conditions: Improving Pre-school Anthropometric Status, Improving Household Food Security, Improving Maternal Nutrition Knowledge
Being tested: Cash transfer, Food transfer, Food and cash transfer, Behavior Communication Change (BCC)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cash transferOther
1500 taka ($18.75) per household distributed monthly
Food transferOther
30 kg rice, 2 kg lentils, and 2 kg micro-nutrient fortified cooking oil per household distributed monthly
Food and cash transferOther
15 kg of rice; 1 kg of lentils and 1 kg of micronutrient fortified cooking oil and 750 taka cash per household, distributed monthly
Behavior Communication Change (BCC)Behavioural
Weekly, one hour meetings on maternal and child nutrition, sanitation and health knowledge, attitudes and practice Occasional home visits

Study groups in NCT02237144
Study group	Role	What they receive
Cash transfer	Experimental	1500 taka ($18.75) per household distributed monthly Receives: Other: Cash transfer
Food transfer	Experimental	30 kg rice, 2 kg lentils, and 2 kg micro-nutrient fortified cooking oil per household distributed monthly Receives: Other: Food transfer
Food and cash transfer	Experimental	15 kg of rice; 1 kg of lentils and 1 kg of micronutrient fortified cooking oil and 750 taka cash per household, distributed monthly Receives: Other: Food and cash transfer
Cash transfer + BCC	Experimental	1500 taka ($18.75) per household distributed monthly Weekly, one hour meetings on maternal and child nutrition, sanitation and health knowledge, attitudes and practice Occasional home visits Receives: Other: Cash transfer; Behavioral: Behavior Communication Change (BCC)
Food transfer + BCC	Experimental	30 kg rice, 2 kg lentils, and 2 kg micro-nutrient fortified cooking oil per household distributed monthly Weekly, one hour meetings on maternal and child nutrition, sanitation and health knowledge, attitudes and practice Occasional home visits Receives: Other: Food transfer; Behavioral: Behavior Communication Change (BCC)

What is being measured

The primary outcome is the main question the study is designed to answer.

Child anthropometry
Height for age z scores Weight for height z scores Weight for age z scores Stunting Wasting Outcomes specified in terms of levels one year after intervention started (2013), two years after intervention started and as changes: 2012-2013, 2013-2014 and 2012-2014
Measured: Baseline. Up to 12 months. Up to 24 months.
Child food intake
Number of unique foods consumed in previous 24 hours Number of food groups consumed in previous 24 hours Consumption of specified food groups - animal source foods, dairy, Vitamin A rich foods etc Caloric consumption in previous 24 hours Outcomes specified in terms of levels one year after intervention started (2013), two years after intervention started and as changes: 2012-2013, 2013-2014 and 2012-2014
Measured: Baseline. Up to 12 months. Up to 24 months.
Child health
Did mother report child was ill in previous 2 weeks Outcomes specified in terms of levels one year after intervention started (2013), two years after intervention started and as changes: 2012-2013, 2013-2014 and 2012-2014
Measured: Baseline. Up to 12 months. Up to 24 months.
Distribution of food intake within the household
Consumption of foods by all household members in previous 24 hours as recalled by mothers as measured by yes/no questions on foods, food groups and calories Outcomes specified in terms of levels one year after intervention started (2013), two years after intervention started and as changes: 2012-2013, 2013-2014 and 2012-2014
Measured: Baseline. Up to 12 months. Up to 24 months.
Household food security
Food groups consumed by household in previous seven days Number of unique foods consumed in previous seven days Number of food groups consumed in previous seven days Number of food groups consumed in previous seven days weighted by nutritional value and frequency of consumption Value of food consumption in previous seven days Household caloric availability in previous seven days Outcomes specified in terms of levels one year after intervention started (2013), two years after intervention started and as changes: 2012-2013, 2013-2014 and 2012-2014
Measured: Baseline. Up to 12 months. Up to 24 months.
Maternal nutrition knowledge
Maternal knowledge of infant and young child feeding practices (IYCF) Knowledge, attitudes, practice of IYCF Scored as yes/no and as a total score on all questions Levels assessed in 2013 and 2014 and as changes between 2012-2013, 2013-2014 and 2012-2014
Measured: Baseline. Up to 12 months. Up to 24 months.

Secondary outcomes (5)

Household consumption
Value of food consumption in previous seven days Value of monthly non-food consumption Value of monthly non-food consumption by specified sub-groups (clothing, medical expenses, education expenses, transport, consumables, semi-durables) Value of monthly household consumption (food and non-food) Outcomes specified in terms of levels one year after intervention started (2013), two years after intervention started and as changes: 2012-2013, 2013-2014 and 2012-2014
Measured: Baseline. Up to 12 months. Up to 24 months.
Household income
Value of annual income derived from agriculture at endline (2014) Value of annual income derived from non-agricultural sources at endline (2014) Value of annual total income derived from all sources at endline (2014) Change in annual income (agriculture, non-agricultural, total) between 2012-2013, 2013-2014 and 2012-2014 Outcomes specified in terms of levels one year after intervention started (2013), two years after intervention started and as changes: 2012-2013, 2013-2014 and 2012-2014
Measured: Baseline. Up to 12 months. Up to 24 months.
Asset accumulation
Index (z score) of consumer durables Index (z score) of productive assets Index of quality of housing stock Productive land ownership (ha) Outcomes specified in terms of levels one year after intervention started (2013), two years after intervention started and as changes: 2012-2013, 2013-2014 and 2012-2014
Measured: Baseline. Up to 12 months. Up to 24 months.
Women's empowerment
Index of women's decision making autonomy within the household Index of women's mobility outside the household Outcome measured as level in 2013, level in 2014 and change between 2013-2014
Measured: Up to 12 months. Up to 24 months.
Information spillovers to non-beneficiaries
Knowledge of infant and young child feeding practices (IYCF) of mothers Knowledge, attitudes, practice of IYCF Scored as yes/no and as a total score on all questions Non-beneficiaries are mothers living near intervention households (within approximately a 10 minute walk) in the following treatment arms: North: cash, cash + BCC, control. South: food, food + BCC, control. Levels assessed in 2014
Measured: Up to 24 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2012Jul 2018

First posted11 Sep 2014 (estimated)
Study startApr 2012
Primary completionJan 2015
Study completionJul 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Improving Pre-school Anthropometric StatusStudies of the same condition, open and under way.
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: Basic science
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Enrolment: 5,000 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02237144
Sponsor's protocol ID: AEARCTR-0000247
Acronym: TMRI
Status last verified: Sep 2019
First submitted: 3 Sep 2014
Last updated: 6 Sep 2019
Results posted: No
Data monitoring committee: No

Publications

Hoddinott J, Ahmed I, Ahmed A, Roy S. Behavior change communication activities improve infant and young child nutrition knowledge and practice of neighboring non-participants in a cluster-randomized trial in rural Bangladesh. PLoS One. 2017 Jun 21;12(6):e0179866. doi: 10.1371/journal.pone.0179866. eCollection 2017.
PubMed 28636674

Study at a glance

From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Transfer Modality Research Initiative - Bangladesh
ClinicalTrials.gov ID: NCT02237144
Acronym / sponsor ID: TMRI / AEARCTR-0000247
Conditions: Improving Pre-school Anthropometric Status, Improving Household Food Security, Improving Maternal Nutrition Knowledge
Study type: Interventional
Recruitment status: Completed
Enrolment: 5,000 participants (actual)
Lead sponsor: International Food Policy Research InstituteUniversity, hospital or other
Collaborators: United Nations World Food Programme (WFP), Federal Ministry of Economic Cooperation and Development (Germany), Swiss Agency for Development and Cooperation, United States Agency for International Development (USAID), Department for International Development, United Kingdom, Consortium of International Agricultural Research Centers
Study start: Apr 2012
Primary completion: Jan 2015 (actual)
Study completion: Jul 2018 (actual)
First posted: 11 Sep 2014 (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.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
Cash transfer	Experimental	Other: Cash transfer1500 taka ($18.75) per household distributed monthly
Food transfer	Experimental	Other: Food transfer30 kg rice, 2 kg lentils, and 2 kg micro-nutrient fortified cooking oil per household distributed monthly
Food and cash transfer	Experimental	Other: Food and cash transfer15 kg of rice; 1 kg of lentils and 1 kg of micronutrient fortified cooking oil and 750 taka cash per household, distributed monthly
Cash transfer + BCC	Experimental	Other: Cash transfer, Behavioral: Behavior Communication Change (BCC)1500 taka ($18.75) per household distributed monthly Weekly, one hour meetings on maternal and child nutrition, sanitation and health knowledge, attitudes and practice Occasional home visits
Food transfer + BCC	Experimental	Other: Food transfer, Behavioral: Behavior Communication Change (BCC)30 kg rice, 2 kg lentils, and 2 kg micro-nutrient fortified cooking oil per household distributed monthly Weekly, one hour meetings on maternal and child nutrition, sanitation and health knowledge, attitudes and practice Occasional home visits

Who may qualify

Ages: 15 to 65 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

Child age < 60 months

Key exclusion criteria (1 listed)

None

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
Cash transfer1500 taka ($18.75) per household distributed monthly	Other	Cash transfer, Cash transfer + BCC
Food transfer30 kg rice, 2 kg lentils, and 2 kg micro-nutrient fortified cooking oil per household distributed monthly	Other	Food transfer, Food transfer + BCC
Food and cash transfer15 kg of rice; 1 kg of lentils and 1 kg of micronutrient fortified cooking oil and 750 taka cash per household, distributed monthly	Other	Food and cash transfer
Behavior Communication Change (BCC)Weekly, one hour meetings on maternal and child nutrition, sanitation and health knowledge, attitudes and practice Occasional home visits	Behavioural	Cash transfer + BCC, Food transfer + BCC

Primary outcome

Child anthropometry
Time frame: Baseline. Up to 12 months. Up to 24 months.
Height for age z scores Weight for height z scores Weight for age z scores Stunting Wasting Outcomes specified in terms of levels one year after intervention started (2013), two years after intervention started and as changes: 2012-2013, 2013-2014 and 2012-2014
Child food intake
Time frame: Baseline. Up to 12 months. Up to 24 months.
Number of unique foods consumed in previous 24 hours Number of food groups consumed in previous 24 hours Consumption of specified food groups - animal source foods, dairy, Vitamin A rich foods etc Caloric consumption in previous 24 hours Outcomes specified in terms of levels one year after intervention started (2013), two years after intervention started and as changes: 2012-2013, 2013-2014 and 2012-2014
Child health
Time frame: Baseline. Up to 12 months. Up to 24 months.
Did mother report child was ill in previous 2 weeks Outcomes specified in terms of levels one year after intervention started (2013), two years after intervention started and as changes: 2012-2013, 2013-2014 and 2012-2014
Distribution of food intake within the household
Time frame: Baseline. Up to 12 months. Up to 24 months.
Consumption of foods by all household members in previous 24 hours as recalled by mothers as measured by yes/no questions on foods, food groups and calories Outcomes specified in terms of levels one year after intervention started (2013), two years after intervention started and as changes: 2012-2013, 2013-2014 and 2012-2014
Household food security
Time frame: Baseline. Up to 12 months. Up to 24 months.
Food groups consumed by household in previous seven days Number of unique foods consumed in previous seven days Number of food groups consumed in previous seven days Number of food groups consumed in previous seven days weighted by nutritional value and frequency of consumption Value of food consumption in previous seven days Household caloric availability in previous seven days Outcomes specified in terms of levels one year after intervention started (2013), two years after intervention started and as changes: 2012-2013, 2013-2014 and 2012-2014
Maternal nutrition knowledge
Time frame: Baseline. Up to 12 months. Up to 24 months.
Maternal knowledge of infant and young child feeding practices (IYCF) Knowledge, attitudes, practice of IYCF Scored as yes/no and as a total score on all questions Levels assessed in 2013 and 2014 and as changes between 2012-2013, 2013-2014 and 2012-2014

5 secondary outcomes

Household consumption
Time frame: Baseline. Up to 12 months. Up to 24 months.
Household income
Time frame: Baseline. Up to 12 months. Up to 24 months.
Asset accumulation
Time frame: Baseline. Up to 12 months. Up to 24 months.
Women's empowerment
Time frame: Up to 12 months. Up to 24 months.
Information spillovers to non-beneficiaries
Time frame: Up to 24 months.

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 6 Sep 2019.
Derived from this study: PubMed 28636674Hoddinott J, Ahmed I, Ahmed A, Roy S. Behavior change communication activities improve infant and young child nutrition knowledge and practice of neighboring non-participants in a cluster-randomized trial in rural Bangladesh. PLoS One. 2017 Jun 21;12(6):e0179866. doi: 10.1371/journal.pone.0179866. eCollection 2017.

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.

Akhter Ahmed, PhD principal investigator

International Food Policy Research Institute

John Hoddinott, DPhil principal investigator

International Food Policy Research Institute

Shalini Roy, PhD principal investigator

International Food Policy Research Institute

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 1 inclusion and 1 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 6 Sep 2019. 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 Bangladesh. 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?

Child anthropometry (time frame: Baseline. Up to 12 months. Up to 24 months.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02237144, which also lists 1 linked publication.

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 6 Sep 2019.