Food SecurityTMRINCT03810300
Sustainability of Impacts of Cash Transfers, Food Transfers, and Behavior Change Communication in Bangladesh
A study testing Cash transfer, Food transfer and Food and cash transfer in people with Food Security and Poverty, run by International Food Policy Research Institute.
Trial summary
This study assesses the sustainability of impacts, 4 years post-program, from a pilot safety net program that was implemented from May 2012-April 2014. The intervention, called the Transfer Modality Research Initiative (TMRI), was assigned following a cluster-randomized controlled trial design in two zones of… Read more about this study
- Who is it for?
- Ages 15 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Food Security, Poverty, Child Nutrition
- 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
- No sites listed yet
- Study dates
- 15 Apr 2012to 15 May 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
- Former participant of Transfer Modality Research Initiative study (in cash, food, cash+BCC, food+BCC, or control arms)
Who cannot join
- -
About this study
Official title: Sustainability of Impacts of Cash Transfers, Food Transfers, and Behavior Change Communication in Bangladesh: Transfer Modality Research Initiative
This study assesses the sustainability of impacts, 4 years post-program, from a pilot safety net program that was implemented from May 2012-April 2014. The intervention, called the Transfer Modality Research Initiative (TMRI), was assigned following a cluster-randomized controlled trial design in two zones of Bangladesh (north and south). Intervention arms were assigned at the village level, where arms were as follows: (1) cash transfers [north and south]; (2) cash transfers + nutrition behavior communication change (BCC) [north only]; (3) food transfers [north and south]; (4) food transfers + nutrition BCC [south only]; (4) food-cash split [north and south]; and (5) control [north and south]. Within treatment villages, women living in very poor households were targeted to receive benefits for two years.
Read the detailed description
The objective of the study is to assess, 4 years after a pilot safety net intervention ended in April 2014, the sustainability of the intervention's impacts on households, children, and women. The intervention, called the Transfer Modality Research Initiative (TMRI), was assigned following a cluster-randomized controlled trial design in two zones of Bangladesh (north and south). WFP-Bangladesh implemented the intervention, and the International Food Policy Research Institute (IFPRI) conducted the impact evaluation research. Intervention arms were assigned at the village level, where arms were as follows: (1) cash transfers [north and south]; (2) cash transfers + nutrition behavior communication change (BCC) [north only]; (3) food transfers [north and south]; (4) food transfers + nutrition BCC [south only]; (5) food-cash split [north and south]; and (5) control [north and south]. Within treatment villages, women living in very poor households were targeted to receive benefits for two years, from May 2012-April 2014. For the original impact evaluation, longitudinal data on 5000 households were collected from 2012-2015 (ClinicalTrials.gov Identifier: NCT02237144).
For the sustainability study in 2018, given available funding, the sampling frame will include 4000 households. This will include all households that were originally in the following arms: (1) cash transfers [north and south]; (2) cash transfers + nutrition BCC [north only]; (3) food transfers [north and south]; (4) food transfers + nutrition BCC [south only]; (5) control [north and south].
- Conditions
- Food Security, Poverty, Child Nutrition, Child Development, Intimate Partner Violence, Gender Dynamics
- Being tested
- Cash transfer, Food transfer, Food and cash transfer, Nutrition behavior Communication Change (BCC), Control
- Keywords
- Cash transfers, Food transfers, Behavior change communication, Sustainability, Social protection, Nutrition, Gender
- Medical subject headings
- Coitus
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
Nutrition behavior Communication Change (BCC)Behavioural
Weekly, group-based, one-hour meetings on maternal and child nutrition, sanitation and health knowledge, attitudes and practice; twice-a-month home visits; monthly community meetings
ControlOther
No transfer, no behavior change communication
| 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 + nutrition BCC | Experimental | 1500 taka ($18.75) per household distributed monthly. Nutrition behavior change communication (weekly, one-hour group-based meetings on maternal and child nutrition, sanitation and health knowledge, attitudes and practice; twice-a-month home visits; monthly community meetings). Receives: Other: Cash transfer; Behavioral: Nutrition behavior Communication Change (BCC) |
| Food transfer + nutrition BCC | Experimental | 30 kg rice, 2 kg lentils, and 2 kg micro-nutrient fortified cooking oil per household distributed monthly. Nutrition behavior change communication (weekly, one-hour group-based meetings on maternal and child nutrition, sanitation and health knowledge, attitudes and practice; twice-a-month home visits; monthly community meetings). Receives: Other: Food transfer; Behavioral: Nutrition behavior Communication Change (BCC) |
| Control | Experimental | No transfer, no behavior change communication Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Food Consumption Score
The Food Consumption Score, as defined by the World Food Programme, is calculated as the number of food groups consumed by the household in the previous 7 days, weighted by each food group's nutritional value and frequency of consumption. Scale range is 0 to 112, with higher values reflecting higher food consumption.
Measured: After 4 years post-intervention
Child height-for-age z-score
Calculated using the 2006 WHO growth reference. This is a continuous measure that represents the number of standard deviations from the mean among comparable children in the WHO growth reference.
Measured: After 4 years post-intervention
Prevalence of physical intimate partner violence
Prevalence of any physical intimate partner violence in the past 12 months measured using the WHO Violence Against Women instrument
Measured: After 4 years post-intervention
Secondary outcomes (36)
Household dietary diversity
Measured by counting the number of food groups consumed by the household
Measured: After 4 years post-intervention
Value of total household consumption
Aggregate value of household food and non-food consumption expenditures. This is a continuous measure calculated from household survey responses on consumption behavior, using the methodology and questionnaire modules described in Deaton and Zaidi (2002). Citation: A.Deaton,, and S. Zaidi. 2002. "Guidelines for Constructing Consumption Aggregates for Welfare Analysis." Washington, DC : World Bank.
Measured: After 4 years post-intervention
Value of household food consumption
Value of household food consumption expenditures. This is a continuous measure calculated from household survey responses on consumption behavior, using the methodology and questionnaire modules described in Deaton and Zaidi (2002). Citation: A.Deaton,, and S. Zaidi. 2002. "Guidelines for Constructing Consumption Aggregates for Welfare Analysis." Washington, DC : World Bank.
Measured: After 4 years post-intervention
Value of household non-food consumption
Value of household non-food consumption expenditures. This is a continuous measure calculated from household survey responses on consumption behavior, using the methodology and questionnaire modules described in Deaton and Zaidi (2002). Citation: A.Deaton,, and S. Zaidi. 2002. "Guidelines for Constructing Consumption Aggregates for Welfare Analysis." Washington, DC : World Bank.
Measured: After 4 years post-intervention
Household food insecurity
Measured using the Household Food Insecurity Access Scale. Scale range is 0 to 27, with higher values reflecting higher food insecurity.
Measured: After 4 years post-intervention
Value of household labor income
Value of annual labor income over all household members
Measured: After 4 years post-intervention
Value of household non-labor income
Value of annual non-labor income over all household members
Measured: After 4 years post-intervention
Value of household asset ownership
Total value of all assets owned
Measured: After 4 years post-intervention
Household land ownership
Area of land owned
Measured: After 4 years post-intervention
Housing quality: interviews
Quality of housing stock. This is measured using a module developed for the study context, and information is collected through household enumerator observation during interviews.
Measured: After 4 years post-intervention
Maternal nutrition knowledge score
Number answered correctly on a test of maternal knowledge regarding infant and young child feeding practices developed for the survey, based on the curriculum of training sessions in the intervention.
Measured: After 4 years post-intervention
Maternal infant and young child feeding practices
Maternal adherence to WHO-recommended infant and young child feeding practices
Measured: After 4 years post-intervention
Child score on Raven's Progressive Matrices
Measured using Raven's Progressive Matrices set A and set B. This is constructed following the test's protocol for scoring.
Measured: After 4 years post-intervention
Child score on Early Grade Reading Assessment
Measured using Early Grade Reading Assessment adapted to local context. This is constructed following the test's protocol for scoring.
Measured: After 4 years post-intervention
Child score on Early Grade Mathematics Assessment
Measured using Early Grade Mathematics Assessment adapted to local context. This is constructed following the test's protocol for scoring.
Measured: After 4 years post-intervention
Child score on Strengths and Difficulties Questionnaire
Measured using Strengths and Difficulties Questionnaire, part of the Development and Well-Being Assessment family of mental heath measures. This is constructed following the test's protocol for scoring.
Measured: After 4 years post-intervention
Child weight-for-height z-score
Calculated using the 2006 WHO growth reference. This is a continuous measure that represents the number of standard deviations from the mean among comparable children in the WHO growth reference.
Measured: After 4 years post-intervention
Prevalence of child stunting
Calculated using the 2006 WHO growth reference
Measured: After 4 years post-intervention
Prevalence of child wasting
Calculated using the 2006 WHO growth reference
Measured: After 4 years post-intervention
Child illness
Mother's report of child illness in previous 2 weeks
Measured: After 4 years post-intervention
Parental interaction with child
Time spent on child stimulation activities in previous 7 days, measured using modules developed for the survey
Measured: After 4 years post-intervention
Parental discipline of the child
Disciplinary measures used in the past month, measured using modules developed for the survey
Measured: After 4 years post-intervention
Community norms on gender
Community leaders' attitudes toward gender, measured using modules developed for the survey
Measured: After 4 years post-intervention
Prevalence of emotional violence
Prevalence of any emotional intimate partner violence in the past 12 months measured using the WHO Violence Against Women instrument
Measured: After 4 years post-intervention
Prevalence of controlling behaviors
Prevalence of any controlling behaviors in the past 12 months measured using the WHO Violence Against Women instrument
Measured: After 4 years post-intervention
Prevalence of individual acts of intimate partner violence
Prevalence of individual acts of intimate partner violence in the past 12 months measured using the WHO Violence Against Women instrument
Measured: After 4 years post-intervention
Individual decisionmaking
Measured using men's and women's decisionmaking modules adapted from pro-WEAI
Measured: After 4 years post-intervention
Individual asset ownership
Measured using men's and women's asset ownership modules developed for the survey
Measured: After 4 years post-intervention
Individual mobility
Measured using men's and women's mobility modules adapted from pro-WEAI
Measured: After 4 years post-intervention
Individual labor force participation
Measured using men's and women's labor modules developed for the survey
Measured: After 4 years post-intervention
Individual attitudes toward gender and intimate partner violence
Measured using men's and women's attitudes toward gender and intimate partner violence modules developed for the survey
Measured: After 4 years post-intervention
Individual social capital
Measured using men's and women's social capital modules developed for the survey
Measured: After 4 years post-intervention
Individual stress
Measured using men's and women's Perceived Stress Scale scores
Measured: After 4 years post-intervention
Individual depression
Measured using men's and women's Patient Health Questionnaire-9 Depression Test scores
Measured: After 4 years post-intervention
Individual aspirations
Measured using men's and women's aspirations modules developed for the survey
Measured: After 4 years post-intervention
Spousal relationship
Measured using men's and women's relationship modules developed for the survey
Measured: After 4 years post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2019
- Study start15 Apr 2012
- Primary completion15 May 2018
- Study completion15 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food SecurityStudies 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)
Sponsor and investigators
- Lead sponsor
- International Food Policy Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Cornell University, Data Analysis and Technical Assistance Ltd, World Food Programme, Bangladesh
- Responsible party
- Sponsor
- Investigators
- Akhter Ahmed, PhD, Principal investigator, International Food Policy Research InstituteShalini Roy, PhD, Principal investigator, International Food Policy Research InstituteJohn Hoddinott, DPhil, Principal investigator, Cornell UniversityMelissa Hidrobo, PhD, Principal investigator, International Food Policy Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03810300
- Sponsor's protocol ID
- 12835
- Acronym
- TMRI
- Status last verified
- Jan 2019
- First submitted
- 14 May 2018
- Last updated
- 18 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sustainability of Impacts of Cash Transfers, Food Transfers, and Behavior Change Communication in Bangladesh: Transfer Modality Research Initiative
- ClinicalTrials.gov ID
- NCT03810300
- Acronym / sponsor ID
- TMRI / 12835
- Conditions
- Food Security, Poverty, Child Nutrition, Child Development, Intimate Partner Violence, Gender Dynamics
- Keywords
- Cash transfers, Food transfers, Behavior change communication, Sustainability, Social protection, Nutrition, Gender
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,000 participants (actual)
- Lead sponsor
- International Food Policy Research InstituteUniversity, hospital or other
- Collaborators
- Cornell University, Data Analysis and Technical Assistance Ltd, World Food Programme, Bangladesh
- Study start
- 15 Apr 2012 (actual)
- Primary completion
- 15 May 2018 (actual)
- Study completion
- 15 May 2018 (actual)
- First posted
- 18 Jan 2019 (actual)
- 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.
This study assesses the sustainability of impacts, 4 years post-program, from a pilot safety net program that was implemented from May 2012-April 2014. The intervention, called the Transfer Modality Research Initiative (TMRI), was assigned following a cluster-randomized controlled trial design in two zones of Bangladesh (north and south). Intervention arms were assigned at the village level, where arms were as follows: (1) cash transfers [north and south]; (2) cash transfers + nutrition behavior communication change (BCC) [north only]; (3) food transfers [north and south]; (4) food transfers + nutrition BCC [south only]; (4) food-cash split [north and south]; and (5) control [north and south]. Within treatment villages, women living in very poor households were targeted to receive benefits for two years.
Detailed description
The objective of the study is to assess, 4 years after a pilot safety net intervention ended in April 2014, the sustainability of the intervention's impacts on households, children, and women. The intervention, called the Transfer Modality Research Initiative (TMRI), was assigned following a cluster-randomized controlled trial design in two zones of Bangladesh (north and south). WFP-Bangladesh implemented the intervention, and the International Food Policy Research Institute (IFPRI) conducted the impact evaluation research. Intervention arms were assigned at the village level, where arms were as follows: (1) cash transfers [north and south]; (2) cash transfers + nutrition behavior communication change (BCC) [north only]; (3) food transfers [north and south]; (4) food transfers + nutrition BCC [south only]; (5) food-cash split [north and south]; and (5) control [north and south]. Within treatment villages, women living in very poor households were targeted to receive benefits for two years, from May 2012-April 2014. For the original impact evaluation, longitudinal data on 5000 households were collected from 2012-2015 (ClinicalTrials.gov Identifier: NCT02237144).
For the sustainability study in 2018, given available funding, the sampling frame will include 4000 households. This will include all households that were originally in the following arms: (1) cash transfers [north and south]; (2) cash transfers + nutrition BCC [north only]; (3) food transfers [north and south]; (4) food transfers + nutrition BCC [south only]; (5) control [north and south].
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 6
| 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 + nutrition BCC | Experimental | Other: Cash transfer, Behavioral: Nutrition behavior Communication Change (BCC)1500 taka ($18.75) per household distributed monthly. Nutrition behavior change communication (weekly, one-hour group-based meetings on maternal and child nutrition, sanitation and health knowledge, attitudes and practice; twice-a-month home visits; monthly community meetings). |
| Food transfer + nutrition BCC | Experimental | Other: Food transfer, Behavioral: Nutrition behavior Communication Change (BCC)30 kg rice, 2 kg lentils, and 2 kg micro-nutrient fortified cooking oil per household distributed monthly. Nutrition behavior change communication (weekly, one-hour group-based meetings on maternal and child nutrition, sanitation and health knowledge, attitudes and practice; twice-a-month home visits; monthly community meetings). |
| Control | Experimental | Other: ControlNo transfer, no behavior change communication |
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)
- Former participant of Transfer Modality Research Initiative study (in cash, food, cash+BCC, food+BCC, or control arms)
Key exclusion criteria (1 listed)
- -
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 + nutrition 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 + nutrition 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 |
| Nutrition behavior Communication Change (BCC)Weekly, group-based, one-hour meetings on maternal and child nutrition, sanitation and health knowledge, attitudes and practice; twice-a-month home visits; monthly community meetings | Behavioural | Cash transfer + nutrition BCC, Food transfer + nutrition BCC |
| ControlNo transfer, no behavior change communication | Other | Control |
Primary outcome
Food Consumption Score
Time frame: After 4 years post-intervention
The Food Consumption Score, as defined by the World Food Programme, is calculated as the number of food groups consumed by the household in the previous 7 days, weighted by each food group's nutritional value and frequency of consumption. Scale range is 0 to 112, with higher values reflecting higher food consumption.
Child height-for-age z-score
Time frame: After 4 years post-intervention
Calculated using the 2006 WHO growth reference. This is a continuous measure that represents the number of standard deviations from the mean among comparable children in the WHO growth reference.
Prevalence of physical intimate partner violence
Time frame: After 4 years post-intervention
Prevalence of any physical intimate partner violence in the past 12 months measured using the WHO Violence Against Women instrument
36 secondary outcomes
Household dietary diversity
Time frame: After 4 years post-intervention
Value of total household consumption
Time frame: After 4 years post-intervention
Value of household food consumption
Time frame: After 4 years post-intervention
Value of household non-food consumption
Time frame: After 4 years post-intervention
Household food insecurity
Time frame: After 4 years post-intervention
Value of household labor income
Time frame: After 4 years post-intervention
Value of household non-labor income
Time frame: After 4 years post-intervention
Value of household asset ownership
Time frame: After 4 years post-intervention
Household land ownership
Time frame: After 4 years post-intervention
Housing quality: interviews
Time frame: After 4 years post-intervention
Maternal nutrition knowledge score
Time frame: After 4 years post-intervention
Maternal infant and young child feeding practices
Time frame: After 4 years post-intervention
Child score on Raven's Progressive Matrices
Time frame: After 4 years post-intervention
Child score on Early Grade Reading Assessment
Time frame: After 4 years post-intervention
Child score on Early Grade Mathematics Assessment
Time frame: After 4 years post-intervention
Child score on Strengths and Difficulties Questionnaire
Time frame: After 4 years post-intervention
Child weight-for-height z-score
Time frame: After 4 years post-intervention
Prevalence of child stunting
Time frame: After 4 years post-intervention
Prevalence of child wasting
Time frame: After 4 years post-intervention
Child illness
Time frame: After 4 years post-intervention
Parental interaction with child
Time frame: After 4 years post-intervention
Parental discipline of the child
Time frame: After 4 years post-intervention
Community norms on gender
Time frame: After 4 years post-intervention
Prevalence of emotional violence
Time frame: After 4 years post-intervention
Prevalence of controlling behaviors
Time frame: After 4 years post-intervention
Prevalence of individual acts of intimate partner violence
Time frame: After 4 years post-intervention
Individual decisionmaking
Time frame: After 4 years post-intervention
Individual asset ownership
Time frame: After 4 years post-intervention
Individual mobility
Time frame: After 4 years post-intervention
Individual labor force participation
Time frame: After 4 years post-intervention
Individual attitudes toward gender and intimate partner violence
Time frame: After 4 years post-intervention
Individual social capital
Time frame: After 4 years post-intervention
Individual stress
Time frame: After 4 years post-intervention
Individual depression
Time frame: After 4 years post-intervention
Individual aspirations
Time frame: After 4 years post-intervention
Spousal relationship
Time frame: After 4 years post-intervention
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 18 Jan 2019.
Related trials for Food Security
Not yet recruiting
Health-Related Social Needs Food Boxes Delivery Program
Food Insecurity
Not yet recruiting
Nutrition Intervention Optimization to Better Utilize Resources and Support Health
Diabete Type 2, Obesity & Overweight
Recruiting
Feasibility of an ADAPTive Intervention to Improve Food Security and Maternal-Child Health
Food Insecurity, Pregnancy
Recruiting
Case Management Dyad
HIV, Pre-exposure Prophylaxis
Recruiting
Cooking HEalthy and Facilitating Early Childhood Development: CHEF-ED Study
Teaching Healthy Cooking Skills to Parents and Their Preschool Children
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
Shalini Roy, PhD principal investigator
International Food Policy Research Institute
John Hoddinott, DPhil principal investigator
Cornell University
Questions about this trial
What is this clinical trial studying?
A study testing Cash transfer, Food transfer and Food and cash transfer in people with Food Security and Poverty, run by International Food Policy Research Institute.
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 18 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Food Consumption Score (time frame: After 4 years post-intervention). The study lists 3 primary outcomes in all. 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 18 Jan 2019.