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MalnutritionNCT02422953

Stunting Prevention Project in Thatta and Sujawal Districts, Sindh Province, Pakistan

A study testing Wheat Soya Blend (WSB), Wawa Mum and Micronutrient Powders (MNP) in people with Malnutrition, run by Aga Khan University at 1 site in Pakistan.

Completed

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

Official record
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Trial summary

Widespread food insecurity and malnutrition are largely the main impairing factors for human capital development in Pakistan. Rates of chronic malnutrition are very high, and acute malnutrition is critical: 44% of children under five are stunted and nationwide global acute malnutrition (GAM) rates amongst children… Read more about this study

Who is it for?
Ages 6 to 59 monthsHealthy volunteers can take part
Conditions the study is for
Malnutrition
What is being tested?
Wheat Soya Blend (WSB), Wawa Mum and Micronutrient Powders (MNP)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,020 participants
Where
1 sitePakistan
Study dates
Aug 2014to 30 Sep 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 6 to 59 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • All pregnant women
  • All lactating mothers (upto 6 months)
  • All children 6-23 months of age
  • All children 24-59 months of age

Who cannot join

  • Refuse to participate in the study
  • Having severe chronic disease

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Aga Khan University

    Karachi, Sindh, 74800

Other trials in Pakistan

About this study

Official title: Effectiveness of Food/Nutrient Based Interventions to Prevent Stunting Among Children Under Five in Thatta and Sujawal Districts, Sindh Province, Pakistan

Widespread food insecurity and malnutrition are largely the main impairing factors for human capital development in Pakistan. Rates of chronic malnutrition are very high, and acute malnutrition is critical: 44% of children under five are stunted and nationwide global acute malnutrition (GAM) rates amongst children under five exceed the WHO critical threshold of 15%. Nutritional status trends also show a deteriorating situation since 1994, when stunting rates were at 36%.

This study evaluates the effectiveness of food based interventions to prevent stunting among children under-five years with focus on window of opportunity (1000 days from conception to 2 years) for addressing stunting. Pregnant women, lactating mothers and children 6-59 months will receive supplements on monthly basis in intervention areas, while participants in control areas will receive routine public health services available in the study area.

Read the detailed description

Children under two are consuming less than half of their daily energy requirements (560 kcal) and lower than recommended levels of micronutrients (one-third of reference nutrient intake for Iron and one-half for Zinc). Overall, less than 4% of children were receiving an acceptable, diverse diet. Food security and nutrition situation in Sindh province is even more dramatic. According to the National Nutrition Survey, 2011, GAM prevalence exceeds 18% while anemia levels amongst children under five reached the alarming level of 72.5%. With this high level of poverty and food insecurity, a food based approach to prevent stunting, together with non- food based approaches is needed.

Therefore, Division of Women and Child Health, Aga Khan University proposes a research study for stronger evidence base on the effectiveness of preventive food/nutrient based interventions on reduction of stunting and developing viable programmes on nutrition under "real" operational conditions. The effectiveness of the project will be measured in terms of the impact of the proposed interventions on the stunting and micronutrient deficiency prevalences in the target group (children and mothers). Given the conditions of project implementation, a quasi-experimental "double difference" design would be appropriate to assess the impact of the intervention. We propose to compare the intervention and non-intervention (control) groups before (first difference) and after the intervention (second difference). Then, the operational implementation of the research comprises a baseline and end line surveys. In addition, a nested cluster randomized controlled trial will be implemented to track the evolution of key variables related to the quality of intervention delivery and intermediate nutrition outcomes. The control clusters will receive routine public and private health services available in the area.

To achieve its purpose and objectives the project design includes core interventions such as complementary feeding using food/nutrient based supplements along with behavior change communication, complemented with other non-food interventions. Using a preventative (blanket) approach, three types of food/nutrient supplements (Wawamum, MNP \& WSB) are considered as part of the interventions.

Conditions
Malnutrition
Being tested
Wheat Soya Blend (WSB), Wawa Mum, Micronutrient Powders (MNP), Behavior change and preventive health massages
Keywords
Stunting, Wasting, Underweight
Medical subject headings
Malnutrition, Growth Disorders, Cachexia, Thinness

What participants receive

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

  • Wheat Soya Blend (WSB)Dietary supplement

    A monthly ration of 5 Kg of Wheat Soya Blend (WSB) will be given to pregnant women every month during pregnancy and lactating mothers for six months after giving birth

  • Wawa MumDietary supplement

    Children 6-23 months of age will receive a daily ration of 50 gram of Wawa Mum during study period

  • Micronutrient Powders (MNP)Dietary supplement

    Children 24-59 months of age will receive a sachet of Micronutrient Powders (MNP) in alternate days

  • Behavior change and preventive health massagesBehavioural

    Behavior change and preventive health massages will be delivered by lady health workers (LHWs) during monthly visits and in group meetings

Study groups in NCT02422953
Study groupRoleWhat they receive
InterventionExperimentalWheat Soya Blend, Wawa Mum, Micronutrient Powders, Behavior change and preventive health massages
Receives: Dietary Supplement: Wheat Soya Blend (WSB); Dietary Supplement: Wawa Mum; Dietary Supplement: Micronutrient Powders (MNP); Behavioral: Behavior change and preventive health massages
ControlNo interventionControl group will receive routine public and private health services available in the area.

What is being measured

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

  1. Stunting-reduction in stunted children in intervention group

    To calculate HAZ scores the 2006 WHO growth reference will be used

    Measured: 2 Years

Secondary outcomes (14)

  1. Pregnancy out come

    Reduction in low birth weight in newborns

    Measured: 2 Years

  2. Mean change in weight-for-height z-score (WHZ)

    To calculate WHZ scores the 2006 WHO growth reference will be used

    Measured: 2 Years

  3. Mean change in weight-for-age z-score (WAZ)

    To calculate WAZ scores the 2006 WHO growth reference will be used

    Measured: 2 Years

  4. Improvement in infant and young child feeding (IYCF) indicators

    Monthly data collection on IYCF practices

    Measured: 2 Years

  5. Linear growth velocity (HAZ increment/month)

    To calculate HAZ score the 2006 WHO growth reference will be used

    Measured: 2 Years

  6. Mean hemoglobin concentration in children 6-59 months of age

    Hemocue will be used to measure Hb concentration

    Measured: 2 Years

  7. Prevalence of childhood anemia (Hb concentration<11g/dL) in children 6-59 months of age

    Hb spot testing will be conducted

    Measured: 2 Years

  8. Mean hemoglobin concentration in mothers

    Hemocue will be used to measure Hb concentration

    Measured: 2 Years

  9. Prevalence of maternal anemia (Hb concentration<12g/dL)

    Hb spot testing will be conducted

    Measured: 2 Years

  10. Impact on maternal BMI

    The change in BMI z-score weight and height will be combined to report BMI in kg/m^2

    Measured: 2 Years

  11. Impact on vitamin A status in children at 24 months

    The change in Vitamin A status (µmol/L) in children at 24 months of age

    Measured: 2 Years

  12. Impact on vitamin D status in children at 24 months

    The change in vitamin D status (ng/mL) in children at 24 months of age

    Measured: 2 Years

  13. Impact on Zinc status in children at 24 months

    The change in Zinc status (µg/dL) in children at 24 months of age

    Measured: 2 Years

  14. Impact on Ferritin status in children at 24 months

    The change in Ferritin status (ng/mL) in children at 24 months of age

    Measured: 2 Years

Timeline

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

  1. First posted22 Apr 2015 (estimated)
  2. Study startAug 2014
  3. Primary completion30 Jun 2018
  4. Study completion30 Sep 2018

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
4,020 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02422953
Sponsor's protocol ID
WFP-Thatta
Status last verified
Nov 2019
First submitted
15 Apr 2015
Last updated
15 Nov 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes: Data are sharing with funding agency on 6-monthly basis

Publications

  • National Nutrition Survey (NNS), 2011. Planning Commission Planning and Development Division Government of Pakistan.

  • WFP (2012): Protracted Relief and Recovery Operations (PRRO). Pakistan 200250. Rome, Italy.

  • Horton, S. Opportunities for investments in nutrition in low-income Asia; 1999. Asian Development Review 17 (1, 2): 246-273.

  • Gorstein J, Sullivan KM, Parvanta I, Begin F. Indicators and Methods for Cross-Sectional Surveys of Vitamin and Mineral Status of Populations. The Micronutrient Initiative (Ottawa) and the Centers for Disease Control and Prevention (Atlanta), May 2007.

  • Donner, A. and Klar, N. Design and Analysis of Cluster Randomization Trials in Health Research. Arnold, London; 2000

  • Soofi SB, Khan GN, Ariff S, Ihtesham Y, Tanimoune M, Rizvi A, Sajid M, Garzon C, de Pee S, Bhutta ZA. Effectiveness of nutritional supplementation during the first 1000-days of life to reduce child undernutrition: A cluster randomized controlled trial in Pakistan. Lancet Reg Health Southeast Asia. 2022 Jul 19;4:100035. doi: 10.1016/j.lansea.2022.100035. eCollection 2022 Sep.

    PubMed 37383995

  • Khan GN, Kureishy S, Ariff S, Rizvi A, Sajid M, Garzon C, Khan AA, de Pee S, Soofi SB, Bhutta ZA. Effect of lipid-based nutrient supplement-Medium quantity on reduction of stunting in children 6-23 months of age in Sindh, Pakistan: A cluster randomized controlled trial. PLoS One. 2020 Aug 13;15(8):e0237210. doi: 10.1371/journal.pone.0237210. eCollection 2020.

    PubMed 32790725

  • Zaidi S, Das JK, Khan GN, Najmi R, Shah MM, Soofi SB. Food supplements to reduce stunting in Pakistan: a process evaluation of community dynamics shaping uptake. BMC Public Health. 2020 Jul 2;20(1):1046. doi: 10.1186/s12889-020-09103-8.

    PubMed 32616009

  • Kureishy S, Khan GN, Arrif S, Ashraf K, Cespedes A, Habib MA, Hussain I, Ullah A, Turab A, Ahmed I, Zaidi S, Soofi SB. A mixed methods study to assess the effectiveness of food-based interventions to prevent stunting among children under-five years in Districts Thatta and Sujawal, Sindh Province, Pakistan: study protocol. BMC Public Health. 2017 Jan 5;17(1):24. doi: 10.1186/s12889-016-3976-y.

    PubMed 28056945

Questions about this trial

What is this clinical trial studying?

A study testing Wheat Soya Blend (WSB), Wawa Mum and Micronutrient Powders (MNP) in people with Malnutrition, run by Aga Khan University at 1 site in Pakistan.

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 4 inclusion and 2 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 15 Nov 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 Pakistan. 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?

Stunting-reduction in stunted children in intervention group (time frame: 2 Years). 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 NCT02422953, which also lists 9 linked publications.

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 15 Nov 2019.

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