Condition category
Nutritional, Metabolic, Endocrine
Date applied
22/11/2017
Date assigned
11/12/2017
Last edited
05/01/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The Federally Administered Tribal Areas (FATA) of Pakistan, represent the worst nutrition situations at national level due to the series of natural disasters and the challenge of militancy and responding military operations limiting access and development of livelihood/economic activities and agriculture. The National Nutrition Survey (NNS) 2011 reflects 58% stunting rates in children under 5 years of age in FATA. This study will review and test Ready to Use Supplementary Foods (RUSF) in a cohort of pregnant (group 1), lactating women (group 2), children 6-23 (group 3) and 24-59 months (group 4) and the subsequent impact on stunting prevention in under 5 children. The aim of this study is to evaluate the effectiveness of selected nutrition-specific interventions improving childhood length for age scores.

Who can participate?
Group 1: Pregnant woman
Group 2: Lactating women
Group 3: Children aged six to 23 months
Group 4: Children aged 24-59 months

What does the study involve?
Participants are allocated to groups selected from 12 health facilities catchment areas. Groups that have a community healthcare worker receive the treatment while groups in the area without a community healthcare worker receive their standard level of care. Those in group 1 and 2 receive a certain type of RUSF. This is given in daily rations throughout pregnancy and the first six months of breastfeeding. Those in the group 3 receive RUSF in daily rations for 18 months. Those in group 4 receive a RUSF daily for 36 months. Data is collected at baseline and followed up with bodymeasurements conducted monthly from each study participant. Participants are followed up for their length for age scores at the end of the project i.e. 3 years. They are also assessed for nutritional intake during pregnancy, maternal weight gain, exclusive breast feeding up-to 6 months, and birth weight.

What are the possible benefits and risks of participating?
Participants may benefit through the consumption of food supplements. There are no risks involved while taking part in this research study except for minor bruise and discomfort during blood sampling.

Where is the study run from?
Agency Surgeon Office (Kurram Pakistan)

When is the study starting and how long is it expected to run for?
July 2017 to December 2020

Who is funding the study?
United Nations World Food Programme (WFP)

Who is the main contact?
1. Dr Muhammad Naseem Khan (Scientific)
drnasim@kmu.edu.pk
2. Dr Zia Ul Haq (Scientific)
drzia@kmu.edu.pk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Muhammad Naseem Khan

ORCID ID

Contact details

Institute of Public Health & Social Sciences
Khyber Medical University
Phase 5 Hayatabad
Peshawar
25000
Pakistan
+92 (0)919 217 268
drnasim@kmu.edu.pk

Type

Scientific

Additional contact

Dr Zia Ul Haq

ORCID ID

Contact details

Institute of Public Health & Social Sciences
Khyber Medical University
Phase 5 Hayatabad
Peshawar
25000
Pakistan
+92 919 217 268
drzia@kmu.edu.pk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A community-based cluster controlled trial to evaluate the effectiveness of Ready to Use Supplementary Foods (RUSF) and proportional contribution of multi-sectoral interventions in the prevention of stunting among children under five years in Kurram Agency, Pakistan

Acronym

Study hypothesis

Selected nutrition-specific interventions implemented during early pregnancy, lactation and in children 6-59 months of age in different bundles will cause a shift of 0.25 in mean LAZ score among children in intervention clusters compared to those in control clusters.

Ethics approval

Ethics Board, Khyber Medical University, 28/08/2017, ref: DIR/KMU-EB/SP/000427

Study design

Interventional cluster controlled trial

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Community

Trial type

Prevention

Patient information sheet

See additional files

Condition

Stunting prevention in children 6-59 months of age

Intervention

The allocation of participants into the four groups in the intervention and control clusters is non-randomized. Clusters (each ~150 households) with a Lady Health Worker (community health workers) are assigned to intervention arm while clusters with no Lady Health Worker are assigned to the control arm. In each of the cluster (both in intervention and control arm) four groups are recruited as:
Group 1: Pregnant women between the ages of 15-49 years
Group 2: Lactating women and group 3 & 4: Children age 6-23 months and 24-59 months.

From each of the cluster an average number of 22 pregnant women, 22 lactating women, 23 six-23 months children and 23 24-59 months are enrolled for the study. Data is collected at baseline and followed up with anthropometric measurements conducted monthly from each study participant along with yearly blood and fecal sample from a sub group of study participants.

The different treatments include:
Lipid-based Nutrient Supplements (LNS) for Pregnant and Lactating Women (Local name: Maamta): These Ready to Use Supplementary Foods (RUSF) are given to pregnant and lactating women in Group 1 and Group 2. Supplementation will start from conception/earliest confirmation of pregnancy while for lactating women during the first 6 months of lactation. Active ingredients include: Roasted chickpeas, roasted yellow lentils, roasted peanuts, soybean oil, palmolein oil, hydrogenated vegetable fat as stabilizer, skimmed milk powder, sugar, maltodextrin, vitamins & minerals, emulsifier and antioxidant. The daily ration: 75 g sachet (One sachet per day is recommended for maintenance of nutritional status), throughout pregnancy and first six month of lactation. Maamta is manufactured within a quality and food safety management environment in accordance with latest version of recognized international standards and best practices and/or guidelines.

Lipid Based Nutrient Supplements (LNS) for Children (Local name: Wawa-mum): These Ready to Use Supplementary Foods (RUSF) are given to children 6-23 months of age in Group 3 of the trial. The active ingredients include: Roasted chickpeas, vegetable oil, dry skimmed milk, sugar, vitamins & minerals, emulsifier and antioxidant. The daily ration is 50 g sachet, one sachet per day is recommended. The average duration of intervention is 18 months under stunting prevention depend on age of the child at the time of assistance, starting from six month till twenty three months of child age. Wawa-mum is manufactured within a quality and food safety management environment in accordance with latest version of recognized international standards and best practices and/or guidelines.

Micro-Nutrient Powder (MNP) for Children (Local name: Vita-Mixe): These Ready to Use Supplementary Foods (RUSF) are given to children 24-59 months of age i.e. group 4 of the trial. Micro-nutrient powder is homogeneous, stable and dry packed in 1 g sachet. The daily ration is 1 gram sachet, one sachet per alternate day is recommended under stunting prevention (one sachet for two days).
The average duration of intervention is 36 months under stunting prevention depends on the age of the child at the time of assistance, starting from twenty four to fifty nine months of child age. MNP is formulated and manufactured in accordance with latest version of recognized international standards and best practices and/or guidelines.

Intervention type

Supplement

Phase

Drug names

Primary outcome measures

1. Change in Length-for-Age Z scores (LAZ) is measured using the height boards (SECA) at each month in the intervention vs control arms, compared to the baseline LAZ score against WHO 2006 growth standards. (Timeframe: Baseline, thereafter monthly till the end of the study (3 years))
2. Change in Weight-for-Age Z scores (WAZ) is measured using the digital weighing scales (SECA) at each month in intervention vs control arms, compared to the baseline WAZ score against WHO 2006 growth standards. (Timeframe: Baseline, thereafter monthly till the end of the study (3 years))
3. Change in Weight-for-Height Z scores (WHZ) is measured using the digital weighing scales (SECA) and height boards (SECA) at each month in intervention vs control arms, compared to the baseline WHZ score against WHO 2006 growth standards. (Timeframe: Baseline, thereafter monthly till the end of the study (3 years)

Secondary outcome measures

1. Infant and Young Child Feeding (IYCF) indicators is measured using a questionnaire (WHO guideline based) at baseline and at the end of the study in the intervention vs control arm. (Timeframe: Baseline and at the end of the study)
2. Birth weight of live newborns is measured using digital weighing scales (SECA) at 24 hours of birth in the intervention vs control arm. (Timeframe: Within 24 hours of delivery)
3. Nutritional intake (energy and protein) measured using 24-hour dietary recall method (FAO guideline based) at baseline and at the end of the study. (Timeframe: Baseline and at the end of the study)
4. Maternal weight gain during pregnancy is measured using digital weighing scales (SECA) at baseline, thereafter monthly till delivery in the intervention vs control arm. (Timeframe: Baseline, thereafter monthly till delivery)
5. Hemoglobin, albumin and micro nutrients like iron, zinc, iodine and vitamins are measured using blood samples at baseline, thereafter yearly till the end of the study (3rd year end) in a subsample in the intervention vs control arm. (Timeframe: Baseline, thereafter yearly till the end of the study (3rd year end))

Overall trial start date

01/07/2017

Overall trial end date

31/12/2020

Reason abandoned

Eligibility

Participant inclusion criteria

Group 1:
1. Pregnant women between the ages of 15-49 years will be recruited in the first group.
2. Pregnant women will be invited in their first trimester (preferably 1st two months of pregnancy).

Group 2:
1. Lactating women will be recruited in this group.
2. Lactating women will be invited within the early days following delivery (preferably within 2 months of delivery).

Group 3 & 4:
1. Children age 6-23 months and 24-59 months will form group 3 and 4 respectively
2. In group 3 children with ages between 6-18 months will be invited for the trial
3. Similarly for group 4 children with ages between 24-48 months will be invited
4. Preferably these children will be recruited from the households from which pregnant and lactating women were invited

Participant type

Healthy volunteer

Age group

Mixed

Gender

Both

Target number of participants

7200

Participant exclusion criteria

1. Children with Severe Acute Malnutrition (SAM) or Moderate Acute Malnutrition (MAM) will be excluded and referred for treatment.
2. Similar nutrition specific interventions currently being implemented in the selected cluster.
3. Participants planning to move from the study area during the study timelines.

Recruitment start date

18/12/2017

Recruitment end date

28/02/2018

Locations

Countries of recruitment

Pakistan

Trial participating centre

Agency Surgeon Office
Kurrum Agency of Federally Administered Tribal Areas of Pakistan
Parachinar
25000
Pakistan

Sponsor information

Organisation

Khyber Medical University

Sponsor details

Phase 5
Hayatabad
Peshawar
25000
Pakistan
+92 (0)919 217 268
drnasim@kmu.edu.pk

Sponsor type

Government

Website

http://www.kmu.edu.pk/

Funders

Funder type

Charity

Funder name

United Nations World Food Programme (WFP)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal around one year after overall trial end date.

IPD sharing statement:
The current data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/12/2021

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

05/01/2018: Internal review.