Trial no.:	PACTR202607783193367	Date of Registration:	31/07/2026
Trial Status:	Retrospective registration - This trial was registered after enrolment of the first participant

TRIAL DESCRIPTION

Public title

Optimizing Under-five Nutrition Outcomes Through Co-Designing and Adapting an Integrated Nutrition Intervention and Evaluate Its Effectiveness.

Official scientific title

Optimizing Under-five Nutrition Outcomes Through Co-Designing and Adapting an Integrated Nutrition Intervention and Evaluate Its Effectiveness. – A Case Study of Communities Surrounding Kansanshi Mine, Solwezi District, Zambia.

Brief summary describing the background and objectives of the trial

Malnutrition continues to be a public health problem globally and is a threat in most developing countries, particularly in southern Asia and sub-Saharan Africa. Malnutrition occurs due to an imbalance in the body where the nutrients needed by the body and the amount used by the body are not proportional. Malnutrition can also be broadly categorized into undernutrition and over nutrition. In the Africa region, the prevalence of stunting is 30.7% which is higher than the global average (22.0%). Poor nutrition is a major burden and continues to be a public health issue of concern in Zambia. Little is known about available and implementable community-based nutrition and wellness programs particularly in under-served communities. Despite major efforts to reduce the burden of malnutrition, the progress towards tackling the different forms of malnutrition remains relatively slow. Mining areas are characterized by household poverty, poor public health facilities, poor health services and limited health programmes. Mining has fuelled public health challenges and little investigation has been done to ascertain effectiveness, compatibility and optimization of CRS programs. To assess the impact of an integrated, context-specific nutrition intervention on the nutritional outcomes of children under five through a three-arm cluster-randomised non-inferiority trial — specifically, to determine whether an optimised intervention (fortified food distribution, cooking demonstrations, and maternal health education) is superior to a standard intervention (cooking demonstrations and education alone) and to no intervention, in reducing underweight, wasting, and stunting over an 8-month implementation period.

Type of trial

Non-Randomised

Acronym (If the trial has an acronym then please provide)

Disease(s) or condition(s) being studied

Nutritional, Metabolic, Endocrine

Sub-Disease(s) or condition(s) being studied

Purpose of the trial

Physical activity and nutrition

Anticipated trial start date

10/01/2024

Actual trial start date

22/01/2024

Anticipated date of last follow up

25/09/2024

Actual Last follow-up date

10/12/2024

Anticipated target sample size (number of participants)

450

Actual target sample size (number of participants)

450

Recruitment status

Completed

Publication URL

Secondary Ids	Issuing authority/Trial register

STUDY DESIGN
Intervention assignment	Allocation to intervention	If randomised, describe how the allocation sequence was generated	Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms	Masking	If masking / blinding was used
Parallel: different groups receive different interventions at same time during study	Non-randomised		Allocation was determined by the holder of the sequence who is situated off site	Open-label(Masking Not Used)

INTERVENTIONS
Intervention type	Intervention name	Dose	Duration	Intervention description	Group size	Nature of control
Experimental Group	Cooking demonstrations and distribution of Instant porridge for underfive children	One box per month	6 months	Optimised Intervention Arm (OIA): ● Fortified instant porridge (Rhino brand: cereals, soya, banana flour, milk powder, vitamins and minerals) — distributed monthly to malnourished/at-risk children and underweight caregivers, for daily consumption (at least once daily) throughout the 8-month implementation period. ● Cooking demonstrations — bi-monthly, hands-on, using locally sourced ingredients supplemented with procured items (cooking oil, kapenta, eggs, milk). ● Healthy Mother + Healthy Child initiative — monthly caregiver health screening (BMI, blood pressure, WHO Self-Reporting Questionnaire) combined with nutrition and responsive-feeding education.	150
Experimental Group	Standard	Every month	6 months	Standard Intervention Arm (SIA): ● Same cooking demonstrations (bi-monthly) and maternal health education (monthly) as the OIA, but with no fortified food distribution	150
Control Group	Control Arm	None	6 months	Control Arm (CA): ● Routine under-five health services only — growth monitoring and promotion, immunisation, vitamin A supplementation, deworming, integrated management of childhood illness, caregiver health education, and referral — with no additional programme activity.	150	Uncontrolled

ELIGIBILITY CRITERIA
List inclusion criteria	List exclusion criteria	Age Category	Minimum age	Maximum age	Gender
The study focused on children under five years of age, specifically those between 6 and 59 months, along with their caregivers, to assess the impact of the intervention on child development and caregiver well-being	Children with chronic health conditions	Infant: 1 Month(s)-12 Month(s),Preschool Child: 2 Year-5 Year	6 Month(s)	4 Year(s)	Both

ETHICS APPROVAL

Has the study received appropriate ethics committee approval

Date the study will be submitted for approval

Date of approval

Name of the ethics committee

Yes

14/08/2023

CBUBREC

Ethics Committee Address
Street address	City	Postal code	Country
Michael Chilufya Sata School of Medicine. Hilcrest.	Ndola	10101	Zambia

Has the study received appropriate ethics committee approval

Date the study will be submitted for approval

Date of approval

Name of the ethics committee

Yes

23/08/2023

NATIONAL HEALTH RESEARCH AUTHORITY

Ethics Committee Address
Street address	City	Postal code	Country
Lot No. 18961/M, off Kasama Road, Chalala, P.O. Box 30075, LUSAKA	Lusaka	10101	Zambia

OUTCOMES
Type of outcome	Outcome	Timepoint(s) at which outcome measured
Primary Outcome	● Prevalence of underweight (weight-for-age Z-score < −2 SD). ● Prevalence of wasting (weight-for-height Z-score < −2 SD). ● Prevalence of stunting (height-for-age Z-score < −2 SD).	Baseline and endline
Secondary Outcome	● Caregiver Body Mass Index (BMI). ● Caregiver psychological distress (WHO Self-Reporting Questionnaire, SRQ). ● Household dietary diversity score (HDDS). ● Household food insecurity (Food Insecurity Experience Scale, FIES).	Baseline and endline

RECRUITMENT CENTRES
Name of recruitment centre	Street address	City	Postal code	Country
Solwezi Foundation	Plot 10367, off Congo Road	Solwezi	10101	Zambia

FUNDING SOURCES
Name of source	Street address	City	Postal code	Country
CBU Center of Exellence	Michael Chilufya Sata School of Medicine. Hilcrest.	Ndola	10101	Zambia

SPONSORS
Sponsor level	Name	Street address	City	Postal code	Country	Nature of sponsor
Primary Sponsor	CBU center of exellence	CBU - graduate school	Kitwe	10101	Zambia	University

COLLABORATORS
Name	Street address	City	Postal code	Country

CONTACT PEOPLE
Role	Name	Email	Phone	Street address
Principal Investigator	Herbert Tato Nyirenda	htnyirenda@gmail.com	+260978229494	Hillcrest,
City	Postal code	Country	Position/Affiliation
Ndola		Zambia	Lecturer
Role	Name	Email	Phone	Street address
Scientific Enquiries	David Mulenga	davykdn@gmail.com	+26097104128	CBU, Hillcrest
City	Postal code	Country	Position/Affiliation
Ndola		Zambia	Copperbelt University
Role	Name	Email	Phone	Street address
Public Enquiries	Hilda Nyambe Silavwe	hildanyambe@gmail.com	+260971801983	UNZA, great east road
City	Postal code	Country	Position/Affiliation
Lusaka		Zambia	University of Zambia

REPORTING
Share IPD	Description	Additional Document Types	Sharing Time Frame	Key Access Criteria
Yes	Following completion of the trial, de-identified individual participant data (child anthropometric outcomes at baseline and endline, caregiver socio-demographic and food-security variables) will be made available, together with a data dictionary and the study protocol. Data are securely stored on a restricted-access cloud platform and under lock and key at Copperbelt University, in accordance with ethical approval CBU/BREC/23/001 (Copperbelt University Biomedical Research Ethics Committee) and National Health Research Authority clearance. Data will be shared with researchers who submit a scientifically sound proposal, subject to approval by the corresponding author (Herbert Tato Nyirenda, tatonyirenda@gmail.com, Copperbelt University) and execution of a data access agreement to protect participant confidentiality. Data will be available from the date of trial registration, with no defined end date.	Statistical Analysis Plan,Study Protocol	for summary results within 12 months of study completion	Summary results of this trial are available in: Nyirenda HT, Mulenga D, Nyambe-Silavwe H. “Leveraging Culinary Nutrition Interventions and Contextual Factors to Combat Child Growth Failure in Mining Communities for Maximum Impact.” Clinical Nutrition Open Science (2024). DOI: 10.1016/j.nutos.2024.12.005. Additional peer-reviewed outputs from this trial are indexed under the corresponding author's ORCID (0000-0001-8045-4384). A full trial-outcomes report is in preparation for submission to a peer-reviewed journal.
URL	Results Available	Results Summary	Result Posting Date	First Journal Publication Date
	No
Result Upload 1:	Result Upload 2:	Result Upload 3:	Result Upload 4:	Result Upload 5:

Result URL Hyperlinks	Link To Protocol
Result URL Hyperlinks

Changes to trial information
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Trial Information	Trial description	25/07/2026	Added as information was missing		To assess the impact of an integrated, context-specific nutrition intervention on the nutritional outcomes of children under five through a three-arm cluster-randomised non-inferiority trial — specifically, to determine whether an optimised intervention (fortified food distribution, cooking demonstrations, and maternal health education) is superior to a standard intervention (cooking demonstrations and education alone) and to no intervention, in reducing underweight, wasting, and stunting over an 8-month implementation period.
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Trial Information	Trial description	25/07/2026	Added as information was missing	To assess the impact of an integrated, context-specific nutrition intervention on the nutritional outcomes of children under five through a three-arm cluster-randomised non-inferiority trial — specifically, to determine whether an optimised intervention (fortified food distribution, cooking demonstrations, and maternal health education) is superior to a standard intervention (cooking demonstrations and education alone) and to no intervention, in reducing underweight, wasting, and stunting over an 8-month implementation period.	Malnutrition continues to be a public health problem globally and is a threat in most developing countries, particularly in southern Asia and sub-Saharan Africa. Malnutrition occurs due to an imbalance in the body where the nutrients needed by the body and the amount used by the body are not proportional. Malnutrition can also be broadly categorized into undernutrition and over nutrition. In the Africa region, the prevalence of stunting is 30.7% which is higher than the global average (22.0%). Poor nutrition is a major burden and continues to be a public health issue of concern in Zambia. Little is known about available and implementable community-based nutrition and wellness programs particularly in under-served communities. Despite major efforts to reduce the burden of malnutrition, the progress towards tackling the different forms of malnutrition remains relatively slow. Mining areas are characterized by household poverty, poor public health facilities, poor health services and limited health programmes. Mining has fuelled public health challenges and little investigation has been done to ascertain effectiveness, compatibility and optimization of CRS programs. To assess the impact of an integrated, context-specific nutrition intervention on the nutritional outcomes of children under five through a three-arm cluster-randomised non-inferiority trial — specifically, to determine whether an optimised intervention (fortified food distribution, cooking demonstrations, and maternal health education) is superior to a standard intervention (cooking demonstrations and education alone) and to no intervention, in reducing underweight, wasting, and stunting over an 8-month implementation period.
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Trial Information	Target no of participants	25/07/2026	N/A	750	450
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Trial Information	Final no of participants	25/07/2026	The Total population of children was the one initially entered	700	450
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Intervention	Intervention List	25/07/2026	This is the actual sample and not the target population		Control Group, Cooking demonstrations and distribution of Instant porridge for underfive children, None, 6 months, None, 150, Uncontrolled
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Intervention	Intervention List	25/07/2026	This is the actual sample and not the target population	Experimental Group, Cooking demonstrations and distribution of Instant porridge for underfive children, One box per month, 6 months, Health education, training in cooking demonstration and distribution of instant porridge, 250,	Experimental Group, Cooking demonstrations and distribution of Instant porridge for underfive children, One box per month, 6 months, Health education, training in cooking demonstration and distribution of instant porridge, 150,
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Intervention	Intervention List	25/07/2026	This is the actual sample and not the target population	Experimental Group, Cooking demonstrations and distribution of Instant porridge for underfive children, One box per month, 6 months, Health education, training in cooking demonstration and distribution of instant porridge, 150,	Experimental Group, Cooking demonstrations and distribution of Instant porridge for underfive children, One box per month, 6 months, Optimised Intervention Arm (OIA): ● Fortified instant porridge (Rhino brand: cereals, soya, banana flour, milk powder, vitamins and minerals) — distributed monthly to malnourished/at-risk children and underweight caregivers, for daily consumption (at least once daily) throughout the 8-month implementation period. ● Cooking demonstrations — bi-monthly, hands-on, using locally sourced ingredients supplemented with procured items (cooking oil, kapenta, eggs, milk). ● Healthy Mother + Healthy Child initiative — monthly caregiver health screening (BMI, blood pressure, WHO Self-Reporting Questionnaire) combined with nutrition and responsive-feeding education. , 150,
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Intervention	Intervention List	25/07/2026	This is the actual sample and not the target population	Experimental Group, Cooking demonstrations, Every month, 6 months, Cooking demonstrations only, 250,	Experimental Group, Cooking demonstrations, Every month, 6 months, Cooking demonstrations only, 150,
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Intervention	Intervention List	25/07/2026	This is the actual sample and not the target population	Experimental Group, Cooking demonstrations, Every month, 6 months, Cooking demonstrations only, 150,	Experimental Group, Standard, Every month, 6 months, Standard Intervention Arm (SIA): ● Same cooking demonstrations (bi-monthly) and maternal health education (monthly) as the OIA, but with no fortified food distribution , 150,
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Intervention	Intervention List	25/07/2026	Updated	Control Group, Cooking demonstrations and distribution of Instant porridge for underfive children, None, 6 months, None, 150, Uncontrolled	Control Group, Control Arm, None, 6 months, Control Arm (CA): ● Routine under-five health services only — growth monitoring and promotion, immunisation, vitamin A supplementation, deworming, integrated management of childhood illness, caregiver health education, and referral — with no additional programme activity. , 150, Uncontrolled
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Outcome	OutCome List	25/07/2026	Made them more clear	Primary Outcome, Stunting, wasting and underweight, Baseline and endline	Primary Outcome, ● Prevalence of underweight (weight-for-age Z-score < −2 SD). ● Prevalence of wasting (weight-for-height Z-score < −2 SD). ● Prevalence of stunting (height-for-age Z-score < −2 SD). , Baseline and endline
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Outcome	OutCome List	25/07/2026	Added outcomes	Secondary Outcome, Trained, , Baseline and endline	Secondary Outcome, ● Caregiver Body Mass Index (BMI). ● Caregiver psychological distress (WHO Self-Reporting Questionnaire, SRQ). ● Household dietary diversity score (HDDS). ● Household food insecurity (Food Insecurity Experience Scale, FIES). , Baseline and endline
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Ethics	Ethics List	25/07/2026	Updated the information	TRUE, CBUBREC, Michael Chilufya Sata School of Medicine. Hilcrest., Ndola, 10101, Zambia, , 14 Aug 2023, +260978229494, herbert.nyirenda@cbu.ac.zm, 43711_40037_4737.pdf	TRUE, CBUBREC, Michael Chilufya Sata School of Medicine. Hilcrest., Ndola, 10101, Zambia, , 14 Aug 2023, +260978229494, cbusombrec@gmail.com, 43711_40037_4737.pdf
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Ethics	Ethics List	25/07/2026	Updated the information	TRUE, CBUBREC, Michael Chilufya Sata School of Medicine. Hilcrest., Ndola, 10101, Zambia, , 14 Aug 2023, +260978229494, cbusombrec@gmail.com, 43711_40037_4737.pdf	TRUE, CBUBREC, Michael Chilufya Sata School of Medicine. Hilcrest., Ndola, 10101, Zambia, , 14 Aug 2023, +260978229494, cbusombrec@gmail.com, 43711_40037_4737.pdf
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Ethics	Ethics List	25/07/2026	Added National Approval		TRUE, NATIONAL HEALTH RESEARCH AUTHORITY, Lot No. 18961/M, off Kasama Road, Chalala, P.O. Box 30075, LUSAKA, Lusaka, 10101, Zambia, , 23 Aug 2023, +260211250309, znhrasec@nhra.org.zm, 43711_40081_4737.pdf
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Eligibility	Minimum age	25/07/2026	Children aged 6 months and above	0 Month(s)	6 Month(s)

Pan African Clinical Trials Registry