NCT07153913

Brief Summary

In a recently completed intervention study, more than 50% of children in Lusaka were found to be stunted by age two, even when nutritional supplements were provided. It seems likely that these high rates of stunting are primarily due to inadequate basic nutritional intake. The main goal of this project is investigate this conjecture through a small pilot study that will be conducted in the urban area of Lusaka.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
20mo left

Started Sep 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress29%
Sep 2025Dec 2027

First Submitted

Initial submission to the registry

August 26, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 4, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

September 5, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Expected
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

January 7, 2026

Status Verified

January 1, 2026

Enrollment Period

11 months

First QC Date

August 26, 2025

Last Update Submit

January 6, 2026

Conditions

Keywords

stuntingfood supplementationcounselingcash tranfers

Outcome Measures

Primary Outcomes (1)

  • Height-for-age z-score

    Children's height for age z-score after six months of interventions

    measured approximately 6 months after initiation of intervention

Study Arms (2)

Control arm

NO INTERVENTION

Families in control group will not receive any support through the study

Food provision and nutritional counseling

EXPERIMENTAL

Families will receive intensive support including bi-weekly nutritional counseling and weekly dropoffs of locally acquired food.

Other: Intensive growth support

Interventions

For women in the intervention group, we will develop a nutritional plan for the child in collaboration with the mother. Mothers will then receive a visit every other week - during this visit, children's health and nutrition will be discussed, and height and weight will be measured by field officers. Detailed food recommendations will be made based on national and international infant and young child feeding guidelines. To ensure appropriate foods are available, field workers will drop off local foods on a weekly basis.

Food provision and nutritional counseling

Eligibility Criteria

Age6 Months - 12 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may not qualify if:

  • expected to move
  • no child health card
  • participating in cash transfer programs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Innovations for Poverty Action Zambia

Lusaka, Lusaka Province, Zambia

Location

MeSH Terms

Conditions

Growth Disorders

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Günther Fink, PhD

    Swiss Tropical & Public Health Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Unit Head and Professor

Study Record Dates

First Submitted

August 26, 2025

First Posted

September 4, 2025

Study Start

September 5, 2025

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

December 31, 2027

Last Updated

January 7, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations