NCT05473312

Brief Summary

Undernutrition in the first 2 years of life is the largest preventable cause of death before age 5. Among those who survive, stunting before age two leaves millions with lifelong physical and cognitive deficits, which are difficult to compensate for later in life. Pakistan is home to the second largest number of stunted children in South Asia. The primary goal of this study is to rehabilitate moderately malnourished children aged 7-23 months and enable mothers to sustain this healthy growth at home by changing their infant and young child feeding (IYCF) practices, child care, hygiene and health-seeking behaviours.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
350

participants targeted

Target at P75+ for not_applicable

Timeline
14mo left

Started Sep 2022

Longer than P75 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

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Study Timeline

Key milestones and dates

Study Progress76%
Sep 2022Jun 2027

First Submitted

Initial submission to the registry

April 12, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 25, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2026

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Expected
Last Updated

January 27, 2026

Status Verified

January 1, 2026

Enrollment Period

3.6 years

First QC Date

April 12, 2022

Last Update Submit

January 24, 2026

Conditions

Health Knowledge, Attitudes, PracticeChild MalnutritionChild RearingHealth Care Seeking BehaviorUndernutritionHealthy NutritionHealth Behavior

Outcome Measures

Primary Outcomes (4)

  • Child weight

    Child weight measurement in kilograms

    Day 1 of each Hearth/home cycle

  • Child weight

    Child weight measurement in kilograms

    Day 14 of each Hearth/home cycle

  • Child weight

    Child weight measurement in kilograms

    Day 28 of each Hearth/home cycle

  • Child weight

    Child weight measurement in kilograms

    Monthly for a total of 12 months

Secondary Outcomes (16)

  • Child length

    Day 1 of each Hearth/home cycle

  • Child length

    Day 14 of each Hearth/home cycle

  • Child length

    Day 28 of each Hearth/home cycle

  • Child length

    Monthly for a total of 12 months

  • Prevalence of infant and young child feeding knowledge and practices

    At baseline

  • +11 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

1. Community Sensitization 2. 28-day behaviour practice (Positive Deviance (PD) /Hearth sessions plus home practice) 3. Supplemental Print Information

Behavioral: Community SensitizationBehavioral: 28-day PD/Hearth SessionsBehavioral: Supplemental Print Information

Control

NO INTERVENTION

Control households will continue with usual practices.

Interventions

Community SensitizationBEHAVIORAL

One event will be developed and delivered for households in each cluster area. Approach and content will be informed by the formative research and CAC input (may include drama and nutrition fairs).

Intervention
28-day PD/Hearth SessionsBEHAVIORAL

Mothers will come together in a home-like setting to rehabilitate their malnourished child (8 dyads/Hearth), learn and practice new feeding and childcare behaviours (during Covid-19: 4 dyads/Hearth). Curriculum and activities will be informed by CAC, CORE Guide and formative research. Two female facilitators will demonstrate, encourage, convey key messages and guide practices.

Intervention
Supplemental Print InformationBEHAVIORAL

The content will be informed by the formative research and CAC, will reinforce Hearth messages, and be adapted for each gender group. Material will be locally produced, engaging, user friendly, and target an illiterate audience (i.e. culturally relevant images with minimal text).

Intervention

Eligibility Criteria

Age7 Months - 9 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Households with a moderately malnourished child (Index child) 7-9 month of age and both parents consenting using thumbprint or written signature (one dyad/household).

You may not qualify if:

  • Any disability that precludes providing informed consent, transient, \< 18 yrs (legal consent age).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aga Khan University Reseach Office

Rahim Yar Khan, Pakistan

Location

MeSH Terms

Conditions

MalnutritionHealth BehaviorBehaviorChild Nutrition DisordersPatient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesTreatment Adherence and Compliance

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 12, 2022

First Posted

July 25, 2022

Study Start

September 1, 2022

Primary Completion

March 30, 2026

Study Completion (Estimated)

June 30, 2027

Last Updated

January 27, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)