NCT07345754

Brief Summary

This project aims to reduce child malnutrition in Pakistan by building on local strengths and practical community solutions. The project focuses on children 7-23 months of age. The investigators will aim to recruit young children between 7-15 months of age, giving the youngest children priority over older children so that participants may be followed longitudinally over 6 and 12 months. The project supports participants for six months through learning, practice, and regular follow-up. The work begins with community sensitization events, where local families learn about healthy feeding for young children through group discussions, visuals, and printed materials. These sessions build awareness, encourage community support, and prepare families for the main intervention. The core of the project is a 28-day behaviour change program. In the first two weeks, mothers and children take part in daily "Hearth" sessions, which are interactive, home-like meetings that teach practical feeding, hygiene, and caregiving skills using local foods. In the next two weeks, mothers apply learned skills at home while being visited regularly by project staff, who provide support and monitor child growth. If children gain at least 400 grams, as recommended by WHO, families graduate to monthly check-ins; if not, families may repeat the 28-day cycle up to three times. This approach targets chronic malnutrition by supporting families in adopting sustainable caregiving practices rather than providing short-term aid. Educational materials developed with community input support the learning process. Designed with visuals and minimal text, the materials are accessible to both literate and illiterate parents and are distributed widely to encourage shared responsibility for child health. To measure success, the project uses surveys and growth measurements for both treatment and control groups. Surveys gather information about family demographics, feeding and hygiene behaviours, and health practices, while trained staff measure children's height and weight at regular intervals. The data will help determine whether the intervention improves children's nutritional status and caregiving practices. Ultimately, the project seeks to empower families and communities to use local resources and knowledge to support healthier child growth. The project combines community engagement, hands-on learning, and scientific evaluation to promote lasting change in how families feed, nurture, and care for young children.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
20mo left

Started Oct 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
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 Progress27%
Oct 2025Dec 2027

Study Start

First participant enrolled

October 1, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 7, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 16, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

2.2 years

First QC Date

January 7, 2026

Last Update Submit

January 15, 2026

Conditions

Keywords

28-day behaviour change programPositive Deviance HearthMalnutritionFeeding parcticesPakistan

Outcome Measures

Primary Outcomes (2)

  • Weight

    Index Child's weight will be measured in Kilogram(Kg) and will be used to assess the Index child's nutritional status.

    At baseline; Hearth Days 1, 13, 28; During monthly home visits; End-Survey after 6 months

  • Weight-for-age Z-score

    Nutritional status of Index child will classify as (1) severely underweight, (2) moderate underweight, (3) mild underweight, (4) well-nourished or normal weight using weight-for-age Z-score as below. Severely underweight if weight-for-age Z-score \<-3 SD of the median. Moderate underweight if weight-for-age Z-score between -2 SD and -3 SD. Mild underweight if weight-for-age Z-score between -1 SD and -2 SD. Normal weight if weight-for-age Z-score between -1 SD and +1 SD.

    At baseline; Hearth Days 1, 13, 28; During monthly home visits; End-Survey after 6 months

Secondary Outcomes (6)

  • Length

    At baseline and 6 months post-intervention

  • Height-for-age Z-score

    At baseline and 6 months post-intervention

  • Mid-upper arm circumference (MUAC)

    At baseline and 6 months post-intervention

  • Weight-for-Height Z-Score

    At baseline and 6 months post-intervention

  • MINIMUM MEAL FREQUENCY 6-23 MONTHS (MMF)

    At baseline and 6 months post-intervention

  • +1 more secondary outcomes

Study Arms (2)

Intervention arm

EXPERIMENTAL

The intervention arm will participate in a 28-day behaviour change program consisting of two-week cycles of Hearth sessions followed by two weeks of home visits to reinforce and practise the newly learned behaviours. Before starting the program, each index child will be referred to a local health clinic for a medical assessment and confirmation of immunization. They will receive vitamin A supplementation and deworming treatment in accordance with national protocol, if required. The intervention arm will undergo the same evaluations as the control arm, including baseline and 6-month follow-up surveys, as well as monthly anthropometric measurements.

Behavioral: 28-day Behavioural Change Program

Control arm

NO INTERVENTION

This arm will not participate in the 28-day behaviour change program and will not not undergo a health facility-based assessment at baseline. The evaluations for this arm will include baseline and follow-up surveys, and monthly anthropometric measurements for up to 6 months. This group will continue to receive routine care from lady health workers (LHWs) and access health services as usual.

Interventions

The study's intervention includes a 28-day program with group sessions in a home-like setting (Hearth) where mothers of moderately malnourished children and family members learn practical ways to prepare nutritious meals and improve caregiving practices. Each cycle has two parts: Group Hearth Sessions (2 weeks): About 15 mother-child pairs attend sessions. Sessions will focus on knowledge about complementary feeding, active feeding, hygiene, caregiving, and health-seeking behaviours. Mothers will take part in cooking and caring demonstrations, rotating through roles to build hands-on skills. Home Practice (2 weeks): Field staff visit each home three times per week to reinforce new behaviours, provide guidance, and monitor progress. Mothers contribute small items such as eggs, rice, or utensils to reflect real-life conditions, while the project provides pots, utensils, and most of the food. This shared approach promotes engagement and helps sustain improved practices at home.

Intervention arm

Eligibility Criteria

Age7 Months - 15 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Eligible participants must meet all of the following conditions:
  • Child-Level Criteria:
  • While children in the intervention phase will range from ages 7-23 months, At the time of recruitment children will range from Ages: 7-15 months.
  • Priority will be given to younger children, aged 7-11 months, followed by 12-15 months to allow completion of the intervention and follow-up visits before the child turns 24 months of age, as complementary feeding refers to feeding practices between the ages of 6-24 months.
  • Moderate malnutrition, defined by: Weight-for-age Z-score between -2 and -3 standard deviations.
  • Household-Level Criteria:
  • Households will be eligible to participate if:
  • They meet the classification of very poor or poor (based on community-defined wealth stratification).
  • Have access to clean water and sanitation.
  • Food secure at time of recruitment, defined as:
  • On government assistant program or at least one adult has permanent employment, or two or more have temporary employment.
  • Ownership of at least one simple livestock (e.g., chicken, goat, or sheep) or express willingness to accept and care for livestock provided by the project team.
  • Access to a kitchen garden, or willingness to establish one with study support
  • Mother Eligibility Criteria:
  • The household is eligible only if the mother meets all of the following:
  • +11 more criteria

You may not qualify if:

  • Children who are Severely malnourished, mildly underweight or of normal weight.
  • Children with Physical disabilities: difficulty in seeing, hearing, picking up small objects with his/her hand.
  • Children with chronic illnesses that may interfere with normal growth (based on past or current medical history):
  • Malabsorption
  • Chronic Kidney Disease
  • Inflammatory Bowel Disease
  • Congenital Heart Disease
  • Endocrine Disorders (e.g., hypothyroidism, growth hormone deficiencies)
  • Chronic Respiratory Diseases (e.g., asthma, lung diseases)
  • Congenital or Acquired Immunodeficiency, and Neurological Disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RYK

Rahim Yar Khan, Punjab Province, Pakistan

RECRUITING

MeSH Terms

Conditions

Child Nutrition DisordersMalnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Central Study Contacts

Rosemin Kassam, Ph.D

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: In Rahim Yar Khan, three union councils (UCs) were selected for the intervention arm, and three UCs were assigned to the control arm.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 7, 2026

First Posted

January 16, 2026

Study Start

October 1, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

January 20, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations