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Table 1 Primary, secondary, and implementation outcomes and measures

From: The Kusamala Program for primary caregivers of children 6–59 months of age hospitalized with severe acute malnutrition in Malawi: study protocol for a cluster-randomized controlled trial

Outcomes

Measures

Primary outcome

 Child development: gross motor, fine motor, language, and social development (t 6 )

Malawi Developmental Assessment Tool (MDAT)

Secondary outcomes (child)

 Nutritional status (t 6 )

Mid-upper arm circumference (MUAC)

Weight-for-length or -height z scores (WLZ or WHZ)

Presence of bilateral pitting oedema

Height-for-age z scores (HAZ)

 Dietary intake (t 6 )

24-h dietary recall

 Readmission to hospital (t 5 t 6 )

Record of readmission to hospital for severe acute malnutrition (SAM)

 Mortality (–t 1 to t 5 or t 5 t 6 )

Death of child confirmed

Secondary outcomes (primary caregiver and household)

 Mental health status (t 6 )

Self-Reporting Questionnaire-20 (SRQ-20)

 Nutritional status (t 6 )

Mid-upper arm circumference (MUAC)

Body mass index (BMI)

 Knowledge, attitudes, and practices (t 6 )

Questionnaire about hygiene and sanitation, nutrition and feeding, and malnutrition

24-h dietary recall of child

 Stimulus and support for children in the household (t 6 )

Home Observation of the Measurement of the Environment (HOME) Inventory

Implementation outcomes

 Participant engagement (t 1 )

Number of enrolled participants who attend day 1 of the Kusamala Program

 Participant adherence (t 1 t 4 )

Number of enrolled participants who attend all 4 days of the Kusamala Program

 Fidelity of the intervention programme

Assessment form of Kusamala Program delivery

 Participant knowledge and attitudes of intervention content (t 5 )

Questionnaire about hygiene and sanitation, nutrition and feeding, and malnutrition