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The PLAY study: a randomised controlled trial of an intervention to improve infant development by encouraging maternal self-efficacy using behavioural feedback

The Play, Love and You Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR202202747620052
Enrollment
210
Registered
2022-02-10
Start date
2022-09-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mental and Behavioural Disorders Nutritional, Metabolic, Endocrine Paediatrics

Interventions

Control Group
Intervention Group

Sponsors

University of the Witwatersrand
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: • Mothers agree to participate for the duration of the study • They reside in Soweto and plan to remain in Soweto for the study duration • Infants are singleton and healthy at delivery according to APGAR >=7 • The mother is aged >=18 years and can complete questionnaires in English • The mother is the primary caregiver

Exclusion criteria

Exclusion criteria: • Infants are born preterm • Mothers have existing diagnosed Diabetes Mellitus Type-1,or Epilepsy

Design outcomes

Primary

MeasureTime frame
Maternal self-efficacy at 12 months compared between intervention and control groups.

Secondary

MeasureTime frame
Breastfeeding self-efficacy from 0 to 6 months compared between intervention and control groups.;Exclusive breast feeding from 0 to 6 months compared between intervention and control groups.;Feasibility and acceptability of the breastfeeding intervention.;Infant development at 12 months compared between the intervention and control groups using the Ages and Stages Questionnaire (ASQ3);Feasibility and acceptability of the health literacy and behavioural feedback intervention;Change in infant weight to length ratio compared between intervention and control groups and infant fat mass index (FMI) (assessed using dual X-ray absorptiometry (DXA) fat mass divided by length) compared between intervention and control groups.;Change in maternal health literacy from 6 to 12 months compared between intervention and control groups;Change in maternal mental health from 0 to 12 months compared between the intervention and control groups;Infant movement behaviours compared between intervention and control groups.;Mother–infant interaction styles compared between intervention and control groups

Countries

South Africa

Contacts

Public ContactAlessandra Prioreschi

Principal investigator

alessandra.prioreschi@wits.ac.za+27839890070

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Aug 9, 2026