Clinical trial NCT05157906: Effects of the Happy Grow Program on Parental Self-confidence: A Randomized, Controlled Open-label Study
Official title: Effects of the Happy Grow Program on Parental Self-confidence: A Randomized, Controlled Open-label Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Responsive Parenting
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2021-12-15
Enrollment: 250
Sex: ALL
Minimum age (years): 24
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized, controlled education-based interventional study without any investigational product. Study subjects are randomized to the intervention or control groups with a follow-up period of 12 weeks.
Primary purpose: OTHER

Brief summary: This is a randomized, controlled education-based interventional study without any investigational product. Study subjects are randomized to the intervention or control groups with a follow-up period of 12 weeks. 250 toddlers between ages 24 and 28 months with first-time primary caregiver (mother or father) from low to mid-income families in Indonesia will be enrolled.

Detailed description: Extensive scientific literature demonstrates that childhood happiness can be nurtured through positive and responsive parenting strategies, and is associated with optimal child development and is a predictor of future happiness.

The Grow Happy program is a translation of scientific literature into parent-friendly educational materials and actionable tips and advice aimed at improving parental knowledge and child happiness through parenting techniques and play.

Although the Grow Happy Program is scientifically validated, it has yet to be clinically tested. It is hypothesized that the Grow Happy program will improve mothers' knowledge and self-confidence related to parenting behaviors that promote happiness and optimal child development.

Eligibility criteria: Inclusion criteria:

1. Caregiver-toddler dyad pair is from low to mid-income households, as defined by a cut-off annual income level of IDR \<4,800,000 according to National Socioeconomic Survey.
2. Toddlers (full-term) between ages of 24 and 28 months at time of enrolment.
3. Normally developing toddlers without any diagnosed behavioral, neurological or eating issues.

Exclusion criteria:

1. Primary caregivers with more than one child.
2. Primary caregivers with diagnosed behavioral or eating issues.
3. Toddlers with weight-for-age value \< -2 SD from the National Indonesian Growth Chart or per WHO Standards at enrollment.
4. Toddlers with height-for-age \< -2 SD from the National Indonesian Growth Chart or per WHO Standards at enrollment.

Primary outcomes:
measure: To increase self-confidence of mothers (vs. control group) to adopt responsive parenting behaviors that promote optimal child development.
timeFrame: Change from baseline (V1) to 12 weeks of intervention (V2).
Secondary outcomes:
measure: Parenting experience
timeFrame: Change from baseline to 12 weeks
measure: Child's health-related quality of life
timeFrame: Change from baseline to 12 weeks
measure: Maternal health-related quality of life
timeFrame: Change from baseline to 12 weeks
measure: Toddler gut comfort
timeFrame: Change from baseline to 12 weeks
measure: Child eating behavior
timeFrame: Change from baseline to 12 weeks
measure: Child temperament
timeFrame: Change from baseline to 12 weeks
measure: Child playfulness
timeFrame: Change from baseline to 12 weeks
measure: Parenting responsiveness behaviors
timeFrame: Change from baseline to 12 weeks
Other outcomes:
Locations:
city: Sleman
country: Indonesia
facility: University Gadjah Mada, Center for Health and Human Nutrition
Study officials:
affiliation: Faculty of Medicine, Public Health and Medicine, Universitas Gadjah Mada
name: Juffrie Mohammad, Ph.D., SpAK
role: PRINCIPAL_INVESTIGATOR
References: