Effects of the Happy Grow Program on Parental Self-confidence: A Randomized, Controlled Open-label Study

NCT05157906 | Completed

• 1 other identifier: 20.29.INF
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Responsive Parenting

Outcome Measures

Primary Outcomes (1)

• To increase self-confidence of mothers (vs. control group) to adopt responsive parenting behaviors that promote optimal child development.

  Mothers' self-confidence based on composite scores from the Toddler Care Questionnaire.

  Change from baseline (V1) to 12 weeks of intervention (V2).

Secondary Outcomes (8)

• Parenting experience

  Change from baseline to 12 weeks

• Child's health-related quality of life

  Change from baseline to 12 weeks

• Maternal health-related quality of life

  Change from baseline to 12 weeks

• Toddler gut comfort

  Change from baseline to 12 weeks

• Child eating behavior

  Change from baseline to 12 weeks

Study Arms (2)

Experimental Group

EXPERIMENTAL

Subjects will have access to the Grow Happy program materials, including the Grow Happy Book, 99+ Ways to Grow Happy Tips and Engagement Videos, which are provided digitally during the trial duration of 12 weeks.

Behavioral: Education based

Control Group

ACTIVE COMPARATOR

No additional education materials will be proactively provided during trial duration. Subjects will only be provided with the Indonesian standard of care only.

Behavioral: Control

Interventions

Education based BEHAVIORAL

The interventional materials will be provided digitally for 12 weeks, with the monthly theme featured from the educational Grow Happy book and related tips and videos that will be released weekly.

Experimental Group

Control BEHAVIORAL

At enrollment, subject will be provided with the Mother and Child booklet, which is the Indonesian standard of care for parenting guidance.

Control Group

Eligibility Criteria

• Age: 24 Months - 28 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• Toddlers (full-term) between ages of 24 and 28 months at time of enrolment.
• Normally developing toddlers without any diagnosed behavioral, neurological or eating issues.

You may not qualify if:

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

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

University Gadjah Mada, Center for Health and Human Nutrition

Sleman, Indonesia

Location

Study Officials

• Juffrie Mohammad, Ph.D., SpAK

  Faculty of Medicine, Public Health and Medicine, Universitas Gadjah Mada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 7, 2021
• First Posted: December 15, 2021
• Study Start: January 15, 2022
• Primary Completion: November 29, 2022
• Study Completion: November 29, 2022
• Last Updated: March 24, 2023

Record last verified: 2023-03

Locations

ID (1)