Randomized Controlled Trial Comparing Adherence to BLISS Versus PLW Complementary Feeding Methods in Infants Aged 6-12 Months
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Shaheed Mohtarma Benazir Bhutto Institue of Trauma
- Enrollment
- 65
- Locations
- 1
- Primary Endpoint
- Adherence to Assigned Complementary Feeding Method
Overview
Brief Summary
This randomized controlled trial aimed to compare adherence to two complementary feeding methods-Baby-Led Introduction to SolidS (BLISS) and Parent-Led Weaning (PLW)-in infants aged 6-12 months. A total of 130 infants aged 6-9 months were randomized to BLISS (n=65) or PLW (n=65) groups. Adherence was defined as self-feeding for BLISS and spoon-fed consistency for PLW. Follow-up continued until 12 months of age. The study found significantly higher adherence in the BLISS group compared to the PLW group (78.5% vs 52.3%, p=0.002).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 6 Months to 12 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Infants aged 6-9 months at the time of enrollment
- •Infants eligible for initiation of complementary feeding
- •Parents or caregivers willing to follow the assigned feeding method
- •Written informed consent obtained from the parent or legal guardian
Exclusion Criteria
- •Infants with congenital malformations affecting feeding
- •Infants with neurological impairments
- •Infants with known food allergies or dietary restrictions
- •Infants with chronic illnesses affecting growth or feeding
Arms & Interventions
(BLISS)
Infants assigned to this group followed the Parent-Led Weaning (PLW) method, receiving spoon-fed complementary foods of appropriate consistency from 6 to 12 months of age.
Intervention: Baby-Led Introduction to SolidS (BLISS) (Behavioral)
(PLW)
A complementary feeding approach encouraging infant self-feeding with appropriately sized solid foods under caregiver supervision.
Intervention: Parent-Led Weaning (PLW) (Behavioral)
Outcomes
Primary Outcomes
Adherence to Assigned Complementary Feeding Method
Time Frame: From 6 months to 12 months of age
Adherence was defined as the infant following the assigned complementary feeding approach: self-feeding of solid foods in the BLISS group and spoon-fed age-appropriate food consistency in the PLW group.
Secondary Outcomes
No secondary outcomes reported
Investigators
Dr. Iqra Hanif
Dr
Shaheed Mohtarma Benazir Bhutto Institue of Trauma