Outcome of Different Complementary Feeding Methods in First Year of Life of Infants

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Complementary Feeding Infant

Age range

6 month–12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shaheed Mohtarma Benazir Bhutto Medical University (SMBBMU), Larkana, Pakistan

Larkana, Sindh, Pakistan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Baby-Led Introduction to SolidS (BLISS)

Behavioral

Caregivers were instructed to offer age-appropriate solid foods that infants could grasp and self-feed, following BLISS principles, with emphasis on safe textures, iron-rich foods, and close supervision during feeding.

Other names: Baby-Led Weaning Modified Approach

Parent-Led Weaning (PLW)

Behavioral

Caregivers fed infants complementary foods using spoon-feeding techniques, progressing food texture and consistency according to age-appropriate feeding recommendations.

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.

Sponsors and collaborators

Lead sponsor

Shaheed Mohtarma Benazir Bhutto Institue of Trauma

Other

Registry information

Official study title

Randomized Controlled Trial Comparing Adherence to BLISS Versus PLW Complementary Feeding Methods in Infants Aged 6-12 Months

Acronym: Complementary

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Mar 12, 2026
Registry last updated: Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed