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

March 11, 2026 updated by: Dr. Iqra Hanif, Shaheed Mohtarma Benazir Bhutto Institue of Trauma

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: (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.
Behavioral: Baby-Led Introduction to SolidS (BLISS)
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
Active Comparator: (PLW)
A complementary feeding approach encouraging infant self-feeding with appropriately sized solid foods under caregiver supervision.
Behavioral: Parent-Led Weaning (PLW)
Caregivers fed infants complementary foods using spoon-feeding techniques, progressing food texture and consistency according to age-appropriate feeding recommendations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From 6 months to 12 months of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shaheed Mohtarma Benazir Bhutto Institue of Trauma

Investigators

  • Principal Investigator: Dr. Iqra hanif, MBBS, Shaheed Mohtarma Benazir Bhutto Medical University (SMBBMU)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 26, 2025

Primary Completion (Actual)

August 25, 2025

Study Completion (Actual)

August 30, 2025

Study Registration Dates

First Submitted

January 18, 2026

First Submitted That Met QC Criteria

March 11, 2026

First Posted (Actual)

March 12, 2026

Study Record Updates

Last Update Posted (Actual)

March 12, 2026

Last Update Submitted That Met QC Criteria

March 11, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SMBBIT (Other Identifier: SMBBIT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared with other researchers. Data will be used only for the purposes of this study and reported in aggregate form without identifying individual participants

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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