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CompletedNCT07467876ComplementaryUpdated Mar 12, 2026

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

An interventional study of Baby-Led Introduction to SolidS (BLISS) and Parent-Led Weaning (PLW) in Complementary Feeding and Infant, sponsored by Shaheed Mohtarma Benazir Bhutto Institue of Trauma. Completed at 1 site in Pakistan. Open to participants aged 6 Months to 12 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-12.

Sponsored by Shaheed Mohtarma Benazir Bhutto Institue of Trauma · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Feb 2025, registered Jan 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
65
Allocation
Randomized
Ages
6 Months to 12 Months
Sex
All
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Study 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).

02

Conditions studied

  • Complementary Feeding
  • Infant

Keywords

  • Adherence
  • Complementary Feeding
  • Infant
  • Weaning
03

In context

Lead sponsor

Shaheed Mohtarma Benazir Bhutto Institue of Trauma is the lead sponsor of 12 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 12 Months
Sexes eligible
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

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
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
65 participants (actual)

Study arms

  • 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)

  • Active comparator
    (PLW)

    A complementary feeding approach encouraging infant self-feeding with appropriately sized solid foods under caregiver supervision.

    Behavioral: Parent-Led Weaning (PLW)

Interventions

  • BehavioralBaby-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.

    Also known as: Baby-Led Weaning Modified Approach

  • BehavioralParent-Led Weaning (PLW)

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

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What researchers measure

Primary outcomes

  1. Adherence to Assigned Complementary Feeding Method

    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.

    Time frame: From 6 months to 12 months of age

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Study locations

1 site
  • Shaheed Mohtarma Benazir Bhutto Medical University (SMBBMU), Larkana, Pakistan
    Larkana, Sindh, Pakistan
08

References and documents

Individual participant data

Plan to share: No — 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

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07467876
Lead sponsor
Shaheed Mohtarma Benazir Bhutto Institue of Trauma
Responsible party
Dr. Iqra Hanif (Dr, Shaheed Mohtarma Benazir Bhutto Institue of Trauma) — Principal investigator
First posted
Mar 12, 2026
Start date
Feb 26, 2025
Primary completion
Aug 25, 2025
Completion
Aug 30, 2025
Last update
Mar 12, 2026

Study contacts

Dr. Iqra hanif, MBBS
principal investigator · Shaheed Mohtarma Benazir Bhutto Medical University (SMBBMU)

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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