Complementary FeedingComplementaryNCT07467876
Outcome of Different Complementary Feeding Methods in First Year of Life of Infants
A study testing Baby-Led Introduction to SolidS (BLISS) and Parent-Led Weaning (PLW) in people with Complementary Feeding and Infant, run by Shaheed Mohtarma Benazir Bhutto Institue of Trauma at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Complementary Feeding, Infant
- What is being tested?
- Baby-Led Introduction to SolidS (BLISS) and Parent-Led Weaning (PLW)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 sitePakistan
- Study dates
- 26 Feb 2025to 30 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Shaheed Mohtarma Benazir Bhutto Medical University (SMBBMU), Larkana, Pakistan
Larkana, Sindh
About this study
Official title: 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).
- Conditions
- Complementary Feeding, Infant
- Being tested
- Baby-Led Introduction to SolidS (BLISS), Parent-Led Weaning (PLW)
- Keywords
- Adherence, Complementary Feeding, Infant, Weaning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baby-Led Introduction to SolidS (BLISS)Behavioural
Also called Baby-Led Weaning Modified Approach
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.
Parent-Led Weaning (PLW)Behavioural
Caregivers fed infants complementary foods using spoon-feeding techniques, progressing food texture and consistency according to age-appropriate feeding recommendations.
| Study group | Role | What they receive |
|---|---|---|
| (BLISS) | Experimental | 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. Receives: Behavioral: Baby-Led Introduction to SolidS (BLISS) |
| (PLW) | Active comparator | A complementary feeding approach encouraging infant self-feeding with appropriately sized solid foods under caregiver supervision. Receives: Behavioral: Parent-Led Weaning (PLW) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From 6 months to 12 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start26 Feb 2025
- Primary completion25 Aug 2025
- Study completion30 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complementary FeedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shaheed Mohtarma Benazir Bhutto Institue of Trauma
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Iqra Hanif, Shaheed Mohtarma Benazir Bhutto Institue of Trauma
- Investigators
- Dr. Iqra hanif, MBBS, Principal investigator, Shaheed Mohtarma Benazir Bhutto Medical University (SMBBMU)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07467876
- Sponsor's protocol ID
- SMBBIT
- Acronym
- Complementary
- Status last verified
- Jan 2026
- First submitted
- 18 Jan 2026
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing Adherence to BLISS Versus PLW Complementary Feeding Methods in Infants Aged 6-12 Months
- ClinicalTrials.gov ID
- NCT07467876
- Acronym / sponsor ID
- Complementary / SMBBIT
- Conditions
- Complementary Feeding, Infant
- Keywords
- Adherence, Complementary Feeding, Infant, Weaning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Shaheed Mohtarma Benazir Bhutto Institue of TraumaUniversity, hospital or other
- Study start
- 26 Feb 2025 (actual)
- Primary completion
- 25 Aug 2025 (actual)
- Study completion
- 30 Aug 2025 (actual)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| (BLISS) | Experimental | Behavioral: Baby-Led Introduction to SolidS (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. |
| (PLW) | Active comparator | Behavioral: Parent-Led Weaning (PLW)A complementary feeding approach encouraging infant self-feeding with appropriately sized solid foods under caregiver supervision. |
Who may qualify
- Ages
- 6 to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Baby-Led Introduction to SolidS (BLISS)Also: Baby-Led Weaning Modified ApproachCaregivers 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. | Behavioural | (BLISS) |
| Parent-Led Weaning (PLW)Caregivers fed infants complementary foods using spoon-feeding techniques, progressing food texture and consistency according to age-appropriate feeding recommendations. | Behavioural | (PLW) |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Iqra hanif, MBBS principal investigator
Shaheed Mohtarma Benazir Bhutto Medical University (SMBBMU)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baby-Led Introduction to SolidS (BLISS) and Parent-Led Weaning (PLW) in people with Complementary Feeding and Infant, run by Shaheed Mohtarma Benazir Bhutto Institue of Trauma at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to Assigned Complementary Feeding Method (time frame: From 6 months to 12 months of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.