GrowthNCT01128517
Maternal Education on Complementary Feeding and Infant Outcome
A study testing Maternal education on complementary feeding and Education in people with Growth, run by Aga Khan University at 1 site in Pakistan.
Trial summary
Overall Objective To evaluate impact of maternal educational strategies (teaching sessions by trained lady health workers, verbal, pictorial and demonstrative) regarding appropriate complementary foods of infants, and assess their impact on nutritional status of after six months of educational intervention. Read more about this study
- Who is it for?
- Ages 3 to 5 months
- Conditions the study is for
- Growth
- What is being tested?
- Maternal education on complementary feeding and Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 1 sitePakistan
- Study dates
- Oct 2008to May 2010
- 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 3 to 5 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants aged 2.5 - 5 months; who are either exclusively breast feed or partially breast feed but have not started complementary feeding or have recently started complementary food (less than 1 week)
- Informed consent
Who cannot join
- Infants found below 5th percentile on weight for age CDC growth charts at baseline will be excluded
- History of two or more hospital admissions for more than 7 days each
- Presence of serious congenital anomalies (cleft palate, congenital heart disease, neural tube defect) or other chronic conditions impairing feeding (e.g. cerebral palsy)
- Presence of acute illness requiring urgent hospitalization
- Infants from families of very low socioeconomic status where adequate calorie-provision is constrained (assessed by a questionnaire on household possessions of items such as mobile phone, bicycle or other vehicle, TV, cemented construction, fuel used for cooking - wood or gas/LPG)
- Infant already enrolled in any trial with a nutritional intervention will be excluded
- Infants who at initial clinical examination are found to be severely anemic
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Maternal Education on Complementary Feeding Have an Impact on Infant Nutritional Status in Low Middle-income Households? A Community Based Randomized Interventional Study in Karachi, Pakistan.
Overall Objective
- To evaluate impact of maternal educational strategies (teaching sessions by trained lady health workers, verbal, pictorial and demonstrative) regarding appropriate complementary foods of infants, and assess their impact on nutritional status of after six months of educational intervention.
Read more
Specific objective • To determine the impact of maternal educational strategies regarding complementary foods by assessing baseline weight, height and mid - upper arm circumference at 2.5 - 5 month of age and then comparing it at 3, 6 and 9 months after enrollment.
(Hypothesis; the investigators hypothesize that there will be a gain of 250 gram weight, 0.5 cm in length and 0.5 cm in MUAC in infants whose mothers received the special education module for complementary feeding, as compare to the children whose mothers doesn't receive education on complementary food.
Secondary objective
- To determine the impact of maternal educational strategies regarding complementary foods by assessing morbidity (number of diarrhea and ARI episodes, at 2.5 - 5 month of age and at then reporting at 3, 6 and 9 months after enrollment). (Hypothesis; the investigators hypothesize that there will be 10% decrease in incidence of diarrhea episodes and ARI episodes in infants whose mother received the special education module for complementary feeding, as compare to the children whose mothers doesn't receive education on complementary food).
ARI can be define as per IMCI guidelines. Increase breathing rate (age specific) along with cough, cold and or wheezing.
Read the detailed description
Study population The study will be conducting in Bhainse colony (BC), Karachi. This is a periurban community area, and catering population mainly belonging to low - middle income households. The study population would be the mothers (having infant of 2.5 - 5 months of age) and their infants in these two study areas.
Inclusion Criteria;
- Infants aged 2.5 - 5 months; who are either exclusively breast feed or partially breast feed but have not started complementary feeding or have recently started complementary food (less than 1 week)
- Informed consent Exclusion Criteria;
- Infants found below 5th percentile on weight for age CDC growth charts 23 at baseline will be excluded.
- History of two or more hospital admissions for more than 7 days each
- Presence of serious congenital anomalies (cleft palate, congenital heart disease, neural tube defect) or other chronic conditions impairing feeding (e.g. cerebral palsy)
- Presence of acute illness requiring urgent hospitalization
- Infants from families of very low socioeconomic status where adequate calorie-provision is constrained (assessed by a questionnaire on household possessions of items such as mobile phone, bicycle or other vehicle, TV, cemented construction, fuel used for cooking - wood or gas/LPG)
- Infant already enrolled in any trial with a nutritional intervention will be excluded.
- Infants who at initial clinical examination are found to be severely anemic.
Data outcome measures Measuring Weight, height and Mid-upper arm circumference The investigators measure serial height, weight and mid-upper arm circumference (MUAC) for each subject at enrollment and subsequently in each visit. Each infant will be measured four times during the study enrollment.
- Height will be measured twice and the results averaged. Duplicate measures that exceed predefined allowable variation will be resolved by the field supervisor, e.g., by returning to the site with the interviewer to repeat the measurements. The height of infants will be measured (to the nearest 0.1 cm) in the recumbent position using a board with a fixed head and sliding foot piece.
- Weight will be measured to the nearest 0.1 kg using a scale that is calibrated daily.
- MUAC will be measure twice each time by using measuring tape. All anthropometric measurements will be taken three times (in each visit) and the mean of the measurements will counted as valid value. Each of the anthropometric indices will be expressed in standard deviation units (SD) from the median of the NCHS/CDC/WHO International Reference Population. Methods are adapted from How to Weigh and Measure Children: Assessing the Nutritional Status of Young Children in Household Surveys, United Nations Department of Technical Cooperation for Development and Statistical Office, 1986. The height and weight measurements will later converted into WAZ, WHZ and HAZ score and the difference in both groups will be analyzed.
- ARI will be measured through standard IMCI guidelines. ARI could be assess by the physician's visit and treatment prescribed.
- Conditions
- Growth
- Being tested
- Maternal education on complementary feeding, Education
- Keywords
- Maternal education, Complementary food, Infant growth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maternal education on complementary feedingBehavioural
Also called Packaged teaching education to mothers on different visits
CF education to the mothers in intervention arm.
- Ten important key messages developed based on recommended practices (WHO/UNICEF, 2000 \& 2006).
- First session --> cover the importance of breast feeding, its continuation for whole two years, hand washing, hygiene and importance of CF initiation at 6 months of age.
- Second session -->breastfeeding promotion, complementary food consistency, initial complementary food selection and age related complementary food education.
- Third session --> previous sessions recall. protein based and iron rich food encouragement.
- The control arm continue to be benefited from the lady health workers program, while breastfeeding promotion would be provided to control arm
EducationBehavioural
Also called Education to mothers given in three teaching modules.
Maternal education on complementary food
| Study group | Role | What they receive |
|---|---|---|
| Bahavioral | Experimental | Education about complementary food given to mothers Receives: Behavioral: Maternal education on complementary feeding; Behavioral: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nutritional status
Height, Weight and Mid Upper Arm circumference
Measured: 7.5 month
Secondary outcomes (3)
Diarrhea episodes
Diarrhea episodes during the study period.
Measured: 7.5 months
Z score (HAZ, WAZ and WHZ scores)
Z scores (wasting, stunting will be measured and compared in between interventional and control group.
Measured: 7.5 months
ARI
ARI will be asses by using standard IMCI guidelines, and/or physician prescription and medications prescribed to the infant.
Measured: 7.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2010 (estimated)
- Study startOct 2008
- Primary completionJan 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GrowthStudies 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
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Investigators
- Ali F Saleem, MBBS, Principal investigator, The Aga Khan University Hospital, Karachi, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01128517
- Sponsor's protocol ID
- MECF
- Status last verified
- Apr 2010
- First submitted
- 17 May 2010
- Last updated
- 24 May 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Maternal Education on Complementary Feeding Have an Impact on Infant Nutritional Status in Low Middle-income Households? A Community Based Randomized Interventional Study in Karachi, Pakistan.
- ClinicalTrials.gov ID
- NCT01128517
- Acronym / sponsor ID
- MECF
- Conditions
- Growth
- Keywords
- Maternal education, Complementary food, Infant growth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 24 May 2010 (estimated)
- 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.
Overall Objective
- To evaluate impact of maternal educational strategies (teaching sessions by trained lady health workers, verbal, pictorial and demonstrative) regarding appropriate complementary foods of infants, and assess their impact on nutritional status of after six months of educational intervention.
Specific objective • To determine the impact of maternal educational strategies regarding complementary foods by assessing baseline weight, height and mid - upper arm circumference at 2.5 - 5 month of age and then comparing it at 3, 6 and 9 months after enrollment.
(Hypothesis; the investigators hypothesize that there will be a gain of 250 gram weight, 0.5 cm in length and 0.5 cm in MUAC in infants whose mothers received the special education module for complementary feeding, as compare to the children whose mothers doesn't receive education on complementary food.
Secondary objective
- To determine the impact of maternal educational strategies regarding complementary foods by assessing morbidity (number of diarrhea and ARI episodes, at 2.5 - 5 month of age and at then reporting at 3, 6 and 9 months after enrollment). (Hypothesis; the investigators hypothesize that there will be 10% decrease in incidence of diarrhea episodes and ARI episodes in infants whose mother received the special education module for complementary feeding, as compare to the children whose mothers doesn't receive education on complementary food).
ARI can be define as per IMCI guidelines. Increase breathing rate (age specific) along with cough, cold and or wheezing.
Detailed description
Study population The study will be conducting in Bhainse colony (BC), Karachi. This is a periurban community area, and catering population mainly belonging to low - middle income households. The study population would be the mothers (having infant of 2.5 - 5 months of age) and their infants in these two study areas.
Inclusion Criteria;
- Infants aged 2.5 - 5 months; who are either exclusively breast feed or partially breast feed but have not started complementary feeding or have recently started complementary food (less than 1 week)
- Informed consent Exclusion Criteria;
- Infants found below 5th percentile on weight for age CDC growth charts 23 at baseline will be excluded.
- History of two or more hospital admissions for more than 7 days each
- Presence of serious congenital anomalies (cleft palate, congenital heart disease, neural tube defect) or other chronic conditions impairing feeding (e.g. cerebral palsy)
- Presence of acute illness requiring urgent hospitalization
- Infants from families of very low socioeconomic status where adequate calorie-provision is constrained (assessed by a questionnaire on household possessions of items such as mobile phone, bicycle or other vehicle, TV, cemented construction, fuel used for cooking - wood or gas/LPG)
- Infant already enrolled in any trial with a nutritional intervention will be excluded.
- Infants who at initial clinical examination are found to be severely anemic.
Data outcome measures Measuring Weight, height and Mid-upper arm circumference The investigators measure serial height, weight and mid-upper arm circumference (MUAC) for each subject at enrollment and subsequently in each visit. Each infant will be measured four times during the study enrollment.
- Height will be measured twice and the results averaged. Duplicate measures that exceed predefined allowable variation will be resolved by the field supervisor, e.g., by returning to the site with the interviewer to repeat the measurements. The height of infants will be measured (to the nearest 0.1 cm) in the recumbent position using a board with a fixed head and sliding foot piece.
- Weight will be measured to the nearest 0.1 kg using a scale that is calibrated daily.
- MUAC will be measure twice each time by using measuring tape. All anthropometric measurements will be taken three times (in each visit) and the mean of the measurements will counted as valid value. Each of the anthropometric indices will be expressed in standard deviation units (SD) from the median of the NCHS/CDC/WHO International Reference Population. Methods are adapted from How to Weigh and Measure Children: Assessing the Nutritional Status of Young Children in Household Surveys, United Nations Department of Technical Cooperation for Development and Statistical Office, 1986. The height and weight measurements will later converted into WAZ, WHZ and HAZ score and the difference in both groups will be analyzed.
- ARI will be measured through standard IMCI guidelines. ARI could be assess by the physician's visit and treatment prescribed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bahavioral | Experimental | Behavioral: Maternal education on complementary feeding, Behavioral: EducationEducation about complementary food given to mothers |
Who may qualify
- Ages
- 3 to 5 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Infants aged 2.5 - 5 months; who are either exclusively breast feed or partially breast feed but have not started complementary feeding or have recently started complementary food (less than 1 week)
- Informed consent
Key exclusion criteria (7 listed)
- Infants found below 5th percentile on weight for age CDC growth charts at baseline will be excluded
- History of two or more hospital admissions for more than 7 days each
- Presence of serious congenital anomalies (cleft palate, congenital heart disease, neural tube defect) or other chronic conditions impairing feeding (e.g. cerebral palsy)
- Presence of acute illness requiring urgent hospitalization
- Infants from families of very low socioeconomic status where adequate calorie-provision is constrained (assessed by a questionnaire on household possessions of items such as mobile phone, bicycle or other vehicle, TV, cemented construction, fuel used for cooking - wood or gas/LPG)
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 |
|---|---|---|
| Maternal education on complementary feedingAlso: Packaged teaching education to mothers on different visitsCF education to the mothers in intervention arm. * Ten important key messages developed based on recommended practices (WHO/UNICEF, 2000 \& 2006). * First session --> cover the importance of breast feeding, its continuation for whole two years, hand washing, hygiene and importance of CF initiation at 6 months of age. * Second session -->breastfeeding promotion, complementary food consistency, initial complementary food selection and age related complementary food education. * Third session --> previous sessions recall. protein based and iron rich food encouragement. * The control arm continue to be benefited from the lady health workers program, while breastfeeding promotion would be provided to control arm | Behavioural | Bahavioral |
| EducationAlso: Education to mothers given in three teaching modules.Maternal education on complementary food | Behavioural | Bahavioral |
Primary outcome
Nutritional status
Time frame: 7.5 month
Height, Weight and Mid Upper Arm circumference
3 secondary outcomes
Diarrhea episodes
Time frame: 7.5 months
Z score (HAZ, WAZ and WHZ scores)
Time frame: 7.5 months
ARI
Time frame: 7.5 months
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 24 May 2010.
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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.
Ali F Saleem, MBBS principal investigator
The Aga Khan University Hospital, Karachi, Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maternal education on complementary feeding and Education in people with Growth, run by Aga Khan University 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 2 inclusion and 7 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 24 May 2010. 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?
Nutritional status (time frame: 7.5 month). 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 24 May 2010.