MalnutritionNF NutritionNCT00816946
District-based Mainstreaming Nutrition Project in Rural Pakistan
A study testing Enhanced education in people with Malnutrition, run by Aga Khan University at 1 site in Pakistan.
Trial summary
This study aims to provide evidence regarding the feasibility of integrating an enhanced maternal and child care health education package into the existing curricula of the National Program for Family Planning and Primary Health Care (LHW Program) and evaluating the feasibility of scaling-up as well as the impact on… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Malnutrition
- What is being tested?
- Enhanced education
- Type of treatment
- Vaccines, Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 1 sitePakistan
- Study dates
- Jul 2008to Feb 2009
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Live born infants and young children from all registered pregnancies within participating villages and catchment population
- pregnant women
- Consent given by at least one of the parents
Who cannot join
- Children born with congenital malformations or serious birth injury
- Suspected non-compliance (mobile and poorly motivated parents).
- Failure to give consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Scaling up Evidence-based Nutrition Interventions to Address Maternal and Child Health Outcomes in Pakistan: a District-based Demonstration Project in Rural Sindh
This study aims to provide evidence regarding the feasibility of integrating an enhanced maternal and child care health education package into the existing curricula of the National Program for Family Planning and Primary Health Care (LHW Program) and evaluating the feasibility of scaling-up as well as the impact on birth outcomes, nutritional status, morbidity patterns and overall survival patterns at the community level.
Read the detailed description
This project aims to do the following:
- To evaluate the operational feasibility of integrating an enhanced health education and nutrition package into the existing curriculum of the National Program for FP/PHC (LHW Program)
- Impact of the implementation of the full package of evidence-based nutrition interventions on the nutrition status, morbidity patterns and overall survival patterns in the district
- Conditions
- Malnutrition
- Being tested
- Enhanced education
- Keywords
- malnutrition, growth
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced educationBehavioural
Enhanced Nutritional education/counseling to mothers on the following topics:
During Pregnancy: diet during pregnancy; antenatal care; iron tablets; colostrum Postpartum period: difficulties during lactation; diet during lactation; EBF; childhood vaccination; newborn care Complementary Feeding General Health: vitamin A; diarrhea management; iodine; hygiene for health; protection from malaria; ARI \& protection against ARI
| Study group | Role | What they receive |
|---|---|---|
| Routine LHW Advice | No intervention | Arm receiving routine advice by their local Lady Health Workers (LHWs) |
| Enhanced LHW Advice | Active comparator | Arm receiving enhanced nutrition and health advice from the local Lady Health Workers (LHWs)during their routine community visits. Receives: Behavioral: Enhanced education |
What is being measured
The primary outcome is the main question the study is designed to answer.
mother pregnancy weight gain in 3rd trimester
Measured: at time of enrollment, 2 weeks before delivery
mothers Hb level
Measured: at time of enrollment, 2 weeks before delivery
child's birthweight
Measured: at birth
Secondary outcomes (2)
young child's growth
Measured: 0, 3, 6, 12, 18 mths, at end of study
dietary diversity of CF
Measured: 6 mths, 9mths, 12mths, 18 mths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2009 (estimated)
- Study startJul 2008
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 3,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Collaborators
- International Centre for Diarrhoeal Disease Research, Bangladesh, National Lady Health Workers Programme, Government of Pakistan
- Responsible party
- Principal investigator, Dr Zulfiqar Ahmed Bhutta, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00816946
- Sponsor's protocol ID
- 753-Ped/ERC-07
- Acronym
- NF Nutrition
- Status last verified
- Jan 2018
- First submitted
- 2 Jan 2009
- Last updated
- 9 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scaling up Evidence-based Nutrition Interventions to Address Maternal and Child Health Outcomes in Pakistan: a District-based Demonstration Project in Rural Sindh
- ClinicalTrials.gov ID
- NCT00816946
- Acronym / sponsor ID
- NF Nutrition / 753-Ped/ERC-07
- Conditions
- Malnutrition
- Keywords
- malnutrition, growth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,000 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Collaborators
- International Centre for Diarrhoeal Disease Research, Bangladesh, National Lady Health Workers Programme, Government of Pakistan
- Study start
- Jul 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 5 Jan 2009 (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.
This study aims to provide evidence regarding the feasibility of integrating an enhanced maternal and child care health education package into the existing curricula of the National Program for Family Planning and Primary Health Care (LHW Program) and evaluating the feasibility of scaling-up as well as the impact on birth outcomes, nutritional status, morbidity patterns and overall survival patterns at the community level.
Detailed description
This project aims to do the following:
- To evaluate the operational feasibility of integrating an enhanced health education and nutrition package into the existing curriculum of the National Program for FP/PHC (LHW Program)
- Impact of the implementation of the full package of evidence-based nutrition interventions on the nutrition status, morbidity patterns and overall survival patterns in the district
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine LHW Advice | No intervention | –Arm receiving routine advice by their local Lady Health Workers (LHWs) |
| Enhanced LHW Advice | Active comparator | Behavioral: Enhanced educationArm receiving enhanced nutrition and health advice from the local Lady Health Workers (LHWs)during their routine community visits. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Live born infants and young children from all registered pregnancies within participating villages and catchment population
- pregnant women
- Consent given by at least one of the parents
Key exclusion criteria (3 listed)
- Children born with congenital malformations or serious birth injury
- Suspected non-compliance (mobile and poorly motivated parents).
- Failure to give consent
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 |
|---|---|---|
| Enhanced educationEnhanced Nutritional education/counseling to mothers on the following topics: During Pregnancy: diet during pregnancy; antenatal care; iron tablets; colostrum Postpartum period: difficulties during lactation; diet during lactation; EBF; childhood vaccination; newborn care Complementary Feeding General Health: vitamin A; diarrhea management; iodine; hygiene for health; protection from malaria; ARI \& protection against ARI | Behavioural | Enhanced LHW Advice |
Primary outcome
mother pregnancy weight gain in 3rd trimester
Time frame: at time of enrollment, 2 weeks before delivery
mothers Hb level
Time frame: at time of enrollment, 2 weeks before delivery
child's birthweight
Time frame: at birth
2 secondary outcomes
young child's growth
Time frame: 0, 3, 6, 12, 18 mths, at end of study
dietary diversity of CF
Time frame: 6 mths, 9mths, 12mths, 18 mths
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 9 Jan 2018.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced education in people with Malnutrition, 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 3 inclusion and 3 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 9 Jan 2018. 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?
mother pregnancy weight gain in 3rd trimester (time frame: at time of enrollment, 2 weeks before delivery). The study lists 3 primary outcomes in all. 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 9 Jan 2018.