UnderweightNCT00198835
Evaluation Research of the Nutrition Interventions in the INHP II Areas of CARE India
A study testing Maternal nutrition and infant feeding advice in people with Underweight and Stunting, run by Johns Hopkins Bloomberg School of Public Health at 1 site in India.
Trial summary
This study is designed to evaluate the effectiveness of CARE India's Integrated Nutrition and Health Program (INHP II) to reduce malnutrition among children 0-23 months of age. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Underweight, Stunting, Wasting
- What is being tested?
- Maternal nutrition and infant feeding advice
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 17,000 participants
- Where
- 1 siteIndia
- Study dates
- Aug 2003to Jul 2007
- 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
- Mothers with a child 0-23 months of age
- Children 0-23 months of age
- Currently pregnant women
- Resides in the program or control area
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
This study is designed to evaluate the effectiveness of CARE India's Integrated Nutrition and Health Program (INHP II) to reduce malnutrition among children 0-23 months of age.
- Conditions
- Underweight, Stunting, Wasting, Anemia
- Being tested
- Maternal nutrition and infant feeding advice
- Keywords
- malnutrition, anemia, infants, children, India
- Medical subject headings
- Thinness, Growth Disorders, Cachexia, Anemia, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maternal nutrition and infant feeding adviceBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of underweight among children 0-23 months
Prevalence of stunting among children 0-23 months
Prevalence of wasting among children 0-23 months
Prevalence of anemia among children 12-23 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startAug 2003
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for UnderweightStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 17,000 participants
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- United States Agency for International Development (USAID)
- Responsible party
- Sponsor
- Investigators
- Michele L Dreyfuss, PhD, MPH, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00198835
- Sponsor's protocol ID
- H.22.03.06.02.A2
- Status last verified
- Jul 2005
- First submitted
- 13 Sep 2005
- Last updated
- 20 Apr 2018
- Results posted
- No
Publications
Singh V, Ahmed S, Dreyfuss ML, Kiran U, Chaudhery DN, Srivastava VK, Ahuja RC, Baqui AH, Darmstadt GL, Santosham M, West KP Jr. An integrated nutrition and health program package on IYCN improves breastfeeding but not complementary feeding and nutritional status in rural northern India: A quasi-experimental randomized longitudinal study. PLoS One. 2017 Sep 20;12(9):e0185030. doi: 10.1371/journal.pone.0185030. eCollection 2017.
PubMed 28931088Singh V, Ahmed S, Dreyfuss ML, Kiran U, Chaudhery DN, Srivastava VK, Ahuja RC, Baqui AH, Darmstadt GL, Santosham M, West KP Jr. Non-governmental organization facilitation of a community-based nutrition and health program: Effect on program exposure and associated infant feeding practices in rural India. PLoS One. 2017 Sep 14;12(9):e0183316. doi: 10.1371/journal.pone.0183316. eCollection 2017.
PubMed 28910328
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Research of the Nutrition Interventions in the INHP II Areas of CARE India
- ClinicalTrials.gov ID
- NCT00198835
- Acronym / sponsor ID
- H.22.03.06.02.A2
- Conditions
- Underweight, Stunting, Wasting, Anemia
- Keywords
- malnutrition, anemia, infants, children, India
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17,000 participants
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- United States Agency for International Development (USAID)
- Study start
- Aug 2003 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 20 Sep 2005 (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 is designed to evaluate the effectiveness of CARE India's Integrated Nutrition and Health Program (INHP II) to reduce malnutrition among children 0-23 months of age.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Mothers with a child 0-23 months of age
- Children 0-23 months of age
- Currently pregnant women
- Resides in the program or control area
Key exclusion criteria (1 listed)
- -
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 nutrition and infant feeding advice | Behavioural | – |
Primary outcome
Prevalence of underweight among children 0-23 months
Prevalence of stunting among children 0-23 months
Prevalence of wasting among children 0-23 months
Prevalence of anemia among children 12-23 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 20 Apr 2018.
- Derived from this study: PubMed 28931088Singh V, Ahmed S, Dreyfuss ML, Kiran U, Chaudhery DN, Srivastava VK, Ahuja RC, Baqui AH, Darmstadt GL, Santosham M, West KP Jr. An integrated nutrition and health program package on IYCN improves breastfeeding but not complementary feeding and nutritional status in rural northern India: A quasi-experimental randomized longitudinal study. PLoS One. 2017 Sep 20;12(9):e0185030. doi: 10.1371/journal.pone.0185030. eCollection 2017.
- Derived from this study: PubMed 28910328Singh V, Ahmed S, Dreyfuss ML, Kiran U, Chaudhery DN, Srivastava VK, Ahuja RC, Baqui AH, Darmstadt GL, Santosham M, West KP Jr. Non-governmental organization facilitation of a community-based nutrition and health program: Effect on program exposure and associated infant feeding practices in rural India. PLoS One. 2017 Sep 14;12(9):e0183316. doi: 10.1371/journal.pone.0183316. eCollection 2017.
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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.
Michele L Dreyfuss, PhD, MPH principal investigator
Johns Hopkins Bloomberg School of Public Health
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 nutrition and infant feeding advice in people with Underweight and Stunting, run by Johns Hopkins Bloomberg School of Public Health at 1 site in India.
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 1 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 20 Apr 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 India. 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?
Prevalence of underweight among children 0-23 months. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00198835, which also lists 2 linked publications.
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 20 Apr 2018.