Infant MalnutritionCHNUDEVNCT02098031
Improving the Nutrition Status of Infants in South-Western Uganda
A study testing Improving nutrition knowledge among mothers in people with Infant Malnutrition and Nutrition Knowledge, run by University of Oslo at 1 site in Uganda.
Trial summary
Undernutrition and growth restriction due to poor diet and inadequate nutrient intake continues to be a global challenge, particularly in the developing countries including Uganda. The etiology of inadequate nutrient supply to infants may relate to lack of resources or knowledge or a combination of both. Read more about this study
- Who is it for?
- Ages 6 months and olderHealthy volunteers can take part
- Conditions the study is for
- Infant Malnutrition, Nutrition Knowledge, Growth
- What is being tested?
- Improving nutrition knowledge among mothers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 511 participants
- Where
- 1 siteUganda
- Study dates
- Mar 2014to Aug 2016
- 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 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- A lead caretaker with a 6-8 months infant (child/lead caretaker pair) who will have given consent to participate in the study. If there is more than one child of the age in the household, the younger one will be taken as the index/study child.
Who cannot join
- Is older than 8 months at baseline
- Congenital malformations or physical handicap that may influence growth or interfere with taking of anthropometric measurements
- Disability that will influence nutrient intake
- Been diagnosed with mental or brain illness as evidenced by mother or health worker.
- If the family that is likely to emigrate during the study period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving the Nutrition Status of 6 to 8 Months Old Children Through Diet Diversification and Better Dietary Intakes in the Kabale and Kisoro Districts in South-Western Uganda
Undernutrition and growth restriction due to poor diet and inadequate nutrient intake continues to be a global challenge, particularly in the developing countries including Uganda. The etiology of inadequate nutrient supply to infants may relate to lack of resources or knowledge or a combination of both. Poor nutrient intake and impaired growth may affect brain and cognitive development.
This study aims to evaluate nutrient intake, growth and cognitive function among children between 6 and 36 months living in the fertile Kabale and Kisoro region in south-western Uganda. The investigators hypothesize that nutrition education to mothers can bring about improved dietary intake and nutritional status among children aged 6-36 months.
A follow-up study was conducted during the period January - July 2022.
- Being tested
- Improving nutrition knowledge among mothers
- Keywords
- Child Nutrition Sciences, Growth and Development, Developing Countries
- Medical subject headings
- Infant Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Improving nutrition knowledge among mothersOther
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | Not described |
| intervention | Experimental | Nutritional intervention (nutrition education) Receives: Other: Improving nutrition knowledge among mothers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the prevalence of stunting (<-2 SD of the WHO, 2006 growth reference standards)
The investigators will measure the change in stunting between the three indicated time points.
Measured: 6-8, 12-16, 20-24 (main outcome time point), 36 months, 7-10 years
Secondary outcomes (13)
Change in mean weight-for-age z-score
The investigators will measure the change in mean weight for age z-score between the three indicated time periods.
Measured: 6-8, 12-16 and 20-24, 36 months, 7-10 years
Change in mean weight-for-height z-score
The investigators will measure the change in mean weight for height z-score between the three indicated time periods.
Measured: 6-8, 12-16, 20-24, 36 months, 7-10 years
Change in mean Mid Upper Arm Circumference (MUAC) z-score
The investigators will measure the change in MUAC between the three indicated time periods.
Measured: 6-8, 12-16, 20-24, 36 months, 7-10 years
Change in mean diet diversification score (DDS)
The investigators will measure the change in DDS between the three indicated time periods.
Measured: 6-8, 12-16, 20-24, 36 months
Change in Ages and Stages Questionnaire Scores (AQS)
The investigators will measure the change in AQS between the three indicated time periods.
Measured: 6-8, 12-16, 20-24, 36 months
Change in The Kaufman Assessment Battery for Children (2nd ed.; KABC-II) and the Test of Variable of Attention (TOVA)
The investigators will measure the change in the scores of these tests at indicated time periods.
Measured: 7-10 years
Change in Bayley Child Development test 3 ed.
The investigators will measure the change in Bayley Child Development test 3 ed. between the three indicated time periods.
Measured: 6-8, 12-16, 20-24, 36 months
Change in gut microbiota
Fecal samples will be collected and the investigators will measure the change in gut microbiota between the three indicated time periods.
Measured: 20-24, 36 months, 7-10 years
Change in oral microbiota
Saliva samples will be collected and the investigators will measure the change in oral microbiota at indicated time periods.
Measured: 36 months, 7-10 years
Change in Mullens test
The investigators will measure the change in Mullens test between the two groups after 36 months.
Measured: 36 months
Change in Becks Depression Inventory II questionnaire to determine the maternal self-reported depression symptoms
The investigators will measure the change in this test between the two groups at indicated time periods
Measured: 7-10 years
Change in the Center for Epidemiological Studies Depression Scale questionnaires to determine the maternal self-reported depression symptoms
The investigators will measure the change in this test between the two groups at indicated time periods
Measured: 7-10 years
Oral health
The investigators will assay caries using photographs
Measured: 7-10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Infant 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 511 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Collaborators
- Kyambogo University
- Responsible party
- Principal investigator, Per Ole Iversen, MD, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02098031
- Sponsor's protocol ID
- 100
- Acronym
- CHNUDEV
- Status last verified
- Nov 2024
- First submitted
- 21 Mar 2014
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Atukunda P, Ngari M, Chen X, Westerberg AC, Iversen PO, Muhoozi G. Longitudinal assessments of child growth: A six-year follow-up of a cluster-randomized maternal education trial. Clin Nutr. 2021 Sep;40(9):5106-5113. doi: 10.1016/j.clnu.2021.08.007. Epub 2021 Aug 20.
PubMed 34461584Kakwangire P, Moss C, Matovu N, Atukunda P, Westerberg AC, Iversen PO, Muhoozi G. The association between dietary diversity and development among children under 24 months in rural Uganda: analysis of a cluster-randomised maternal education trial. Public Health Nutr. 2021 Sep;24(13):4286-4296. doi: 10.1017/S136898002100077X. Epub 2021 Mar 12.
PubMed 33706831Atukunda P, Muhoozi GK, Diep LM, Berg JP, Westerberg AC, Iversen PO. The association of urine markers of iodine intake with development and growth among children in rural Uganda: a secondary analysis of a randomised education trial. Public Health Nutr. 2021 Aug;24(12):3730-3739. doi: 10.1017/S1368980020001603. Epub 2020 Jul 13.
PubMed 32654677Atukunda P, Muhoozi GKM, van den Broek TJ, Kort R, Diep LM, Kaaya AN, Iversen PO, Westerberg AC. Child development, growth and microbiota: follow-up of a randomized education trial in Uganda. J Glob Health. 2019 Jun;9(1):010431. doi: 10.7189/jogh.09.010431.
PubMed 31131103Muhoozi GKM, Atukunda P, Diep LM, Mwadime R, Kaaya AN, Skaare AB, Willumsen T, Westerberg AC, Iversen PO. Nutrition, hygiene, and stimulation education to improve growth, cognitive, language, and motor development among infants in Uganda: A cluster-randomized trial. Matern Child Nutr. 2018 Apr;14(2):e12527. doi: 10.1111/mcn.12527. Epub 2017 Sep 19.
PubMed 28925580
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Nutrition Status of 6 to 8 Months Old Children Through Diet Diversification and Better Dietary Intakes in the Kabale and Kisoro Districts in South-Western Uganda
- ClinicalTrials.gov ID
- NCT02098031
- Acronym / sponsor ID
- CHNUDEV / 100
- Keywords
- Child Nutrition Sciences, Growth and Development, Developing Countries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 511 participants (actual)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Collaborators
- Kyambogo University
- Study start
- Mar 2014
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 27 Mar 2014 (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.
Undernutrition and growth restriction due to poor diet and inadequate nutrient intake continues to be a global challenge, particularly in the developing countries including Uganda. The etiology of inadequate nutrient supply to infants may relate to lack of resources or knowledge or a combination of both. Poor nutrient intake and impaired growth may affect brain and cognitive development.
This study aims to evaluate nutrient intake, growth and cognitive function among children between 6 and 36 months living in the fertile Kabale and Kisoro region in south-western Uganda. The investigators hypothesize that nutrition education to mothers can bring about improved dietary intake and nutritional status among children aged 6-36 months.
A follow-up study was conducted during the period January - July 2022.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | – |
| intervention | Experimental | Other: Improving nutrition knowledge among mothersNutritional intervention (nutrition education) |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- A lead caretaker with a 6-8 months infant (child/lead caretaker pair) who will have given consent to participate in the study. If there is more than one child of the age in the household, the younger one will be taken as the index/study child.
Key exclusion criteria (5 listed)
- Is older than 8 months at baseline
- Congenital malformations or physical handicap that may influence growth or interfere with taking of anthropometric measurements
- Disability that will influence nutrient intake
- Been diagnosed with mental or brain illness as evidenced by mother or health worker.
- If the family that is likely to emigrate during the study period
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 |
|---|---|---|
| Improving nutrition knowledge among mothers | Other | intervention |
Primary outcome
Change in the prevalence of stunting (<-2 SD of the WHO, 2006 growth reference standards)
Time frame: 6-8, 12-16, 20-24 (main outcome time point), 36 months, 7-10 years
The investigators will measure the change in stunting between the three indicated time points.
13 secondary outcomes
Change in mean weight-for-age z-score
Time frame: 6-8, 12-16 and 20-24, 36 months, 7-10 years
Change in mean weight-for-height z-score
Time frame: 6-8, 12-16, 20-24, 36 months, 7-10 years
Change in mean Mid Upper Arm Circumference (MUAC) z-score
Time frame: 6-8, 12-16, 20-24, 36 months, 7-10 years
Change in mean diet diversification score (DDS)
Time frame: 6-8, 12-16, 20-24, 36 months
Change in Ages and Stages Questionnaire Scores (AQS)
Time frame: 6-8, 12-16, 20-24, 36 months
Change in The Kaufman Assessment Battery for Children (2nd ed.; KABC-II) and the Test of Variable of Attention (TOVA)
Time frame: 7-10 years
Change in Bayley Child Development test 3 ed.
Time frame: 6-8, 12-16, 20-24, 36 months
Change in gut microbiota
Time frame: 20-24, 36 months, 7-10 years
Change in oral microbiota
Time frame: 36 months, 7-10 years
Change in Mullens test
Time frame: 36 months
Change in Becks Depression Inventory II questionnaire to determine the maternal self-reported depression symptoms
Time frame: 7-10 years
Change in the Center for Epidemiological Studies Depression Scale questionnaires to determine the maternal self-reported depression symptoms
Time frame: 7-10 years
Oral health
Time frame: 7-10 years
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 Nov 2024.
- Derived from this study: PubMed 34461584Atukunda P, Ngari M, Chen X, Westerberg AC, Iversen PO, Muhoozi G. Longitudinal assessments of child growth: A six-year follow-up of a cluster-randomized maternal education trial. Clin Nutr. 2021 Sep;40(9):5106-5113. doi: 10.1016/j.clnu.2021.08.007. Epub 2021 Aug 20.
- Derived from this study: PubMed 33706831Kakwangire P, Moss C, Matovu N, Atukunda P, Westerberg AC, Iversen PO, Muhoozi G. The association between dietary diversity and development among children under 24 months in rural Uganda: analysis of a cluster-randomised maternal education trial. Public Health Nutr. 2021 Sep;24(13):4286-4296. doi: 10.1017/S136898002100077X. Epub 2021 Mar 12.
- Derived from this study: PubMed 32654677Atukunda P, Muhoozi GK, Diep LM, Berg JP, Westerberg AC, Iversen PO. The association of urine markers of iodine intake with development and growth among children in rural Uganda: a secondary analysis of a randomised education trial. Public Health Nutr. 2021 Aug;24(12):3730-3739. doi: 10.1017/S1368980020001603. Epub 2020 Jul 13.
- Derived from this study: PubMed 31131103Atukunda P, Muhoozi GKM, van den Broek TJ, Kort R, Diep LM, Kaaya AN, Iversen PO, Westerberg AC. Child development, growth and microbiota: follow-up of a randomized education trial in Uganda. J Glob Health. 2019 Jun;9(1):010431. doi: 10.7189/jogh.09.010431.
- Derived from this study: PubMed 28925580Muhoozi GKM, Atukunda P, Diep LM, Mwadime R, Kaaya AN, Skaare AB, Willumsen T, Westerberg AC, Iversen PO. Nutrition, hygiene, and stimulation education to improve growth, cognitive, language, and motor development among infants in Uganda: A cluster-randomized trial. Matern Child Nutr. 2018 Apr;14(2):e12527. doi: 10.1111/mcn.12527. Epub 2017 Sep 19.
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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 Improving nutrition knowledge among mothers in people with Infant Malnutrition and Nutrition Knowledge, run by University of Oslo at 1 site in Uganda.
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 1 inclusion and 5 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 Nov 2024. 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 Uganda. 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?
Change in the prevalence of stunting (<-2 SD of the WHO, 2006 growth reference standards) (time frame: 6-8, 12-16, 20-24 (main outcome time point), 36 months, 7-10 years). 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 NCT02098031, which also lists 5 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 Nov 2024; AzTrials last refreshed its copy on 8 Nov 2026.