Child Nutrition DisordersNCT01679535
A Nutrition/Hygiene Education Program for the Prevention of Child Malnutrition in Rural Kenya
A study testing nutrition and hygiene education in people with Child Nutrition Disorders, run by University of New Mexico at 1 site in United States.
Trial summary
This study will determine if an education program about hygiene and child feeding practices, taught by local village community health workers, will improve child growth and decrease the prevalence of childhood malnutrition in a rural region of Kenya. Read more about this study
- Who is it for?
- Ages 1 month to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Child Nutrition Disorders
- What is being tested?
- nutrition and hygiene education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 246 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Dec 2014
- 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 1 month to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Child of a mother living in the catchment area of the study who delivered during the enrollment period
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of New Mexico
Albuquerque, New Mexico, 87131
About this study
This study will determine if an education program about hygiene and child feeding practices, taught by local village community health workers, will improve child growth and decrease the prevalence of childhood malnutrition in a rural region of Kenya.
- Conditions
- Child Nutrition Disorders
- Being tested
- nutrition and hygiene education
- Keywords
- Infant nutrition disorder, Child nutrition disorders, Malnutrition, Protein-energy malnutrition
- Medical subject headings
- Child Nutrition Disorders, Infant Nutrition Disorders, Malnutrition, Protein-Energy Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nutrition and hygiene educationBehavioural
Monthly education sessions about child feeding and hygiene for mothers of young children, conducted by local Kenyan community health workers
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | nutrition and hygiene education by community health workers Receives: Behavioral: nutrition and hygiene education |
What is being measured
The primary outcome is the main question the study is designed to answer.
malnutrition prevalence
Child malnutrition rates, as measured by the prevalence of underweight, wasting, and growth stunting of the children in each group
Measured: Measured when children are 24 months of age
Secondary outcomes (1)
Child growth
Child growth as measured by change in z score of the children in each group
Measured: Measured when children are 24 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 posted6 Sep 2012 (estimated)
- Study startNov 2011
- Primary completionDec 2014
- Study completionDec 2014
Why it stopped: Not an applicable clinical trial (ACT).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Child Nutrition DisordersStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 246 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- University of Nairobi
- Responsible party
- Sponsor
- Investigators
- Angelo J Tomedi, MD, Principal investigator, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01679535
- Sponsor's protocol ID
- TOMEDI-12-049
- Status last verified
- Mar 2024
- First submitted
- 29 Aug 2012
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Black RE, Allen LH, Bhutta ZA, Caulfield LE, de Onis M, Ezzati M, Mathers C, Rivera J; Maternal and Child Undernutrition Study Group. Maternal and child undernutrition: global and regional exposures and health consequences. Lancet. 2008 Jan 19;371(9608):243-60. doi: 10.1016/S0140-6736(07)61690-0. No abstract available.
PubMed 18207566Bhutta ZA, Ahmed T, Black RE, Cousens S, Dewey K, Giugliani E, Haider BA, Kirkwood B, Morris SS, Sachdev HP, Shekar M; Maternal and Child Undernutrition Study Group. What works? Interventions for maternal and child undernutrition and survival. Lancet. 2008 Feb 2;371(9610):417-40. doi: 10.1016/S0140-6736(07)61693-6.
PubMed 18206226Dewey KG, Adu-Afarwuah S. Systematic review of the efficacy and effectiveness of complementary feeding interventions in developing countries. Matern Child Nutr. 2008 Apr;4 Suppl 1(Suppl 1):24-85. doi: 10.1111/j.1740-8709.2007.00124.x.
PubMed 18289157
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Nutrition/Hygiene Education Program for the Prevention of Child Malnutrition in Rural Kenya
- ClinicalTrials.gov ID
- NCT01679535
- Acronym / sponsor ID
- TOMEDI-12-049
- Conditions
- Child Nutrition Disorders
- Keywords
- Infant nutrition disorder, Child nutrition disorders, Malnutrition, Protein-energy malnutrition
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not an applicable clinical trial (ACT).
- Enrolment
- 246 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Collaborators
- University of Nairobi
- Study start
- Nov 2011 (actual)
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 6 Sep 2012 (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 will determine if an education program about hygiene and child feeding practices, taught by local village community health workers, will improve child growth and decrease the prevalence of childhood malnutrition in a rural region of Kenya.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: nutrition and hygiene educationnutrition and hygiene education by community health workers |
Who may qualify
- Ages
- 1 month to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Child of a mother living in the catchment area of the study who delivered during the enrollment period
Key exclusion criteria (0 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 |
|---|---|---|
| nutrition and hygiene educationMonthly education sessions about child feeding and hygiene for mothers of young children, conducted by local Kenyan community health workers | Behavioural | Intervention |
Primary outcome
malnutrition prevalence
Time frame: Measured when children are 24 months of age
Child malnutrition rates, as measured by the prevalence of underweight, wasting, and growth stunting of the children in each group
1 secondary outcome
Child growth
Time frame: Measured when children are 24 months of age
Results and safety
The study was stopped early (reason given: Not an applicable clinical trial (ACT).). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Results publication: PubMed 18207566Black RE, Allen LH, Bhutta ZA, Caulfield LE, de Onis M, Ezzati M, Mathers C, Rivera J; Maternal and Child Undernutrition Study Group. Maternal and child undernutrition: global and regional exposures and health consequences. Lancet. 2008 Jan 19;371(9608):243-60. doi: 10.1016/S0140-6736(07)61690-0. No abstract available.
- Results publication: PubMed 18206226Bhutta ZA, Ahmed T, Black RE, Cousens S, Dewey K, Giugliani E, Haider BA, Kirkwood B, Morris SS, Sachdev HP, Shekar M; Maternal and Child Undernutrition Study Group. What works? Interventions for maternal and child undernutrition and survival. Lancet. 2008 Feb 2;371(9610):417-40. doi: 10.1016/S0140-6736(07)61693-6.
- Results publication: PubMed 18289157Dewey KG, Adu-Afarwuah S. Systematic review of the efficacy and effectiveness of complementary feeding interventions in developing countries. Matern Child Nutr. 2008 Apr;4 Suppl 1(Suppl 1):24-85. doi: 10.1111/j.1740-8709.2007.00124.x.
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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.
Angelo J Tomedi, MD principal investigator
University of New Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nutrition and hygiene education in people with Child Nutrition Disorders, run by University of New Mexico at 1 site in United States.
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 0 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: stopped early, as of the sponsor's last update on 12 Mar 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 United States. 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 was stopped early (reason given: Not an applicable clinical trial (ACT).). Results are not available in the source record.
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?
malnutrition prevalence (time frame: Measured when children are 24 months of age). 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 NCT01679535, which also lists 3 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 12 Mar 2024.