Infant and Young Child FeedingNCT01405755
Partnering With Media and Vaccination Program to Improve Infant and Young Child Feeding
A study testing Appropriate complementary feeding messages in people with Infant and Young Child Feeding, run by University of South Carolina at 1 site in Mexico.
Trial summary
Infant and young child feeding (IYCF) is a key determinant of under-nutrition and overweight in young children. In Mexico, breastfeeding extends well into the second half of infancy, but animal-source foods, cereals, and legumes are not regularly provided to the child by 9 mo. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Infant and Young Child Feeding
- What is being tested?
- Appropriate complementary feeding messages
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 1 siteMexico
- Study dates
- Sep 2010to Mar 2013
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Mothers with healthy children between 6 and 24 mo
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Mexican National Institute of Public Health
Cuernavaca, Morelos, 62100
About this study
Infant and young child feeding (IYCF) is a key determinant of under-nutrition and overweight in young children. In Mexico, breastfeeding extends well into the second half of infancy, but animal-source foods, cereals, and legumes are not regularly provided to the child by 9 mo. This study evaluates whether knowledge and practices about dietary diversity and food consistency can be improved using a two-component intervention strategy in semi-urban communities in Mexico. The two components will deliver appropriate complementary feeding messages using: (a) nurses during the 1st National Vaccination Week (NVW); and (b) radio messages and interviews. The intervention is evaluated using a cluster randomized design in small semi-urban communities in two states in Mexico with pre- and post-test questionnaires designed to assess changes in feeding behaviors.
- Conditions
- Infant and Young Child Feeding
- Being tested
- Appropriate complementary feeding messages
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Appropriate complementary feeding messagesBehavioural
Messages delivered through National Vaccine Program and radio
| Study group | Role | What they receive |
|---|---|---|
| National Vaccine Program Plus Radio | Experimental | Appropriate complementary feeding messages delivered using: (a) nurses during the 1st National Vaccination Week (NVW); and (b) radio. Receives: Behavioral: Appropriate complementary feeding messages |
| Comparison (no intervention) | No intervention | No complementary feeding messages delivered. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Provision of flesh-food or vitamin A-rich food
Mothers provide at least one flesh-food (i.e., beef, chicken, fish, liver) or one vitamin A-rich fruit or vegetable in the previous day
Measured: Change from baseline to 5 months
Secondary outcomes (1)
Provision of solid, semi-solid, or soft foods (i.e., not runny soups or broths) Provision of solid, semi-solid, or soft foods
Mothers provide solid, semi-solid, or soft foods (i.e., not runny soups or broths) at least 1 meal/d (6-12 mo) or 2 meals/d (12-24 mo)
Measured: Change from baseline to 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2011 (estimated)
- Study startSep 2010
- Primary completionAug 2011
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infant and Young Child FeedingStudies of the same condition, open and under way.
- More trials run by University of South CarolinaThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 420 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Mexican National Institute of Public Health
- Responsible party
- Principal investigator, Edward Frongillo, Jr., University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01405755
- Sponsor's protocol ID
- Pro00007388
- Status last verified
- Apr 2019
- First submitted
- 27 Jul 2011
- Last updated
- 19 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Monterrosa EC, Frongillo EA, Gonzalez de Cossio T, Bonvecchio A, Villanueva MA, Thrasher JF, Rivera JA. Scripted messages delivered by nurses and radio changed beliefs, attitudes, intentions, and behaviors regarding infant and young child feeding in Mexico. J Nutr. 2013 Jun;143(6):915-22. doi: 10.3945/jn.112.169235. Epub 2013 Apr 24.
PubMed 23616510
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Partnering With Media and Vaccination Program to Improve Infant and Young Child Feeding
- ClinicalTrials.gov ID
- NCT01405755
- Acronym / sponsor ID
- Pro00007388
- Conditions
- Infant and Young Child Feeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Collaborators
- Mexican National Institute of Public Health
- Study start
- Sep 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 29 Jul 2011 (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.
Infant and young child feeding (IYCF) is a key determinant of under-nutrition and overweight in young children. In Mexico, breastfeeding extends well into the second half of infancy, but animal-source foods, cereals, and legumes are not regularly provided to the child by 9 mo. This study evaluates whether knowledge and practices about dietary diversity and food consistency can be improved using a two-component intervention strategy in semi-urban communities in Mexico. The two components will deliver appropriate complementary feeding messages using: (a) nurses during the 1st National Vaccination Week (NVW); and (b) radio messages and interviews. The intervention is evaluated using a cluster randomized design in small semi-urban communities in two states in Mexico with pre- and post-test questionnaires designed to assess changes in feeding behaviors.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| National Vaccine Program Plus Radio | Experimental | Behavioral: Appropriate complementary feeding messagesAppropriate complementary feeding messages delivered using: (a) nurses during the 1st National Vaccination Week (NVW); and (b) radio. |
| Comparison (no intervention) | No intervention | –No complementary feeding messages delivered. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Mothers with healthy children between 6 and 24 mo
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Appropriate complementary feeding messagesMessages delivered through National Vaccine Program and radio | Behavioural | National Vaccine Program Plus Radio |
Primary outcome
Provision of flesh-food or vitamin A-rich food
Time frame: Change from baseline to 5 months
Mothers provide at least one flesh-food (i.e., beef, chicken, fish, liver) or one vitamin A-rich fruit or vegetable in the previous day
1 secondary outcome
Provision of solid, semi-solid, or soft foods (i.e., not runny soups or broths) Provision of solid, semi-solid, or soft foods
Time frame: Change from baseline to 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 19 Apr 2019.
- Derived from this study: PubMed 23616510Monterrosa EC, Frongillo EA, Gonzalez de Cossio T, Bonvecchio A, Villanueva MA, Thrasher JF, Rivera JA. Scripted messages delivered by nurses and radio changed beliefs, attitudes, intentions, and behaviors regarding infant and young child feeding in Mexico. J Nutr. 2013 Jun;143(6):915-22. doi: 10.3945/jn.112.169235. Epub 2013 Apr 24.
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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 Appropriate complementary feeding messages in people with Infant and Young Child Feeding, run by University of South Carolina at 1 site in Mexico.
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 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 19 Apr 2019. 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 Mexico. 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?
Provision of flesh-food or vitamin A-rich food (time frame: Change from baseline to 5 months). 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 NCT01405755, which also lists 1 linked publication.
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 19 Apr 2019.