- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01405755
Partnering With Media and Vaccination Program to Improve Infant and Young Child Feeding
April 17, 2019 updated by: Edward Frongillo, Jr., University of South Carolina
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
420
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Morelos
-
Cuernavaca, Morelos, Mexico, 62100
- Mexican National Institute of Public Health
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Mothers with healthy children between 6 and 24 mo
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: National Vaccine Program Plus Radio
Appropriate complementary feeding messages delivered using: (a) nurses during the 1st National Vaccination Week (NVW); and (b) radio.
|
Messages delivered through National Vaccine Program and radio
|
|
NO_INTERVENTION: Comparison (no intervention)
No complementary feeding messages delivered.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Change from baseline to 5 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
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)
|
Change from baseline to 5 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2010
Primary Completion (ACTUAL)
August 1, 2011
Study Completion (ACTUAL)
March 1, 2013
Study Registration Dates
First Submitted
July 27, 2011
First Submitted That Met QC Criteria
July 28, 2011
First Posted (ESTIMATE)
July 29, 2011
Study Record Updates
Last Update Posted (ACTUAL)
April 19, 2019
Last Update Submitted That Met QC Criteria
April 17, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- Pro00007388
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.