NCT01405755

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
420

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 27, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 29, 2011

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

April 19, 2019

Status Verified

April 1, 2019

Enrollment Period

11 months

First QC Date

July 27, 2011

Last Update Submit

April 17, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    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

    Change from baseline to 5 months

Study Arms (2)

National Vaccine Program Plus Radio

EXPERIMENTAL

Appropriate complementary feeding messages delivered using: (a) nurses during the 1st National Vaccination Week (NVW); and (b) radio.

Behavioral: Appropriate complementary feeding messages

Comparison (no intervention)

NO INTERVENTION

No complementary feeding messages delivered.

Interventions

Messages delivered through National Vaccine Program and radio

National Vaccine Program Plus Radio

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Mothers with healthy children between 6 and 24 mo

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mexican National Institute of Public Health

Cuernavaca, Morelos, 62100, Mexico

Location

Related Publications (1)

  • 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.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 27, 2011

First Posted

July 29, 2011

Study Start

September 1, 2010

Primary Completion

August 1, 2011

Study Completion

March 1, 2013

Last Updated

April 19, 2019

Record last verified: 2019-04

Locations