NCT04250896

Brief Summary

Background: The sending of text messages (short messaging service, SMS) has been proven as an effective strategy in behavior change. In Mexico, the Strategy of Comprehensive Care for the Nutrition (EsIAN for its acronym in Spanish ) focuses on improving access to information for the main caregivers of child beneficiaries on the practice of infant feeding and healthy physical activity. Objective: To assess whether the mHealth (or mobile health) strategy or the sending of SMS has an effect on knowledge, attitudes, intentionality, perceived control and practices to prevent childhood malnutrition in a population living in poverty. Design: Randomized effectiveness trial by conglomerates. Participants: 400 primary caregivers of children \<59 months and health personnel working in the health units included in the study. Control group: Healthy child care in standard health units plus exposure to EsIAN. Intervention group: In addition to the control group, the SMS are sent through a cell pone through the RapidPro platform on practices related to prevention of child malnutrition (in primary caregivers) and the reinforcement of counseling for the prevention of infant malnutrition (with health personnel). Randomization: The first level health units were stratified by state (Morelos or Yucatan); rural and urban area and affiliation institution (Secretary of Health or Mexican Institute of Social Security); and randomized to be assigned to the control or intervention group; 400 primary caregivers of children \<59 months in total will be included for the study. Main measures of interest: State of nutrition and knowledge, attitudes or practices on breastfeeding, physical activity, adoption and preparation of healthy foods and beverages in primary caregivers of children\<5 years old; and advice on the key messages of EsIAN by health providers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2020

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 31, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

August 1, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 6, 2021

Completed
Last Updated

September 14, 2021

Status Verified

September 1, 2021

Enrollment Period

3 months

First QC Date

October 31, 2019

Last Update Submit

September 13, 2021

Conditions

Overweight and Obesity

Keywords

Randomised controlled trialText messagingInfant feeding practicehealth unitBMIMobile phoneprevention

Outcome Measures

Primary Outcomes (1)

  • prevalence of overweight and obesity

    Through the measurements of weight and height to children under 60 months, the estimator of body mass index adjusted for age will be calculated to determine prevalence of overweight (+1 SD. Z score ) and obesity (+2 SD Z score).

    basal and through study completion, an average of 9 months.

Secondary Outcomes (2)

  • Proportion of caregivers / mothers with correct infant feeding practices scale

    basal and through study completion, an average of 9 months.

  • Proportion of caregivers / mothers with correct physical activity practices scale

    basal and through study completion, an average of 9 months.

Other Outcomes (1)

  • knowledge and attitudes related to infant feeding practices and physical activity of child

    basal and through study completion, an average of 9 months.

Study Arms (2)

Control

OTHER

Control group will receive standard child care in health units plus exposure to EsIAN (Strategy of Integral Attention to Nutrition)

Other: Control group

Intervention

EXPERIMENTAL

Intervention group will receive SMS messages sent through a cell pone in addition to the control group receive (standard child care in health units plus exposure to EsIAN)

Behavioral: SMS´s sending by cell phone for behavior change

Interventions

Control groupOTHER

Standard child care in health unit plus exposure to EsIAN

Control
SMS´s sending by cell phone for behavior changeBEHAVIORAL

SMS messages sent through a cell pone through the RapidPro platform on practices related to the prevention of infant malnutrition to primary caregivers and the strengthening of counseling for the prevention of infant malnutrition with health providers.

Intervention

Eligibility Criteria

AgeUp to 59 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Primary caregivers whose beneficiaries children are cared in the health units selected for the study and who have a cell pone in home
  • Health personnel who provides services to Prospera population in the health units selected for the study and that have a cell pone
  • Primary caregiver, must care for at least one child under 60 months users of the health units selected for the study

You may not qualify if:

  • Primary caregivers and health personnel who do not have a cell pone or who do not have connectivity in their communities
  • Health personnel, who have been in office for a least 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ministry of Health of Morelos State

Cuernavaca, Mexico

Location

Related Publications (1)

  • Lozada-Tequeanes AL, Theodore FL, Kim-Herrera E, Garcia-Guerra A, Quezada-Sanchez AD, Alvarado-Casas R, Bonvecchio A. Effectiveness and Implementation of a Text Messaging mHealth Intervention to Prevent Childhood Obesity in Mexico in the COVID-19 Context: Mixed Methods Study. JMIR Mhealth Uhealth. 2024 Apr 9;12:e55509. doi: 10.2196/55509.

    PMID: 38592753DERIVED

MeSH Terms

Conditions

OverweightObesity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Anabelle Bonvecchio, PhD

    Mexican National Institute of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
The randomized unit is the health center
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Control group will receive standard child care in health units plus exposure to EsIAN (Strategy of Integral Attention to Nutrition of Mexico). At the same time as the intervention group, in addition to the control group, will receive SMS through a cell pone on practices related to the prevention of infant malnutrition (in primary caregivers) and the strengthening of counseling for the prevention of infant malnutrition with health providers.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Research in Nutrition Policies and Programs

Study Record Dates

First Submitted

October 31, 2019

First Posted

January 31, 2020

Study Start

August 1, 2020

Primary Completion

November 1, 2020

Study Completion

September 6, 2021

Last Updated

September 14, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

ME(1)