mHealth for Prevention of Childhood Obesity in Mexico (mHealth)

September 13, 2021 updated by: Anabelle Bonvecchio Arenas, Mexican National Institute of Public Health

Using Behavioral Science and mHealth Tools for Early Prevention of Childhood Obesity in Mexico

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

RapidPro is a tecnological platform of programming of short messaging service (SMS) for cell phone.

Morelos is the name of one of the central states of Mexico Yucatan is the name of one of the south states of Mexico

Study Type

Interventional

Enrollment (Actual)

1000

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

  • Mexico
      • Cuernavaca, Mexico
        • Ministry of Health of Morelos State

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

No older than 4 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Control
Control group will receive standard child care in health units plus exposure to EsIAN (Strategy of Integral Attention to Nutrition)
Other: Control group
Standard child care in health unit plus exposure to EsIAN
EXPERIMENTAL: Intervention
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
prevalence of overweight and obesity
Time Frame: basal and through study completion, an average of 9 months.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of caregivers / mothers with correct infant feeding practices scale
Time Frame: basal and through study completion, an average of 9 months.
Practices related to breastfeeding, complementary food and healthy nutrition during childhood (scale of 0-20 values , which high scores >15 is correct)
basal and through study completion, an average of 9 months.
Proportion of caregivers / mothers with correct physical activity practices scale
Time Frame: basal and through study completion, an average of 9 months.
Practices of physical activity to less 5 years old (scale of 0-20 values , which high scores >15 is correct)
basal and through study completion, an average of 9 months.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
knowledge and attitudes related to infant feeding practices and physical activity of child
Time Frame: basal and through study completion, an average of 9 months.
scales of knowledge and attitudes about nutrition and physical activity of the child (scale of 0-5 values, which high scores is agreement or very important)
basal and through study completion, an average of 9 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mexican National Institute of Public Health

Collaborators

UNICEF

Investigators

  • Principal Investigator: Anabelle Bonvecchio, PhD, Mexican National Institute of Public Health

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 (ACTUAL)

August 1, 2020

Primary Completion (ACTUAL)

November 1, 2020

Study Completion (ACTUAL)

September 6, 2021

Study Registration Dates

First Submitted

October 31, 2019

First Submitted That Met QC Criteria

January 29, 2020

First Posted (ACTUAL)

January 31, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 14, 2021

Last Update Submitted That Met QC Criteria

September 13, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CI1547

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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