mHealth for Prevention of Childhood Obesity in Mexico

Overweight and Obesity Clinical Trial

— mHealth  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04250896
• Other study ID #: CI1547
• Status: Completed
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: September 6, 2021

Study information

• Verified date: September 2021
• Source: Mexican National Institute of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: September 6, 2021
• Est. primary completion date: November 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 59 Months

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overweight
• Overweight and Obesity
• Pediatric Obesity

Intervention

Other:
• Control group
Standard child care in health unit 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.

Locations

Country	Name	City	State
Mexico	Ministry of Health of Morelos State	Cuernavaca

Sponsors (2)

Lead Sponsor	Collaborator
Mexican National Institute of Public Health	UNICEF

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	knowledge and attitudes related to infant feeding practices and physical activity of child	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.
Primary	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	Proportion of caregivers / mothers with correct infant feeding practices scale	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.
Secondary	Proportion of caregivers / mothers with correct physical activity practices scale	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.