Clinical trial NCT04250896: mHealth for Prevention of Childhood Obesity in Mexico
Official title: Using Behavioral Science and mHealth Tools for Early Prevention of Childhood Obesity in Mexico
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Keywords: Randomised controlled trial
Text messaging
Infant feeding practice
health unit
BMI
Mobile phone
prevention
Lead sponsor: Mexican National Institute of Public Health
Sponsor class: OTHER_GOV
Collaborators: name: UNICEF
First posted: 2020-01-31
Enrollment: 1000
Sex: ALL
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: prevalence of overweight and obesity
timeFrame: basal and through study completion, an average of 9 months.
Secondary outcomes:
measure: Proportion of caregivers / mothers with correct infant feeding practices scale
timeFrame: basal and through study completion, an average of 9 months.
measure: Proportion of caregivers / mothers with correct physical activity practices scale
timeFrame: basal and through study completion, an average of 9 months.
Other outcomes:
measure: knowledge and attitudes related to infant feeding practices and physical activity of child
timeFrame: basal and through study completion, an average of 9 months.
Locations:
city: Cuernavaca
country: Mexico
facility: Ministry of Health of Morelos State
Study officials:
affiliation: Mexican National Institute of Public Health
name: Anabelle Bonvecchio, PhD
role: PRINCIPAL_INVESTIGATOR
References: