Overweight and ObesitymHealthNCT04250896
mHealth for Prevention of Childhood Obesity in Mexico
A study testing SMS´s sending by cell phone for behavior change in people with Overweight and Obesity, run by Mexican National Institute of Public Health at 1 site in Mexico.
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… Read more about this study
- Who is it for?
- Ages Up to 59 months
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- SMS´s sending by cell phone for behavior change
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteMexico
- Study dates
- 1 Aug 2020to 6 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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
- Conditions
- Overweight and Obesity
- Being tested
- Control group, SMS´s sending by cell phone for behavior change
- Keywords
- Randomised controlled trial, Text messaging, Infant feeding practice, health unit, BMI, Mobile phone, prevention
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control groupOther
Standard child care in health unit plus exposure to EsIAN
SMS´s sending by cell phone for behavior changeBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | Control group will receive standard child care in health units plus exposure to EsIAN (Strategy of Integral Attention to Nutrition) Receives: 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) Receives: Behavioral: SMS´s sending by cell phone for behavior change |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: basal and through study completion, an average of 9 months.
Secondary outcomes (2)
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)
Measured: basal and through study completion, an average of 9 months.
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)
Measured: basal and through study completion, an average of 9 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study start1 Aug 2020
- Primary completion1 Nov 2020
- Study completion6 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mexican National Institute of Public Health
- Sponsor type
- Other government
- Collaborators
- UNICEF
- Responsible party
- Principal investigator, Anabelle Bonvecchio Arenas, Mexican National Institute of Public Health
- Investigators
- Anabelle Bonvecchio, PhD, Principal investigator, Mexican National Institute of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04250896
- Sponsor's protocol ID
- CI1547
- Acronym
- mHealth
- Status last verified
- Sep 2021
- First submitted
- 31 Oct 2019
- Last updated
- 14 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38592753
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Behavioral Science and mHealth Tools for Early Prevention of Childhood Obesity in Mexico
- ClinicalTrials.gov ID
- NCT04250896
- Acronym / sponsor ID
- mHealth / CI1547
- Conditions
- Overweight and Obesity
- Keywords
- Randomised controlled trial, Text messaging, Infant feeding practice, health unit, BMI, Mobile phone, prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Mexican National Institute of Public HealthOther government
- Collaborators
- UNICEF
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 Nov 2020 (actual)
- Study completion
- 6 Sep 2021 (actual)
- First posted
- 31 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Other: Control groupControl group will receive standard child care in health units plus exposure to EsIAN (Strategy of Integral Attention to Nutrition) |
| Intervention | Experimental | Behavioral: SMS´s sending by cell phone for behavior changeIntervention 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) |
Who may qualify
- Ages
- Up to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control groupStandard child care in health unit plus exposure to EsIAN | Other | Control |
| SMS´s sending by cell phone for behavior changeSMS 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. | Behavioural | Intervention |
Primary outcome
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).
2 secondary outcomes
Proportion of caregivers / mothers with correct infant feeding practices scale
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2021.
- Derived from this study: PubMed 38592753Lozada-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anabelle Bonvecchio, PhD principal investigator
Mexican National Institute of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMS´s sending by cell phone for behavior change in people with Overweight and Obesity, run by Mexican National Institute of Public Health at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of overweight and obesity (time frame: basal and through study completion, an average of 9 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04250896, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2021.