Gestational Weight GainNCT05114174
Evaluation and Implementation of an mHealth Intervention Called Mami-educ to Fight Against Gestational Obesity
A study testing mami-educ in people with Gestational Weight Gain and Obesity, Maternal, run by Universidad San Sebastián at 2 sites in Chile.
Trial summary
The World Federation of Obesity warns that the main health problem of the next decade will be childhood obesity. Furthermore, obesity and its consequences have been reported to originate in intrauterine life. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Weight Gain, Obesity, Maternal
- What is being tested?
- mami-educ
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesChile
- Study dates
- 3 Jan 2022to 18 Dec 2023
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women who receive care in the 6 CESFAMs of El Bosque and Aconcagua Valley over 18 years of age; pregnant women with gestational age ≤ 12 weeks of gestation (first trimester)
- Pregnant women with a single pregnancy
- Healthy pregnant women
- Chilean or immigrant women who speak Spanish
- The participants must have a mobile device that allows the use of the Telegram application
- Pregnant women who agree to be randomized
- Pregnant women who have voluntarily signed the informed consent to participate in this study
Who cannot join
- A multiple pregnancy
- Conditions that require a special diet
- Participants with psychiatric illness or other pre-pregnancy pathology
- History of recurrent abortions
Trial locations and contacts
2 sites in 1 country.
Chile2 sites
Fabián Pardo
San Felipe, Valparaiso
Delia I Chiarello
Santiago, Providencia
About this study
Official title: Evaluation and Implementation of an mHealth Intervention to Prevent Gestational Obesity in the Metropolitan Region and the Aconcagua Valley.
The World Federation of Obesity warns that the main health problem of the next decade will be childhood obesity. Furthermore, obesity and its consequences have been reported to originate in intrauterine life. Gestational obesity produces profound effects on fetal genome programming, thereby inducing changes in prenatal metabolism that extend to the postnatal period, which is also associated with increased susceptibility to developing cardiovascular and metabolic diseases in adulthood.
Excessive maternal weight gain early in pregnancy has been repeatedly associated with increased adiposity in childhood and adolescence of its offspring. Obesity is a complex phenomenon influenced by social determinants of health, which include demographic, socioeconomic, behavioral, environmental, and genetic factors. At the primary prevention level, nutrition constitutes a modifiable risk factor during pregnancy. Therefore establishing healthy nutritional behaviors during the first trimester of pregnancy is key to the primary prevention of the intergenerational transmission of obesity.
Read more
New ways of approaching the target population are required to maintain nutritional recommendations as a priority in the daily decision-making (top of mind) of pregnant women. For many women, this period is a powerful motivator for self-care.
Interventions based on behavioral theories provide a better understanding of the underlying mechanisms that determine health-related behavior change and have the potential to be more effective in promoting adherence to weight gain control. Social Cognitive Theory (TCS) is an integrated model of behavior change commonly applied in mobile health interventions that address diet, physical activity or weight loss.
Mobile health programs (mHealth) are potentially more effective than face-to-face interventions, especially during a public health emergency like the COVID-19 outbreak. This proposal intends to "deliver" messages with evidence-based information directly to pregnant women, in order to influence their nutritional behavior to avoid excessive gestational weight gain.
The hypothesis of this proposal is that the mHealth intervention called "mami-educ", which consists of sending messages with nutrition counseling during pregnancy through the Telegram platform, is effective in reducing excessive gestational weight gain in pregnant women attending Family Health Care Centers in an urban and predominantly rural area.
- Conditions
- Gestational Weight Gain, Obesity, Maternal
- Being tested
- mami-educ
- Keywords
- mHealth, Gestational obesity, Social theory
- Medical subject headings
- Gestational Weight Gain, Pregnancy in Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mami-educOther
The intervention corresponds to sending 3 messages a week through Telegram, with nutritional information, for 12 consecutive weeks (a different nutritional topic each week). The messages address the three domains of learning, cognitive, affective, and psychomotor for each topic.
| Study group | Role | What they receive |
|---|---|---|
| Usual care group | No intervention | Pregnant women enrolled in the prenatal control program who receive routine medical care. |
| mami-educ group | Experimental | Pregnant women enrolled in the prenatal care program who receive routine medical care and nutritional messages mom-educ. Receives: Other: mami-educ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gestational weight gain
Maternal weight gain measure in kilograms by month
Measured: Nine months
Secondary outcomes (4)
Maternal outcome
Medical diagnosis of of either preeclampsia, gestational diabetes or gestational hypertension
Measured: Nine months
Perinatal outcome
Labor delivery week
Measured: At birth
Apgar score
Apgar score report
Measured: At birth
Newborn birth weight
Newborn birth weight measure in grams
Measured: At birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start3 Jan 2022
- Primary completion1 Jul 2023
- Study completion18 Dec 2023
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 Gestational Weight GainStudies 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
- Classic randomized clinical trial (RCT).
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad San Sebastián
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de Valparaiso, Fondo de Fomento al Desarrollo Científico y Tecnológico, Fondef.
- Responsible party
- Principal investigator, Delia Indira Chiarello, Universidad San Sebastián
- Investigators
- Delia I Chiarello, Ph.D, Study director, Universidad San Sebastián
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05114174
- Sponsor's protocol ID
- SA21I0099
- Status last verified
- Oct 2022
- First submitted
- 15 Oct 2021
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chiarello DI, Pardo F, Moya J, Pino M, Rodriguez A, Araneda ME, Bertini A, Gutierrez J. An mHealth Intervention to Reduce Gestational Obesity (mami-educ): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2023 Feb 15;12:e44456. doi: 10.2196/44456.
PubMed 36790846
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Implementation of an mHealth Intervention to Prevent Gestational Obesity in the Metropolitan Region and the Aconcagua Valley.
- ClinicalTrials.gov ID
- NCT05114174
- Acronym / sponsor ID
- SA21I0099
- Conditions
- Gestational Weight Gain, Obesity, Maternal
- Keywords
- mHealth, Gestational obesity, Social theory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Universidad San SebastiánUniversity, hospital or other
- Collaborators
- Universidad de Valparaiso, Fondo de Fomento al Desarrollo Científico y Tecnológico, Fondef.
- Study start
- 3 Jan 2022 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 18 Dec 2023 (actual)
- First posted
- 9 Nov 2021 (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.
The World Federation of Obesity warns that the main health problem of the next decade will be childhood obesity. Furthermore, obesity and its consequences have been reported to originate in intrauterine life. Gestational obesity produces profound effects on fetal genome programming, thereby inducing changes in prenatal metabolism that extend to the postnatal period, which is also associated with increased susceptibility to developing cardiovascular and metabolic diseases in adulthood.
Excessive maternal weight gain early in pregnancy has been repeatedly associated with increased adiposity in childhood and adolescence of its offspring. Obesity is a complex phenomenon influenced by social determinants of health, which include demographic, socioeconomic, behavioral, environmental, and genetic factors. At the primary prevention level, nutrition constitutes a modifiable risk factor during pregnancy. Therefore establishing healthy nutritional behaviors during the first trimester of pregnancy is key to the primary prevention of the intergenerational transmission of obesity.
New ways of approaching the target population are required to maintain nutritional recommendations as a priority in the daily decision-making (top of mind) of pregnant women. For many women, this period is a powerful motivator for self-care.
Interventions based on behavioral theories provide a better understanding of the underlying mechanisms that determine health-related behavior change and have the potential to be more effective in promoting adherence to weight gain control. Social Cognitive Theory (TCS) is an integrated model of behavior change commonly applied in mobile health interventions that address diet, physical activity or weight loss.
Mobile health programs (mHealth) are potentially more effective than face-to-face interventions, especially during a public health emergency like the COVID-19 outbreak. This proposal intends to "deliver" messages with evidence-based information directly to pregnant women, in order to influence their nutritional behavior to avoid excessive gestational weight gain.
The hypothesis of this proposal is that the mHealth intervention called "mami-educ", which consists of sending messages with nutrition counseling during pregnancy through the Telegram platform, is effective in reducing excessive gestational weight gain in pregnant women attending Family Health Care Centers in an urban and predominantly rural area.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- Classic randomized clinical trial (RCT).
| Arm | Type | Receives |
|---|---|---|
| Usual care group | No intervention | –Pregnant women enrolled in the prenatal control program who receive routine medical care. |
| mami-educ group | Experimental | Other: mami-educPregnant women enrolled in the prenatal care program who receive routine medical care and nutritional messages mom-educ. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Pregnant women who receive care in the 6 CESFAMs of El Bosque and Aconcagua Valley over 18 years of age; pregnant women with gestational age ≤ 12 weeks of gestation (first trimester)
- Pregnant women with a single pregnancy
- Healthy pregnant women
- Chilean or immigrant women who speak Spanish
- The participants must have a mobile device that allows the use of the Telegram application
Key exclusion criteria (4 listed)
- A multiple pregnancy
- Conditions that require a special diet
- Participants with psychiatric illness or other pre-pregnancy pathology
- History of recurrent abortions
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 |
|---|---|---|
| mami-educThe intervention corresponds to sending 3 messages a week through Telegram, with nutritional information, for 12 consecutive weeks (a different nutritional topic each week). The messages address the three domains of learning, cognitive, affective, and psychomotor for each topic. | Other | mami-educ group |
Primary outcome
Gestational weight gain
Time frame: Nine months
Maternal weight gain measure in kilograms by month
4 secondary outcomes
Maternal outcome
Time frame: Nine months
Perinatal outcome
Time frame: At birth
Apgar score
Time frame: At birth
Newborn birth weight
Time frame: At birth
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 11 Aug 2025.
- Derived from this study: PubMed 36790846Chiarello DI, Pardo F, Moya J, Pino M, Rodriguez A, Araneda ME, Bertini A, Gutierrez J. An mHealth Intervention to Reduce Gestational Obesity (mami-educ): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2023 Feb 15;12:e44456. doi: 10.2196/44456.
- 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.
Delia I Chiarello, Ph.D study director
Universidad San Sebastián
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mami-educ in people with Gestational Weight Gain and Obesity, Maternal, run by Universidad San Sebastián at 2 sites in Chile.
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 7 inclusion and 4 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 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Chile. 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?
Gestational weight gain (time frame: Nine 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 NCT05114174, 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 11 Aug 2025.