Clinical trial NCT05114174: Evaluation and Implementation of an mHealth Intervention Called Mami-educ to Fight Against Gestational Obesity
Official title: Evaluation and Implementation of an mHealth Intervention to Prevent Gestational Obesity in the Metropolitan Region and the Aconcagua Valley.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gestational Weight Gain
Obesity, Maternal
Keywords: mHealth
Gestational obesity
Social theory
Lead sponsor: Universidad San Sebastián
Sponsor class: OTHER
Collaborators: name: Universidad de Valparaiso
name: Fondo de Fomento al Desarrollo Científico y Tecnológico, Fondef.
First posted: 2021-11-09
Enrollment: 511
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Classic randomized clinical trial (RCT).
Primary purpose: PREVENTION

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* A multiple pregnancy
* Conditions that require a special diet
* Participants with psychiatric illness or other pre-pregnancy pathology
* History of recurrent abortions

Primary outcomes:
measure: Gestational weight gain
timeFrame: Nine months
Secondary outcomes:
measure: Maternal outcome
timeFrame: Nine months
measure: Perinatal outcome
timeFrame: At birth
measure: Apgar score
timeFrame: At birth
measure: Newborn birth weight
timeFrame: At birth
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Delia I Chiarello
state: Providencia
city: San Felipe
country: Chile
facility: Fabián Pardo
state: Valparaíso
Study officials:
affiliation: Universidad San Sebastián
name: Delia I Chiarello, Ph.D
role: STUDY_DIRECTOR
References: