Evaluation and Implementation of an mHealth Intervention Called Mami-educ to Fight Against Gestational Obesity

Gestational Weight Gain Clinical Trial

Official title:

Evaluation and Implementation of an mHealth Intervention to Prevent Gestational Obesity in the Metropolitan Region and the Aconcagua Valley.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05114174
• Other study ID #: SA21I0099
• Status: Recruiting
• Phase: N/A
• Start date: January 3, 2022
• Est. completion date: December 18, 2023

Study information

• Verified date: October 2022
• Source: Universidad San Sebastián
• Contact: Delia I Chiarello, Ph.D.
• Phone: +56965774469
• Email: delia.chiarello[@]uss.cl
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 511
• Est. completion date: December 18, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Gestational Weight Gain
• Obesity
• Weight Gain

Intervention

Other:
• mami-educ
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.

Locations

Country	Name	City	State
Chile	Fabián Pardo	San Felipe	Valparaíso
Chile	Delia I Chiarello	Santiago	Providencia

Sponsors (3)

Lead Sponsor	Collaborator
Universidad San Sebastián	Fondo de Fomento al Desarrollo Científico y Tecnológico, Fondef., Universidad de Valparaiso

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gestational weight gain	Maternal weight gain measure in kilograms by month	Nine months
Secondary	Maternal outcome	Medical diagnosis of of either preeclampsia, gestational diabetes or gestational hypertension	Nine months
Secondary	Perinatal outcome	Labor delivery week	At birth
Secondary	Apgar score	Apgar score report	At birth
Secondary	Newborn birth weight	Newborn birth weight measure in grams	At birth