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

NCT05114174 | Completed

• 1 other identifier: SA21I0099
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

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.

Conditions

Gestational Weight Gain; Obesity, Maternal

Keywords

mHealth; Gestational obesity; Social theory

Outcome Measures

Primary Outcomes (1)

• Gestational weight gain

  Maternal weight gain measure in kilograms by month

  Nine months

Secondary Outcomes (4)

• Maternal outcome

  Nine months

• Perinatal outcome

  At birth

• Apgar score

  At birth

• Newborn birth weight

  At birth

Study Arms (2)

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.

Other: mami-educ

Interventions

mami-educ OTHER

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.

mami-educ group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Universidad San Sebastián: lead
• Universidad de Valparaiso: collaborator
• Fondo de Fomento al Desarrollo Científico y Tecnológico, Fondef.: collaborator

Study Sites (2)

Delia I Chiarello

Santiago, Providencia, Chile

Location

Fabián Pardo

San Felipe, Región de Valparaíso, Chile

Location

Related Publications (1)

• 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.

  PMID: 36790846 DERIVED

MeSH Terms

Conditions

Gestational Weight Gain; Pregnancy in Obesity

Condition Hierarchy (Ancestors)

Weight Gain; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Delia I Chiarello, Ph.D

  Universidad San Sebastián

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Blinding will be done in a single-blind fashion. The care provider will be blinded to the randomization of the subjects to avoid bias in routine care.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator Ph.D.

Model Details: Classic randomized clinical trial (RCT).

Study Record Dates

• First Submitted: October 15, 2021
• First Posted: November 9, 2021
• Study Start: January 3, 2022
• Primary Completion: July 1, 2023
• Study Completion: December 18, 2023
• Last Updated: August 11, 2025

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CL (2)