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

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.

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 Overview

• Status: Recruiting
• Conditions: Gestational Weight Gain; Obesity, Maternal
• Intervention / Treatment: Other: mami-educ

• Study Type: Interventional
• Enrollment (Anticipated): 511
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Delia I Chiarello, Ph.D.; Phone Number: +56965774469; Email: delia.chiarello@uss.cl

Study Locations

• Chile
  • Providencia
    • Santiago, Providencia, Chile
      • Recruiting
      • Delia I Chiarello
      • Contact: Delia I Chiarello, Ph.D.; Phone Number: +56965774469; Email: delia.chiarello@uss.cl
      • Principal Investigator: Delia I Chiarello, Ph.D.
      • Sub-Investigator: Jessica Moya, Msc
  • Valparaíso
    • San Felipe, Valparaíso, Chile
      • Recruiting
      • Fabián Pardo
      • Contact: Fabián Pardo, Ph.D.; Email: fabian.pardo@uv.cl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual care group; Pregnant women enrolled in the prenatal control program who receive routine medical care.
Experimental: mami-educ group; Pregnant women enrolled in the prenatal care program who receive routine medical care and nutritional messages mom-educ.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gestational weight gain	Maternal weight gain measure in kilograms by month	Nine months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal outcome	Medical diagnosis of of either preeclampsia, gestational diabetes or gestational hypertension	Nine months
Perinatal outcome	Labor delivery week	At birth
Apgar score	Apgar score report	At birth
Newborn birth weight	Newborn birth weight measure in grams	At birth

Collaborators and Investigators

• Sponsor: Universidad San Sebastián
• Collaborators: Universidad de Valparaiso; Fondo de Fomento al Desarrollo Científico y Tecnológico, Fondef.
• Investigators: Study Director: Delia I Chiarello, Ph.D, Universidad San Sebastian

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2022
• Primary Completion (Anticipated): July 1, 2023
• Study Completion (Anticipated): December 18, 2023

Study Registration Dates

• First Submitted: October 15, 2021
• First Submitted That Met QC Criteria: October 28, 2021
• First Posted (Actual): November 9, 2021

Study Record Updates

• Last Update Posted (Actual): November 3, 2022
• Last Update Submitted That Met QC Criteria: October 31, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: mHealth; Gestational obesity; Social theory
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Pregnancy Complications; Body Weight Changes; Obesity; Weight Gain; Obesity, Maternal; Gestational Weight Gain
• Other Study ID Numbers: SA21I0099

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No