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

Primary Purpose

Gestational Weight Gain, Obesity, Maternal

Status
Recruiting
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
mami-educ
Sponsored by
Universidad San Sebastián
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gestational Weight Gain focused on measuring mHealth, Gestational obesity, Social theory

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Delia I ChiarelloRecruiting
  • Fabián PardoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual care group

mami-educ group

Arm Description

Pregnant women enrolled in the prenatal control program who receive routine medical care.

Pregnant women enrolled in the prenatal care program who receive routine medical care and nutritional messages mom-educ.

Outcomes

Primary Outcome Measures

Gestational weight gain
Maternal weight gain measure in kilograms by month

Secondary Outcome Measures

Maternal outcome
Medical diagnosis of of either preeclampsia, gestational diabetes or gestational hypertension
Perinatal outcome
Labor delivery week
Apgar score
Apgar score report
Newborn birth weight
Newborn birth weight measure in grams

Full Information

First Posted
October 15, 2021
Last Updated
October 31, 2022
Sponsor
Universidad San Sebastián
Collaborators
Universidad de Valparaiso, Fondo de Fomento al Desarrollo Científico y Tecnológico, Fondef.
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1. Study Identification

Unique Protocol Identification Number
NCT05114174
Brief Title
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 3, 2022 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
December 18, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad San Sebastián
Collaborators
Universidad de Valparaiso, Fondo de Fomento al Desarrollo Científico y Tecnológico, Fondef.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Weight Gain, Obesity, Maternal
Keywords
mHealth, Gestational obesity, Social theory

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Classic randomized clinical trial (RCT).
Masking
Care Provider
Masking Description
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.
Allocation
Randomized
Enrollment
511 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usual care group
Arm Type
No Intervention
Arm Description
Pregnant women enrolled in the prenatal control program who receive routine medical care.
Arm Title
mami-educ group
Arm Type
Experimental
Arm Description
Pregnant women enrolled in the prenatal care program who receive routine medical care and nutritional messages mom-educ.
Intervention Type
Other
Intervention Name(s)
mami-educ
Intervention Description
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.
Primary Outcome Measure Information:
Title
Gestational weight gain
Description
Maternal weight gain measure in kilograms by month
Time Frame
Nine months
Secondary Outcome Measure Information:
Title
Maternal outcome
Description
Medical diagnosis of of either preeclampsia, gestational diabetes or gestational hypertension
Time Frame
Nine months
Title
Perinatal outcome
Description
Labor delivery week
Time Frame
At birth
Title
Apgar score
Description
Apgar score report
Time Frame
At birth
Title
Newborn birth weight
Description
Newborn birth weight measure in grams
Time Frame
At birth

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Delia I Chiarello, Ph.D.
Phone
+56965774469
Email
delia.chiarello@uss.cl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Delia I Chiarello, Ph.D
Organizational Affiliation
Universidad San Sebastián
Official's Role
Study Director
Facility Information:
Facility Name
Delia I Chiarello
City
Santiago
State/Province
Providencia
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Delia I Chiarello, Ph.D.
Phone
+56965774469
Email
delia.chiarello@uss.cl
First Name & Middle Initial & Last Name & Degree
Delia I Chiarello, Ph.D.
First Name & Middle Initial & Last Name & Degree
Jessica Moya, Msc
Facility Name
Fabián Pardo
City
San Felipe
State/Province
Valparaíso
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabián Pardo, Ph.D.
Email
fabian.pardo@uv.cl

12. IPD Sharing Statement

Plan to Share IPD
No

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

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