Effectiveness of a Motivational Interviewing-based Intervention From Pregnancy to 2 Years of Age.

NCT ID: NCT03444415

Last Updated: 2018-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

414 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2018-12-31

Brief Summary

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The main objective of this study is to evaluate the effect of an early and intensive intervention, based on techniques of effective counseling on healthy habits for parents, in order to reduce mean BMI at 2 years of age Secondly, the investigators will analyze the weighted increase of children's BMI, the eating habits of parents and children, duration of breastfeeding, physical activity level of parents and children and the children sleeping habits. In order to achieve it, the investigators have developed a randomized trial by Primary Care Centers, controlled by two parallel groups of study, open and multicenter study. The investigator team will recruit 414 pregnant women bwtween 12 and 16 weeks of gestation who will or will not receive an intervention, depending on their Primary Care Centers. The investigators will develop an intervention for parents, based on effective counseling techniques which are grounded on Motivational Interviewing approach with the objective of transmitting habits to reach a healthy lifestyle. The intervention consists in six workshops (90 minutes long), two prenatal and four postnatal, directed by professionals of the Field Researchers Basic Group (Family Practitioners, Pediatricians, Nurses and Midwives). Previously the field researchers will receive specialized training. This intervention will be compared to the usual model of care for children and women.

Detailed Description

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Conditions

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Childhood Obesity Prevention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Motivational interviewing in groups

The Intervention is performed at Primary Care Centers by health professionals (General Practitioners, Nurses, Pediatricians and Midwives), during pregnancy and the first 2 years of the child. Researchers will be trained in motivational interviewing and group dynamics. Intervention consists of six 90 minutes workshops, two of those during pregnancy and the other four within the following two years after the birth of the children. They intend to encourage the shift towards healthy lifestyles to parents on issues related to diet, physical activity and smoking habit, encourage breastfeeding and increase their knowledge and self-efficacy to promote healthy habits regarding diet, physical activity and sleep habits of their children.

Group Type EXPERIMENTAL

Motivational interviewing in groups

Intervention Type OTHER

Intervention consists of six 90 minutes workshops, two of those during pregnancy and the other four within the following two years after the birth of the children.

Control Group

Control Group: Usual Care as established in the "Programa Integral de Atención a la Mujer" (Comprehensive Program of Woman Assistance) and the "Programa de Atención al Niño Sano" (Well Child Program) in the Servicio Murciano de Salud.

Parents will receive information about height, weight, and BMI percentile provided by a health professional during usual well child visits.

Group Type OTHER

Usual care

Intervention Type OTHER

Parents will receive information about height, weight, and BMI percentile provided by a health professional during usual well child visits

Interventions

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Motivational interviewing in groups

Intervention consists of six 90 minutes workshops, two of those during pregnancy and the other four within the following two years after the birth of the children.

Intervention Type OTHER

Usual care

Parents will receive information about height, weight, and BMI percentile provided by a health professional during usual well child visits

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Attended in Primary Care Centers and not planning to change their place of residence in the period covered by the study.
* Women over 18 years of age.
* Gestational age between 12 and 16 weeks.
* Women whose pregnancy is liable of follow-up in Primary Care.

Exclusion Criteria

* Women who cannot communicate in Spanish.
* Women with metabolic diseases that modify their weight (diabetes, hypothyroidism, hyperthyroidism, etc.).
* Maternal history of a serious medical or psychiatric illness or drug or alcohol abuse.
* Multiple pregnancy.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pedro Pérez López

Role: PRINCIPAL_INVESTIGATOR

SMS

Locations

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Pedro Pérez López

Murcia, Alcantarilla-Sangonera, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Maria Gonzalez Barberá

Role: CONTACT

659 55 44 76

[email protected] Gonzalez Barberá

Role: CONTACT

659 09 62 13

Facility Contacts

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Pedro Pérez López

Role: primary

659 09 62 13

Other Identifiers

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PROGESPI

Identifier Type: -

Identifier Source: org_study_id

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