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

F

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

Status

Unknown

Conditions

Childhood Obesity Prevention

Treatments

Other: Usual care
Other: Motivational interviewing in groups

Study type

Interventional

Funder types

Other

Identifiers

NCT03444415
PROGESPI

Details and patient eligibility

About

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.

Enrollment

414 estimated patients

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Will be included all pregnant women who have given their consent and who meet the following 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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

414 participants in 2 patient groups

Motivational interviewing in groups
Experimental group
Description:
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.
Treatment:
Other: Motivational interviewing in groups
Control Group
Other group
Description:
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.
Treatment:
Other: Usual care

Trial contacts and locations

1

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Central trial contact

mariagb94@gmail.com Gonzalez Barberá; Maria Gonzalez Barberá

Data sourced from clinicaltrials.gov

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