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

Not Applicable

• Conditions: Childhood Obesity Prevention

• Registration Number: NCT03444415
• Lead Sponsor: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

Brief Summary

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

Not available

Study Timeline

• Study Start: 2015-11
• Status Verified: 2017-12
• Study First Submitted: 2017-12-12
• Study First Submitted QC: 2018-02-22
• Last Update Submitted: 2018-02-22
• Study First Posted: 2018-02-23
• Last Update Posted: 2018-02-23
• Primary Completion: 2018-09
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 414

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
BMI	2 years of age	The investigator team will collect weight and height, calculate the BMI and we will work out the BMI Z-score according to WHO growth standards.

Secondary Outcome Measures

Name	Time	Method
Physical Activity patterns in children	2 years of age	PREDIMED study questionnaire
Food intake habits in parents	2 years of age	PREDIMED study questionnaire
Smoking habit in parents (self-reported): measuring the percentage of parents who smoke, consumption of cigarettes per day, and their level of motivation to quit smoking through the Richmond Test.	2 years of age	Richmond Test.
Socio - demographic variables: Number of siblings, country of origin, educational level and social class, according to the proposal of the Spanish Society of Epidemiology and the Spanish Society of Family and Community Medicine.	2 years of age	PREDIMED study questionnaire
Anthropometry of parents:	2 years of age	Weight and height will be combined to report BMI in kg/m\^2
Duration of breastfeeding	2 years of age	The investigator team will measure the time of exclusive and mixed breastfeeding, in months, according to the regarding questions of the National Health Survey 2011-2012.
Sleep habits	2 years of age	PREDIMED study questionnaire
Weight growth rate	2 years of age	WHO standardS
Physical activity in parents:	2 years of age	International Physical Activity Questionnaire (IPAQ)
Children's dietary habits	2 years of age	PREDIMED study questionnaire

Trial Locations

Locations (1)

Pedro Pérez López; 🇪🇸 Murcia, Alcantarilla-Sangonera, Spain