Clinical trial NCT03444415: Effectiveness of a Motivational Interviewing-based Intervention From Pregnancy to 2 Years of Age.
Official title: Effectiveness of a Motivational Interviewing-based Intervention From Pregnancy to 2 Years Old.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Childhood Obesity Prevention
Keywords: Obesity
Children
Pregnancy
Motivational interview
Family Care
Primary Care
Lead sponsor: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Sponsor class: OTHER
First posted: 2018-02-23
Enrollment: 414
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: BMI
timeFrame: 2 years of age
Secondary outcomes:
measure: Weight growth rate
timeFrame: 2 years of age
measure: Food intake habits in parents
timeFrame: 2 years of age
measure: Physical activity in parents:
timeFrame: 2 years of age
measure: 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.
timeFrame: 2 years of age
measure: Anthropometry of parents:
timeFrame: 2 years of age
measure: Duration of breastfeeding
timeFrame: 2 years of age
measure: Children's dietary habits
timeFrame: 2 years of age
measure: Physical Activity patterns in children
timeFrame: 2 years of age
measure: Sleep habits
timeFrame: 2 years of age
measure: 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.
timeFrame: 2 years of age
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Pedro Pérez López
state: Alcantarilla-Sangonera
Study officials:
affiliation: SMS
name: Pedro Pérez López
role: PRINCIPAL_INVESTIGATOR
References: