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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03444415
Acronym
PROGESPI
Enrollment
414
Registered
2018-02-23
Start date
2015-11-30
Completion date
2018-12-31
Last updated
2018-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Childhood Obesity Prevention

Keywords

Obesity, Children, Pregnancy, Motivational interview, Family Care, Primary Care

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.

Interventions

OTHERMotivational 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.

OTHERUsual care

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

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
BMI2 years of ageThe 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

MeasureTime frameDescription
Food intake habits in parents2 years of agePREDIMED study questionnaire
Physical activity in parents:2 years of ageInternational Physical Activity Questionnaire (IPAQ)
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 ageRichmond Test.
Anthropometry of parents:2 years of ageWeight and height will be combined to report BMI in kg/m\^2
Weight growth rate2 years of ageWHO standardS
Children's dietary habits2 years of agePREDIMED study questionnaire
Physical Activity patterns in children2 years of agePREDIMED study questionnaire
Sleep habits2 years of agePREDIMED study questionnaire
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 agePREDIMED study questionnaire
Duration of breastfeeding2 years of ageThe 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.

Countries

Spain

Contacts

Primary ContactMaria Gonzalez Barberá
mariagb94@gmail.com659 55 44 76
Backup Contactmariagb94@gmail.com Gonzalez Barberá
mariagb94@gmail.com659 09 62 13

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026