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

Childhood Obesity Prevention Clinical Trial

— PROGESPI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03444415
• Other study ID #: PROGESPI
• Status: Recruiting
• Phase: N/A
• First received: December 12, 2017
• Last updated: February 22, 2018
• Start date: November 2015
• Est. completion date: December 2018

Study information

• Verified date: December 2017
• Source: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
• Contact: Maria Gonzalez Barberá
• Phone: 659 55 44 76
• Email: mariagb94[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 414
• Est. completion date: December 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Childhood Obesity Prevention
• Pediatric Obesity

Intervention

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

Locations

Country	Name	City	State
Spain	Pedro Pérez López	Murcia	Alcantarilla-Sangonera

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BMI	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.	2 years of age
Secondary	Weight growth rate	WHO standardS	2 years of age
Secondary	Food intake habits in parents	PREDIMED study questionnaire	2 years of age
Secondary	Physical activity in parents:	International Physical Activity Questionnaire (IPAQ)	2 years of age
Secondary	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.	Richmond Test.	2 years of age
Secondary	Anthropometry of parents:	Weight and height will be combined to report BMI in kg/m^2	2 years of age
Secondary	Duration of breastfeeding	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.	2 years of age
Secondary	Children's dietary habits	PREDIMED study questionnaire	2 years of age
Secondary	Physical Activity patterns in children	PREDIMED study questionnaire	2 years of age
Secondary	Sleep habits	PREDIMED study questionnaire	2 years of age
Secondary	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.	PREDIMED study questionnaire	2 years of age