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

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

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.

Study Overview

• Status: Unknown
• Conditions: Childhood Obesity Prevention
• Intervention / Treatment: Other: Motivational interviewing in groups; Other: Usual care

• Study Type: Interventional
• Enrollment (Anticipated): 414
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maria Gonzalez Barberá; Phone Number: 659 55 44 76; Email: mariagb94@gmail.com
• Study Contact Backup: Name: mariagb94@gmail.com Gonzalez Barberá; Phone Number: 659 09 62 13; Email: mariagb94@gmail.com

Study Locations

• Spain
  • Alcantarilla-Sangonera
    • Murcia, Alcantarilla-Sangonera, Spain, 30820
      • Recruiting
      • Pedro Pérez López
      • Contact: Pedro Pérez López; Phone Number: 659 09 62 13

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Motivational interviewing in groups; 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.	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.
Other: Control Group; 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.	Other: Usual care; Parents will receive information about height, weight, and BMI percentile provided by a health professional during usual well child visits

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight growth rate	WHO standardS	2 years of age
Food intake habits in parents	PREDIMED study questionnaire	2 years of age
Physical activity in parents:	International Physical Activity Questionnaire (IPAQ)	2 years of age
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
Anthropometry of parents:	Weight and height will be combined to report BMI in kg/m^2	2 years of age
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
Children's dietary habits	PREDIMED study questionnaire	2 years of age
Physical Activity patterns in children	PREDIMED study questionnaire	2 years of age
Sleep habits	PREDIMED study questionnaire	2 years of age
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

Collaborators and Investigators

• Sponsor: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
• Investigators: Principal Investigator: Pedro Pérez López, SMS

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2015
• Primary Completion (Anticipated): September 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: December 12, 2017
• First Submitted That Met QC Criteria: February 22, 2018
• First Posted (Actual): February 23, 2018

Study Record Updates

• Last Update Posted (Actual): February 23, 2018
• Last Update Submitted That Met QC Criteria: February 22, 2018
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Obesity; Primary Care; Pregnancy; Children; Motivational interview; Family Care
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity
• Other Study ID Numbers: PROGESPI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No