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

Primary Purpose

Childhood Obesity Prevention

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Motivational interviewing in groups
Usual care
Sponsored by
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Childhood Obesity Prevention focused on measuring Obesity, Children, Pregnancy, Motivational interview, Family Care, Primary Care

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Pedro Pérez LópezRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Motivational interviewing in groups

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Weight growth rate
WHO standardS
Food intake habits in parents
PREDIMED study questionnaire
Physical activity in parents:
International 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.
Richmond Test.
Anthropometry of parents:
Weight and height will be combined to report BMI in kg/m^2
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.
Children's dietary habits
PREDIMED study questionnaire
Physical Activity patterns in children
PREDIMED study questionnaire
Sleep habits
PREDIMED 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.
PREDIMED study questionnaire

Full Information

First Posted
December 12, 2017
Last Updated
February 22, 2018
Sponsor
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
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1. Study Identification

Unique Protocol Identification Number
NCT03444415
Brief Title
Effectiveness of a Motivational Interviewing-based Intervention From Pregnancy to 2 Years of Age.
Acronym
PROGESPI
Official Title
Effectiveness of a Motivational Interviewing-based Intervention From Pregnancy to 2 Years Old.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 2015 (Actual)
Primary Completion Date
September 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity Prevention
Keywords
Obesity, Children, Pregnancy, Motivational interview, Family Care, Primary Care

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
414 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Motivational interviewing in groups
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Motivational interviewing in groups
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
Parents will receive information about height, weight, and BMI percentile provided by a health professional during usual well child visits
Primary Outcome Measure Information:
Title
BMI
Description
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.
Time Frame
2 years of age
Secondary Outcome Measure Information:
Title
Weight growth rate
Description
WHO standardS
Time Frame
2 years of age
Title
Food intake habits in parents
Description
PREDIMED study questionnaire
Time Frame
2 years of age
Title
Physical activity in parents:
Description
International Physical Activity Questionnaire (IPAQ)
Time Frame
2 years of age
Title
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.
Description
Richmond Test.
Time Frame
2 years of age
Title
Anthropometry of parents:
Description
Weight and height will be combined to report BMI in kg/m^2
Time Frame
2 years of age
Title
Duration of breastfeeding
Description
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.
Time Frame
2 years of age
Title
Children's dietary habits
Description
PREDIMED study questionnaire
Time Frame
2 years of age
Title
Physical Activity patterns in children
Description
PREDIMED study questionnaire
Time Frame
2 years of age
Title
Sleep habits
Description
PREDIMED study questionnaire
Time Frame
2 years of age
Title
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.
Description
PREDIMED study questionnaire
Time Frame
2 years of age

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Gonzalez Barberá
Phone
659 55 44 76
Email
mariagb94@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
mariagb94@gmail.com Gonzalez Barberá
Phone
659 09 62 13
Email
mariagb94@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pedro Pérez López
Organizational Affiliation
SMS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pedro Pérez López
City
Murcia
State/Province
Alcantarilla-Sangonera
ZIP/Postal Code
30820
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pedro Pérez López
Phone
659 09 62 13

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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