Effectiveness of a Motivational Interviewing-based Intervention From Pregnancy to 2 Years of Age.
PROGESPI
1 other identifier
interventional
414
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2015
CompletedFirst Submitted
Initial submission to the registry
December 12, 2017
CompletedFirst Posted
Study publicly available on registry
February 23, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedFebruary 23, 2018
December 1, 2017
2.8 years
December 12, 2017
February 22, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (10)
Weight growth rate
2 years of age
Food intake habits in parents
2 years of age
Physical activity in parents:
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.
2 years of age
Anthropometry of parents:
2 years of age
- +5 more secondary outcomes
Study Arms (2)
Motivational interviewing in groups
EXPERIMENTALThe 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
OTHERControl 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.
Interventions
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.
Parents will receive information about height, weight, and BMI percentile provided by a health professional during usual well child visits
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pedro Pérez López
Murcia, Alcantarilla-Sangonera, 30820, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pedro Pérez López
SMS
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 12, 2017
First Posted
February 23, 2018
Study Start
November 1, 2015
Primary Completion
September 1, 2018
Study Completion
December 1, 2018
Last Updated
February 23, 2018
Record last verified: 2017-12