Childhood Obesity PreventionPROGESPINCT03444415
Effectiveness of a Motivational Interviewing-based Intervention From Pregnancy to 2 Years of Age.
A study testing Motivational interviewing in groups in people with Childhood Obesity Prevention, run by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity Prevention
- What is being tested?
- Motivational interviewing in groups
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 414 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2015to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Pedro Pérez López
Murcia, Alcantarilla-Sangonera, 30820
Pedro Pérez López, 659 09 62 13
About this study
Official title: 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.
- Conditions
- Childhood Obesity Prevention
- Being tested
- Motivational interviewing in groups, Usual care
- Keywords
- Obesity, Children, Pregnancy, Motivational interview, Family Care, Primary Care
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational interviewing in groupsOther
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 careOther
Parents will receive information about height, weight, and BMI percentile provided by a health professional during usual well child visits
| Study group | Role | What they receive |
|---|---|---|
| Motivational interviewing in groups | Experimental | 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. Receives: Other: Motivational interviewing in groups |
| Control Group | Other | 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. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years of age
Secondary outcomes (10)
Weight growth rate
WHO standardS
Measured: 2 years of age
Food intake habits in parents
PREDIMED study questionnaire
Measured: 2 years of age
Physical activity in parents:
International Physical Activity Questionnaire (IPAQ)
Measured: 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.
Measured: 2 years of age
Anthropometry of parents:
Weight and height will be combined to report BMI in kg/m^2
Measured: 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.
Measured: 2 years of age
Children's dietary habits
PREDIMED study questionnaire
Measured: 2 years of age
Physical Activity patterns in children
PREDIMED study questionnaire
Measured: 2 years of age
Sleep habits
PREDIMED study questionnaire
Measured: 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
Measured: 2 years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2018
- Study startNov 2015
- Primary completionSep 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood Obesity PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 414 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pedro Pérez López, Principal investigator, SMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03444415
- Sponsor's protocol ID
- PROGESPI
- Acronym
- PROGESPI
- Status last verified
- Dec 2017
- First submitted
- 12 Dec 2017
- Last updated
- 23 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Motivational Interviewing-based Intervention From Pregnancy to 2 Years Old.
- ClinicalTrials.gov ID
- NCT03444415
- Acronym / sponsor ID
- PROGESPI / PROGESPI
- Conditions
- Childhood Obesity Prevention
- Keywords
- Obesity, Children, Pregnancy, Motivational interview, Family Care, Primary Care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 414 participants (estimated)
- Lead sponsor
- Fundacion para la Formacion e Investigacion Sanitarias de la Region de MurciaUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 23 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motivational interviewing in groups | Experimental | Other: Motivational interviewing in groupsThe 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 | Other | Other: Usual careControl 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational interviewing in groupsIntervention 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 | Motivational interviewing in groups |
| Usual careParents will receive information about height, weight, and BMI percentile provided by a health professional during usual well child visits | Other | Control Group |
Primary outcome
BMI
Time frame: 2 years of age
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.
10 secondary outcomes
Weight growth rate
Time frame: 2 years of age
Food intake habits in parents
Time frame: 2 years of age
Physical activity in parents:
Time frame: 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.
Time frame: 2 years of age
Anthropometry of parents:
Time frame: 2 years of age
Duration of breastfeeding
Time frame: 2 years of age
Children's dietary habits
Time frame: 2 years of age
Physical Activity patterns in children
Time frame: 2 years of age
Sleep habits
Time frame: 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.
Time frame: 2 years of age
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pedro Pérez López principal investigator
SMS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational interviewing in groups in people with Childhood Obesity Prevention, run by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Gonzalez Barberá (659 55 44 76, mariagb94@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BMI (time frame: 2 years of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2018.