Childhood ObesityOBEMATNCT02889406
Motivation Approach for Childhood Obesity Treatment
A study testing Motivational intervention in people with Childhood Obesity, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
Trial summary
In a recent study, we have demonstrated that the motivational therapy approach to treat childhood obesity is highly effective at clinical and metabolic levels. This efficacy has been proved in a clinical outpatient setting. Read more about this study
- Who is it for?
- Ages 8 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- Motivational intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 334 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2016to Sep 2019
- 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 8 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Obese patients which are between 8 and 13 years at enrolment, using as diagnostic criteria of obesity values of body mass index (BMI) above the 97th percentile of Hernandez references from 1988
Who cannot join
- Participants who do not sign the informed consent
- Children with eating disorders
- Families not available to attend to intervention scheduled visits
- Simultaneous participation in another randomized trial
- Presence of endocrine disorders (GH disorder, hypothyroidism, Cushing's disease, precocious puberty or other)
- Illiteracy or lack knowledge of local languages
Trial locations and contacts
1 site in 1 country.
Spain1 site
Unitat Suport a la Recerca (Tarragona-Reus) Idiap Jordi Gol
Reus, Tarragona, 43202
About this study
Official title: Clinical and Metabolic Efficacy of the Motivational Approach, Coordinated Between Primary Care and the Clinical Health Services for Childhood Obesity Treatment: Randomized Clinical Trial
In a recent study, we have demonstrated that the motivational therapy approach to treat childhood obesity is highly effective at clinical and metabolic levels. This efficacy has been proved in a clinical outpatient setting. However, a standardized collaborative approach between the clinic and the primary care services would allow a faster and easier approach to childhood obesity treatment. Furthermore, this motivational and educational intervention would benefit from the current technologic facilities, the long term effect of the education at group level, in terms of food shopping plan, healthy, fast and cheap cooking methods that would be useful specially in low income families (with a higher prevalence of childhood obesity).
The aim of this study is assessing the clinical and metabolic efficacy of a family intervention, coordinated between the clinical and primary care services from the Tarragona health-care region, using a motivational therapy at individual and group levels, which involves e-Health tools (wearable), focusing on families with an 8 to 13 years old obese child.
The design will be a clustered randomized control trial, with an intervention group that will receive a multicomponent motivational and educational plan which will be compared to a control group receiving the usual recommendations performed in primary care centres (n=167 per group). The treatment of both study groups will last 12 months and will be performed at the primary care centres. In parallel, the study team will validate the methodology used to assess body composition in obese children as well as the changes produced by the intervention.
Read the detailed description
MAIN OBJECTIVE To evaluate the effectiveness of a motivational intervention for the treatment of childhood obesity, coordinated between primary care and specialized services, multicomponent, integrating techniques of fast and healthy cooking and eHealth tools (wearable), compared to the usual intervention performed in paediatrics.
SPECIFIC OBJECTIVES
- To evaluate the effectiveness of a multicomponent motivational intervention compared to usual intervention performed in regular paediatrics clinical practice
- On BMI control of obese children between 8 and 13 years old
- On metabolic control of obese children between 8 and 13 years old,
- On increasing physical activity of obese children between 8 and 13 years old,
- On acquiring a healthy eating pattern in obese children between 8 and 13 years old.
- To establish methodological background for implantation of a motivational intervention coordinated between primary care services and specialized services.
- To validate the use of bioelectrical impedance analysis (BIA) and dual X-ray absorptiometry (DXA) in the follow up and treatment of childhood obesity compared to four-compartment model of body composition.
- METHODOLOGY
5.1 Design Randomized controlled clinical trial cluster, with an intervention group (IG) which will receive 12 months of motivational counselling, together with workshops focused on family nutrition education and techniques of fast and healthy cooking and physical activity; and with eHealth tools (wearable) to support; and a control group (CG) that will follow the usual recommendations.
5.2 STUDY POPULATION The Health Region of Tarragona includes a population of 600,000 people (36,000 children from 8 to 13 years). With regard to the 6.6% of childhood obesity prevalence in our country (Schroder 2014), we estimate an eligible population of 2376 obese children aged 8-13 years old.
5.3 SAMPLE SIZE The number of individuals of a simple random design, multiplied by the design effect has been considered to calculate the sample size of each stratum (Basic Care Unit). Accepting an alpha risk of 0.05 and a beta risk of 0.2 in a bilateral contrast, 98 subjects were needed in each group to detect a difference equal to or greater than 0.36 units of BMI z-score. It is assumed that common standard deviation is 0.75. A 30% lost to follow up rate (GRANMO 7.12) has been estimated. To calculate the design effect, estimates of intracluster correlation coefficient in cluster randomized trials in primary care are generally lower than 0.05. The effect of the design corresponds to 1.7. Assuming these values, the final size of the study sample would be of 167 subjects in each group (12 individuals for each primary care centre, in 15 basic care units (BCUs)).
5.4 RANDOMIZATION AND BLINDING Basic Care Units (BCU) doctor-nurse are the unit of randomization. Randomization will be 1: 1 and will be made with EPIDAT 3.0 statistical program. Given the nature of the intervention participants or researchers cannot be blinded. Professional in charge of statistical analysis will be blinded as well.
- Conditions
- Childhood Obesity
- Being tested
- Motivational intervention
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational interventionBehavioural
motivational interviewing schema
| Study group | Role | What they receive |
|---|---|---|
| Motivational intervention | Experimental | Following the motivational interviewing schema, structured in 2 phases of treatment (motivational and intervention) and organised in 11 visits (one each month). The first and last visits will be performed in consultations of endocrinology unit from referral hospitals; the other visits will be held in paediatric primary care setting. Visits will be scheduled monthly and each one will last between 15 and 20 minutes.
In addition to individualized visits, three group workshops focused in nutrition education for families will be organized. Each workshop will last 45 minutes and will target parents/mothers and obese children, separately. Receives: Behavioral: Motivational intervention |
| Control group | No intervention | Children who are assigned to the control group will follow the usual treatment performed in paediatrics, what is following the Clinical Practice Guideline on the prevention and treatment of child and adolescent obesity. Monthly visits will be conducted in which weight, height and waist circumference will be measured and compliance with the initial advice will be reviewed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in BMI z-score
Changes in BMI z-score between the first visit and 12 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionSep 2018 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Childhood ObesityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 334 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Collaborators
- University Rovira i Virgili
- Responsible party
- Sponsor
- Investigators
- Josep Basora, MD, Study director, Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02889406
- Sponsor's protocol ID
- PI15/01411
- Acronym
- OBEMAT
- Status last verified
- Aug 2016
- First submitted
- 11 Jul 2016
- Last updated
- 5 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Luque V, Feliu A, Escribano J, Ferre N, Flores G, Monne R, Gutierrez-Marin D, Guillen N, Munoz-Hernando J, Zaragoza-Jordana M, Gispert-Llaurado M, Rubio-Torrents C, Nunez-Roig M, Alcazar M, Ferre R, Basora JM, Hsu P, Alegret-Basora C, Arasa F, Venables M, Singh P, Closa-Monasterolo R. The Obemat2.0 Study: A Clinical Trial of a Motivational Intervention for Childhood Obesity Treatment. Nutrients. 2019 Feb 16;11(2):419. doi: 10.3390/nu11020419.
PubMed 30781525
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Metabolic Efficacy of the Motivational Approach, Coordinated Between Primary Care and the Clinical Health Services for Childhood Obesity Treatment: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02889406
- Acronym / sponsor ID
- OBEMAT / PI15/01411
- Conditions
- Childhood Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 334 participants (estimated)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Collaborators
- University Rovira i Virgili
- Study start
- Sep 2016
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 5 Sep 2016 (estimated)
- 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.
In a recent study, we have demonstrated that the motivational therapy approach to treat childhood obesity is highly effective at clinical and metabolic levels. This efficacy has been proved in a clinical outpatient setting. However, a standardized collaborative approach between the clinic and the primary care services would allow a faster and easier approach to childhood obesity treatment. Furthermore, this motivational and educational intervention would benefit from the current technologic facilities, the long term effect of the education at group level, in terms of food shopping plan, healthy, fast and cheap cooking methods that would be useful specially in low income families (with a higher prevalence of childhood obesity).
The aim of this study is assessing the clinical and metabolic efficacy of a family intervention, coordinated between the clinical and primary care services from the Tarragona health-care region, using a motivational therapy at individual and group levels, which involves e-Health tools (wearable), focusing on families with an 8 to 13 years old obese child.
The design will be a clustered randomized control trial, with an intervention group that will receive a multicomponent motivational and educational plan which will be compared to a control group receiving the usual recommendations performed in primary care centres (n=167 per group). The treatment of both study groups will last 12 months and will be performed at the primary care centres. In parallel, the study team will validate the methodology used to assess body composition in obese children as well as the changes produced by the intervention.
Detailed description
MAIN OBJECTIVE To evaluate the effectiveness of a motivational intervention for the treatment of childhood obesity, coordinated between primary care and specialized services, multicomponent, integrating techniques of fast and healthy cooking and eHealth tools (wearable), compared to the usual intervention performed in paediatrics.
SPECIFIC OBJECTIVES
- To evaluate the effectiveness of a multicomponent motivational intervention compared to usual intervention performed in regular paediatrics clinical practice
- On BMI control of obese children between 8 and 13 years old
- On metabolic control of obese children between 8 and 13 years old,
- On increasing physical activity of obese children between 8 and 13 years old,
- On acquiring a healthy eating pattern in obese children between 8 and 13 years old.
- To establish methodological background for implantation of a motivational intervention coordinated between primary care services and specialized services.
- To validate the use of bioelectrical impedance analysis (BIA) and dual X-ray absorptiometry (DXA) in the follow up and treatment of childhood obesity compared to four-compartment model of body composition.
- METHODOLOGY
5.1 Design Randomized controlled clinical trial cluster, with an intervention group (IG) which will receive 12 months of motivational counselling, together with workshops focused on family nutrition education and techniques of fast and healthy cooking and physical activity; and with eHealth tools (wearable) to support; and a control group (CG) that will follow the usual recommendations.
5.2 STUDY POPULATION The Health Region of Tarragona includes a population of 600,000 people (36,000 children from 8 to 13 years). With regard to the 6.6% of childhood obesity prevalence in our country (Schroder 2014), we estimate an eligible population of 2376 obese children aged 8-13 years old.
5.3 SAMPLE SIZE The number of individuals of a simple random design, multiplied by the design effect has been considered to calculate the sample size of each stratum (Basic Care Unit). Accepting an alpha risk of 0.05 and a beta risk of 0.2 in a bilateral contrast, 98 subjects were needed in each group to detect a difference equal to or greater than 0.36 units of BMI z-score. It is assumed that common standard deviation is 0.75. A 30% lost to follow up rate (GRANMO 7.12) has been estimated. To calculate the design effect, estimates of intracluster correlation coefficient in cluster randomized trials in primary care are generally lower than 0.05. The effect of the design corresponds to 1.7. Assuming these values, the final size of the study sample would be of 167 subjects in each group (12 individuals for each primary care centre, in 15 basic care units (BCUs)).
5.4 RANDOMIZATION AND BLINDING Basic Care Units (BCU) doctor-nurse are the unit of randomization. Randomization will be 1: 1 and will be made with EPIDAT 3.0 statistical program. Given the nature of the intervention participants or researchers cannot be blinded. Professional in charge of statistical analysis will be blinded as well.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motivational intervention | Experimental | Behavioral: Motivational interventionFollowing the motivational interviewing schema, structured in 2 phases of treatment (motivational and intervention) and organised in 11 visits (one each month). The first and last visits will be performed in consultations of endocrinology unit from referral hospitals; the other visits will be held in paediatric primary care setting. Visits will be scheduled monthly and each one will last between 15 and 20 minutes. In addition to individualized visits, three group workshops focused in nutrition education for families will be organized. Each workshop will last 45 minutes and will target parents/mothers and obese children, separately. |
| Control group | No intervention | –Children who are assigned to the control group will follow the usual treatment performed in paediatrics, what is following the Clinical Practice Guideline on the prevention and treatment of child and adolescent obesity. Monthly visits will be conducted in which weight, height and waist circumference will be measured and compliance with the initial advice will be reviewed. |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Obese patients which are between 8 and 13 years at enrolment, using as diagnostic criteria of obesity values of body mass index (BMI) above the 97th percentile of Hernandez references from 1988
Key exclusion criteria (6 listed)
- Participants who do not sign the informed consent
- Children with eating disorders
- Families not available to attend to intervention scheduled visits
- Simultaneous participation in another randomized trial
- Presence of endocrine disorders (GH disorder, hypothyroidism, Cushing's disease, precocious puberty or other)
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 interventionmotivational interviewing schema | Behavioural | Motivational intervention |
Primary outcome
Changes in BMI z-score
Time frame: 12 months
Changes in BMI z-score between the first visit and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2016.
- Derived from this study: PubMed 30781525Luque V, Feliu A, Escribano J, Ferre N, Flores G, Monne R, Gutierrez-Marin D, Guillen N, Munoz-Hernando J, Zaragoza-Jordana M, Gispert-Llaurado M, Rubio-Torrents C, Nunez-Roig M, Alcazar M, Ferre R, Basora JM, Hsu P, Alegret-Basora C, Arasa F, Venables M, Singh P, Closa-Monasterolo R. The Obemat2.0 Study: A Clinical Trial of a Motivational Intervention for Childhood Obesity Treatment. Nutrients. 2019 Feb 16;11(2):419. doi: 10.3390/nu11020419.
- Individual participant dataSharing planned: No
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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.
Josep Basora, MD study director
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
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 intervention in people with Childhood Obesity, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina 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 1 inclusion and 6 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 5 Sep 2016. 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 Josep Basora, MD (+34977778515, jbasora.tarte.ics@gencat.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in BMI z-score (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02889406, which also lists 1 linked publication.
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 5 Sep 2016.