Childhood ObesityOBEMAT20NCT03749200
Motivational Approach to Treat Childhood Obesity
A study testing Obemat2.0 therapy and Regular practise in primary care in people with Childhood Obesity and Metabolic Syndrome, run by Institut Investigacio Sanitaria Pere Virgili at 4 sites in Spain.
Trial summary
The treatment of childhood obesity is challenging. Although dietary and physical activity recommendations are widely known, the willingness to change lifestyles within the family is not easy to be achieved. Read more about this study
- Who is it for?
- Ages 8 to 15 years
- Conditions the study is for
- Childhood Obesity, Metabolic Syndrome, Body Composition
- What is being tested?
- Obemat2.0 therapy and Regular practise in primary care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 319 participants
- Where
- 4 sitesSpain
- Study dates
- 1 Jan 2016to 31 Dec 2021
- 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 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age range between 8 and <14 years at enrolment (so that, children would end the treatment at maximum age of 15 years
- BMI > 97th percentile of Hernandez references from 1988 (Hernández et al., 1988) as indicated by the Guidelines for Clinical Practice of the Spanish Health System (Grupo de trabajo de la Guía de Práctica Clínica sobre la Prevención y el Tratamiento de la Obesidad Infantojuvenil. Ministerio de Ciencia e Innovación [Spanish Ministry of Sciencee and Innovation], 2009) for the diagnose of the childhood obesity.
Who cannot join
- Children with eating disorders
- Families not available to attend to scheduled visits
- Simultaneous participation in another clinical trial
- Presence of endocrine disorders (GH disorder, hypothyroidism, Cushing's disease, early puberty or other)
- Lack of command of local languages
Trial locations and contacts
4 sites in 1 country.
Spain4 sites
Faculty of Medicine, C/ Sant Llorenç 21
Reus, Tarragona, 43201
Iispv- Hospital Sant Joan de Reus
Reus, Tarragona, E43204
IDIAP Jordi Gol
Reus, Tarragona
Hospital de Tarragona Joan XXIII
Tarragona, 43005
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
The treatment of childhood obesity is challenging. Although dietary and physical activity recommendations are widely known, the willingness to change lifestyles within the family is not easy to be achieved. Motivational interviewing has been shown as a possibly effective method to increase adherence to dietary recommendations in the obese adult.
There is scarce evidence showing whether implementing a motivational interview in obese children could be effective.
The aim of this clinical trial is assessing the effect of a motivational interview, coordinated between the clinical and primary care services on 8 to 14 years old obese children.
Read the detailed description
In a recent study, the investigators 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 easy cooking methods.
The aim of this clinical trial is to test the efficacy of a multicomponent motivational intervention for the treatment of childhood obesity, coordinated between primary care and hospital specialized services, integrating motivational individual interviews, educational groups and eHealth tools (wearable), compared to the usual intervention performed in paediatrics.
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.
Children assigned to the control group receive advices as recommended by the Clinical Practice Guidelines (17). At visits, the family receive explanations about carrying out a balanced diet, divided into 5 meals, in order to provide a moderate energy intake reduction. An increase in physical activity, both in terms of leisure activity, as sports regular practise are recommended. Monthly visits are organized in which weight and height are measured, and compliance with recommendations are actually taking place.
Children assigned to the intervention group receive similar recommendations to those in the control group but under a motivational interview schema. This means that each visit, objectives from the last visit are fulfiled, the therapists try to make the family recongnizing the changes to be done by themselves, rather than imposing by demonstrating ambivalences, and objectives for the next visit are agreed. Furthermore, three workshops as group therapy are organized with the following topics: 1. Increasing physical actty sing an eHEalth monitor, 2. Food choices and dietary balance, and 3. Cooking methods.
- Conditions
- Childhood Obesity, Metabolic Syndrome, Body Composition
- Being tested
- Obemat2.0 therapy, Regular practise in primary care
- Keywords
- Childhood Obesity, Motivational therapy
- Medical subject headings
- Pediatric Obesity, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Obemat2.0 therapyOther
Regular practise in primary careOther
| Study group | Role | What they receive |
|---|---|---|
| Obemat2.0 Intervention Group | Experimental | Intervention: Obemat2.0 therapy (11 Motivational Interview Visits, 3 Workshops) Duration: 12 months (+3 months). Setting: Primary care centers Providers: pediatritians and nurses trained to perform motivational interview Visits description: The interviews follow a structure: 1. Checking the accomplishment of objectives to congratulate and motivate the patient. 2. A specific topic per visit is explained to the participant and family. 3. A task related to the topic (i.e. to plan a weekly menu for the family) is given to be brought back at the next visit. 4th. Objectives about diet, weight and physical activity are defined to be accomplished until the next visit. The follow-up of the structure is ensured by means of a printed material that the therapists provide each visit to participants. Receives: Other: Obemat2.0 therapy |
| Control Group | Active comparator | Control Intervention: regular practise in primary care (11 individual monthly visits) Duration: 12 months (+3 months). Setting: Primary care centers. Providers: standard pediatritians and nurses Children and their families receive the usual recommendations conducted in primary care centers based on the Clinical Practice Guidelines on the Prevention and Treatment of Child and Adolescent Obesity. At visits, the family receive explanations about carrying out a balanced diet, divided into 5 meals, to provide a moderate energy reduction from the previous intake. An increase in physical activity, both in terms of leisure activity, as sports regular practise is recommended. Monthly visits are organized in which weight and height are measured and compliance with advice is reviewed. Receives: Other: Regular practise in primary care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index z-score
Changes in BMI z-score between the baseline visit and the final assessment
Measured: 12 (+3) months
Secondary outcomes (9)
Abdominal obesity (waist circumference)
Changes in waist circumference (cm) between the baseline visit and the final assessment
Measured: 12 (+3) months
Abdominal obesity (waist to height)
Changes in waist-to-height circumference (ratio) between the baseline visit and the final assessment
Measured: 12 (+3) months
Body composition: fat mass (kg)
Changes in fat mass (kg) between the baseline visit and the final assessment
Measured: 12 (+3) months
Body composition: lean mass (kg)
Changes in lean mass (kg) between the baseline visit and the final assessment
Measured: 12 (+3) months
Body composition: fat mass index (kg/m2)
Changes in fat mass index between the baseline visit and the final assessment
Measured: 12 (+3) months
Body composition: lean mass index (kg/m2)
Changes in lean mass index between the baseline visit and the final assessment
Measured: 12 (+3) months
HOMA-IR
Changes in insulin resistance between the baseline visit and the final assessment
Measured: 12 (+3) months
Blood Pressure
Changes in systolic and diastoli blood pressure (s-score) between the baseline visit and the final assessment
Measured: 12 (+3) months
Tryglycerides
Changes in tryglycerides (mg/dl) between the baseline visit and the final assessment
Measured: 12 (+3) months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2018
- Study start1 Jan 2016
- Primary completion30 Dec 2020
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Model description
- Randomized clustered clinical trial, with treatment on obese children in 2 arms: a control group (CG) that will follow the usual recommendations of pediatricians and nurses in the primary care centres and an intervention group (IG) that will receive a structured motivation-based interview combined with group therapy and eHealth. the treatment of the two arms will last 12 (+3) months
- Masking
- None (open label)
- Enrolment
- 319 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Investigacio Sanitaria Pere Virgili
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Català de la Salut, Hospital Universitari Joan XXIII de Tarragona., Hospital Universitari Sant Joan de Reus, Instituto de Salud Carlos III, Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina, University Rovira i Virgili
- Responsible party
- Principal investigator, Ricardo Closa, Institut Investigacio Sanitaria Pere Virgili
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03749200
- Sponsor's protocol ID
- PI15/00970
- Acronym
- OBEMAT20
- Status last verified
- May 2024
- First submitted
- 8 Oct 2018
- Last updated
- 3 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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 30781525Luque V, Feliu A, Closa-Monasterolo R, Munoz-Hernando J, Ferre N, Gutierrez-Marin D, Guillen N, Basora J, Hsu P, Alegret-Basora C, Serrano MA, Mallafre M, Alejos AM, Balcells EN, Boada A, Paixa S, Mimbrero G, Gil-Mancha S, Tudela-Valls C, Alcazar M, Escribano J; Obemat2.0 Study Group. Impact of the motivational interviewing for childhood obesity treatment: The Obemat2.0 randomized clinical trial. Pediatr Obes. 2024 Jul;19(7):e13125. doi: 10.1111/ijpo.13125. Epub 2024 May 11.
PubMed 38733242Okubo Y, Ishitsuka K, Goto A. Impact of COVID-19 pandemic on physical health amongst children: Difference-in-differences analyses of nationwide school health checkup database. Pediatr Obes. 2024 Jul;19(7):e13126. doi: 10.1111/ijpo.13126. Epub 2024 May 10.
PubMed 38726751
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2024. 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
- NCT03749200
- Acronym / sponsor ID
- OBEMAT20 / PI15/00970
- Conditions
- Childhood Obesity, Metabolic Syndrome, Body Composition
- Keywords
- Childhood Obesity, Motivational therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 319 participants (actual)
- Lead sponsor
- Institut Investigacio Sanitaria Pere VirgiliUniversity, hospital or other
- Collaborators
- Institut Català de la Salut, Hospital Universitari Joan XXIII de Tarragona., Hospital Universitari Sant Joan de Reus, Instituto de Salud Carlos III, Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina, University Rovira i Virgili
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 21 Nov 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 treatment of childhood obesity is challenging. Although dietary and physical activity recommendations are widely known, the willingness to change lifestyles within the family is not easy to be achieved. Motivational interviewing has been shown as a possibly effective method to increase adherence to dietary recommendations in the obese adult.
There is scarce evidence showing whether implementing a motivational interview in obese children could be effective.
The aim of this clinical trial is assessing the effect of a motivational interview, coordinated between the clinical and primary care services on 8 to 14 years old obese children.
Detailed description
In a recent study, the investigators 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 easy cooking methods.
The aim of this clinical trial is to test the efficacy of a multicomponent motivational intervention for the treatment of childhood obesity, coordinated between primary care and hospital specialized services, integrating motivational individual interviews, educational groups and eHealth tools (wearable), compared to the usual intervention performed in paediatrics.
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.
Children assigned to the control group receive advices as recommended by the Clinical Practice Guidelines (17). At visits, the family receive explanations about carrying out a balanced diet, divided into 5 meals, in order to provide a moderate energy intake reduction. An increase in physical activity, both in terms of leisure activity, as sports regular practise are recommended. Monthly visits are organized in which weight and height are measured, and compliance with recommendations are actually taking place.
Children assigned to the intervention group receive similar recommendations to those in the control group but under a motivational interview schema. This means that each visit, objectives from the last visit are fulfiled, the therapists try to make the family recongnizing the changes to be done by themselves, rather than imposing by demonstrating ambivalences, and objectives for the next visit are agreed. Furthermore, three workshops as group therapy are organized with the following topics: 1. Increasing physical actty sing an eHEalth monitor, 2. Food choices and dietary balance, and 3. Cooking methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized clustered clinical trial, with treatment on obese children in 2 arms: a control group (CG) that will follow the usual recommendations of pediatricians and nurses in the primary care centres and an intervention group (IG) that will receive a structured motivation-based interview combined with group therapy and eHealth. the treatment of the two arms will last 12 (+3) months
| Arm | Type | Receives |
|---|---|---|
| Obemat2.0 Intervention Group | Experimental | Other: Obemat2.0 therapyIntervention: Obemat2.0 therapy (11 Motivational Interview Visits, 3 Workshops) Duration: 12 months (+3 months). Setting: Primary care centers Providers: pediatritians and nurses trained to perform motivational interview Visits description: The interviews follow a structure: 1. Checking the accomplishment of objectives to congratulate and motivate the patient. 2. A specific topic per visit is explained to the participant and family. 3. A task related to the topic (i.e. to plan a weekly menu for the family) is given to be brought back at the next visit. 4th. Objectives about diet, weight and physical activity are defined to be accomplished until the next visit. The follow-up of the structure is ensured by means of a printed material that the therapists provide each visit to participants. |
| Control Group | Active comparator | Other: Regular practise in primary careControl Intervention: regular practise in primary care (11 individual monthly visits) Duration: 12 months (+3 months). Setting: Primary care centers. Providers: standard pediatritians and nurses Children and their families receive the usual recommendations conducted in primary care centers based on the Clinical Practice Guidelines on the Prevention and Treatment of Child and Adolescent Obesity. At visits, the family receive explanations about carrying out a balanced diet, divided into 5 meals, to provide a moderate energy reduction from the previous intake. An increase in physical activity, both in terms of leisure activity, as sports regular practise is recommended. Monthly visits are organized in which weight and height are measured and compliance with advice is reviewed. |
Who may qualify
- Ages
- 8 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age range between 8 and <14 years at enrolment (so that, children would end the treatment at maximum age of 15 years
- BMI > 97th percentile of Hernandez references from 1988 (Hernández et al., 1988) as indicated by the Guidelines for Clinical Practice of the Spanish Health System (Grupo de trabajo de la Guía de Práctica Clínica sobre la Prevención y el Tratamiento de la Obesidad Infantojuvenil. Ministerio de Ciencia e Innovación [Spanish Ministry of Sciencee and Innovation], 2009) for the diagnose of the childhood obesity.
Key exclusion criteria (5 listed)
- Children with eating disorders
- Families not available to attend to scheduled visits
- Simultaneous participation in another clinical trial
- Presence of endocrine disorders (GH disorder, hypothyroidism, Cushing's disease, early puberty or other)
- Lack of command of local languages
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 |
|---|---|---|
| Obemat2.0 therapy | Other | Obemat2.0 Intervention Group |
| Regular practise in primary care | Other | Control Group |
Primary outcome
Body Mass Index z-score
Time frame: 12 (+3) months
Changes in BMI z-score between the baseline visit and the final assessment
9 secondary outcomes
Abdominal obesity (waist circumference)
Time frame: 12 (+3) months
Abdominal obesity (waist to height)
Time frame: 12 (+3) months
Body composition: fat mass (kg)
Time frame: 12 (+3) months
Body composition: lean mass (kg)
Time frame: 12 (+3) months
Body composition: fat mass index (kg/m2)
Time frame: 12 (+3) months
Body composition: lean mass index (kg/m2)
Time frame: 12 (+3) months
HOMA-IR
Time frame: 12 (+3) months
Blood Pressure
Time frame: 12 (+3) months
Tryglycerides
Time frame: 12 (+3) months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2024.
- Background: 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.
- Results publication: PubMed 38733242Luque V, Feliu A, Closa-Monasterolo R, Munoz-Hernando J, Ferre N, Gutierrez-Marin D, Guillen N, Basora J, Hsu P, Alegret-Basora C, Serrano MA, Mallafre M, Alejos AM, Balcells EN, Boada A, Paixa S, Mimbrero G, Gil-Mancha S, Tudela-Valls C, Alcazar M, Escribano J; Obemat2.0 Study Group. Impact of the motivational interviewing for childhood obesity treatment: The Obemat2.0 randomized clinical trial. Pediatr Obes. 2024 Jul;19(7):e13125. doi: 10.1111/ijpo.13125. Epub 2024 May 11.
- Derived from this study: PubMed 38726751Okubo Y, Ishitsuka K, Goto A. Impact of COVID-19 pandemic on physical health amongst children: Difference-in-differences analyses of nationwide school health checkup database. Pediatr Obes. 2024 Jul;19(7):e13126. doi: 10.1111/ijpo.13126. Epub 2024 May 10.
- Results: access to full textLink provided by the sponsor.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Obemat2.0 therapy and Regular practise in primary care in people with Childhood Obesity and Metabolic Syndrome, run by Institut Investigacio Sanitaria Pere Virgili at 4 sites 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 2 inclusion and 5 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: finished, as of the sponsor's last update on 3 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Mass Index z-score (time frame: 12 (+3) 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 NCT03749200, which also lists 3 linked publications.
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 3 Jun 2024.