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Motivational Approach to Treat Childhood Obesity (OBEMAT20)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03749200
Recruitment Status : Active, not recruiting
First Posted : November 21, 2018
Last Update Posted : September 16, 2020
Sponsor:
Collaborators:
Institut Català de la Salut
Hospital Universitari Joan XXIII de Tarragona.
Hospital Universitari Sant Joan de Reus
Instituto de Salud Carlos III
Jordi Gol i Gurina Foundation
University Rovira i Virgili
Information provided by (Responsible Party):
Ricardo Closa, Institut Investigacio Sanitaria Pere Virgili

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Childhood Obesity Metabolic Syndrome Body Composition Other: Obemat2.0 therapy Other: Regular practise in primary care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 319 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Masking Description: Given the nature of the intervention participants or researchers could not be blinded.
Primary Purpose: Treatment
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
Actual Study Start Date : January 1, 2016
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : December 31, 2021

Arm Intervention/treatment
Experimental: Obemat2.0 Intervention Group
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.
Other: Obemat2.0 therapy
Active Comparator: Control Group
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.
Other: Regular practise in primary care



Primary Outcome Measures :
  1. Body Mass Index z-score [ Time Frame: 12 (+3) months ]
    Changes in BMI z-score between the baseline visit and the final assessment


Secondary Outcome Measures :
  1. Abdominal obesity (waist circumference) [ Time Frame: 12 (+3) months ]
    Changes in waist circumference (cm) between the baseline visit and the final assessment

  2. Abdominal obesity (waist to height) [ Time Frame: 12 (+3) months ]
    Changes in waist-to-height circumference (ratio) between the baseline visit and the final assessment

  3. Body composition: fat mass (kg) [ Time Frame: 12 (+3) months ]
    Changes in fat mass (kg) between the baseline visit and the final assessment

  4. Body composition: lean mass (kg) [ Time Frame: 12 (+3) months ]
    Changes in lean mass (kg) between the baseline visit and the final assessment

  5. Body composition: fat mass index (kg/m2) [ Time Frame: 12 (+3) months ]
    Changes in fat mass index between the baseline visit and the final assessment

  6. Body composition: lean mass index (kg/m2) [ Time Frame: 12 (+3) months ]
    Changes in lean mass index between the baseline visit and the final assessment

  7. HOMA-IR [ Time Frame: 12 (+3) months ]
    Changes in insulin resistance between the baseline visit and the final assessment

  8. Blood Pressure [ Time Frame: 12 (+3) months ]
    Changes in systolic and diastoli blood pressure (s-score) between the baseline visit and the final assessment

  9. Tryglycerides [ Time Frame: 12 (+3) months ]
    Changes in tryglycerides (mg/dl) between the baseline visit and the final assessment



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03749200


Locations
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Spain
Faculty of Medicine, C/ Sant Llorenç 21
Reus, Tarragona, Spain, 43201
Iispv- Hospital Sant Joan de Reus
Reus, Tarragona, Spain, E43204
IDIAP Jordi Gol
Reus, Tarragona, Spain
Hospital de Tarragona Joan XXIII
Tarragona, Spain, 43005
Sponsors and Collaborators
Institut Investigacio Sanitaria Pere Virgili
Institut Català de la Salut
Hospital Universitari Joan XXIII de Tarragona.
Hospital Universitari Sant Joan de Reus
Instituto de Salud Carlos III
Jordi Gol i Gurina Foundation
University Rovira i Virgili
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Responsible Party: Ricardo Closa, Dr. PhD, Institut Investigacio Sanitaria Pere Virgili
ClinicalTrials.gov Identifier: NCT03749200    
Other Study ID Numbers: PI15/00970
First Posted: November 21, 2018    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Ricardo Closa, Institut Investigacio Sanitaria Pere Virgili:
Childhood Obesity
Motivational therapy
Additional relevant MeSH terms:
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Obesity
Metabolic Syndrome
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases