Motivational Approach to Treat Childhood Obesity

NCT03749200 | Completed

• 1 other identifier: PI15/00970
• Study Type: interventional
• Target: 319
• Locations: 1 country
• Sites: 4

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.

Conditions

Childhood Obesity; Metabolic Syndrome; Body Composition

Keywords

Childhood Obesity; Motivational therapy

Outcome Measures

Primary Outcomes (1)

• Body Mass Index z-score

  Changes in BMI z-score between the baseline visit and the final assessment

  12 (+3) months

Secondary Outcomes (9)

• Abdominal obesity (waist circumference)

  12 (+3) months

• Abdominal obesity (waist to height)

  12 (+3) months

• Body composition: fat mass (kg)

  12 (+3) months

• Body composition: lean mass (kg)

  12 (+3) months

• Body composition: fat mass index (kg/m2)

  12 (+3) months

Study Arms (2)

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.

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.

Other: Regular practise in primary care

Interventions

Obemat2.0 therapy OTHER

Obemat2.0 Intervention Group

Regular practise in primary care OTHER

Control Group

Eligibility Criteria

• Age: 8 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut Investigacio Sanitaria Pere Virgili: lead
• Institut Català de la Salut: collaborator
• Hospital Universitari Joan XXIII de Tarragona.: collaborator
• Hospital Universitari Sant Joan de Reus: collaborator
• Instituto de Salud Carlos III: collaborator
• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina: collaborator
• University Rovira i Virgili: collaborator

Study Sites (4)

Faculty of Medicine, C/ Sant Llorenç 21

Reus, Tarragona, 43201, Spain

Location

Iispv- Hospital Sant Joan de Reus

Reus, Tarragona, E43204, Spain

Location

IDIAP Jordi Gol

Reus, Tarragona, Spain

Location

Hospital de Tarragona Joan XXIII

Tarragona, 43005, Spain

Location

Related Publications (2)

• 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.

  PMID: 30781525 BACKGROUND

• Luque 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.

  PMID: 38733242 RESULT

Related Links

• Results: access to full text

MeSH Terms

Conditions

Pediatric Obesity; Metabolic Syndrome

Interventions

Primary Health Care

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Given the nature of the intervention participants or researchers could not be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. PhD

Model Details: 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

Study Record Dates

• First Submitted: October 8, 2018
• First Posted: November 21, 2018
• Study Start: January 1, 2016
• Primary Completion: December 30, 2020
• Study Completion: December 31, 2021
• Last Updated: June 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (4)