Efficacy of ENTREN-F Program: A Psycho-family Intervention in Childhood Obesity
Condition: Childhood Obesity
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      ENTREN-F Programme describes a novel structured psychosocial family-based intervention from
      Primary Care using a train trip metaphor aimed at improving healthy lifestyles for the whole
      family. It is oriented to children aged 8-12 years old who have overweight or obesity. The
      ENTREN-F intervention lasts 6 months and consists in 12 biweekly 2-h2 sessions in group,
      following a multidisciplinary perspective.

      The main aim is to examine the efficacy of the intervention program 'ENTREN-F' (intervention
      for children plus family intervention) on anthropometrics, behaviour, psychological and
      family factors, from a multidisciplinary perspective, compared with another group
      participating in the same program 'ENTREN' (intervention for children without family
      intervention) and with a control group (usual treatment) among Spanish children with
      overweight and obesity. Finally, (2) the second aim was to evaluate whether the changes were
      maintained 6, 12 and 18 months after the end of the intervention.

      Hypothesis The specific hypotheses of the present study were as follows: (a) There will be
      significant differences in the adherence to treatment, being higher in the ENTREN-F group (b)
      There will be improvements in clinical outcomes regarding the anthropometric variables of the
      child, the level of physical activity, psychological distress, and eating disorder of the
      child, after both interventions (ENTREN and ENTREN-F programme), in comparison to control
      group (d) There will be only improvements in clinical outcomes regarding in the family's
      healthy life-style, psychological distress of the parents, and the family environment, after
      the intervention of the ENTREN-F programme. (e) The significant changes produced will remain
      stable at the 6,12 and 18-month follow-up in the ENTREN-F group.
    

Detailed description: 
      Sample: The sample will be made up of 240 children of 8-12 years old (IMC>P90). The dropout
      rate is expected to be 20%. The majority of the participants will be recruited through
      Primary Health Care Services, in collaboration with Paediatrics Area. A small percentage of
      the sample contacted the program after receiving information from their school or advertising
      posters. After assessment, they are assigned randomly to one of the three conditions.

      For Patient Registries:

        -  Spanish Ministry of Economy, Industry and Competitiveness provides an annual quality
           assurance for monitoring and auditing all financial projects (4-yr). This plan addresses
           data validation and registry procedures.

        -  A review of databases is regularly scheduled.

        -  Sample size assessment has been verified, specifying the number of participants
           necessary to demonstrate an effect (size effect; N=240). Regarding the sample size,
           assuming a two-tailed test α = .05 and a power (1 - β) of .80, estimating a 23%
           difference in the prevalence rates of childhood obesity, and applying a correction of
           according to the guidelines of Browner, Newman, Cummings and Hulley (2007) to anticipate
           a possible sample loss of approximately 20%, based on the study by Robertson (2008), a
           sample size of 80 children per group has been estimated (n = 240). Therefore, it is
           expected to collect substantial changes with an N = 60 in each of the groups at the end
           of the 12-month follow-up.

        -  A preliminary statistical analysis plan has been described with the analytical
           principles and statistical techniques to be employed in order to address the primary and
           secondary objectives, as specified in the study protocol or plan. A preliminary plan for
           missing data has also taken into account and missing values will be taken into account
           in analyses. An expert methodologist collaborates in the Project and advises us in this
           field of work.

        -  Standard operating procedures to address registration operations and analysis
           activities, such as patient recruitment, data collection, data management, data
           analysis, adverse event reporting, and change management. All members of the Project has
           received a specific training by A.R.S.

        -  A data dictionary that contains detailed descriptions of each variable used by the
           registry, including the source of the variable, coding information if used and normal
           ranges if relevant. This document is provided to the principal members of the team.

      Assessment: The clinical evaluation consists in an interview where socio-demographic and
      family clinical variables are evaluated, the semi-structured child diagnostic interview is
      carried out (K-SADS-PL) based on Diagnostic and Statistical Manual of Mental Disorders
      (DSM-5) criteria and a battery of questionnaires are administered to the child and both
      parents. Assessment are carried out over time (T0 baseline vs. T1 post/6-month vs.T2, T3 and
      T4, 6, 12 and 18-month follow-up, respectively).

      Multidisciplinary team: Most of the sessions of the psycho-family sessions workshop group and
      the psychological workshop group with children are conducted by psychologists, with at least
      Clinical Psych MSc, some of them also doing Clinical Psych PhD. All therapists have received
      specific training prior to the protocol and work from Motivational Interview perspective. The
      team also has a nutritionist, psychiatrist and an expert in physical activity, training in
      Motivational Interview. Finally, paediatricians and nurses from the health centres in the
      area collaborate actively in the Project. Meetings for feedback about the progress of the
      project and annual specialist seminars are organized. The results and progress are also
      shared in Paediatrics and Psychology conferences. A multidisciplinary project from Primary
      Care, combining the joint effort of different professionals that allows a rapid and effective
      overweight patient care protocol to be developed. Interest has grown in the Project by
      international PhD students and Postgraduate students as evidenced in their project
      collaboration and consequent training.

      Relevance of the study: Overall, this project will represent a significant contribution to
      the scientific understanding of this field as well as a significant savings in economic costs
      derived from this illness. It is expected to have an important clinical impact in the Madrid
      region, providing assistance to 240 families in the hospital. This is a pioneer research
      project that examines the efficacy of the new program of psychosocial family-based
      intervention for childhood overweight and obesity within Primary Care. The innovation and
      creativity of the ENTREN program for children highlights the broad content in emotional
      self-regulation, which has two aims: it helps to overcome the emotional difficulties
      (frustration, anxiety, impatience) and modify their eating habits, in turn, it could help to
      reduce the onset of unhealthy eating patterns or their prevalence (binge eating, emotional
      eating, picking). In addition, it highlights the inclusion of the family as a key factor in
      the change and implement of healthy lifestyles in children with overweight/obesity. The
      programme ENTREN-F (pilot study results) has been awarded by the Ministry of Health and
      Consumer Affairs, Strategy for Nutrition, Physical Activity and Prevention of Obesity (NAOS
      annual Award) in December 2017.

      Ethical approval: The study received ethical approval by the Child and Adolescent Hospital
      Niño Jesús (Ref. R-0058/16), Central Committee of Research, Primary Care Commission (Ref.
      32/17; 13.12.17) and Autonomous University Ethics approval (CEI-76-1394).
    

Intervention name(s): ENTREN; ENTREN-F; Control group
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): ENTREN intervention for children (cognitive-behavioral perspective + motivational interview); ENTREN intervention for children + family intervention.; Behavioral modification of habits
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: ENTREN is based on a exhaustive previous literature review. It uses a cognitive-behavioural perspective, has a duration of 6 months and includes a module for children treatment centred on emotional regulation. Some contents from "LEARN Program for Weight Management" were adapted to childhood stages for the ENTREN programme, which includes five main dimensions: lifestyle, physical activity, health attitudes, social relationships, and nutrition. Spanish health guidelines from the Health Ministry, aimed to promote healthy eating habits and physical activity, were also taken into account. Motivational interviewing techniques have also been integrated into the sessions to promote children's and families' commitment to their health. Specifically, family content has been developed to adapt parental democratic educational style and improve communication with their children. A previous pilot study of ENTREN programme was conducted to describe its feasibility and acceptability in Primary Care.
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: childhood obesity; psycho-family intervention; controlled and randomized clinical trial; emotional regulation