Efficacy of ENTREN-F Program: A Psycho-family Intervention in Childhood Obesity

Study Overview
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Brief Summary
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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
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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).

Official Title
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Efficacy of ENTREN-F Program: A Psycho-family and Multidisciplinary Intervention for Children From 8 to 12 Years Old With Childhood Obesity: A Controlled and Randomized Clinical Trial

Conditions
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Childhood Obesity

Intervention / Treatment
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* Behavioral: ENTREN
* Behavioral: ENTREN-F
* Behavioral: Control group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 8-12 years BMI > Percentile 90 Presenter of physical and cognitive development according to sex and age Good understanding of Spanish orally and in writing. Do not present any difficulty that prevents the performance of autonomous physical activities Exclusion Criteria: standing obesity caused by a genetic syndrome the child or none of their primary caregivers do not have adequate command of oral or written Spanish a) Intellectual disability b) dieting supervised by an endocrine specialist at the time of the evaluation c) To suffer a serious psychological or medical disorder that requires immediate intervention d) Do not present excess weight as a side effect of a pharmacological treatment that could act as a confounding variable.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ENTREN Programme<br>This intervention consists in a total of 12 biweekly sessions: 9 sessions of 2-hr only for children, with a further three 3-hr sessions attended by both families and children together: nutrition, physical activity sessions, and a closing event session. Children content was developed based a cognitive-behavioural perspective, and included motivational interviewing tools. The aim of the children's programme is, to promote healthy eating habits, problem awareness, motivation to change unhealthy behaviours, health commitment, emotional regulation, social skills and self-esteem. One 2-hr session at 6, 12 and 18-month follow-up was provided to refresh skills, their physical activity, and nutritional behaviours. | Behavioral: ENTREN<br>* ENTREN intervention for children (cognitive-behavioral perspective + motivational interview)<br>|
| Experimental: ENTREN-F Programme<br>ENTREN-F has the same children's intervention than ENTREN. It has extra 6 2-hr sessions to work on family environment and communication, plus three 2-hr sessions attended by both families and children together. One 2-hr session at 6, 12 and 18-month follow-up was provided to refresh skills, their physical activity, and nutritional behaviours. | Behavioral: ENTREN-F<br>* ENTREN intervention for children + family intervention.<br>|
| Other: Control group<br>The intervention of this group consists in usual treatment in Primary Care provided by Endocrinology Services. 3 monthly face-to-face consultations and continuous online monitoring are provided to these families, oriented to promote healthy habits of nutrition and physical activity for 6 months. It works from an exclusively behavioural perspective. A token economy is used with the families as a system of contingency management based on the systematic reinforcement of target behaviour. | Behavioral: Control group<br>* Behavioral modification of habits<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from children's weight (z-BMI score) | Rate of overweight and obesity in the children's sample. Instrument: Seca digital (Type 799 and 769) weighing scales. | Change from baseline (pre-intervention) at immediately after 6 months intervention, 12 and 18 months follow-up. | 
| Change from levels of physical activity | Levels of light, moderate and vigorous physical activity. Instrument: accelerometers. | Change from baseline (pre-intervention) at immediately after 6 months intervention and 18 months follow-up. | 
| Prevalence of child psychiatric disorders | Percent of children with a psychiatric diagnosis according to DSM-5 criteria. Instrument: The Schedule for Affective Disorders and Schizophrenia for School-Age Children Present and Lifetime version. | Baseline (pre-intervention) | 
| Change from levels of anxiety symptomatology in children | Questionnaire Spence Children's Anxiety Scale (SCAS): levels of anxiety. Minimum/maximum values: 0-114. Higher scores mean a worse outcome. | Change from baseline (pre-intervention) at immediately after 6 months intervention, 12 and 18 months follow-up. | 
| Change from levels of depressive symptomatology in children | Questionnaire Children's Depression Inventory (CDI): levels of depressive symptomatology. Minimum/maximum values: 0-54. Spanish risk cut off-point: 19 Higher scores mean a worse outcome. | Change from baseline (pre-intervention) at immediately after 6 months intervention, 12 and 18 months follow-up. | 
| Change from perceived weight-stigma in children | Questionnaire Weight Bias Internalization Scale for Children (WBIS-C). Minimum/maximum score: 11-44 Higher scores on the WBIS-C indicate higher level of weight bias internalization. | Change from baseline (pre-intervention) at immediately after 6 months intervention. | 
| Change from incidence of teasing in children | Questionnaire Perception of Teasing Scale (POTS). It has two factors, weight and competency. Higher scores in each subscale mean a worse outcome (higher prevalence of teasing). Perception of Teasing Scale (POTS): Two scales: weight (SUME item1 + item2 + item3 + item4 + item5 + item6) and competency (SUME item7 + item8 + item9 + item10 + item11) Likert Scale 5 points. Maximum score: 30 (weight scale) and 25 (competency scale). Higher scores in each scale mean a worse outcome. | Change from baseline (pre-intervention) at immediately after intervention, 6, 12 and 18 months follow-up. | 
| Change from levels of self-esteem in children | Questionnaire Lawrence's Self-Esteem Questionnaire (LAWSEQ): levels of self-esteem in children. Minimum/maximum value: 0-24. A score below average (score 9) means low self-esteem. A score higher than 9 points means high self-esteem. | Change from baseline (pre-intervention) at immediately after intervention, 6, 12 and 18 months follow-up. | 
| Change from emotional regulation in children | Questionnaire Trait Meta-Mood Scale (TMMS-24). It has three scales: identification, comprehension and regulation of emotions (8 items/scale). Likert Scale 1-5 points. Higher scores in each subscale mean a better outcome. | Change from baseline (pre-intervention) at immediately after intervention, 6, 12 and 18 months follow-up. | 
| Change from eating behaviors in children | Dutch Eating Behaviour Questionnaire for children (DEBQ-C) with scales for restrained, emotional, and external eating. Higher scores in each subscale mean a worse outcome. | Change from baseline (pre-intervention) at immediately after intervention, 6, 12 and 18 months follow-up. | 
| Change from levels of perfectionism in children | Questionnaire Child-Adolescent Perfectionism Scale (CAPS): levels of perfectionism. Subscales of Self-Oriented Perfectionism and Socially Prescribed Perfectionism. The Self-oriented Perfectionism subscale is scored by summing the following items: 1, 2, 4, 6, 7, 9, 11, 14, 16, 18, 20, 22. The Socially Prescribed Perfectionism subscale is scored by summing the following items: 3, 5, 8, 10, 12, 13, 15, 17, 19, 21. Important: Reverse the following items: 3, 9, 18. Higher scores mean a worse outcome. | Change from baseline (pre-intervention) at immediately after intervention, 6, 12 and 18 months follow-up. | 
| Accumulation of psychosocial stress events during childhood | Questionnaire: number of psychosocial stress events in school family and social contexts | Baseline (pre-intervention) | 
| Change from health habits (nutrition and physical activity) from children and their principal caregiver's | Semi-structured interview about health habits (nutrition and physical activity) | Change from baseline (pre-intervention) at immediately after intervention, 6, 12 and 18 months follow-up. | 
| Change from levels of expressed emotion in family environment | Questionnaire Family Questionnaire (FQ): incidence of expressed emotion in principal caregiver's (two subscales emotional over-involvement and levels of criticism). Higher scores mean a worse outcome. Risk cut-off point in each subscale: scoring over 23 (criticism) and scoring over 27 (emotional over-involvement). | Change from baseline (pre-intervention) at immediately after intervention, 6, 12 and 18 months follow-up. | 
| Change from parental child feeding perceptions, attitudes and practices | Questionnaire Child Feeding Questionnaire (CFQ): rate of maladaptive parental child feeding perceptions, attitudes and practices. Higher scores mean a worse outcome. | Change from baseline (pre-intervention) at immediately after intervention, 6, 12 and 18 months follow-up. | 
| Change from parental educational styles | Questionnaire Child's Reports of Parental Behavior Inventory (CRPBI): prevalence and changes of parental educational styles. Each parenting style is related to the sum of specific scores on each subscale. Higher scores on each subscale mean a higher prevalence of this educational style. | Change from baseline (pre-intervention) at immediately after intervention, 6, 12 and 18 months follow-up. | 
| Change from awareness of the problem and motivation to change about the overweight of their children | Questionnaire Change Assessment Scale (URICA): awareness of the problem and motivation to change about the overweight of their children. | Change from baseline (pre-intervention) at immediately after intervention, 6 and 18 months follow-up. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Caregiver's Body Mass Index (BMI) | Body Mass Index (weight/height) | Change from baseline (pre-intervention) at immediately after intervention, 12 and 18 months follow-up. | 
| Family socio-demographic variables | Semi-structured interview: parents' age, marital status, nationality educational level, current job, socioeconomic status. | Baseline (pre-intervention) | 
| Health habits and eating patterns in principal caregivers. | Semi-structure interview carried out with principal caregivers to explore their feeding routine and the presence/absence of eating disorders symptomatology | Baseline (pre-intervention) | 
| Change of eating behaviors in adults | Dutch Eating Behaviour Questionnaire (DEBQ) with scales for restrained, emotional, and external eating. Higher scores in each subscale mean a worse outcome. | Change from baseline (pre-intervention) at immediately after intervention, 6 and 18 months follow-up. | 
| Levels of psychological well-being in principal caregivers | Questionnaire: Stressful Life Events and Daily Hassles (SRRS). A total value for stressful life events can be worked out by adding up the scores for each event experienced over a 12 month period. If a person has less the 150 life change units they have a 30% chance of suffering from stress. 150 - 299 life change units equates to a 50% chance of suffering from stress. Over 300 life units means a person has an 80% chance of developing a stress related illness. | Baseline (pre-intervention) | 
| Levels of psychological well-being in principal caregivers | Levels of depressive symptomatology. Beck's Depression Inventory (BDI). Higher scores mean a worse outcome. | Change from baseline (pre-intervention) at immediately after intervention, 6 and 18 months follow-up. | 
| Child executive functions screening | Questionnaire Behavior Rating Inventory of Executive Function (BRIEF2-F): screening of executive functioning in children. This questionnaire is answered by principal caregiver's. Eight clinical scales (Inhibit, Shift, Emotional Control, Initiate, Working Memory, Plan/Organize, Organization of Materials, Monitor) and an overall score. All 63 items are rated in terms of frequency on a 3-point scale: 0 (never), 1 (sometimes), 2 (often). | Baseline (pre-intervention) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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childhood obesity, psycho-family intervention, controlled and randomized clinical trial, emotional regulation