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

Childhood Obesity Clinical Trial

— ENTREN-OB  

Official title:

"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"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04465799
• Other study ID #: PSI201679471R Science Ministry
• Secondary ID: Ref00099489. 201
• Status: Completed
• Phase: N/A
• Start date: November 20, 2016
• Est. completion date: December 31, 2021

Study information

• Verified date: November 2022
• Source: Universidad Autonoma de Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: December 31, 2021
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

Inclusion Criteria:

1. Age between 8-12 years

2. BMI > Percentile 90

3. Presenter of physical and cognitive development according to sex and age

4. Good understanding of Spanish orally and in writing.

5. Do not present any difficulty that prevents the performance of autonomous physical activities

Exclusion Criteria:

1. standing obesity caused by a genetic syndrome

2. 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.

Related Conditions & MeSH terms

• Childhood Obesity
• Obesity
• Pediatric Obesity

Intervention

Behavioral:
• ENTREN
ENTREN intervention for children (cognitive-behavioral perspective + motivational interview)
• ENTREN-F
ENTREN intervention for children + family intervention.
• Control group
Behavioral modification of habits

Locations

Country	Name	City	State
Spain	Ms. Sepúlveda. Coordinator of ENTREN Program. ANOBAS Group Research. School of Psychology (AUM) Web: www.anobas.es Contact: anarosa.sepulveda@uam.es/programaentren@gmail.com	Madrid

Sponsors (5)

Lead Sponsor	Collaborator
Universidad Autonoma de Madrid	Fondation de France, Hospital Infantil Universitario Niño Jesús, Madrid, Spain, Ministerio de Economía y Competitividad, Spain, NAOS Institute of Life Science

Country where clinical trial is conducted

Spain, 

References & Publications (8)

Blanco M, Sepulveda AR, Lacruz T, Parks M, Real B, Martin-Peinador Y, Román FJ. Examining Maternal Psychopathology, Family Functioning and Coping Skills in Childhood Obesity: A Case-Control Study. Eur Eat Disord Rev. 2017 Sep;25(5):359-365. doi: 10.1002/erv.2527. Epub 2017 Jun 1. — View Citation

Blanco M, Veiga OL, Sepúlveda AR, Izquierdo-Gomez R, Román FJ, López S, Rojo M. [Family environment, physical activity and sedentarism in preadolescents with childhood obesity: ANOBAS case-control study]. Aten Primaria. 2020 Apr;52(4):250-257. doi: 10.1016/j.aprim.2018.05.013. Epub 2019 Mar 18. Spanish. — View Citation

Hemmingsson E. A new model of the role of psychological and emotional distress in promoting obesity: conceptual review with implications for treatment and prevention. Obes Rev. 2014 Sep;15(9):769-79. doi: 10.1111/obr.12197. Epub 2014 Jun 16. Review. — View Citation

Robertson W, Fleming J, Kamal A, Hamborg T, Khan KA, Griffiths F, Stewart-Brown S, Stallard N, Petrou S, Simkiss D, Harrison E, Kim SW, Thorogood M. Randomised controlled trial evaluating the effectiveness and cost-effectiveness of 'Families for Health', a family-based childhood obesity treatment intervention delivered in a community setting for ages 6 to 11 years. Health Technol Assess. 2017 Jan;21(1):1-180. doi: 10.3310/hta21010. — View Citation

Rojo M, Lacruz T, Solano S, Gutiérrez A, Beltrán-Garrayo L, Veiga OL, Graell M, Sepúlveda AR. Family-reported barriers and predictors of short-term attendance in a multidisciplinary intervention for managing childhood obesity: A psycho-family-system based — View Citation

Rojo M, Lacruz T, Solano S, Vivar M, Del Río A, Martínez J, Foguet S, Marín M, Moreno-Encinas A, Veiga ÓL, Cabanas V, Rey C, Graell M, Sepúlveda AR. ENTREN-F family-system based intervention for managing childhood obesity: Study protocol for a randomized — View Citation

Sepúlveda AR, Solano S, Blanco M, Lacruz T, Graell M. Prevalence of childhood mental disorders in overweight and obese Spanish children: Identifying loss of control eating. Psychiatry Res. 2018 Sep;267:175-181. doi: 10.1016/j.psychres.2018.06.019. Epub 2018 Jun 8. — View Citation

Sepúlveda AR, Solano S, Blanco M, Lacruz T, Veiga O. Feasibility, acceptability, and effectiveness of a multidisciplinary intervention in childhood obesity from primary care: Nutrition, physical activity, emotional regulation, and family. Eur Eat Disord R — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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)
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	Accumulation of psychosocial stress events during childhood	Questionnaire: number of psychosocial stress events in school family and social contexts	Baseline (pre-intervention)
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	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.
Secondary	Family socio-demographic variables	Semi-structured interview: parents' age, marital status, nationality educational level, current job, socioeconomic status.	Baseline (pre-intervention)
Secondary	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)
Secondary	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.
Secondary	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)
Secondary	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.
Secondary	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)

External Links

•   Research Group webpage. ANOBAS Research Team website (Faculty of Psychology - AUM). Three lines of research currently active (EDs, childhood obesity and body dysmorphia). Information about team members, the ENTREN program and resources for professionals.