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

NCT04465799 | Completed DMC

• 2 other identifiers: PSI201679471R Science MinistryRef00099489. 2019-ES-000-6711.
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Childhood Obesity

Keywords

childhood obesity; psycho-family intervention; controlled and randomized clinical trial; emotional regulation

Outcome Measures

Primary Outcomes (17)

• 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 Outcomes (7)

• Primary Caregiver's Body Mass Index (BMI)

  Change from baseline (pre-intervention) at immediately after intervention, 12 and 18 months follow-up.

• Family socio-demographic variables

  Baseline (pre-intervention)

• Health habits and eating patterns in principal caregivers.

  Baseline (pre-intervention)

• Change of eating behaviors in adults

  Change from baseline (pre-intervention) at immediately after intervention, 6 and 18 months follow-up.

• Levels of psychological well-being in principal caregivers

  Baseline (pre-intervention)

Study Arms (3)

ENTREN Programme

EXPERIMENTAL

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

ENTREN-F Programme

EXPERIMENTAL

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

Control group

OTHER

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

Interventions

ENTREN BEHAVIORAL

ENTREN intervention for children (cognitive-behavioral perspective + motivational interview)

ENTREN Programme

ENTREN-F BEHAVIORAL

ENTREN intervention for children + family intervention.

ENTREN-F Programme

Control group BEHAVIORAL

Behavioral modification of habits

Control group

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Autonoma de Madrid: lead
• Hospital Infantil Universitario Niño Jesús, Madrid, Spain: collaborator
• Fondation de France: collaborator
• NAOS Institute of Life Science: collaborator
• Ministerio de Economía y Competitividad, Spain: collaborator

Study Sites (1)

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, 28049, Spain

Location

Related Publications (8)

• Sepulveda 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.

  PMID: 29909128 BACKGROUND

• Blanco M, Sepulveda AR, Lacruz T, Parks M, Real B, Martin-Peinador Y, Roman 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.

  PMID: 28568706 BACKGROUND

• Blanco M, Veiga OL, Sepulveda AR, Izquierdo-Gomez R, Roman FJ, Lopez 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.

  PMID: 30898477 BACKGROUND

• 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.

  PMID: 24931366 BACKGROUND

• 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.

  PMID: 28059054 BACKGROUND

• Sepulveda 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 Rev. 2020 Mar;28(2):184-198. doi: 10.1002/erv.2702. Epub 2019 Dec 4.

  PMID: 31802570 RESULT

• Rojo M, Lacruz T, Solano S, Vivar M, Del Rio A, Martinez J, Foguet S, Marin M, Moreno-Encinas A, Veiga OL, Cabanas V, Rey C, Graell M, Sepulveda AR. ENTREN-F family-system based intervention for managing childhood obesity: Study protocol for a randomized controlled trial at primary care. Obes Res Clin Pract. 2022 Jul-Aug;16(4):319-329. doi: 10.1016/j.orcp.2022.07.001. Epub 2022 Jul 22.

  PMID: 35871907 RESULT

• Rojo M, Lacruz T, Solano S, Gutierrez A, Beltran-Garrayo L, Veiga OL, Graell M, Sepulveda AR. Family-reported barriers and predictors of short-term attendance in a multidisciplinary intervention for managing childhood obesity: A psycho-family-system based randomised controlled trial (ENTREN-F). Eur Eat Disord Rev. 2022 Nov;30(6):746-759. doi: 10.1002/erv.2913. Epub 2022 May 28.

  PMID: 35644038 RESULT

Related 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.

MeSH Terms

Conditions

Pediatric Obesity; Emotional Regulation

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Self-Control; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Ana R Sepúlveda, PhD

  Universidad Autonoma de Madrid

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator. Senior Lecturer and Researcher.

Model Details: 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.

Study Record Dates

• First Submitted: April 14, 2020
• First Posted: July 10, 2020
• Study Start: November 20, 2016
• Primary Completion: September 1, 2020
• Study Completion: December 31, 2021
• Last Updated: November 9, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: IPD will become available from December of 2021. Period of availability: unlimited after publication. Request and a revision of the request are both necessary conditions.
• Access Criteria: The study protocol will also be available. The structure of the program and the specific content of the sessions will be available in a published guidebook. Upon prior request, a document with the interpretation of the items in SPSS databases, a description of the instruments and outcomes variables included in this study, may also be provided. PhD. Ana Rosa Sepúlveda will be the responsible of reviewing all request, and taking a final decision. Criteria for reviewing requests: National and international Research Groups related to childhood obesity or eating disorders. Types of analyses: replica of ENTREN's RCT in other countries or meta-analyses studies.

Locations

ES (1)