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

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

Interventions

BEHAVIORAL

ENTREN

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

BEHAVIORAL

ENTREN-F

ENTREN intervention for children + family intervention.

BEHAVIORAL

Control group

Behavioral modification of habits

Sponsors & Collaborators

• Hospital Infantil Universitario Niño Jesús, Madrid, Spain

  collaborator OTHER

• Fondation de France

  collaborator OTHER

• NAOS Institute of Life Science

  collaborator INDUSTRY

• Ministerio de Economía y Competitividad, Spain

  collaborator OTHER_GOV

• Universidad Autonoma de Madrid

  lead OTHER

Principal Investigators

• Ana R Sepúlveda, PhD · Universidad Autonoma de Madrid

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

8 Years

Max Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-11-20

Primary Completion

2020-09-30

Completion

2021-12-31

Countries

• Spain

Study Locations