Effectiveness of an Intervention Programme for Childhood Obesity: FAMILIACT

Summary

Objectives. To assess the effectiveness of a programmed family/group intervention to reduce weight in the treatment of obesity in children 7 to 12 years old in front of usual treatment. Design. Cluster randomized controlled trial, multicenter. Location. Primary health care centers. Participants. Obese children 7 to 12 years old of primary health care centers. Body mass index (BMI) \> P 97. Patients give Informed consent. Sampling. Randomized cluster assigned. Assignation unit: primary care center. Analysis unit. Patient (Children and childminder). Size: 280 patients (140 by group). Principal measurements Variables.BMI z score (BMI-SDS) after the 6 month intervention and after 12 -month follow-up. Secondary Measurements Variables. quality of Mediterranean diet, Brief questionnaire of physical activity in children. Brief Physical Activity Assessment Tool (BPAAT) for adults (Parents) , apgar-family questionnaire. sociocultural level., educational level, Gender. Age. BMI parents, family antecedent. Analysis: Primary effectiveness. Initial comparability of groups according to the outcome and confusion variables. Mean differences in z score of BMI with 95% confidence intervals, between groups and generation of a multivariate and multilevel model. Analysis by intention to treat.

Conditions

• Childhood Obesity

Interventions

BEHAVIORAL

Active Families

This intervention, based on the methodology of meaningful learning, will have two components: group education aimed at parents (caregivers) and and education directed to children in the reviews in consultation. Group education (caregivers) groups will consist of 6 sessions, which will be given every two weeks, as determined in the program's follow-up annex, in the 3 months after the initial assessment. The content of the sessions is defined in attached annex. Regarding the proposed methodology, it has nuances and tools different from the traditional ones to achieve significant learning in the field of health. It is based on participatory methods and a more profound modification of knowledge, skills, emotions and attitudes than the brief advice that is used in family intervention in scheduled consultations.

OTHER

Madrid's Primary Healthcare Standardized Service portfolio

An anamnesis or functional assessment on the following aspects: o Family history of obesity up to 2nd degree inbreeding. o Nutritional status - metabolic that includes at least no meals/day and daily consumption of liquids, fruits, vegetables, dairy, fats and sugars. o Activity - exercise that includes at least the type and intensity of exercise and time spent on sedentary activities (television, video games or the like). o Self-concept that includes at least the existence or not of behavioral problems and body image problems. o Role - relationships that include at least the performance of extracurricular activities. A care plan in relation to identified problems and/or situations reviewed on a biannual basis. They will be supplemented with the study-specific variables listed in the data collection notebook.

Sponsors & Collaborators

• Gerencia de Atención Primaria, Madrid

  lead OTHER_GOV

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

7 Years

Max Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-12-10

Primary Completion

2024-12-14

Completion

2024-12-14

Countries

• Spain

Study Locations