ClinicalTrials.Veeva

Menu

Evaluation of a Family Intervention Program for the Management of Overweight or Obese Children (NEREU)

F

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Status and phase

Unknown
Phase 4

Conditions

Overweight
Children
Obesity

Treatments

Behavioral: Nereu group
Behavioral: Counselling group

Study type

Interventional

Funder types

Other

Identifiers

NCT01878994
PI12/02220

Details and patient eligibility

About

Objectives: To evaluate the effectiveness of the Nereu program compared to standard care (advice on increased physical activity and nutrition) such as a health intervention tool for the childhood obesity management

Methods/Design: The study design is a randomized controlled multicenter clinical trial using two types of treatment. Population and sample: Children 6 to 12 years with overweight or obesity, according to the z score of body mass index (BMI z) >= 1 for age and gender defined by International Obesity Task Force (IOTF). It is considered necessary to recruit 100 children: 50 control group (CG) and 50 Intervention (IG). Study Intervention: Nereu Group: 8 month intervention with 3 weekly training sessions doing physical exercise for children and a weekly session for parents of physical activity and healthy eating habits and behaviour strategies, that involves both parental and child participation. The control group will receive a monthly session of healthy physical and eating habits. Main Outcome Measures: Improvement of BMI z, physical activity and nutrition habits, behaviour components and quality life related to health at the end, 6 and 12 months after intervention.

Enrollment

100 estimated patients

Sex

All

Ages

6 to 12 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Children aged between 6 to 12 years old
  • Overweight or obese according to the IOTF criteria

Exclusion criteria

  • Medical co-morbidities: Diabetes mellitus or hypercholesterolemia or cardiovascular disease that could be contraindicate the sport practice.
  • Use of medication that might have an effect on weight loss.
  • previous enrolment in another similar treatment program based on reducing obesity.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

100 participants in 2 patient groups, including a placebo group

Counselling Group
Placebo Comparator group
Description:
Each family will receive a single monthly meeting, a total of 8 with 10 minutes duration each one. The sessions will take place in the consultation of the paediatrician and it will be delivered by the child's nurse or/and paediatrician. The sessions' contents are about promotion of healthy eating and physical activity habits.
Treatment:
Behavioral: Counselling group
Nereu Group
Experimental group
Description:
The Nereu treatment program is an intensive family-based behavioural multi-component lifestyle intervention. Consist in an intensive treatment of 8 months duration (from October to May, that is, an academic year). The intervention is a multidisciplinary intervention consisting in 4 structured components: (a) physical activity training for children, (b) family theoretical and practical sessions for parents, (c) behaviour strategies, that involves both parental and child participation (d) weekend extra activities.
Treatment:
Behavioral: Nereu group

Trial contacts and locations

1

Loading...

Central trial contact

Conepció Teixidó, Phd; Noemí Serra, Mrs

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems