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

Evaluation of Family Intervention Program for the Treatment of Overweight or Obese Children (Nereu Program): Randomized Clinical Trial

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01878994

Acronym

NEREU

Enrollment

100

Registered

2013-06-17

Start date

2013-01-31

Completion date

2015-12-31

Last updated

2013-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children, Obesity, Overweight

Keywords

Overweight, Obesity, Children, Behaviour, Physical Activity, Nutrition

Brief summary

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.

Interventions

BEHAVIORALCounselling group

BEHAVIORALNereu group

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

6 Years to 12 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Change from Baseline in Body mass index z score (BMIz)	4 times: at baseline, at the end of the intervention (8 months later of the baseline), 6 and 12 months post intervention	Weight is measured to the nearest of 0.1 kg using an electronic scale and height (Ht) to the nearest of 0.1 cm with a stadiometer, in lightly dressed and without shoes. The BMIz is calculated according z score of BMI adjusted by age and gender (IOTF).

Secondary

Measure	Time frame	Description
Change from baseline in Physical activity habits	4 times: at baseline, at the end of the intervention (8 months later of the baseline), 6 and 12 months post intervention	To measure physical activity will be used an Actigraph accelerometers (GT3X+ models), it will be wear by participants during all day for seven consecutive days.

Countries

Spain

Contacts

Primary ContactConepció Teixidó, Phd

cteixido.lleida.ics@gencat.cat

Backup ContactNoemí Serra, Mrs

nserra@inefc.es

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 22, 2026