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Lifestyle Modification Intervention for Obese Children

9 febbraio 2018 aggiornato da: Nor Baizura Md. Yusop, Universiti Putra Malaysia

Effectiveness of a Stage-based Lifestyle Modification Intervention for Obese Children

Interventions that encompass behavioral modifications of dietary intake and physical activity dietary management are essential for the management of obese children. This study assessed the effectiveness of a stage-based lifestyle modification intervention for obese children. A total of 50 obese children (7-11 years) were randomized to intervention (n=25) or control (n=25) group. Data were collected at baseline, at follow-up (every month) and at six-month post-intervention. The intervention group (IG) received stage-based lifestyle modification intervention based on Nutrition Practice Guideline for the Management of Childhood Obesity, while the control group (CG) received standard treatment. Changes in body composition, physical activity, and dietary intake were examined in both intervention and control groups.

Panoramica dello studio

Descrizione dettagliata

Main Objective:

To evaluate the effectiveness of Stage-based Lifestyle Modification Intervention for the Management of Childhood Obesity

Specific objectives:

To compare changes in body composition, energy and nutrient intake, as well as physical activity between children receiving the Stage-based Lifestyle Modification Intervention (i.e. intervention group) and the standard treatment (i.e. control group) for the management of childhood obesity.

Study hypothesis:

There is significant different in body mass index (BMI) and body composition, energy and nutrient intakes and physical activity between children receiving nutrition clinical practice guideline (treatment group) and existing management of childhood obesity (control group)?

Interventions Eighty two children will be assigned to two groups, namely Group A (intervention) and Group B (control).

Intervention Group (IG):

The participants will receive treatment based on nutrition clinical practice guideline for the management of childhood obesity. Participants in IG will be received a nutrition clinical practice guideline for the management of childhood obesity that comprised several activities, including nutrition counselling, aerobic sessions, a hands-on activity (healthy food preparation) and 'Sharing is Caring'. The Nutrition Practice Guideline for the Management of Childhood Obesity that comprised recommendations for assessment of nutritional status, determination of energy requirement, dietary prescriptions and physical activity modifications will be used. Participants' SOC for dietary and physical activity behaviours will be determined before any information was given to ensure that the selected educational topic will be tailored to the participant's current SOC. Several educational tools that match participant's current SOC will be used. Nutritional counselling lasted for one hour, and at least two goals for dietary and physical activity will be determined at the end of the session. The researcher (Nor Baizura, M.Y), a trained dietitian, provided nutrition counselling to parents/caregivers and children. An aerobic session will be conducted to encourage participants to be more active and increase their motivation levels, while a hands-on activity is aimed at increasing the knowledge of participants about healthy food preparation. 'Sharing is Caring' session is to encourage parents/caregivers to share their experiences during the intervention period.

b. Control group (CG):

The respondents will receive treatment based on the existing practice for the management of childhood obesity. Only nutritional counselling will be received by CG and standard treatment based on current practices by most dietitians in Malaysia for weight management of obese children will be used. Nutrition counseling is provided by dietitians but not delivered based on SOC as the IG. During nutrition counseling, participants will be assessed and informed about their nutritional status, and this will be followed by advice on dietary intake and physical activity. Participants will be advised to reduce intakes of fats and sweetened drinks, increase intakes of fruits and vegetables, increase physical activity and reduce sedentary activity, but they will not informed specifically about the amounts or quantities of the food to be taken. The nutritional counseling will be conducted for half an hour, and only a related brochure on childhood obesity will be disseminated.

Primary outcome measures: BMI-for-age z-scores Secondary outcome measures: Body composition (waist circumference, mid-upper arm circumference and body fat percentage) - Energy and nutrient intakes (macronutrients, sugar and fiber) -Physical activity

Tipo di studio

Interventistico

Iscrizione (Effettivo)

50

Fase

  • Non applicabile

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 7 anni a 11 anni (Bambino)

Accetta volontari sani

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

The participants will be included if they are:

  • Children aged 2 - 12 years old
  • Obese based on the WHO growth chart 2007 (BMI-for-age more than +2SD)

Exclusion Criteria:

The participants will be excluded if they are:

  • Diagnosed with diabetes mellitus, psychiatric disorder (e.g. schizophrenia, severe autism or
  • mental retardation or psychosis), or other serious medical conditions.
  • Receiving medications that would potentially promote weight gain or weight loss.
  • Involved in any weight management program
  • Overweight, normal weight and underweight

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Gruppo di intervento
The participants will receive treatment based on nutrition clinical practice guideline for the management of childhood obesity. Participants in IG will be received a nutrition clinical practice guideline for the management of childhood obesity that comprised several activities, including nutrition counselling, aerobic sessions, a hands-on activity (healthy food preparation) and 'Sharing is Caring'. The Nutrition Practice Guideline for the Management of Childhood Obesity that comprised recommendations for assessment of nutritional status, determination of energy requirement, dietary prescriptions and physical activity modifications will be used. Participants' SOC for dietary and physical activity behaviors will be determined before any information was given to ensure that the selected educational topic will be tailored to the participant's current SOC.
Altro: Gruppo di controllo
The participants will receive treatment based on the existing practice for the management of childhood obesity. Only nutritional counseling will be received by CG and standard treatment based on current practices by most dietitians in Malaysia for weight management of obese children will be used.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
weight (kg)
Lasso di tempo: 24 weeks
24 weeks
Height (cm)
Lasso di tempo: 24 weeks
24 weeks
BMI-for-age Z score
Lasso di tempo: 24 weeks
24 weeks

Misure di risultato secondarie

Misura del risultato
Lasso di tempo
waist circumference (cm)
Lasso di tempo: 24 weeks
24 weeks
Mid-upper Arm Muscle Circumference (cm)
Lasso di tempo: 24 weeks
24 weeks
Body fat (%)
Lasso di tempo: 24 weeks
24 weeks
Energy (kcal)
Lasso di tempo: 24 weeks
24 weeks
carbohydrate (g)
Lasso di tempo: 24 weeks
24 weeks
Protein (g)
Lasso di tempo: 24 weeks
24 weeks
Fat (g)
Lasso di tempo: 24 weeks
24 weeks
Sugar (g)
Lasso di tempo: 24 weeks
24 weeks
Fiber (g)
Lasso di tempo: 24 weeks
24 weeks
Physical Activity Questionnaire for Older Children (PAQ-C)
Lasso di tempo: 24 weeks
24 weeks

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

2 febbraio 2012

Completamento primario (Effettivo)

10 marzo 2014

Completamento dello studio (Effettivo)

10 marzo 2014

Date di iscrizione allo studio

Primo inviato

4 febbraio 2018

Primo inviato che soddisfa i criteri di controllo qualità

9 febbraio 2018

Primo Inserito (Effettivo)

12 febbraio 2018

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

12 febbraio 2018

Ultimo aggiornamento inviato che soddisfa i criteri QC

9 febbraio 2018

Ultimo verificato

1 febbraio 2018

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • UPM/FPSK/PADS/T7-MJKEtikalPer

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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