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Lifestyle Modification Intervention for Obese Children

9 februari 2018 bijgewerkt door: 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.

Studie Overzicht

Gedetailleerde beschrijving

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

Studietype

Ingrijpend

Inschrijving (Werkelijk)

50

Fase

  • Niet toepasbaar

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

7 jaar tot 11 jaar (Kind)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verdrievoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Interventie groep
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.
Ander: Controlegroep
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
weight (kg)
Tijdsspanne: 24 weeks
24 weeks
Height (cm)
Tijdsspanne: 24 weeks
24 weeks
BMI-for-age Z score
Tijdsspanne: 24 weeks
24 weeks

Secundaire uitkomstmaten

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

2 februari 2012

Primaire voltooiing (Werkelijk)

10 maart 2014

Studie voltooiing (Werkelijk)

10 maart 2014

Studieregistratiedata

Eerst ingediend

4 februari 2018

Eerst ingediend dat voldeed aan de QC-criteria

9 februari 2018

Eerst geplaatst (Werkelijk)

12 februari 2018

Updates van studierecords

Laatste update geplaatst (Werkelijk)

12 februari 2018

Laatste update ingediend die voldeed aan QC-criteria

9 februari 2018

Laatst geverifieerd

1 februari 2018

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • UPM/FPSK/PADS/T7-MJKEtikalPer

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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