Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Lifestyle Modification Intervention for Obese Children

9. februar 2018 opdateret af: 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.

Studieoversigt

Detaljeret beskrivelse

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

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

50

Fase

  • Ikke anvendelig

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

7 år til 11 år (Barn)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Interventionsgruppe
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.
Andet: Kontrolgruppe
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
weight (kg)
Tidsramme: 24 weeks
24 weeks
Height (cm)
Tidsramme: 24 weeks
24 weeks
BMI-for-age Z score
Tidsramme: 24 weeks
24 weeks

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

2. februar 2012

Primær færdiggørelse (Faktiske)

10. marts 2014

Studieafslutning (Faktiske)

10. marts 2014

Datoer for studieregistrering

Først indsendt

4. februar 2018

Først indsendt, der opfyldte QC-kriterier

9. februar 2018

Først opslået (Faktiske)

12. februar 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. februar 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. februar 2018

Sidst verificeret

1. februar 2018

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • UPM/FPSK/PADS/T7-MJKEtikalPer

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Fedme hos børn

3
Abonner