- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT03429699
Lifestyle Modification Intervention for Obese Children
Effectiveness of a Stage-based Lifestyle Modification Intervention for Obese Children
Přehled studie
Postavení
Podmínky
Detailní popis
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
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Trojnásobný
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Zásahová skupina
|
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.
|
|
Jiný: Kontrolní skupina
|
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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
|
weight (kg)
Časové okno: 24 weeks
|
24 weeks
|
|
Height (cm)
Časové okno: 24 weeks
|
24 weeks
|
|
BMI-for-age Z score
Časové okno: 24 weeks
|
24 weeks
|
Sekundární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
|
waist circumference (cm)
Časové okno: 24 weeks
|
24 weeks
|
|
Mid-upper Arm Muscle Circumference (cm)
Časové okno: 24 weeks
|
24 weeks
|
|
Body fat (%)
Časové okno: 24 weeks
|
24 weeks
|
|
Energy (kcal)
Časové okno: 24 weeks
|
24 weeks
|
|
carbohydrate (g)
Časové okno: 24 weeks
|
24 weeks
|
|
Protein (g)
Časové okno: 24 weeks
|
24 weeks
|
|
Fat (g)
Časové okno: 24 weeks
|
24 weeks
|
|
Sugar (g)
Časové okno: 24 weeks
|
24 weeks
|
|
Fiber (g)
Časové okno: 24 weeks
|
24 weeks
|
|
Physical Activity Questionnaire for Older Children (PAQ-C)
Časové okno: 24 weeks
|
24 weeks
|
Spolupracovníci a vyšetřovatelé
Sponzor
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
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