- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03429699
Lifestyle Modification Intervention for Obese Children
Effectiveness of a Stage-based Lifestyle Modification Intervention for Obese Children
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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 de estudio
Inscripción (Actual)
Fase
- No aplica
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Grupo de intervención
|
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.
|
|
Otro: Grupo de control
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
weight (kg)
Periodo de tiempo: 24 weeks
|
24 weeks
|
|
Height (cm)
Periodo de tiempo: 24 weeks
|
24 weeks
|
|
BMI-for-age Z score
Periodo de tiempo: 24 weeks
|
24 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
waist circumference (cm)
Periodo de tiempo: 24 weeks
|
24 weeks
|
|
Mid-upper Arm Muscle Circumference (cm)
Periodo de tiempo: 24 weeks
|
24 weeks
|
|
Body fat (%)
Periodo de tiempo: 24 weeks
|
24 weeks
|
|
Energy (kcal)
Periodo de tiempo: 24 weeks
|
24 weeks
|
|
carbohydrate (g)
Periodo de tiempo: 24 weeks
|
24 weeks
|
|
Protein (g)
Periodo de tiempo: 24 weeks
|
24 weeks
|
|
Fat (g)
Periodo de tiempo: 24 weeks
|
24 weeks
|
|
Sugar (g)
Periodo de tiempo: 24 weeks
|
24 weeks
|
|
Fiber (g)
Periodo de tiempo: 24 weeks
|
24 weeks
|
|
Physical Activity Questionnaire for Older Children (PAQ-C)
Periodo de tiempo: 24 weeks
|
24 weeks
|
Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- UPM/FPSK/PADS/T7-MJKEtikalPer
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .