- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03429699
Lifestyle Modification Intervention for Obese Children
Effectiveness of a Stage-based Lifestyle Modification Intervention for Obese Children
연구 개요
상태
정황
상세 설명
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
연구 유형
등록 (실제)
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 개입 그룹
|
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.
|
|
다른: 대조군
|
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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
weight (kg)
기간: 24 weeks
|
24 weeks
|
|
Height (cm)
기간: 24 weeks
|
24 weeks
|
|
BMI-for-age Z score
기간: 24 weeks
|
24 weeks
|
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
waist circumference (cm)
기간: 24 weeks
|
24 weeks
|
|
Mid-upper Arm Muscle Circumference (cm)
기간: 24 weeks
|
24 weeks
|
|
Body fat (%)
기간: 24 weeks
|
24 weeks
|
|
Energy (kcal)
기간: 24 weeks
|
24 weeks
|
|
carbohydrate (g)
기간: 24 weeks
|
24 weeks
|
|
Protein (g)
기간: 24 weeks
|
24 weeks
|
|
Fat (g)
기간: 24 weeks
|
24 weeks
|
|
Sugar (g)
기간: 24 weeks
|
24 weeks
|
|
Fiber (g)
기간: 24 weeks
|
24 weeks
|
|
Physical Activity Questionnaire for Older Children (PAQ-C)
기간: 24 weeks
|
24 weeks
|
공동 작업자 및 조사자
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .