Lifestyle Modification Intervention for Obese Children
Primary Purpose
Childhood Obesity, Life Style Modification
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Stage-based Lifestyle Modification Intervention for the Management of Childhood Obesity
Existing practice for the management of childhood obesity
Sponsored by
About this trial
This is an interventional treatment trial for Childhood Obesity
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Intervention group
Control group
Arm Description
Outcomes
Primary Outcome Measures
weight (kg)
Height (cm)
BMI-for-age Z score
Secondary Outcome Measures
waist circumference (cm)
Mid-upper Arm Muscle Circumference (cm)
Body fat (%)
Energy (kcal)
carbohydrate (g)
Protein (g)
Fat (g)
Sugar (g)
Fiber (g)
Physical Activity Questionnaire for Older Children (PAQ-C)
Full Information
NCT ID
NCT03429699
First Posted
February 4, 2018
Last Updated
February 9, 2018
Sponsor
Universiti Putra Malaysia
1. Study Identification
Unique Protocol Identification Number
NCT03429699
Brief Title
Lifestyle Modification Intervention for Obese Children
Official Title
Effectiveness of a Stage-based Lifestyle Modification Intervention for Obese Children
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
February 2, 2012 (Actual)
Primary Completion Date
March 10, 2014 (Actual)
Study Completion Date
March 10, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universiti Putra Malaysia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity, Life Style Modification
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Title
Control group
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
Stage-based Lifestyle Modification Intervention for the Management of Childhood Obesity
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Existing practice for the management of childhood obesity
Intervention Description
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.
Primary Outcome Measure Information:
Title
weight (kg)
Time Frame
24 weeks
Title
Height (cm)
Time Frame
24 weeks
Title
BMI-for-age Z score
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
waist circumference (cm)
Time Frame
24 weeks
Title
Mid-upper Arm Muscle Circumference (cm)
Time Frame
24 weeks
Title
Body fat (%)
Time Frame
24 weeks
Title
Energy (kcal)
Time Frame
24 weeks
Title
carbohydrate (g)
Time Frame
24 weeks
Title
Protein (g)
Time Frame
24 weeks
Title
Fat (g)
Time Frame
24 weeks
Title
Sugar (g)
Time Frame
24 weeks
Title
Fiber (g)
Time Frame
24 weeks
Title
Physical Activity Questionnaire for Older Children (PAQ-C)
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29490648
Citation
Md Yusop NB, Mohd Shariff Z, Hwu TT, Abd Talib R, Spurrier N. The effectiveness of a stage-based lifestyle modification intervention for obese children. BMC Public Health. 2018 Mar 1;18(1):299. doi: 10.1186/s12889-018-5206-2.
Results Reference
derived
Learn more about this trial
Lifestyle Modification Intervention for Obese Children
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