Lifestyle Modification Intervention for Obese Children
Condition: Childhood Obesity; Life Style Modification
MeSH terms: Pediatric Obesity
Study type: Interventional

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
    

Intervention name(s): Stage-based Lifestyle Modification Intervention for the Management of Childhood Obesity; Existing practice for the management of childhood obesity
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment