search
Back to results

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
Universiti Putra Malaysia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Childhood Obesity

Eligibility Criteria

7 Years - 11 Years (Child)All SexesAccepts Healthy Volunteers

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

    First Posted
    February 4, 2018
    Last Updated
    February 9, 2018
    Sponsor
    Universiti Putra Malaysia
    search

    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

    We'll reach out to this number within 24 hrs