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Effects of Omega-3 Supplementation on Nutritional Status and Physical Activity of Obese Children

Primary Purpose

Life Style Modification, Childhood Obesity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Omega 3
stage-based lifestyle modification intervention
Sponsored by
Universiti Putra Malaysia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Life Style Modification focused on measuring Childhood obesity, Life style modification, Omega 3, supplementation

Eligibility Criteria

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

Inclusion Criteria:

  • Children aged 7 to 11 years old.
  • Classified as obese (>+2SD) based on BMI-for-age for 5 to 19 years old (WHO, 2007).

Exclusion Criteria:

• Children diagnosed with asthma, diabetes mellitus (DM), psychiatric disorders (e.g.

schizophrenia, severe autism or mental retardation, or psychosis), or other serious medical conditions.

  • Children receiving medications that could potentially promote weight gain or weight loss.was sent to lab for lipid profile, FBG, insulin, hs-CRP and ferritin analysis.
  • Children participating in any weight management programmes.
  • Overweight, normal weight and underweight children.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    Intervention Group

    Control Group

    Arm Description

    stage-based lifestyle modification intervention and fish oil supplement (omega-3). Stage-based Lifestyle Modification consists of several activities that include nutrition counselling, aerobic sessions, a hands-on activity 'Let's Play' and 'Sharing is Caring' Participants in the intervention group were also given fish oil capsules containing n-3 LCPUFA (DHA and EPA) for a duration of 16 weeks. The participants were required to consume two fish oil capsules, providing 1320 mg n-3 LCPUFA (792 mg EPA, 20:5n-3 and 528 mg DHA, 22:6n-3), and 6 IU vitamin E (D-alpha tocopherol) daily. The EPA and DHA ratio was 1.5:1.

    Only received Stage-based Lifestyle Modification consists of several activities that include nutrition counselling, aerobic sessions, a hands-on activity 'Let's Play' and 'Sharing is Caring'

    Outcomes

    Primary Outcome Measures

    BMI-for-age change
    Height and weight were measured to calculate BMI-for-age

    Secondary Outcome Measures

    waist circumference [cm]
    Participants with abdominal obesity were determined based on the 90th percentile values for WC for sex and age
    Mid-Upper Arm Muscle Circumference [cm] Mid-Upper Arm Muscle Circumference
    A fibreglass tape (measuring tape SECA 201 SECA Vogel and Halke Gmbh & Co., Germany) was used to measure MAC at non-vascular access sites of participants. Participants were required to stand in an erect position with the upper arm approximately parallel to the body and their forearms placed palm down across the middle of the body with the elbow bent to 90 degrees. The midpoint of the tip of the acromion process and the olecranon process was marked. The middle of the arm perpendicular to the long axis of the divisional was measured using a fibreglass tape. The measurement was recorded to the nearest 0.1 cm. The following formula was used to calculate MUAMC. Mid-Upper Arm Muscle Circumference
    Total cholesterol [TC] mmol/L
    A trained nurse and lab assistant performed blood drawing in the Haematology Lab, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia. Five ml blood samples were collected three times; baseline, week 16 and week 24. All participants were required to fast overnight (10 to 12 hours), except for one to two glasses of plain water before the blood draw session. A fasting blood sample was collected from a peripheral vein of the arm for lipid profile, FBG, insulin, hs-CRP and ferritin analysis.
    Triglyceride mmol/L
    A trained nurse and lab assistant performed blood drawing in the Haematology Lab, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia. Five ml blood samples were collected three times; baseline, week 16 and week 24. All participants were required to fast overnight (10 to 12 hours), except for one to two glasses of plain water before the blood draw session. A fasting blood sample was collected from a peripheral vein of the arm for lipid profile, FBG, insulin, hs-CRP and ferritin analysis.
    Low-density lipoprotein [LDL] mmol/L
    A trained nurse and lab assistant performed blood drawing in the Haematology Lab, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia. Five ml blood samples were collected three times; baseline, week 16 and week 24. All participants were required to fast overnight (10 to 12 hours), except for one to two glasses of plain water before the blood draw session. A fasting blood sample was collected from a peripheral vein of the arm for lipid profile, FBG, insulin, hs-CRP and ferritin analysis.
    High-density lipoprotein [HDL]) mmol/L
    Fasting blood glucose (FBG), insulin and homeostasis model assessment insulin-A trained nurse and lab assistant performed blood drawing in the Haematology Lab, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia. Five ml blood samples were collected three times; baseline, week 16 and week 24. All participants were required to fast overnight (10 to 12 hours), except for one to two glasses of plain water before the blood draw session. A fasting blood sample was collected from a peripheral vein of the arm for lipid profile, FBG, insulin, hs-CRP and ferritin analysis.
    Fasting blood glucose (FBG) mmol/L
    A trained nurse and lab assistant performed blood drawing in the Haematology Lab, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia. Five ml blood samples were collected three times; baseline, week 16 and week 24. All participants were required to fast overnight (10 to 12 hours), except for one to two glasses of plain water before the blood draw session. A fasting blood sample was collected from a peripheral vein of the arm for lipid profile, FBG, insulin, hs-CRP and ferritin analysis.
    Insulin [uU/mL]
    A trained nurse and lab assistant performed blood drawing in the Haematology Lab, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia. Five ml blood samples were collected three times; baseline, week 16 and week 24. All participants were required to fast overnight (10 to 12 hours), except for one to two glasses of plain water before the blood draw session. A fasting blood sample was collected from a peripheral vein of the arm for lipid profile, FBG, insulin, hs-CRP and ferritin analysis.
    Homeostasis model assessment insulin-resistance index (HOMA-IR index)
    HOMA-IR index, as a measure of insulin resistance, was calculated as [fasting insulin (μU/mL)]X[fasting glucose (mmol/L)]/22.5
    DHA
    Plasma lipid extraction process was carried out based on the principle of the Folch Method. For analysis of fatty acids' on the same day with the preparation of FAME, a total of 500 μl of hexane was added to the FAME and it was dried and analysed using gas chromatography (GC) 6890N (Network GC System).
    EPA
    Plasma lipid extraction process was carried out based on the principle of the Folch Method. For analysis of fatty acids' on the same day with the preparation of FAME, a total of 500 μl of hexane was added to the FAME and it was dried and analysed using gas chromatography (GC) 6890N (Network GC System).
    Adiponectin
    Plasma levels of adiponectin were determined using a novel enzyme-linked immunosorbent assay (ELISA) (ALPCO Diagnostics, Salem, NH) (ADIPOA).
    High-sensitivity C-reactive protein (hs-CRP)[mg/L]
    A trained nurse and lab assistant performed blood drawing in the Haematology Lab, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia. Five ml blood samples were collected three times; baseline, week 16 and week 24. All participants were required to fast overnight (10 to 12 hours), except for one to two glasses of plain water before the blood draw session. A fasting blood sample was collected from a peripheral vein of the arm for lipid profile, FBG, insulin, hs-CRP and ferritin analysis.
    Serum ferritin[ng/mL]
    A trained nurse and lab assistant performed blood drawing in the Haematology Lab, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia. Five ml blood samples were collected three times; baseline, week 16 and week 24. All participants were required to fast overnight (10 to 12 hours), except for one to two glasses of plain water before the blood draw session. A fasting blood sample was collected from a peripheral vein of the arm for lipid profile, FBG, insulin, hs-CRP and ferritin analysis.
    calorie
    Three day food record
    Carbohydrate [g & %]
    Three day food record
    Protein [g & %]
    Three day food record
    Fat [g & %]
    Three day food record
    Saturated fatty acid [g & %]
    Three day food record
    Polyunsaturated fatty acid [g & %]
    Three day food record
    monounsaturated fatty acid [g & %]
    Three day food record
    Fibre [g & %]
    Three day food record
    Sugar [g & %]
    Three day food record
    Physical activity level
    Physical Activity Questionnaire for Older Children (PAQ-C)

    Full Information

    First Posted
    October 30, 2019
    Last Updated
    November 10, 2019
    Sponsor
    Universiti Putra Malaysia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04156971
    Brief Title
    Effects of Omega-3 Supplementation on Nutritional Status and Physical Activity of Obese Children
    Official Title
    Effects of Omega-3 Long-Chain Polyunsaturated Fatty Acids (N-3 LCPUFA) Supplementation on Body Composition, Biochemical Profile, Diet and Physical Activity of Obese Children
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    June 1, 2013 (Actual)
    Primary Completion Date
    July 31, 2014 (Actual)
    Study Completion Date
    February 28, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universiti Putra Malaysia

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Omega-3 Long-Chain Polyunsaturated Fatty Acids has potential as a supplement that can accelerate the effects of a weight management program in children. This study assessed the effects of fish oil supplementation on biochemical profile, body composition, diet and physical activity of obese children. A total of 37 obese children (7-11 years) were randomized to intervention (n=19) or control (n=18) group. Data were collected at baseline, at follow-up (every four weeks) and at 24 of the interventions. The intervention group (IG) received stage-based lifestyle modification intervention and fish oil supplement, while the control group (CG) received stage-based lifestyle modification intervention only. Changes in biochemical profile, body composition, diet and physical activity were examined in both intervention and control groups.
    Detailed Description
    Main objective To determine the effect of stage-based lifestyle modification and n-3 LCPUFA (DHA and EPA) supplements on body composition, biochemical profile, diet and physical activity of obese children. Specific objectives 1. To compare changes in: i. Primary outcome: BMI-for-age ii. Secondary outcomes: Body composition (waist circumference [WC], mid-upper arm muscle circumference [MUAMC] and body fat percentage) Biochemical profile: Lipid profile (total cholesterol [TC], triglyceride [TG], low-density lipoprotein [LDL] and high-density lipoprotein [HDL]), fasting blood glucose (FBG), insulin and Homeostasis model assessment insulin-resistance index (HOMA-IR index), Fatty acid composition (DHA and EPA) Others: Adiponectin, high-sensitivity C-reactive protein (hs-CRP) and serum ferritin iii. Energy and nutrient intakes (Macronutrients, Saturated Fatty Acids [SFA], Polyunsaturated Fatty Acids [PUFA], Monounsaturated Fatty Acids [MUFA], Cholesterol and sugar and dietary fiber) vii. Physical activity between children receiving Stage-based Lifestyle Modification for the Management of Childhood Obesity with or without supplementation of 1320 mg of n-3 LCPUFA (DHA and EPA). Intervention Group Participants in the intervention group received Stage-based Lifestyle Modification and 16 weeks' supplementation of n-3 LCPUFA (DHA and EPA). Stage-based Lifestyle Modification Stage-based Lifestyle Modification consists of several activities that include nutrition counselling, aerobic sessions, a hands-on activity 'Let's Play' and 'Sharing is Caring'. The recommendation for the dietary and physical activity modification was based on the NPG for the Management of Childhood Obesity (developed in Phase I). During the nutrition counselling session, educational topics related to dietary (reduce intake of fat and increase intake of fruits and vegetables) and physical activity modification (reduce sedentary activity and increase physical activity) were delivered based on the TTM. Participants' SOC for dietary and physical activity were determined before any information was given. This was important to ensure that the selected educational topic was tailored to the participant's current SOC. For each counselling session, at least two goals, one for dietary and one for physical activity, were set. Parents/caregivers were encouraged to participate in the nutrition counselling session. An aerobic session was conducted to encourage participants to be more active and increase their motivation levels, while a hands-on activity 'Let's Play' was aimed at increasing the knowledge of participants about food choices, food selection and healthy food preparation. The last activity was the 'Sharing is Caring' session to encourage parents/caregivers to share their experiences during the intervention period. Supplementation of n-3 LCPUFA (DHA and EPA) Participants in the intervention group were given fish oil capsules containing n-3 LCPUFA (DHA and EPA) for a duration of 16 weeks. The participants were required to consume two fish oil capsules, providing 1320 mg n-3 LCPUFA (792 mg EPA, 20:5n-3 and 528 mg DHA, 22:6n-3), and 6 IU vitamin E (D-alpha tocopherol) daily. The EPA and DHA ratio were, 1.5:1. The role of vitamin E is to stabilise the oil and is equal to 57%, 53.6% and 42.6% of Vitamin E RNI for Malaysia (2005) for children aged 7 to 9 years old, 10 to 12-year-old girls and 10 to 12-year-old boys, respectively. Participants were instructed to consume the capsules once a day before breakfast. Determination of Dosage Prior to supplementation with n-3 LCPUFA (DHA and EPA), other guidelines and outcomes of previous studies were reviewed. The recommendation of n-3 LCPUFA intake is 0.3 to 1.2% of total calorie intake. Supplementation of 0.6% of DHA/EPA from total energy is an acceptable range and an effective dosage for weight reduction in children and below the potential level that could lead to complications The required dosage for the study ranged from 1186.7 mg to 1326.6 mg per day. Thus, the participants were asked to consume two fish oil capsules per day, which is equal to 1320 mg/day. Girls aged 7 to 9 years in the study consumed about 260 mg of DHA and EPA above their suggested amount. However, the amount is still below the potential level that could lead to complications. Each participant received sufficient fish oil capsules (60 capsules) for one month (30 days) of the intervention period. Control Group Participants received Stage-based Lifestyle Modification for the management of childhood obesity only. Study Measurements Information on demographic and socioeconomic, medical status, Child Feeding Questionnaire (CFQ), Family Eating and Activity Habits Questionnaire (FEAHQ) and Nutrition Knowledge at baseline were obtained though face-to-face interviews between researcher and parents/caregivers. With the help of their parents/caregivers, participants completed the Physical Activity Questionnaire for Older Children (PAQ-C) and three-day food record. Clear instructions were given to the parents/caregivers before they answered the questionnaires. In each visit, participants' anthropometric measurements were obtained and their BP was taken. Blood analysis was conducted at baseline, week 16 and week 24 for lipid profile, FBG, insulin and HOMA-IR index, fatty acid composition (DHA and EPA), adiponectin, hs-CRP and serum ferritin.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Life Style Modification, Childhood Obesity
    Keywords
    Childhood obesity, Life style modification, Omega 3, supplementation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    A parallel study is a type of clinical study where two groups of treatments. The intervention group (IG) received stage-based lifestyle modification intervention and fish oil supplement, while the control group (CG) received stage-based lifestyle modification intervention only.
    Masking
    ParticipantCare Provider
    Masking Description
    After the parents/caregivers completed the consent form, the participants were age matched and randomized using a permuted block method, with a block size of four, into either IG or CG. To guarantee allocation concealment, we had the recommendation the randomization carried out by an independent third party.
    Allocation
    Randomized
    Enrollment
    37 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention Group
    Arm Type
    Experimental
    Arm Description
    stage-based lifestyle modification intervention and fish oil supplement (omega-3). Stage-based Lifestyle Modification consists of several activities that include nutrition counselling, aerobic sessions, a hands-on activity 'Let's Play' and 'Sharing is Caring' Participants in the intervention group were also given fish oil capsules containing n-3 LCPUFA (DHA and EPA) for a duration of 16 weeks. The participants were required to consume two fish oil capsules, providing 1320 mg n-3 LCPUFA (792 mg EPA, 20:5n-3 and 528 mg DHA, 22:6n-3), and 6 IU vitamin E (D-alpha tocopherol) daily. The EPA and DHA ratio was 1.5:1.
    Arm Title
    Control Group
    Arm Type
    Other
    Arm Description
    Only received Stage-based Lifestyle Modification consists of several activities that include nutrition counselling, aerobic sessions, a hands-on activity 'Let's Play' and 'Sharing is Caring'
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Omega 3
    Intervention Type
    Behavioral
    Intervention Name(s)
    stage-based lifestyle modification intervention
    Primary Outcome Measure Information:
    Title
    BMI-for-age change
    Description
    Height and weight were measured to calculate BMI-for-age
    Time Frame
    Change from Baseline SBMI-for-age at 24 weeks
    Secondary Outcome Measure Information:
    Title
    waist circumference [cm]
    Description
    Participants with abdominal obesity were determined based on the 90th percentile values for WC for sex and age
    Time Frame
    Every four weeks for a duration of 24 weeks
    Title
    Mid-Upper Arm Muscle Circumference [cm] Mid-Upper Arm Muscle Circumference
    Description
    A fibreglass tape (measuring tape SECA 201 SECA Vogel and Halke Gmbh & Co., Germany) was used to measure MAC at non-vascular access sites of participants. Participants were required to stand in an erect position with the upper arm approximately parallel to the body and their forearms placed palm down across the middle of the body with the elbow bent to 90 degrees. The midpoint of the tip of the acromion process and the olecranon process was marked. The middle of the arm perpendicular to the long axis of the divisional was measured using a fibreglass tape. The measurement was recorded to the nearest 0.1 cm. The following formula was used to calculate MUAMC. Mid-Upper Arm Muscle Circumference
    Time Frame
    Every four weeks for a duration of 24 weeks
    Title
    Total cholesterol [TC] mmol/L
    Description
    A trained nurse and lab assistant performed blood drawing in the Haematology Lab, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia. Five ml blood samples were collected three times; baseline, week 16 and week 24. All participants were required to fast overnight (10 to 12 hours), except for one to two glasses of plain water before the blood draw session. A fasting blood sample was collected from a peripheral vein of the arm for lipid profile, FBG, insulin, hs-CRP and ferritin analysis.
    Time Frame
    week 0, week 16 and week 24
    Title
    Triglyceride mmol/L
    Description
    A trained nurse and lab assistant performed blood drawing in the Haematology Lab, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia. Five ml blood samples were collected three times; baseline, week 16 and week 24. All participants were required to fast overnight (10 to 12 hours), except for one to two glasses of plain water before the blood draw session. A fasting blood sample was collected from a peripheral vein of the arm for lipid profile, FBG, insulin, hs-CRP and ferritin analysis.
    Time Frame
    week 0, week 16 and week 24
    Title
    Low-density lipoprotein [LDL] mmol/L
    Description
    A trained nurse and lab assistant performed blood drawing in the Haematology Lab, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia. Five ml blood samples were collected three times; baseline, week 16 and week 24. All participants were required to fast overnight (10 to 12 hours), except for one to two glasses of plain water before the blood draw session. A fasting blood sample was collected from a peripheral vein of the arm for lipid profile, FBG, insulin, hs-CRP and ferritin analysis.
    Time Frame
    week 0, week 16 and week 24
    Title
    High-density lipoprotein [HDL]) mmol/L
    Description
    Fasting blood glucose (FBG), insulin and homeostasis model assessment insulin-A trained nurse and lab assistant performed blood drawing in the Haematology Lab, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia. Five ml blood samples were collected three times; baseline, week 16 and week 24. All participants were required to fast overnight (10 to 12 hours), except for one to two glasses of plain water before the blood draw session. A fasting blood sample was collected from a peripheral vein of the arm for lipid profile, FBG, insulin, hs-CRP and ferritin analysis.
    Time Frame
    week 0, week 16 and week 24
    Title
    Fasting blood glucose (FBG) mmol/L
    Description
    A trained nurse and lab assistant performed blood drawing in the Haematology Lab, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia. Five ml blood samples were collected three times; baseline, week 16 and week 24. All participants were required to fast overnight (10 to 12 hours), except for one to two glasses of plain water before the blood draw session. A fasting blood sample was collected from a peripheral vein of the arm for lipid profile, FBG, insulin, hs-CRP and ferritin analysis.
    Time Frame
    week 0, week 16 and week 24
    Title
    Insulin [uU/mL]
    Description
    A trained nurse and lab assistant performed blood drawing in the Haematology Lab, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia. Five ml blood samples were collected three times; baseline, week 16 and week 24. All participants were required to fast overnight (10 to 12 hours), except for one to two glasses of plain water before the blood draw session. A fasting blood sample was collected from a peripheral vein of the arm for lipid profile, FBG, insulin, hs-CRP and ferritin analysis.
    Time Frame
    week 0, week 16 and week 24
    Title
    Homeostasis model assessment insulin-resistance index (HOMA-IR index)
    Description
    HOMA-IR index, as a measure of insulin resistance, was calculated as [fasting insulin (μU/mL)]X[fasting glucose (mmol/L)]/22.5
    Time Frame
    week 0, week 16 and week 24
    Title
    DHA
    Description
    Plasma lipid extraction process was carried out based on the principle of the Folch Method. For analysis of fatty acids' on the same day with the preparation of FAME, a total of 500 μl of hexane was added to the FAME and it was dried and analysed using gas chromatography (GC) 6890N (Network GC System).
    Time Frame
    week 0, week 16 and week 24
    Title
    EPA
    Description
    Plasma lipid extraction process was carried out based on the principle of the Folch Method. For analysis of fatty acids' on the same day with the preparation of FAME, a total of 500 μl of hexane was added to the FAME and it was dried and analysed using gas chromatography (GC) 6890N (Network GC System).
    Time Frame
    week 0, week 16 and week 24
    Title
    Adiponectin
    Description
    Plasma levels of adiponectin were determined using a novel enzyme-linked immunosorbent assay (ELISA) (ALPCO Diagnostics, Salem, NH) (ADIPOA).
    Time Frame
    week 0, week 16 and week 24
    Title
    High-sensitivity C-reactive protein (hs-CRP)[mg/L]
    Description
    A trained nurse and lab assistant performed blood drawing in the Haematology Lab, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia. Five ml blood samples were collected three times; baseline, week 16 and week 24. All participants were required to fast overnight (10 to 12 hours), except for one to two glasses of plain water before the blood draw session. A fasting blood sample was collected from a peripheral vein of the arm for lipid profile, FBG, insulin, hs-CRP and ferritin analysis.
    Time Frame
    week 0, week 16 and week 24
    Title
    Serum ferritin[ng/mL]
    Description
    A trained nurse and lab assistant performed blood drawing in the Haematology Lab, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia. Five ml blood samples were collected three times; baseline, week 16 and week 24. All participants were required to fast overnight (10 to 12 hours), except for one to two glasses of plain water before the blood draw session. A fasting blood sample was collected from a peripheral vein of the arm for lipid profile, FBG, insulin, hs-CRP and ferritin analysis.
    Time Frame
    week 0, week 16 and week 24
    Title
    calorie
    Description
    Three day food record
    Time Frame
    Every four weeks for a duration of 24 weeks
    Title
    Carbohydrate [g & %]
    Description
    Three day food record
    Time Frame
    Every four weeks for a duration of 24 weeks
    Title
    Protein [g & %]
    Description
    Three day food record
    Time Frame
    Every four weeks for a duration of 24 weeks
    Title
    Fat [g & %]
    Description
    Three day food record
    Time Frame
    Every four weeks for a duration of 24 weeks
    Title
    Saturated fatty acid [g & %]
    Description
    Three day food record
    Time Frame
    Every four weeks for a duration of 24 weeks
    Title
    Polyunsaturated fatty acid [g & %]
    Description
    Three day food record
    Time Frame
    Every four weeks for a duration of 24 weeks
    Title
    monounsaturated fatty acid [g & %]
    Description
    Three day food record
    Time Frame
    Every four weeks for a duration of 24 weeks
    Title
    Fibre [g & %]
    Description
    Three day food record
    Time Frame
    Every four weeks for a duration of 24 weeks
    Title
    Sugar [g & %]
    Description
    Three day food record
    Time Frame
    Every four weeks for a duration of 24 weeks
    Title
    Physical activity level
    Description
    Physical Activity Questionnaire for Older Children (PAQ-C)
    Time Frame
    Every four weeks for a duration of 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: Children aged 7 to 11 years old. Classified as obese (>+2SD) based on BMI-for-age for 5 to 19 years old (WHO, 2007). Exclusion Criteria: • Children diagnosed with asthma, diabetes mellitus (DM), psychiatric disorders (e.g. schizophrenia, severe autism or mental retardation, or psychosis), or other serious medical conditions. Children receiving medications that could potentially promote weight gain or weight loss.was sent to lab for lipid profile, FBG, insulin, hs-CRP and ferritin analysis. Children participating in any weight management programmes. Overweight, normal weight and underweight children.

    12. IPD Sharing Statement

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    Effects of Omega-3 Supplementation on Nutritional Status and Physical Activity of Obese Children

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