Effects of Omega-3 Supplementation on Nutritional Status and Physical Activity of Obese Children
Condition: Life Style Modification; Childhood Obesity
MeSH terms: Pediatric Obesity
Study type: Interventional

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).

        1. 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.

        2. 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.
    

Intervention name(s): Omega 3; stage-based lifestyle modification intervention
Intervention type(s): Dietary Supplement; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention 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: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Childhood obesity; Life style modification; Omega 3; supplementation