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

NCT04156971 | Completed

• 1 other identifier: JPD_Feb(13)05(Interview)
• Study Type: interventional
• Target: 37
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Life Style Modification; Childhood Obesity

Keywords

Childhood obesity; Life style modification; Omega 3; supplementation

Outcome Measures

Primary Outcomes (1)

• BMI-for-age change

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

  Change from Baseline SBMI-for-age at 24 weeks

Secondary Outcomes (24)

• waist circumference [cm]

  Every four weeks for a duration of 24 weeks

• Mid-Upper Arm Muscle Circumference [cm] Mid-Upper Arm Muscle Circumference

  Every four weeks for a duration of 24 weeks

• Total cholesterol [TC] mmol/L

  week 0, week 16 and week 24

• Triglyceride mmol/L

  week 0, week 16 and week 24

• Low-density lipoprotein [LDL] mmol/L

  week 0, week 16 and week 24

Study Arms (2)

Intervention Group

EXPERIMENTAL

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.

Dietary Supplement: Omega 3; Behavioral: stage-based lifestyle modification intervention

Control Group

OTHER

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'

Behavioral: stage-based lifestyle modification intervention

Interventions

Omega 3 DIETARY_SUPPLEMENT

Intervention Group

stage-based lifestyle modification intervention BEHAVIORAL

Control Group; Intervention Group

Eligibility Criteria

• Age: 7 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universiti Putra Malaysia: lead

MeSH Terms

Conditions

Pediatric Obesity

Interventions

Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer

Model Details: 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.

Study Record Dates

• First Submitted: October 30, 2019
• First Posted: November 8, 2019
• Study Start: June 1, 2013
• Primary Completion: July 31, 2014
• Study Completion: February 28, 2015
• Last Updated: November 13, 2019

Record last verified: 2019-11