Life Style ModificationNCT04156971
Effects of Omega-3 Supplementation on Nutritional Status and Physical Activity of Obese Children
A study testing Omega 3 and stage-based lifestyle modification intervention in people with Life Style Modification and Childhood Obesity, run by Universiti Putra Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Life Style Modification, Childhood Obesity
- What is being tested?
- Omega 3 and stage-based lifestyle modification intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2013to 28 Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 7 to 11 years old.
- Classified as obese (>+2SD) based on BMI-for-age for 5 to 19 years old (WHO, 2007).
Who cannot join
- 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.
About this study
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
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.
Read the 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
- 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.
- Conditions
- Life Style Modification, Childhood Obesity
- Being tested
- Omega 3, stage-based lifestyle modification intervention
- Keywords
- Childhood obesity, Life style modification, Omega 3, supplementation
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega 3Dietary supplement
stage-based lifestyle modification interventionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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' Receives: Behavioral: stage-based lifestyle modification intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI-for-age change
Height and weight were measured to calculate BMI-for-age
Measured: Change from Baseline SBMI-for-age at 24 weeks
Secondary outcomes (24)
waist circumference [cm]
Participants with abdominal obesity were determined based on the 90th percentile values for WC for sex and age
Measured: Every four weeks for a duration of 24 weeks
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
Measured: Every four weeks for a duration of 24 weeks
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.
Measured: week 0, week 16 and week 24
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.
Measured: week 0, week 16 and week 24
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.
Measured: week 0, week 16 and week 24
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.
Measured: week 0, week 16 and week 24
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.
Measured: week 0, week 16 and week 24
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.
Measured: week 0, week 16 and week 24
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
Measured: week 0, week 16 and week 24
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).
Measured: week 0, week 16 and week 24
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).
Measured: week 0, week 16 and week 24
Adiponectin
Plasma levels of adiponectin were determined using a novel enzyme-linked immunosorbent assay (ELISA) (ALPCO Diagnostics, Salem, NH) (ADIPOA).
Measured: week 0, week 16 and week 24
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.
Measured: week 0, week 16 and week 24
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.
Measured: week 0, week 16 and week 24
calorie
Three day food record
Measured: Every four weeks for a duration of 24 weeks
Carbohydrate [g & %]
Three day food record
Measured: Every four weeks for a duration of 24 weeks
Protein [g & %]
Three day food record
Measured: Every four weeks for a duration of 24 weeks
Fat [g & %]
Three day food record
Measured: Every four weeks for a duration of 24 weeks
Saturated fatty acid [g & %]
Three day food record
Measured: Every four weeks for a duration of 24 weeks
Polyunsaturated fatty acid [g & %]
Three day food record
Measured: Every four weeks for a duration of 24 weeks
monounsaturated fatty acid [g & %]
Three day food record
Measured: Every four weeks for a duration of 24 weeks
Fibre [g & %]
Three day food record
Measured: Every four weeks for a duration of 24 weeks
Sugar [g & %]
Three day food record
Measured: Every four weeks for a duration of 24 weeks
Physical activity level
Physical Activity Questionnaire for Older Children (PAQ-C)
Measured: Every four weeks for a duration of 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2019
- Study start1 Jun 2013
- Primary completion31 Jul 2014
- Study completion28 Feb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Life Style ModificationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Putra Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nor Baizura Md. Yusop, Universiti Putra Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04156971
- Sponsor's protocol ID
- JPD_Feb(13)05(Interview)
- Status last verified
- Nov 2019
- First submitted
- 30 Oct 2019
- Last updated
- 13 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04156971
- Acronym / sponsor ID
- JPD_Feb(13)05(Interview)
- Conditions
- Life Style Modification, Childhood Obesity
- Keywords
- Childhood obesity, Life style modification, Omega 3, supplementation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Universiti Putra MalaysiaUniversity, hospital or other
- Study start
- 1 Jun 2013 (actual)
- Primary completion
- 31 Jul 2014 (actual)
- Study completion
- 28 Feb 2015 (actual)
- First posted
- 8 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Dietary Supplement: Omega 3, Behavioral: stage-based lifestyle modification interventionstage-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. |
| Control Group | Other | Behavioral: stage-based lifestyle modification interventionOnly 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' |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children aged 7 to 11 years old.
- Classified as obese (>+2SD) based on BMI-for-age for 5 to 19 years old (WHO, 2007).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega 3 | Dietary supplement | Intervention Group |
| stage-based lifestyle modification intervention | Behavioural | Control Group, Intervention Group |
Primary outcome
BMI-for-age change
Time frame: Change from Baseline SBMI-for-age at 24 weeks
Height and weight were measured to calculate BMI-for-age
24 secondary outcomes
waist circumference [cm]
Time frame: Every four weeks for a duration of 24 weeks
Mid-Upper Arm Muscle Circumference [cm] Mid-Upper Arm Muscle Circumference
Time frame: Every four weeks for a duration of 24 weeks
Total cholesterol [TC] mmol/L
Time frame: week 0, week 16 and week 24
Triglyceride mmol/L
Time frame: week 0, week 16 and week 24
Low-density lipoprotein [LDL] mmol/L
Time frame: week 0, week 16 and week 24
High-density lipoprotein [HDL]) mmol/L
Time frame: week 0, week 16 and week 24
Fasting blood glucose (FBG) mmol/L
Time frame: week 0, week 16 and week 24
Insulin [uU/mL]
Time frame: week 0, week 16 and week 24
Homeostasis model assessment insulin-resistance index (HOMA-IR index)
Time frame: week 0, week 16 and week 24
DHA
Time frame: week 0, week 16 and week 24
EPA
Time frame: week 0, week 16 and week 24
Adiponectin
Time frame: week 0, week 16 and week 24
High-sensitivity C-reactive protein (hs-CRP)[mg/L]
Time frame: week 0, week 16 and week 24
Serum ferritin[ng/mL]
Time frame: week 0, week 16 and week 24
calorie
Time frame: Every four weeks for a duration of 24 weeks
Carbohydrate [g & %]
Time frame: Every four weeks for a duration of 24 weeks
Protein [g & %]
Time frame: Every four weeks for a duration of 24 weeks
Fat [g & %]
Time frame: Every four weeks for a duration of 24 weeks
Saturated fatty acid [g & %]
Time frame: Every four weeks for a duration of 24 weeks
Polyunsaturated fatty acid [g & %]
Time frame: Every four weeks for a duration of 24 weeks
monounsaturated fatty acid [g & %]
Time frame: Every four weeks for a duration of 24 weeks
Fibre [g & %]
Time frame: Every four weeks for a duration of 24 weeks
Sugar [g & %]
Time frame: Every four weeks for a duration of 24 weeks
Physical activity level
Time frame: Every four weeks for a duration of 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2019.
Related trials for Life Style Modification
Active, not recruiting
A Pilot Factorial Trial of an Integrated Lifestyle Intervention
Physical Inactivity, Overweight and Obesity
Active, not recruitingPhase 2
Effectiveness Study of a Lifestyle Intervention Versus Metformin in Mothers With Recent Gestational Diabetes
Weight Loss, Gestational Diabetes Mellitus in Pregnancy
Recruiting
Stress Reduction and Lifestyle Modification in Irritable Bowel Syndrome Patients
Irritable Bowel Syndrome
Recruiting
iWAIST Trial: ERCG (Endoscopic Radial Compression Gastroplasty) +Optimized Lifestyle Intervention (OLI) vs Sham + OLI for Weight Loss
Overweight and/or Obesity, Metabolic Syndrome
Recruiting
Ambient Air and Noise Effect on Cardiovascular Health Risk and Lifestyle Intervention to Attenuate It (METSGREEN)
Cardiovascular Diseases (CVD), Metabolic Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Omega 3 and stage-based lifestyle modification intervention in people with Life Style Modification and Childhood Obesity, run by Universiti Putra Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BMI-for-age change (time frame: Change from Baseline SBMI-for-age at 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2019.