Childhood ObesityNCT03429699
Lifestyle Modification Intervention for Obese Children
A study testing Stage-based Lifestyle Modification Intervention for the Management of Childhood Obesity and Existing practice for the management of childhood obesity in people with Childhood Obesity and Life Style Modification, run by Universiti Putra Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity, Life Style Modification
- What is being tested?
- Stage-based Lifestyle Modification Intervention for the Management of Childhood Obesity and Existing practice for the management of childhood obesity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 2 Feb 2012to 10 Mar 2014
- 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
- 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)
Who cannot join
- 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
About this study
Official title: Effectiveness of a Stage-based Lifestyle Modification Intervention for Obese Children
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.
Read the 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.
- 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
- Conditions
- Childhood Obesity, Life Style Modification
- Being tested
- Stage-based Lifestyle Modification Intervention for the Management of Childhood Obesity, Existing practice for the management of childhood obesity
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stage-based Lifestyle Modification Intervention for the Management of Childhood ObesityBehavioural
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.
Existing practice for the management of childhood obesityBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Not described Receives: Behavioral: Stage-based Lifestyle Modification Intervention for the Management of Childhood Obesity |
| Control group | Other | Not described Receives: Behavioral: Existing practice for the management of childhood obesity |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight (kg)
Measured: 24 weeks
Height (cm)
Measured: 24 weeks
BMI-for-age Z score
Measured: 24 weeks
Secondary outcomes (10)
waist circumference (cm)
Measured: 24 weeks
Mid-upper Arm Muscle Circumference (cm)
Measured: 24 weeks
Body fat (%)
Measured: 24 weeks
Energy (kcal)
Measured: 24 weeks
carbohydrate (g)
Measured: 24 weeks
Protein (g)
Measured: 24 weeks
Fat (g)
Measured: 24 weeks
Sugar (g)
Measured: 24 weeks
Fiber (g)
Measured: 24 weeks
Physical Activity Questionnaire for Older Children (PAQ-C)
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2018
- Study start2 Feb 2012
- Primary completion10 Mar 2014
- Study completion10 Mar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Childhood ObesityStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 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
- NCT03429699
- Sponsor's protocol ID
- UPM/FPSK/PADS/T7-MJKEtikalPer
- Status last verified
- Feb 2018
- First submitted
- 4 Feb 2018
- Last updated
- 12 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29490648
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Stage-based Lifestyle Modification Intervention for Obese Children
- ClinicalTrials.gov ID
- NCT03429699
- Acronym / sponsor ID
- UPM/FPSK/PADS/T7-MJKEtikalPer
- Conditions
- Childhood Obesity, Life Style Modification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Universiti Putra MalaysiaUniversity, hospital or other
- Study start
- 2 Feb 2012 (actual)
- Primary completion
- 10 Mar 2014 (actual)
- Study completion
- 10 Mar 2014 (actual)
- First posted
- 12 Feb 2018 (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.
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.
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Stage-based Lifestyle Modification Intervention for the Management of Childhood Obesity |
| Control group | Other | Behavioral: Existing practice for the management of childhood obesity |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged 2 - 12 years old
- Obese based on the WHO growth chart 2007 (BMI-for-age more than +2SD)
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Stage-based Lifestyle Modification Intervention for the Management of Childhood ObesityThe 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. | Behavioural | Intervention group |
| Existing practice for the management of childhood obesityThe 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. | Behavioural | Control group |
Primary outcome
weight (kg)
Time frame: 24 weeks
Height (cm)
Time frame: 24 weeks
BMI-for-age Z score
Time frame: 24 weeks
10 secondary outcomes
waist circumference (cm)
Time frame: 24 weeks
Mid-upper Arm Muscle Circumference (cm)
Time frame: 24 weeks
Body fat (%)
Time frame: 24 weeks
Energy (kcal)
Time frame: 24 weeks
carbohydrate (g)
Time frame: 24 weeks
Protein (g)
Time frame: 24 weeks
Fat (g)
Time frame: 24 weeks
Sugar (g)
Time frame: 24 weeks
Fiber (g)
Time frame: 24 weeks
Physical Activity Questionnaire for Older Children (PAQ-C)
Time frame: 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 12 Feb 2018.
- Derived from this study: PubMed 29490648Md 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.
- Individual participant dataSharing planned: No
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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 Stage-based Lifestyle Modification Intervention for the Management of Childhood Obesity and Existing practice for the management of childhood obesity in people with Childhood Obesity and Life Style Modification, 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 3 inclusion and 6 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 12 Feb 2018. 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?
weight (kg) (time frame: 24 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03429699, which also lists 1 linked publication.
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 12 Feb 2018.