Educational Materials (ST-NEPCO) During Nutrition Counselling for Obese ChildrenST-NEPCONCT04884451
Evaluation of a Stage-Based Tailored, Nutrition Education Package for Childhood Obesity (ST-NEPCO) (7-12 Years Old)
A study testing Lifestyle modification in people with Educational Materials (ST-NEPCO) During Nutrition Counselling for Obese Children, run by Universiti Putra Malaysia at 1 site in Malaysia.
Trial summary
A randomized controlled trial will be used to determine the effectiveness of ST-NEPCO. The study will involve obese children aged 7 to 11 years old. Participants will be assigned randomly to either the intervention or control group. Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Educational Materials (ST-NEPCO) During Nutrition Counselling for Obese Children
- What is being tested?
- Lifestyle modification
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteMalaysia
- Study dates
- 3 Apr 2021to Dec 2021
- 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 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 7 to 11 years old
- Children classified as obese (>+2SD) based on BMI-for-age for 5 to 19 years old (WHO, 2007).
Who cannot join
- Children diagnosed with chronic asthma, diabetes mellitus, psychiatric disorders (e.g. schizophrenia, severe autism or mental retardation, or psychosis), or other serious medical conditions.
- Children receiving medications that can potentially promote weight gain or weight loss.
- Children participating in any weight management program
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
Universiti Putra Malaysia Teaching Hospital
Serdang, Selangor, 43400
FARIDZATUL SYUHADA ABDUL RASHID, +603-9769 9763, faridzatul@upm.edu.my
About this study
A randomized controlled trial will be used to determine the effectiveness of ST-NEPCO. The study will involve obese children aged 7 to 11 years old. Participants will be assigned randomly to either the intervention or control group. The intervention group will receive counselling from the researcher based on ST-NEPCO, meanwhile the control group will receive counseling from dietitians based on the routine care for the management of childhood obesity. The study will be conducted for duration of 24 weeks. The individual counseling session will be held once a month for each participant during the weekend.
- Being tested
- Lifestyle modification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle modificationBehavioural
Diet and physical activity modification and behavioral approach
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants will receive nutritional counselling from the researcher based on Stage-Based, Nutrition Education Package for Childhood Obesity (ST-NEPCO). Nutritional advice and educational tools will be provided according to participants' stages of change. Receives: Behavioral: Lifestyle modification |
| Control | No intervention | Participants will receive counseling from dietitians based on the routine care for the management of childhood obesity. |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI-for-age z -score change
BMI-for-age z-score will be calculated using the WHO AnthroPlus software (http://www.who.int/growthref/tools/en) and the WHO 2007 growth reference will be used to determine the BMI-for-age z-score of participants (de Onis et al., 2007).
Measured: Change from baseline to week 24
Secondary outcomes (5)
Body composition (BMI, Lean Body Mass (LBM), Body Fat Mass (BFM) change
Body composition was measured using a body composition analyzer (InBody S10®; Biospace Co., Ltd., Seoul, Korea). This device uses multiple frequencies (1 kHz, 5 kHz, 50 kHz, 250 kHz, 500 kHz, and 1,000 kHz) of BIA technology and contains 8-point tactile electrodes that were attached to the left and right thumb, middle finger, and ankles. Subjects were in stand position; their arms and legs did not come into contact with each other, and they did not talk or move during the measurement, which lasted 2 minutes.
Measured: Change from baseline to week 24
Waist and hip circumferences change
WC will be measured using a fibreglass tape (measuring tape SECA 201 SECA Vogel and Halke Gmbh \& Co., Germany) at the highest point of the iliac crest at minimal respiration when the participant in a standing position. HC will be obtained at the widest area of hips, which is at the greatest protuberance of the buttocks. The 90th percentile values for WC for sex and age by Poh et al. (2011) will be used as cut-off values to identify respondents with abdominal obesity.
Measured: Change from baseline to week 24
Energy and nutrient intakes [macronutrients, Saturated Fatty Acids (SFA), sugar and dietary fibre] change
Dietary intake will be obtained using three-day food record at baseline and every follow-up visits. Participants and parents/caregivers will be taught about portion size estimation and household measurement to fill in the three-day food record. Pictures from the Atlas of Food Exchanges and Portion Sizes (food album) (Suzana et al., 2002), a set of household measurement tools (glass, soup bowl, plate, cup, teaspoon and tablespoon) and food models will be used to guide parents/caregivers in estimating portion sizes.
Measured: Change from baseline to week 24
Physical activity score change
Physical activity will be assessed using The Physical Activity Questionnaire for Older Children (PAQ-C) (Kowalski et al., 2004). Subjects will be classified into low, moderate and high physical activity categories with a mean total score ranging from 1.00 to 2.33, 2.34 to 3.66 and 3.67 to 5.00, respectively (Baharudin et al., 2014; Kowalski et al., 2004). Internal consistency (Cronbach's alpha) calculated from baseline was 0.73.
Measured: Change from baseline to week 24
Stage of readiness to lose weight change
The measurement will be based on the scale for SOC (The S-Weight) to assess the readiness to lose weight for overweight and obese individual. It consists of five options that are mutually exclusive, among which participants have to choose in order to be allocated to one of the five SOC (Ceccarini, Borrello, Pietrabissa, Manzoni, \& Castelnuovo, 2015).
Measured: Change from baseline to week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2021
- Study start3 Apr 2021
- Primary completionNov 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Educational Materials (ST-NEPCO) During Nutrition Counselling for Obese ChildrenStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
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
- NCT04884451
- Sponsor's protocol ID
- JKEUPM-2019-375
- Acronym
- ST-NEPCO
- Status last verified
- May 2021
- First submitted
- 4 May 2021
- Last updated
- 13 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Stage-Based Tailored, Nutrition Education Package for Childhood Obesity (ST-NEPCO) (7-12 Years Old)
- ClinicalTrials.gov ID
- NCT04884451
- Acronym / sponsor ID
- ST-NEPCO / JKEUPM-2019-375
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universiti Putra MalaysiaUniversity, hospital or other
- Study start
- 3 Apr 2021 (actual)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 13 May 2021 (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.
A randomized controlled trial will be used to determine the effectiveness of ST-NEPCO. The study will involve obese children aged 7 to 11 years old. Participants will be assigned randomly to either the intervention or control group. The intervention group will receive counselling from the researcher based on ST-NEPCO, meanwhile the control group will receive counseling from dietitians based on the routine care for the management of childhood obesity. The study will be conducted for duration of 24 weeks. The individual counseling session will be held once a month for each participant during the weekend.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Lifestyle modificationParticipants will receive nutritional counselling from the researcher based on Stage-Based, Nutrition Education Package for Childhood Obesity (ST-NEPCO). Nutritional advice and educational tools will be provided according to participants' stages of change. |
| Control | No intervention | –Participants will receive counseling from dietitians based on the routine care for the management of childhood obesity. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children aged 7 to 11 years old
- Children classified as obese (>+2SD) based on BMI-for-age for 5 to 19 years old (WHO, 2007).
Key exclusion criteria (3 listed)
- Children diagnosed with chronic asthma, diabetes mellitus, psychiatric disorders (e.g. schizophrenia, severe autism or mental retardation, or psychosis), or other serious medical conditions.
- Children receiving medications that can potentially promote weight gain or weight loss.
- Children participating in any weight management program
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 |
|---|---|---|
| Lifestyle modificationDiet and physical activity modification and behavioral approach | Behavioural | Intervention |
Primary outcome
BMI-for-age z -score change
Time frame: Change from baseline to week 24
BMI-for-age z-score will be calculated using the WHO AnthroPlus software (http://www.who.int/growthref/tools/en) and the WHO 2007 growth reference will be used to determine the BMI-for-age z-score of participants (de Onis et al., 2007).
5 secondary outcomes
Body composition (BMI, Lean Body Mass (LBM), Body Fat Mass (BFM) change
Time frame: Change from baseline to week 24
Waist and hip circumferences change
Time frame: Change from baseline to week 24
Energy and nutrient intakes [macronutrients, Saturated Fatty Acids (SFA), sugar and dietary fibre] change
Time frame: Change from baseline to week 24
Physical activity score change
Time frame: Change from baseline to week 24
Stage of readiness to lose weight change
Time frame: Change from baseline to week 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2021.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle modification in people with Educational Materials (ST-NEPCO) During Nutrition Counselling for Obese Children, run by Universiti Putra Malaysia at 1 site in 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 3 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: status not confirmed, as of the sponsor's last update on 13 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact nor baizura md yusop (+603-97692931, norbaizura@upm.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BMI-for-age z -score change (time frame: Change from baseline to week 24). 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 May 2021.