Evaluation of a Stage-Based Tailored, Nutrition Education Package for Childhood Obesity (ST-NEPCO) (7-12 Years Old) (ST-NEPCO)

May 11, 2021 updated by: Nor Baizura Md. Yusop, Universiti Putra Malaysia
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Malaysia
    • Selangor
      • Serdang, Selangor, Malaysia, 43400
        • Recruiting
        • Universiti Putra Malaysia Teaching Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

7 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention
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.
Behavioral: Lifestyle modification
Diet and physical activity modification and behavioral approach
No Intervention: Control
Participants will receive counseling from dietitians based on the routine care for the management of childhood obesity.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Change from baseline to week 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Body composition (BMI, Lean Body Mass (LBM), Body Fat Mass (BFM) change
Time Frame: Change from baseline to week 24
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.
Change from baseline to week 24
Waist and hip circumferences change
Time Frame: Change from baseline to week 24
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.
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
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.
Change from baseline to week 24
Physical activity score change
Time Frame: Change from baseline to week 24
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.
Change from baseline to week 24
Stage of readiness to lose weight change
Time Frame: Change from baseline to week 24
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).
Change from baseline to week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universiti Putra Malaysia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 3, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 4, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 13, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 13, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • JKEUPM-2019-375

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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