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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04884451
Acronym
ST-NEPCO
Enrollment
60
Registered
2021-05-13
Start date
2021-04-03
Completion date
2021-12-31
Last updated
2021-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Educational Materials (ST-NEPCO) During Nutrition Counselling for Obese Children

Brief 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. 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.

Interventions

BEHAVIORALLifestyle modification

Diet and physical activity modification and behavioral approach

Sponsors

Universiti Putra Malaysia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
7 Years to 12 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
BMI-for-age z -score changeChange from baseline to week 24BMI-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).

Secondary

MeasureTime frameDescription
Body composition (BMI, Lean Body Mass (LBM), Body Fat Mass (BFM) changeChange from baseline to week 24Body 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.
Waist and hip circumferences changeChange from baseline to week 24WC 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.
Stage of readiness to lose weight changeChange from baseline to week 24The 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).
Energy and nutrient intakes [macronutrients, Saturated Fatty Acids (SFA), sugar and dietary fibre] changeChange from baseline to week 24Dietary 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.
Physical activity score changeChange from baseline to week 24Physical 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.

Countries

Malaysia

Contacts

Primary Contactnor baizura md yusop
norbaizura@upm.edu.my+603-97692931

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026