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Clinical Trials/NCT04884451
NCT04884451
Unknown
Not Applicable

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

Universiti Putra Malaysia1 site in 1 country60 target enrollmentApril 3, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Educational Materials (ST-NEPCO) During Nutrition Counselling for Obese Children
Sponsor
Universiti Putra Malaysia
Enrollment
60
Locations
1
Primary Endpoint
BMI-for-age z -score change
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 3, 2021
End Date
December 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Nor Baizura Md. Yusop

Dr

Universiti Putra Malaysia

Eligibility Criteria

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

Outcomes

Primary Outcomes

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).

Secondary Outcomes

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

Study Sites (1)

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