Evaluation of a Stage-Based Tailored, Nutrition Education Package for Childhood Obesity (ST-NEPCO) (7-12 Years Old)
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Universiti Putra Malaysia
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- BMI-for-age z -score change
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 7 Years to 12 Years (Child)
- Sex
- All
- Accepts 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
Arms & Interventions
Control
Participants will receive counseling from dietitians based on the routine care for the management of childhood obesity.
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.
Intervention: Lifestyle modification (Behavioral)
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)
Investigators
Nor Baizura Md. Yusop
Dr
Universiti Putra Malaysia