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

NCT04884451 | Unknown

• 1 other identifier: JKEUPM-2019-375
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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).

  Change from baseline to week 24

Secondary Outcomes (5)

• 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

• Energy and nutrient intakes [macronutrients, Saturated Fatty Acids (SFA), sugar and dietary fibre] change

  Change from baseline to week 24

• Physical activity score change

  Change from baseline to week 24

• Stage of readiness to lose weight change

  Change from baseline to week 24

Study Arms (2)

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.

Behavioral: Lifestyle modification

Control

NO INTERVENTION

Participants will receive counseling from dietitians based on the routine care for the management of childhood obesity.

Interventions

Lifestyle modification BEHAVIORAL

Diet and physical activity modification and behavioral approach

Intervention

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiti Putra Malaysia: lead

Study Sites (1)

Universiti Putra Malaysia Teaching Hospital

Serdang, Selangor, 43400, Malaysia

RECRUITING

Central Study Contacts

nor baizura md yusop

CONTACT

+603-97692931; norbaizura@upm.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: May 4, 2021
• First Posted: May 13, 2021
• Study Start: April 3, 2021
• Primary Completion: November 1, 2021
• Study Completion: December 1, 2021
• Last Updated: May 13, 2021

Record last verified: 2021-05

Locations

MY (1)