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

NCT ID: NCT04884451

Last Updated: 2021-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-03

Study Completion Date

2021-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Lifestyle modification

Intervention Type BEHAVIORAL

Diet and physical activity modification and behavioral approach

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Lifestyle modification

Diet and physical activity modification and behavioral approach

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

7 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universiti Putra Malaysia

OTHER

Sponsor Role lead

Responsible Party

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Nor Baizura Md. Yusop

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Universiti Putra Malaysia Teaching Hospital

Serdang, Selangor, Malaysia

Site Status RECRUITING

Countries

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Malaysia

Central Contacts

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nor baizura md yusop

Role: CONTACT

+603-97692931

Facility Contacts

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FARIDZATUL SYUHADA ABDUL RASHID

Role: primary

+603-9769 9763

Other Identifiers

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JKEUPM-2019-375

Identifier Type: -

Identifier Source: org_study_id

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