NCT06546644

Brief Summary

The proposed research aims to assess how well a structured intervention is intended to reduce childhood obesity. The intervention addresses food and physical activity behaviors, important determinants of obesity, by concentrating on these elements. The goal of nutritional and physical education is to raise knowledge about the negative effects of obesity and encourage healthy eating habits in children and their caregivers. These educational campaigns will be delivered primarily through schools, guaranteeing a wide audience and consistent messaging.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 3, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 9, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

August 15, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2025

Completed
Last Updated

August 9, 2024

Status Verified

August 1, 2024

Enrollment Period

8 months

First QC Date

August 3, 2024

Last Update Submit

August 7, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Dietary knowledge

    Dietary knowledge will be measured by 24-hour dietary recall questionnaire Healthy Eating Index (HEI): Scores range from 0 to 100, with higher scores indicating better diet quality. Below 51: Poor diet. 51-80: Needs improvement. Above 80: Good diet

    6-months from baseline

  • Physical activity education

    Physical activity education will be measured by Global physical activity questionnaire(WHO) Total Physical Activity (MET-minutes): The intensity of activities is expressed in Metabolic Equivalent of Task (MET) minutes. MET values are: Vigorous-intensity activity: 8.0 METs. Moderate-intensity activity: 4.0 METs. Walking: 4.0 METs. Low Activity: \< 600 MET-minutes/week Moderate Activity: 600-2999 MET-minutes/week High Activity: ≥ 3000 MET-minutes/week Sedentary Behavior: More than 8 hours/day of sitting may indicate high sedentary behavior.

    6-months from baseline

Secondary Outcomes (2)

  • Health-related quality of life

    6-months from baseline

  • Body mass index (BMI)

    6-months from baseline

Study Arms (2)

Intervention group

EXPERIMENTAL

The children in the intervention group will receive a school-based structured health intervention to prevent obesity in children aged 5-12 years. A pre-tested validated structured school-based intervention is developed for children in the intervention group. The intervention included behavior change regarding dietary patterns and physical activity. Education will be provided to children in lectures, PowerPoint, smart handouts, and videos. The parents will also be involved in this educational stream through seminars and parent schools specially organized events.

Behavioral: Structured school-based intervention

Control

NO INTERVENTION

The children in the control group will receive no intervention.

Interventions

A pre-tested validated structured school-based intervention is developed for children in the intervention group. The intervention included behavior change regarding dietary patterns and physical activity. Education will be provided to children in lectures, PowerPoint, smart handouts, and videos. The parents will also be involved in this educational stream through seminars and parent schools specially organized events.

Intervention group

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children of age between 5 to 12 years.
  • Enrollment at one of the selected schools.

You may not qualify if:

  • Children and their parents who did not give assent and consent to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

City School Nawab shah

Nawabshah, Sindh, 67450, Pakistan

Location

Related Publications (6)

  • World Health Organisation. (2020, October 19). Noncommunicable diseases: Childhood Overweight and Obesity. Www.who.int. https://www.who.int/news-room/questions-and-answers/item/noncommunicable-diseases-childhood-overweight-and-obesity.

    RESULT
  • Guidelines on Physical Activity, Sedentary Behaviour and Sleep for Children under 5 Years of Age. Geneva: World Health Organization; 2019. Available from http://www.ncbi.nlm.nih.gov/books/NBK541170/

  • Homs C, Berruezo P, Segun G, Estrada L, de Bont J, Riera-Romani J, Carrillo-Alvarez E, Schroder H, Mila R, Gomez SF. Family-based intervention to prevent childhood obesity among school-age children of low socioeconomic status: study protocol of the FIVALIN project. BMC Pediatr. 2021 May 21;21(1):246. doi: 10.1186/s12887-021-02697-x.

  • Battaglia G, Giustino V, Tabacchi G, Alesi M, Galassi C, Modica C, Palma A, Bellafiore M. Effectiveness of a Physical Education Program on the Motor and Pre-literacy Skills of Preschoolers From the Training-To-Health Project: A Focus on Weight Status. Front Sports Act Living. 2020 Dec 16;2:579421. doi: 10.3389/fspor.2020.579421. eCollection 2020.

  • L'hôte, E., Hawkins, N., Lead, U., Strategist, S., Levay, K., & Fellow, R. (2021). Prepared for Impact on Urban Health Changing the Childhood Obesity Conversation to Improve Children's Health. https://www.frameworksinstitute.org/wp-content/uploads/2021/04/GSTC-Childhood-obesity-report-032021.pdf

    RESULT
  • Yuksel HS, Sahin FN, Maksimovic N, Drid P, Bianco A. School-Based Intervention Programs for Preventing Obesity and Promoting Physical Activity and Fitness: A Systematic Review. Int J Environ Res Public Health. 2020 Jan 3;17(1):347. doi: 10.3390/ijerph17010347.

MeSH Terms

Conditions

Pediatric ObesityChild Behavior

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Only the Outcomes Assessor will be blinded regarding group allocation
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The participants after baseline measures, will be randomly assigned into two groups intervention and control in a parallel way.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

August 3, 2024

First Posted

August 9, 2024

Study Start

August 15, 2024

Primary Completion

April 15, 2025

Study Completion

April 15, 2025

Last Updated

August 9, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

The study protocol, statistical plan, and results will be disseminated by publications

Locations