NCT04463069

Brief Summary

Considering that children with intellectual disability (ID) might be more vulnerable to obesity than their counterparts in the general population. This study aimed to develop and evaluate the effectiveness of an adapted physical activity (APA) program in reducing weight among adolescents with ID. The hypothesis of the study was the APA program would be able to decrease obesity among adolescents with ID.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

September 1, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

June 28, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 9, 2020

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

August 11, 2021

Completed
Last Updated

May 9, 2022

Status Verified

April 1, 2022

Enrollment Period

10 months

First QC Date

June 28, 2020

Results QC Date

November 10, 2020

Last Update Submit

April 12, 2022

Conditions

Keywords

adolescentsintellectual disabilityoverweightobesityphysical activityintervention

Outcome Measures

Primary Outcomes (1)

  • BMI Change

    The primary outcome variable was change in BMI (weight (kg) / height2 (m)) that was further calculated from the height and weight measured at school in the morning time. Height was measured to the nearest 0.1 cm using a stadiometer and weight was measured to the nearest 0.1 kg on a TANITA digital scale (TBF-410) with the subject wearing lightweight clothing and no shoes.

    Change from baseline at 4 months and 9 months

Secondary Outcomes (8)

  • BMIz Change

    Change from baseline at 4 months and 9 months

  • Weight Change

    Change from baseline at 4 months and 9 months

  • Percent Body Fat Change

    Change from baseline at 4 months and 9 months

  • Waist Circumference Change

    Change from baseline at 4 months and 9 months

  • Waist-to-height Ratio Change

    Change from baseline at 4 months and 9 months

  • +3 more secondary outcomes

Study Arms (2)

intervention group

EXPERIMENTAL

Participants in the intervention group participated in the APA intervention consisting of simple and fun endurance and strength-building exercise at a frequency of two sessions per week.

Other: Adapted physical activity

control group

NO INTERVENTION

Participants in the control group received no intervention in the study time period.

Interventions

This PA program was modified from an adapted physical activity (APA) program that designed for obesity management among adolescents with intellectual disability (ID). The aim of the APA program was to promote PA and health for people in special needs. In this study, the APA program was carefully designed based on a comprehensive pre-intervention assessment of each adolescent with ID, so that can be able to address their individual needs in learning and adaption. The APA program comprised three stages of APA training at school and each stage consisted of simple and fun endurance and strength-building exercise, at a frequency of two sessions per week, and lasting for about three months.

intervention group

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • aged between 12 and 18 years
  • overweight and obesity
  • mild or moderate intellectual disability

You may not qualify if:

  • physical disability
  • medical predispositions towards obesity (genetic syndrome or drug treatment)
  • contraindications (e.g. asthma, heart disease)
  • having participated in other exercise programs in the past 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hong Kong Bapist University

Hong Kong, China

Location

MeSH Terms

Conditions

ObesityIntellectual DisabilityOverweightMotor Activity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesNeurodevelopmental DisordersMental DisordersBehavior

Results Point of Contact

Title
Dr. Yang Gao
Organization
Hong Kong Baptist University

Study Officials

  • Yang Gao, PhD

    Hong Kong Baptist University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 28, 2020

First Posted

July 9, 2020

Study Start

September 1, 2018

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

May 9, 2022

Results First Posted

August 11, 2021

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations