NCT04079439

Brief Summary

The main objective of this project is to enhance physical activity in youths and adults with intellectual disabilities (IDs) by developing and testing a tailored e-heath support for motivation and participation in physical activity.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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 20, 2019

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 6, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

January 10, 2023

Status Verified

June 1, 2021

Enrollment Period

4 months

First QC Date

August 20, 2019

Last Update Submit

January 9, 2023

Conditions

Intellectual Disability

Outcome Measures

Primary Outcomes (1)

  • Steps per day

    The primary outcome is physical activity, objectively assessed by steps per day measured with an accelerometer. This will objectively assess physical activity and sedentary time. Change in steps per day is being assessed at baseline, after three months of intervention and after 6 months of intervention.

    Baseline, 3 months and 6 months

Secondary Outcomes (10)

  • Physical activity

    Baseline, 3 months and 6 months

  • Blood pressure

    Baseline, 3 months and 6 months

  • Waist Circumference

    Baseline, 3 months and 6 months

  • Body Mass Index (BMI)

    Baseline, 3 months and 6 months

  • Physical functioning

    Baseline, 3 months and 6 months

  • +5 more secondary outcomes

Study Arms (2)

Intervention

OTHER

Tailored e-heath support for physical activity with a focus on communication and rewards, using commercial accelerometers for measurements

Behavioral: Physical activity with tailored e-health support

Control group

NO INTERVENTION

Standard care

Interventions

Physical activity with tailored e-health supportBEHAVIORAL

The planned e-health intervention will contain several elements: A motivating smartphone app registers indoor- and outdoor activity as well as activity from the use of an ergometer-bike. For recording of outdoor activity commercial wrist-born accelerometers will be used. The app-solution will be motivating and result in a reward after a predefined level of activity.

Also known as: Activity planner
Intervention

Eligibility Criteria

Age16 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Intellectual disability
  • Age 15-60 years
  • Low physical activity
  • Sedentary lifestyle

You may not qualify if:

  • Medical contradictions for participation
  • High levels of physical activity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of North Norway

Tromsø, 9019, Norway

Location

Related Publications (1)

  • Michalsen H, Wangberg SC, Hartvigsen G, Jaccheri L, Muzny M, Henriksen A, Olsen MI, Thrane G, Jahnsen RB, Pettersen G, Arntzen C, Anke A. Physical Activity With Tailored mHealth Support for Individuals With Intellectual Disabilities: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 Jun 29;9(6):e19213. doi: 10.2196/19213.

    PMID: 32437328DERIVED

MeSH Terms

Conditions

Intellectual Disability

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Audny Anke, Professor

    University Hospital of North Norway

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Two-armed randomised controlled study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2019

First Posted

September 6, 2019

Study Start

January 1, 2020

Primary Completion

May 1, 2020

Study Completion

January 1, 2022

Last Updated

January 10, 2023

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will share

A study protocol article will be published

Shared Documents
STUDY PROTOCOL
Time Frame
The study protocol will be sent in and published during the year 2020.
Access Criteria
Study protocol will be published and will be available from publication date and forward.

Locations

NO(1)