NCT03783611

Brief Summary

The beneficial effects of physical activity (PA) for older adults are well known. Yet, few older adults reach the health guideline of 150 minutes/week of moderate-intensity PA. eHealth interventions are effective in raising PA levels in older adults on the short-term. However, intermediate- or long-term effects have been examined rarely. This study aimed to investigate the effect of the eHealth intervention 'MyPlan 2.0' on both accelerometer-based and self-reported PA levels in Belgian older adults on the short- and intermediate-term. This study was a randomized controlled trial with three measurement moments (baseline (n=72), post (five weeks after baseline; n=68) and follow-up (three months after baseline; n=68). At all measurement moments, participants in the control group and intervention group filled out the International Physical Activity Questionnaire and wore an accelerometer during one week. Participants in the intervention group got access to the eHealth intervention 'MyPlan 2.0' and used it for five consecutive weeks after baseline. 'MyPlan 2.0' was based on self-regulatory theory and focused on both pre- and post-intentional processes to increase PA.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2016

Shorter than P25 for not_applicable

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 7, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 16, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 16, 2017

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

December 12, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 21, 2018

Completed
Last Updated

May 16, 2019

Status Verified

May 1, 2019

Enrollment Period

7 months

First QC Date

December 12, 2018

Last Update Submit

May 14, 2019

Conditions

Outcome Measures

Primary Outcomes (4)

  • change in accelerometer-based physical activity

    participants wear an accelerometer (activity monitor) to objectively measure their physical activity levels. The investigators examine change in total physical activity (sum of light- intensity and moderate-to-vigorous physical activity) and moderate-to-vigorous physical activity. Higher values represent more physical activity.

    change between baseline and post (5 weeks after baseline)

  • change in accelerometer-based physical activity

    participants wear an accelerometer (activity monitor) to objectively measure their physical activity levels. The investigators examine change in total physical activity (sum of light-intensity and moderate-to-vigorous physical activity) and moderate-to-vigorous physical activity.

    change between baseline and follow-up (3 months after baseline)

  • change in self-reported physical activity

    the validated International Physical Activity Questionnaire (IPAQ) is used to assess self-reported weekly physical activity in three domains (leisure-time, transport, household). Within each domain, different intensities and types of physical activity are assessed. Minutes per week of physical activity in all subdomains are assessed, namely leisure-time walking, leisure-time moderate physical activity, leisure-time vigorous physical activity, moderate physical activity in the garden, vigorous physical activity in the garden, moderate physical activity at home, walking for transport and cycling for transport. The physical activity data are truncated to realistic maxima based on the official IPAQ guidelines. These guidelines subscribe that the maximum amount of physical activity for each subdomain is maximum 840 minutes per week.

    change between baseline and post (5 weeks after baseline)

  • change in self-reported physical activity

    the validated International Physical Activity Questionnaire (IPAQ) is used to assess self-reported weekly physical activity in three domains (leisure-time, transport, household). Within each domain, different types and intensities of physical activity are assessed. Minutes per week of physical activity in all subdomains are assessed, namely leisure-time walking, leisure-time moderate physical activity, leisure-time vigorous physical activity, moderate physical activity in the garden, vigorous physical activity in the garden, moderate physical activity at home, walking for transport and cycling for transport. The physical activity data are truncated to realistic maxima based on the official IPAQ guidelines. These guidelines subscribe that the maximum amount of physical activity for each subdomain is maximum 840 minutes per week.

    change between baseline and follow-up (3 months after baseline)

Study Arms (2)

Intervention group

EXPERIMENTAL

The intervention group has access to the MyPlan 2.0. eHealth intervention. MyPlan is a eHealth intervention designed to increase physical activity. The intervention is based on the self-regulation theory and focuses on pre- and post-intentional processes to increase physical activity.

Behavioral: MyPlan 2.0.

control group

NO INTERVENTION

The control group receives no intervention

Interventions

MyPlan 2.0.BEHAVIORAL

eHealth intervention to increase physical activity in older adults. MyPlan 2.0 consists of five website visits. The first website visit contains pre- and post-intentional processes. The following four website visits contains mainly post-intentional processes. During the first website, participants fill in a questionnaire about their physical activity levels, and receive feedback. Furthermore, they are asked to make an action plan and think about barriers to reach their activity goals and possible solutions to tackle these barriers. During the other four website visits, participants receive feedback about their behavior change process and their action plan (did they reach their goal)? During these website visits, they can adapt their action plans.

Intervention group

Eligibility Criteria

Age65 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • retired
  • able to walk 100 meters without assistance
  • speak and understand Dutch
  • have an email address

You may not qualify if:

  • severe physical health problems
  • not retired
  • not able to speak and understand Dutch
  • not having an email address

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Van Dyck D, Herman K, Poppe L, Crombez G, De Bourdeaudhuij I, Gheysen F. Results of MyPlan 2.0 on Physical Activity in Older Belgian Adults: Randomized Controlled Trial. J Med Internet Res. 2019 Oct 7;21(10):e13219. doi: 10.2196/13219.

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Greet Cardon, PhD

    University Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Movement and Sports Sciences

Study Record Dates

First Submitted

December 12, 2018

First Posted

December 21, 2018

Study Start

November 7, 2016

Primary Completion

June 16, 2017

Study Completion

June 16, 2017

Last Updated

May 16, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will share

only researchers of our own research group will have access to the full data of the participants, only for research purposes. Only anonymized data will be shared with other researchers of our own research group. other researchers can obtain research information upon request

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
the data will be available when the study is finished (June 2017) and will be available for ten years.
Access Criteria
the data will be stored on the Ghent University share system that can be accessed with a personal log in and password