Physical ActivityNCT04116372

Increasing Physical Activity in Empty Nest and Retirement Populations: A Feasibility Trial of an Online Intervention

A study testing Digital Health Online Platform in people with Physical Activity and Health Promotion, run by University of Victoria at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 40 to 90 yearsHealthy volunteers can take part
Conditions the study is for: Physical Activity, Health Promotion
What is being tested?: Digital Health Online Platform
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 46 participants
Where: 1 siteCanada
Study dates: 10 Oct 2019to 30 Nov 2021
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 90 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Potential participants will be included if they have either a) recently (within 6 months) retired, or b) experienced children moving out of the familial home. In addition, potential participants must have access to the internet at home, and have a smart phone or home computer that can support the eHealth application we are using. Potential participants must currently be not meeting the physical activity (PA) guidelines (less than 150 minutes of moderate to vigorous aerobic activity). There will be no delimitations to the sample based on socio-economic or ethnic variables.

Who cannot join

Participants will be excluded from the project if they not have access to the Internet, are unable to speak/read English, are engaging in moderate-to vigorous PA (MVPA) sufficient to meet the PA Guidelines, have an existing chronic medical condition potentially making them at risk of injury or ill health from increasing their physical activity (assessed using the GAQ)

Trial locations and contacts

1 site in 1 country.

Canada1 site

UVIC
Victoria, British Columbia

Other trials in Canada

About this study

Internet-based health promotion programs have the potential to reach more individuals than in person interventions, without overtaxing healthcare resources. Having a high quality, user-centered web-based program can help maximize user engagement and adherence. Thus, the primary objective of this pilot study is to examine the feasibility and acceptability of a web-based physical activity behavior change program on recently retired and/or empty nest populations. The primary research question is: Is it worthwhile to conduct a larger scale eHealth study targeting empty nest and/or retired populations based on preliminary results and feedback from this pilot study. We will also be examining changes other behavioral indicators related to physical activity as a secondary outcome measure.

Read the detailed description

Background: Physical activity is associated with management and/or prevention of over 25 chronic health conditions; however the majority of adults in North America are not active enough to experience these benefits. Behavioral strategies have been shown to be effective for increasing physical activity, and our online platform includes components of several behavioral strategies including goal setting and feedback.

Target Population: Sedentary adults who have recently (within 6 months of enrollment) retired, or had their last child leave the family home, living in Victoria, British-Columbia, Canada.

Sample Size: 80 participants, 20 participants per group - Empty Nest (Control) Empty Nest (intervention), Retired (Control), Retired (Intervention).

Intervention: Participants in each Empty Nest and Retirement participant pool will be randomized to two groups: 1 - Waitlist control group, 2 - Access to Online Platform. Half of the empty nest participant group and half of the retired participant group will receive an intervention, with the other half representing the control comparison group. Participants from both groups will complete an online questionnaires at baseline and 10 weeks. The intervention group will also be asked for an in-person exit interview.

Conditions: Physical Activity, Health Promotion
Being tested: Digital Health Online Platform
Medical subject headings: Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Digital Health Online PlatformBehavioural
The website has 10 lessons that the participant will gain access to on a weekly basis. Lesson titles are as follows:
Lesson 1 - Benefits of Physical Activity on Chronic Disease Lesson 2 - Mental benefits of Physical Activities Lesson 3 - Increasing Self Confidence for Physical Activities Lesson 4 - Learning about your Emotions Lesson 5 - Building Social Support Lesson 6 - Building Physical Activity Opportunity Lesson 7 - Goal Setting and Planning Lesson 8 - Self Monitoring Lesson 9 - Habit Lesson 10 - Identity

Study groups in NCT04116372
Study group	Role	What they receive
Empty Nest Intervention Group	Experimental	Participants will complete a baseline questionnaire, and receive access to the our online platform for 10 weeks. Completing the online platform is designed to encourage participants to engage in physical activity. At 2 and 5 weeks, a check-in session will occur over the phone. At 10 weeks the participant will be contacted to return to the lab to complete the final questionnaire, and do a wrap up interview. The end-of-trial qualitative interview will evaluate participant satisfaction and feasibility of the intervention. For this reason a lab employee unaffiliated with this study will complete these in person interviews. Receives: Behavioral: Digital Health Online Platform
Retirement Intervention Group	Experimental	Participants will complete a baseline questionnaire, and receive access to the our online platform for 10 weeks. Completing the online platform is designed to encourage participants to engage in physical activity. At 2 and 5 weeks, a check-in session will occur over the phone. At 10 weeks the participant will be contacted to return to the lab to complete the final questionnaire, and do a wrap up interview. The end-of-trial qualitative interview will evaluate participant satisfaction and feasibility of the intervention. For this reason a lab employee unaffiliated with this study will complete these in person interviews. Receives: Behavioral: Digital Health Online Platform
Empty Nest Control Group	No intervention	This group will complete baseline and final questionnaires (online or paper). At the end of the study this group will have the option to receive access to the other group's materials (online platform) if they wish, for the 10 week period following the study.
Retirement Control Group	No intervention	This group will complete baseline and final questionnaires (online or paper). At the end of the study this group will have the option to receive access to the other group's materials (online platform) if they wish, for the 10 week period following the study.

What is being measured

The primary outcome is the main question the study is designed to answer.

Recruitment rate (monthly)
For the full scale RCT, we are looking for a 1 day per week or 30 min MVPA change which equates to an approximate effect size of d = .35. This equates to roughly 65 per group (130 for a two group trial). If we recruit for 2 years in the large trial (assuming a six month time period for each person in the intervention) we need to be recruiting at least 6 per month. If we decide on a three armed trial, we will need to recruit at least 8 per month.
Measured: 4 months
Participant retention
Number of participants who complete both baseline and end of study (10 week) measures. A 80-100% retention rate is indicative of a strong trial (Jackson \& Waters, 2005).
Measured: 10 weeks
Participant intervention satisfaction/evaluation
For satisfaction ratings, mean and standard deviations will be calculated for the quantitative satisfaction and evaluation questionnaire. Given that scores of 1 (ex. not helpful, did not use the tools) and 2 (ex. Somewhat helpful, used a little bit of the tools) indicated levels of dissatisfaction, and 3 (ex. Quite helpful, used a bit of the tools) and 4 (ex. Extremely helpful, used a lot of the tools) indicated some sort of satisfaction, a mean score of ≥ 2.5 will be deemed acceptable for recommendation for a full RCT.
Measured: 10 weeks

Secondary outcomes (6)

Change in self-reported physical activity from baseline to 10 weeks
Measured from questionnaire using Godin's personal self report leisure time measurement tool, also known as the Leisure Score Index (LSI). The Leisure Score Index contains three questions, which assess the frequency of mild, moderate, and strenuous activity performed for at least 10 minutes during free time in a typical week. Changes in these measures will be examined
Measured: Baseline - 10 weeks
Change in physical activity beliefs, attitudes, barriers, and motivation from baseline to 10 weeks.
Included in questionnaire - Ajzen's theory of planned behaviour questionnaire will be applied to measure participants' beliefs, attitudes, barriers, and motivation related to physical activity.
Measured: Baseline - 10 weeks
Change in physical activity behaviour regulation from baseline to 10 weeks.
Included in questionnaire - 5 items adapted from Umstattd's scale measuring physical activity self-regulation strategies in older adults. Changes in this measure will be examined
Measured: Baseline - 10 weeks
Change in physical activity habits from baseline to 10 weeks.
Included in questionnaire - 12 Self Report Habit Index items from the measure developed by Verplanken and Orbell and adapted to physical activity by Chatzisarantis and Hagger. Changes in this measure will be examined
Measured: Baseline - 10 weeks
Change in physical activity identity from baseline to 10 weeks.
Included in questionnaire - Anderson and Cychosz Exercise Identity Scale is used to measure participants' identification as someone who participates in physical activity.
Measured: Baseline - 10 weeks
Change in quality of life measured using the Short Form 12 questionnaire.
The online questionnaire will asses participants' quality of life using the short form 12 questionnaire
Measured: Baseline - 10 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Oct 201930 Nov 2021

First posted4 Oct 2019
Study start10 Oct 2019
Primary completion30 Nov 2021
Study completion30 Nov 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Physical ActivityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 46 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04116372
Sponsor's protocol ID: 05-281982
Status last verified: May 2022
First submitted: 3 Oct 2019
Last updated: 18 May 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Jackson N, Waters E; Guidelines for Systematic Reviews in Health Promotion and Public Health Taskforce. Criteria for the systematic review of health promotion and public health interventions. Health Promot Int. 2005 Dec;20(4):367-74. doi: 10.1093/heapro/dai022. Epub 2005 Sep 16.
PubMed 16169885

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Increasing Physical Activity in Empty Nest and Retirement Populations: A Feasibility Trial of an Online Intervention
ClinicalTrials.gov ID: NCT04116372
Acronym / sponsor ID: 05-281982
Conditions: Physical Activity, Health Promotion
Study type: Interventional
Recruitment status: Completed
Enrolment: 46 participants (actual)
Lead sponsor: University of VictoriaUniversity, hospital or other
Study start: 10 Oct 2019 (actual)
Primary completion: 30 Nov 2021 (actual)
Study completion: 30 Nov 2021 (actual)
First posted: 4 Oct 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Target Population: Sedentary adults who have recently (within 6 months of enrollment) retired, or had their last child leave the family home, living in Victoria, British-Columbia, Canada.

Sample Size: 80 participants, 20 participants per group - Empty Nest (Control) Empty Nest (intervention), Retired (Control), Retired (Intervention).

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Empty Nest Intervention Group	Experimental	Behavioral: Digital Health Online PlatformParticipants will complete a baseline questionnaire, and receive access to the our online platform for 10 weeks. Completing the online platform is designed to encourage participants to engage in physical activity. At 2 and 5 weeks, a check-in session will occur over the phone. At 10 weeks the participant will be contacted to return to the lab to complete the final questionnaire, and do a wrap up interview. The end-of-trial qualitative interview will evaluate participant satisfaction and feasibility of the intervention. For this reason a lab employee unaffiliated with this study will complete these in person interviews.
Retirement Intervention Group	Experimental	Behavioral: Digital Health Online PlatformParticipants will complete a baseline questionnaire, and receive access to the our online platform for 10 weeks. Completing the online platform is designed to encourage participants to engage in physical activity. At 2 and 5 weeks, a check-in session will occur over the phone. At 10 weeks the participant will be contacted to return to the lab to complete the final questionnaire, and do a wrap up interview. The end-of-trial qualitative interview will evaluate participant satisfaction and feasibility of the intervention. For this reason a lab employee unaffiliated with this study will complete these in person interviews.
Empty Nest Control Group	No intervention	–This group will complete baseline and final questionnaires (online or paper). At the end of the study this group will have the option to receive access to the other group's materials (online platform) if they wish, for the 10 week period following the study.
Retirement Control Group	No intervention	–This group will complete baseline and final questionnaires (online or paper). At the end of the study this group will have the option to receive access to the other group's materials (online platform) if they wish, for the 10 week period following the study.

Who may qualify

Ages: 40 to 90 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Potential participants will be included if they have either a) recently (within 6 months) retired, or b) experienced children moving out of the familial home. In addition, potential participants must have access to the internet at home, and have a smart phone or home computer that can support the eHealth application we are using. Potential participants must currently be not meeting the physical activity (PA) guidelines (less than 150 minutes of moderate to vigorous aerobic activity). There will be no delimitations to the sample based on socio-economic or ethnic variables.

Key exclusion criteria (1 listed)

Participants will be excluded from the project if they not have access to the Internet, are unable to speak/read English, are engaging in moderate-to vigorous PA (MVPA) sufficient to meet the PA Guidelines, have an existing chronic medical condition potentially making them at risk of injury or ill health from increasing their physical activity (assessed using the GAQ)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Digital Health Online PlatformThe website has 10 lessons that the participant will gain access to on a weekly basis. Lesson titles are as follows: Lesson 1 - Benefits of Physical Activity on Chronic Disease Lesson 2 - Mental benefits of Physical Activities Lesson 3 - Increasing Self Confidence for Physical Activities Lesson 4 - Learning about your Emotions Lesson 5 - Building Social Support Lesson 6 - Building Physical Activity Opportunity Lesson 7 - Goal Setting and Planning Lesson 8 - Self Monitoring Lesson 9 - Habit Lesson 10 - Identity	Behavioural	Empty Nest Intervention Group, Retirement Intervention Group

Primary outcome

Recruitment rate (monthly)
Time frame: 4 months
For the full scale RCT, we are looking for a 1 day per week or 30 min MVPA change which equates to an approximate effect size of d = .35. This equates to roughly 65 per group (130 for a two group trial). If we recruit for 2 years in the large trial (assuming a six month time period for each person in the intervention) we need to be recruiting at least 6 per month. If we decide on a three armed trial, we will need to recruit at least 8 per month.
Participant retention
Time frame: 10 weeks
Number of participants who complete both baseline and end of study (10 week) measures. A 80-100% retention rate is indicative of a strong trial (Jackson \& Waters, 2005).
Participant intervention satisfaction/evaluation
Time frame: 10 weeks
For satisfaction ratings, mean and standard deviations will be calculated for the quantitative satisfaction and evaluation questionnaire. Given that scores of 1 (ex. not helpful, did not use the tools) and 2 (ex. Somewhat helpful, used a little bit of the tools) indicated levels of dissatisfaction, and 3 (ex. Quite helpful, used a bit of the tools) and 4 (ex. Extremely helpful, used a lot of the tools) indicated some sort of satisfaction, a mean score of ≥ 2.5 will be deemed acceptable for recommendation for a full RCT.

6 secondary outcomes

Change in self-reported physical activity from baseline to 10 weeks
Time frame: Baseline - 10 weeks
Change in physical activity beliefs, attitudes, barriers, and motivation from baseline to 10 weeks.
Time frame: Baseline - 10 weeks
Change in physical activity behaviour regulation from baseline to 10 weeks.
Time frame: Baseline - 10 weeks
Change in physical activity habits from baseline to 10 weeks.
Time frame: Baseline - 10 weeks
Change in physical activity identity from baseline to 10 weeks.
Time frame: Baseline - 10 weeks
Change in quality of life measured using the Short Form 12 questionnaire.
Time frame: Baseline - 10 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
Background: PubMed 16169885Jackson N, Waters E; Guidelines for Systematic Reviews in Health Promotion and Public Health Taskforce. Criteria for the systematic review of health promotion and public health interventions. Health Promot Int. 2005 Dec;20(4):367-74. doi: 10.1093/heapro/dai022. Epub 2005 Sep 16.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Digital Health Online Platform in people with Physical Activity and Health Promotion, run by University of Victoria at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment rate (monthly) (time frame: 4 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04116372, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022.