Insomnia, PrimaryNCT04227574

Effects of Messaging App Reminder on the Compliance of Zero-Time Exercise (ZTEx)

A study testing Zero Time Exercise training + WhatsApp anti-inertia reminders and Zero Time Exercise training alone in people with Insomnia, Primary, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.

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

This is a proof-of-concept pilot nested in the RCT titled, 'Zero-time Exercise on Inactive Adults With Insomnia Disorder'. It aims to evaluate the effects of a simple WhatsApp intervention on exercise adherence and on sleep and related outcomes. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Insomnia, Primary
What is being tested?: Zero Time Exercise training + WhatsApp anti-inertia reminders and Zero Time Exercise training alone
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 68 participants
Where: 1 siteHong Kong
Study dates: 31 Jan 2020to 30 Jun 2023
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 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Hong Kong residents,
ethnic Chinese aged 18-65 years with the ability to communicate in Cantonese or Putonghua,
who fulfil the DSM-5 diagnostic criteria for insomnia disorder according to a validated diagnostic tool, the Brief Insomnia Questionnaire (we include primary insomnia because it is more homogenous and less complicated than comorbid insomnia; if ZTEx is found to be effective for primary insomnia, then comorbid insomnia can be targeted in future studies),
scored at least 10 points in the Insomnia Severity Index,
are ambulant and can independently perform daily activities,
are physically inactive, defined as not having participated in at least 150 min of moderate intensity or 75 min of vigorous intensity physical activity a week, or the equivalent combination over the previous 3 months by self-report
have a smartphone compatible with WhatsApp, and
willing to give informed consent

Who cannot join

any current diagnosis fulfilling the DSM-IV criteria of a major depressive disorder, generalized anxiety disorders, post-traumatic stress disorder, panic disorder, substance use disorders, or schizophrenia as screened using the Chinese version of the Structured Clinical Interview for DSM-IV;
other sleep disorders, including circadian rhythm disorder, narcolepsy, obstructive sleep apnoea (OSA), and restless leg syndrome (RLS)/periodic leg movement disorder (PLMD) as determined based on cut-off scores (≥ 7 on narcolepsy; ≥ 8 on circadian rhythm disorder; ≥ 15 on OSA; ≥ 7 on RLS/PLMD) using SLEEP-50. If in doubt, subjects will be referred to our team psychiatrist (KF Chung) for further assessment;
any current medical conditions or side-effects of medication that are contributing significantly to the subject's insomnia;
taking medications or currently participating in other psychotherapies for insomnia or other psychiatric disorders;
impaired cognitive functioning (<22 points in HK-MoCA) or with difficulty in giving consent or understanding instructions;
pregnant;

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shift work;
whose physical condition is such that physicians recommend that they refrain from exercising; and
fulfilling the criterion for obesity for Asians (body mass index, of 27.5 or above)

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

School of Nursing, the Hong Kong Polytechnic University
Hong Kong

Other trials in Hong Kong

About this study

Official title: Effects of Messaging App Reminder on the Compliance of Zero-Time Exercise (ZTEx): A Nested Proof-of-concept Pilot Study

Read the detailed description

This is the second phase of another study - 'Zero-time Exercise on Inactive Adults With Insomnia Disorder'.

In the first phase (baseline to week 8), 136 subjects will be randomly allocated to the ZTEx intervention or the sleep hygiene education (SHE) comparison group. They will receive two 2-hour ZTEx training or SHE lessons and practice ZTEx or follow the sleep hygiene instruction for 24 weeks.

The second phase of the study (weeks 9-24)will commence after completion of the assessment of the RCT at week 8. Subjects in the Zero-time Exercise (ZTEx) group will be randomly divided into either an ZTEx with WhatsApp reminder (ZTEx+R) group or an ZTEx without WhatsApp reminder (ZTEx alone) group to evaluate the effects of WhatsApp reminders on exercise adherence and sleep and related outcomes.

Conditions: Insomnia, Primary
Being tested: Zero Time Exercise training + WhatsApp anti-inertia reminders, Zero Time Exercise training alone
Keywords: Insomnia
Medical subject headings: Sleep Initiation and Maintenance Disorders

What participants receive

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

Zero Time Exercise training + WhatsApp anti-inertia remindersOther
Zero Time Exercise encourage people to increase physical exercise by simple movements that can be done any time at any places. We offer a 2-session training course to train the subjects to do zero-time exercise.
In addition, WhatsApp anti-inertia reminders will be sent daily by the research assistant to remind and encourage the participants to practice the Zero Time Exercise.
Zero Time Exercise training aloneOther
Zero Time Exercise encourage people to increase physical exercise by simple movements that can be done any time at any places. We offer a 2-session training course to train the subjects to do zero-time exercise.

Study groups in NCT04227574
Study group	Role	What they receive
Zero Time Exercise training + WhatsApp anti-inertia reminders	Experimental	Subjects in this group will receive daily WhatsApp anti-inertia reminders from the research assistant to remind and encourage them to practice Zero Time Exercise. Receives: Other: Zero Time Exercise training + WhatsApp anti-inertia reminders
Zero Time Exercise training alone	Active comparator	Subjects in this group will not receive any WhatsApp reminders from week 8 to 24. Receives: Other: Zero Time Exercise training alone

What is being measured

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

Change in Insomnia Severity Index
The subjects rate the severity of insomnia, the distress, and the functional impairment associated with insomnia on a 5-point scale. The score ranges from 0 to 28. The higher the score, the worse the outcome is.
Measured: week 8, week 16, week 24
Change in the intervention adherence
Patients will be told to record their daily physical activities or sleep health hygiene compliance onto the log.
Measured: week 8, week 16, week 24

Secondary outcomes (13)

Sleep diary (7-day)
The standardized sleep diary records the daily bedtime and rising time, from which the total time in bed (TIB) can be calculated.
Measured: week 8, week 16, week 24
Hospital Anxiety and Depression Scale
The Hospital Anxiety and Depression Scale is a 14-items self-administered questionnaire, which assesses the severity of depressive and anxiety symptoms. The score ranges from 0-21 for either depression or anxiety. The higher the score, the worse the outcome is.
Measured: week 8, week 16, week 24
Multidimensional fatigue inventory-20
Multidimensional fatigue inventory-20 is a 20-items self-report instrument designed to measure severity of fatigue. The score ranges from 20 to 100. The higher the score, the worse the outcome is.
Measured: week 8, week 16, week 24
Actigraphy (7-day)
Actigraphy measures wrist movements to assess sleep or waking state, is accomplished through an accelerometer in a wrist worn device.
Measured: week 8, week 16, week 24
Accelerometer (7-day)
Accelerometer measures wrist movements to assess the physical activity levels.
Measured: week 8, week 16, week 24
Change in WAIS-IV Digit Span forward test
Change in Wechsler Adult Intelligence Scale, 4th edition (WAIS-IV) Digit Span forward test score will be used to measure the attention function.
Measured: week 8, week 16, week 24
Change in WAIS-IV Color Trails Test
Change in Wechsler Adult Intelligence Scale, 4th edition (WAIS-IV) Color Trails Test score will be used to measure the attention function.
Measured: week 8, week 16, week 24
Change in WAIS-IV Stroop color-word Test
Change in Wechsler Adult Intelligence Scale, 4th edition (WAIS-IV) Stroop color-word Test score will be used to measure the attention function.
Measured: week 8, week 16, week 24
Change in the Hong Kong List Learning Test (HKLLT)
Change in HKLLT Test score will be used to measure the memory function.
Measured: week 8, week 16, week 24
Change in Digit Span-backward and forward test
Change in Digit Span-backward and forward test score will be used to measure the memory function.
Measured: week 8, week 16, week 24
Change in the interference index of Color Trails Test
Change in the interference index of Color Trails Test score will be used to measure the executive function
Measured: week 8, week 16, week 24
Change in the interference index of Stroop color-word Test
Change in the interference index of Stroop color-word Test score will be used to measure the executive function
Measured: week 8, week 16, week 24
Change in the Wisconsin Card Sorting Test
Change in the Wisconsin Card Sorting Test score will be used to measure the executive function
Measured: week 8, week 16, week 24

Timeline

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

31 Jan 202030 Jun 2023

First posted13 Jan 2020
Study start31 Jan 2020
Primary completion30 Jun 2023
Study completion30 Jun 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Insomnia, PrimaryStudies of the same condition, open and under way.
More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
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: 68 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04227574
Sponsor's protocol ID: WAM
Status last verified: Sep 2023
First submitted: 6 Jan 2020
Last updated: 26 Sep 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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?

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Study at a glance

From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Messaging App Reminder on the Compliance of Zero-Time Exercise (ZTEx): A Nested Proof-of-concept Pilot Study
ClinicalTrials.gov ID: NCT04227574
Acronym / sponsor ID: WAM
Conditions: Insomnia, Primary
Keywords: Insomnia
Study type: Interventional
Recruitment status: Completed
Enrolment: 68 participants (actual)
Lead sponsor: The Hong Kong Polytechnic UniversityUniversity, hospital or other
Study start: 31 Jan 2020 (actual)
Primary completion: 30 Jun 2023 (actual)
Study completion: 30 Jun 2023 (actual)
First posted: 13 Jan 2020 (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

This is the second phase of another study - 'Zero-time Exercise on Inactive Adults With Insomnia Disorder'.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Zero Time Exercise training + WhatsApp anti-inertia reminders	Experimental	Other: Zero Time Exercise training + WhatsApp anti-inertia remindersSubjects in this group will receive daily WhatsApp anti-inertia reminders from the research assistant to remind and encourage them to practice Zero Time Exercise.
Zero Time Exercise training alone	Active comparator	Other: Zero Time Exercise training aloneSubjects in this group will not receive any WhatsApp reminders from week 8 to 24.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Hong Kong residents,
ethnic Chinese aged 18-65 years with the ability to communicate in Cantonese or Putonghua,
who fulfil the DSM-5 diagnostic criteria for insomnia disorder according to a validated diagnostic tool, the Brief Insomnia Questionnaire (we include primary insomnia because it is more homogenous and less complicated than comorbid insomnia; if ZTEx is found to be effective for primary insomnia, then comorbid insomnia can be targeted in future studies),
scored at least 10 points in the Insomnia Severity Index,
are ambulant and can independently perform daily activities,

Key exclusion criteria (9 listed)

any current diagnosis fulfilling the DSM-IV criteria of a major depressive disorder, generalized anxiety disorders, post-traumatic stress disorder, panic disorder, substance use disorders, or schizophrenia as screened using the Chinese version of the Structured Clinical Interview for DSM-IV;
other sleep disorders, including circadian rhythm disorder, narcolepsy, obstructive sleep apnoea (OSA), and restless leg syndrome (RLS)/periodic leg movement disorder (PLMD) as determined based on cut-off scores (≥ 7 on narcolepsy; ≥ 8 on circadian rhythm disorder; ≥ 15 on OSA; ≥ 7 on RLS/PLMD) using SLEEP-50. If in doubt, subjects will be referred to our team psychiatrist (KF Chung) for further assessment;
any current medical conditions or side-effects of medication that are contributing significantly to the subject's insomnia;
taking medications or currently participating in other psychotherapies for insomnia or other psychiatric disorders;
impaired cognitive functioning (<22 points in HK-MoCA) or with difficulty in giving consent or understanding instructions;

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
Zero Time Exercise training + WhatsApp anti-inertia remindersZero Time Exercise encourage people to increase physical exercise by simple movements that can be done any time at any places. We offer a 2-session training course to train the subjects to do zero-time exercise. In addition, WhatsApp anti-inertia reminders will be sent daily by the research assistant to remind and encourage the participants to practice the Zero Time Exercise.	Other	Zero Time Exercise training + WhatsApp anti-inertia reminders
Zero Time Exercise training aloneZero Time Exercise encourage people to increase physical exercise by simple movements that can be done any time at any places. We offer a 2-session training course to train the subjects to do zero-time exercise.	Other	Zero Time Exercise training alone

Primary outcome

Change in Insomnia Severity Index
Time frame: week 8, week 16, week 24
The subjects rate the severity of insomnia, the distress, and the functional impairment associated with insomnia on a 5-point scale. The score ranges from 0 to 28. The higher the score, the worse the outcome is.
Change in the intervention adherence
Time frame: week 8, week 16, week 24
Patients will be told to record their daily physical activities or sleep health hygiene compliance onto the log.

13 secondary outcomes

Sleep diary (7-day)
Time frame: week 8, week 16, week 24
Hospital Anxiety and Depression Scale
Time frame: week 8, week 16, week 24
Multidimensional fatigue inventory-20
Time frame: week 8, week 16, week 24
Actigraphy (7-day)
Time frame: week 8, week 16, week 24
Accelerometer (7-day)
Time frame: week 8, week 16, week 24
Change in WAIS-IV Digit Span forward test
Time frame: week 8, week 16, week 24
Change in WAIS-IV Color Trails Test
Time frame: week 8, week 16, week 24
Change in WAIS-IV Stroop color-word Test
Time frame: week 8, week 16, week 24
Change in the Hong Kong List Learning Test (HKLLT)
Time frame: week 8, week 16, week 24
Change in Digit Span-backward and forward test
Time frame: week 8, week 16, week 24
Change in the interference index of Color Trails Test
Time frame: week 8, week 16, week 24
Change in the interference index of Stroop color-word Test
Time frame: week 8, week 16, week 24
Change in the Wisconsin Card Sorting Test
Time frame: week 8, week 16, week 24

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 26 Sep 2023.
Individual participant dataSharing planned: No

Related trials for Insomnia, Primary

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COVID-19, Long COVID
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Active Coping: Interdisciplinary Program for Chronic Pain, Physiotherapy Unit (Spain)
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Not yet recruitingObservational study
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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.

WF Yeung principal investigator

School of Nursing, the Hong Kong Polytechnic University

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

Questions about this trial

What is this clinical trial studying?

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 8 inclusion and 9 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 26 Sep 2023. 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 Hong Kong. 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?

Change in Insomnia Severity Index (time frame: week 8, week 16, week 24). The study lists 2 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 NCT04227574.

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 26 Sep 2023.