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

NCT04227574 | Completed

• 1 other identifier: WAM
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Insomnia, Primary

Keywords

Insomnia

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  week 8, week 16, week 24

Secondary Outcomes (13)

• Sleep diary (7-day)

  week 8, week 16, week 24

• Hospital Anxiety and Depression Scale

  week 8, week 16, week 24

• Multidimensional fatigue inventory-20

  week 8, week 16, week 24

• Actigraphy (7-day)

  week 8, week 16, week 24

• Accelerometer (7-day)

  week 8, week 16, week 24

Study Arms (2)

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.

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.

Other: Zero Time Exercise training alone

Interventions

Zero Time Exercise training + WhatsApp anti-inertia reminders OTHER

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 + WhatsApp anti-inertia reminders

Zero Time Exercise training alone OTHER

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.

Zero Time Exercise training alone

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;
• 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)

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

School of Nursing, the Hong Kong Polytechnic University

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• WF Yeung

  School of Nursing, the Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 6, 2020
• First Posted: January 13, 2020
• Study Start: January 31, 2020
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: September 26, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)