HypokinesiaNCT02601534
Be Healthy, So Easy: FAMILY Education Project
A study testing Zero-time Exercise and Healthy Eating in people with Hypokinesia, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
The goal of the study is to evaluate the effectiveness of a family-focused, interactive, and theory-based intervention to reduce the sedentary behavior and increase physical activity, family communication and well-being of the participants. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypokinesia
- What is being tested?
- Zero-time Exercise and Healthy Eating
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 673 participants
- Where
- 1 siteHong Kong
- Study dates
- Jul 2015to Jun 2017
- 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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Parents with at least on child between 3 and 18;
- Parents with at least primary school educational level:
- Parents who can read and write Chinese.
Who cannot join
- People with a serious health condition that might prevent them from participating in physical activity;
- Parents who do not have a child between 3 and 18.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of the study is to evaluate the effectiveness of a family-focused, interactive, and theory-based intervention to reduce the sedentary behavior and increase physical activity, family communication and well-being of the participants.
The intervention is to use Zero-time Exercise, the positive psychology theme "Appreciation and Gratitude" [23, 24], and role modelling approach to get sedentary people to start exercising, increase levels of physical activity, family communication and well-being of the participants and their family members.
The intervention aims to encourage positive and sustainable health actions among participants and their family members.
Read the detailed description
Lack of physical activity is a behavioural risk for non-communicable diseases. The World Health Organization (WHO) reported that physical inactivity and unhealthy diets are two of the four main behavioural risk factors that contribute to non-communicable diseases. Globally, people who are overweight and obese, particularly if these people are physically inactive. They are at risk for morbidity and mortality.
Hong Kong-specific data demonstrates that many people cannot meet World Health Organization targets for physical activity. The Hong Kong Behavioural Risk Factor Survey reported that, for the seven days prior to the survey, about half (52.0%) of adults aged 18-64 had not done any moderate physical activity. Overall, only 37.5% of the respondents met the WHO's recommended physical activity level of at least 150 minutes of moderate or 75 minutes of vigorous physical activity a week for adults.
There is emerging evidence of effective behavioral interventions to decrease sedentary behavior. Some studies focused on reducing screen time or active workstations that encourage standing at the computer. Others focus on increased use of stairs instead of lifts. These interventions used behaviour change techniques such as goal-setting and behavioural self-monitoring. As previous approaches have not shown promising results, new approaches are needed to reduce sedentary behaviour and increase exercise or physical activity.
The goal of the study is to evaluate the effectiveness of a family-focused, interactive, and theory-based intervention to reduce the sedentary behavior and increase physical activity of the participants.
The intervention is to use Zero-time Exercise, the positive psychology theme "Appreciation and Gratitude", and role modelling approach to get sedentary people to start exercising, increase levels of physical activity, family communication and well-being of the participants and their family members. The intervention aims to encourage positive and sustainable health actions among participants and their family members.
Needs assessment and focus group interview will be conducted before program design and after conducting the training, respectively. Process evaluation will be performed to evaluate the process of each component of the program. Qualitative and quantitative assessments will be used to evaluate the effectiveness of this Zero-time Exercise intervention.
- Conditions
- Hypokinesia
- Being tested
- Zero-time Exercise, Healthy Eating
- Keywords
- sedentary behaviour, physical activity
- Medical subject headings
- Hypokinesia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zero-time ExerciseBehavioural
a knowledge and motivation enhancement session at baseline, an experience sharing session at 3 months, a family gathering session at 6 months, and a holistic health session at 12 months (not a part of cRCT, for the collection of feedback only) as well as biweekly/monthly mobile messages to improve physical activity habit.
Healthy EatingBehavioural
a knowledge and motivation enhancement session at baseline, an experience sharing session at 3 months, a family gathering session at 6 months, and a holistic health session at 12 months (not a part of cRCT, for the collection of feedback only) as well as biweekly/monthly mobile messages to improve dietary habit.
| Study group | Role | What they receive |
|---|---|---|
| Zero-time Exercise (PA) group | Experimental | The intervention arm (PA group) aims to improve family communication and well-being, reduce sedentary behavior and increase physical activity. The programme includes a knowledge and motivation enhancement session at baseline, an experience sharing session at 3 months, a family gathering session at 6 months, and a holistic health session at 12 months after the first session as well as biweekly/monthly mobile messages.
The holistic health session is not a part of the cRCT, it aims to collect one-year feedback from participants and provides additional health information to improve dietary habits. Receives: Behavioral: Zero-time Exercise |
| Healthy Eating (HE) group | Placebo comparator | The control arm (HE group) aims to improve family communication and well-being and enhance healthy eating habits. Participants are required to engage their family members in their activities. The programme includes a knowledge and motivation enhancement session at baseline, an experience sharing session at 3 months, a family gathering session at 6 months, and a holistic health session at 12 months after the first session as well as biweekly/monthly mobile messages.
The holistic health session is not a part of the cRCT, it aims to collect one-year feedback from participants and provides additional health information to improve physical activity habit. Receives: Behavioral: Healthy Eating |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in behavior on performing physical activity in relation to Zero-time Exercise, moderate and vigorous exercises
Behaviors on performing physical activity will be assessed by outcome-based questionnaire
Measured: baseline, 3 months
Secondary outcomes (8)
Change in behavior on performing physical activity in relation to Zero-time Exercise, moderate and vigorous exercises
Behavior on performing physical activity will be assessed by outcome-based and physical activity questionnaire
Measured: baseline, 3 months, 6 months, 1 year
Change in behavior on taking healthy diet
Behavior on taking healthy diet will be assessed by outcome-based healthy diet questionnaire
Measured: baseline, 3 months, 6 months, 1 year
Attitude on performing Zero-time Exercise,
Attitude on performing physical activity in relation to Zero-time Exercise will be assessed by outcome-based questionnaire
Measured: immediate after training session, 3 months, 6 months, 1 year
Perceived ability and intention to motivate participants themselves and their family to increase Zero-time Exercise
Perceived ability and intention to motivate participants themselves and their family members on performing Zero-time Exercise will be assessed by outcome-based questionnaire
Measured: baseline, 3 months, 6 months, 1 year
Change in participants' own health and happiness
Personal health and happiness will be assessed by outcome-based questionnaire
Measured: baseline, 3 months, 6 months, 1 year
Change in participants' family harmony
Family harmony will be assessed by outcome-based questionnaire
Measured: baseline, 3 months, 6 months, 1 year
Change in physical fitness performance (Endurance)
Endurance will be assessed through a simple fitness test called foot pedaling
Measured: baseline, 3 months,6 months, 1 year
Family members' behavior on performing physical activity in relation to Zero-time Exercise,
Family members' behavior on performing physical activity in relation to Zero-time Exercise will be assessed by outcome-based questionnaire
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2015 (estimated)
- Study startJul 2015
- Primary completionJun 2017
- Study completionJun 2017
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 HypokinesiaStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 673 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Caritas Medical Centre, Hong Kong, The Hong Kong Jockey Club Charities Trust
- Responsible party
- Principal investigator, Dr. Agnes Yuen-Kwan Lai, The University of Hong Kong
- Investigators
- Agnes YK Lai, DN, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02601534
- Sponsor's protocol ID
- UW 15-330
- Status last verified
- Jul 2018
- First submitted
- 5 Nov 2015
- Last updated
- 12 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lai AYK, Lam EYW, Fabrizo C, Lee DPK, Wan ANT, Tsang JSY, Ho LM, Stewart SM, Lam TH. A Community-Based Lifestyle-Integrated Physical Activity Intervention to Enhance Physical Activity, Positive Family Communication, and Perceived Health in Deprived Families: A Cluster Randomized Controlled Trial. Front Public Health. 2020 Sep 15;8:434. doi: 10.3389/fpubh.2020.00434. eCollection 2020.
PubMed 33042934
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Be Healthy, So Easy: FAMILY Education Project
- ClinicalTrials.gov ID
- NCT02601534
- Acronym / sponsor ID
- UW 15-330
- Conditions
- Hypokinesia
- Keywords
- sedentary behaviour, physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 673 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Caritas Medical Centre, Hong Kong, The Hong Kong Jockey Club Charities Trust
- Study start
- Jul 2015 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 10 Nov 2015 (estimated)
- 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.
The goal of the study is to evaluate the effectiveness of a family-focused, interactive, and theory-based intervention to reduce the sedentary behavior and increase physical activity, family communication and well-being of the participants.
The intervention is to use Zero-time Exercise, the positive psychology theme "Appreciation and Gratitude" [23, 24], and role modelling approach to get sedentary people to start exercising, increase levels of physical activity, family communication and well-being of the participants and their family members.
The intervention aims to encourage positive and sustainable health actions among participants and their family members.
Detailed description
Lack of physical activity is a behavioural risk for non-communicable diseases. The World Health Organization (WHO) reported that physical inactivity and unhealthy diets are two of the four main behavioural risk factors that contribute to non-communicable diseases. Globally, people who are overweight and obese, particularly if these people are physically inactive. They are at risk for morbidity and mortality.
Hong Kong-specific data demonstrates that many people cannot meet World Health Organization targets for physical activity. The Hong Kong Behavioural Risk Factor Survey reported that, for the seven days prior to the survey, about half (52.0%) of adults aged 18-64 had not done any moderate physical activity. Overall, only 37.5% of the respondents met the WHO's recommended physical activity level of at least 150 minutes of moderate or 75 minutes of vigorous physical activity a week for adults.
There is emerging evidence of effective behavioral interventions to decrease sedentary behavior. Some studies focused on reducing screen time or active workstations that encourage standing at the computer. Others focus on increased use of stairs instead of lifts. These interventions used behaviour change techniques such as goal-setting and behavioural self-monitoring. As previous approaches have not shown promising results, new approaches are needed to reduce sedentary behaviour and increase exercise or physical activity.
The goal of the study is to evaluate the effectiveness of a family-focused, interactive, and theory-based intervention to reduce the sedentary behavior and increase physical activity of the participants.
The intervention is to use Zero-time Exercise, the positive psychology theme "Appreciation and Gratitude", and role modelling approach to get sedentary people to start exercising, increase levels of physical activity, family communication and well-being of the participants and their family members. The intervention aims to encourage positive and sustainable health actions among participants and their family members.
Needs assessment and focus group interview will be conducted before program design and after conducting the training, respectively. Process evaluation will be performed to evaluate the process of each component of the program. Qualitative and quantitative assessments will be used to evaluate the effectiveness of this Zero-time Exercise intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zero-time Exercise (PA) group | Experimental | Behavioral: Zero-time ExerciseThe intervention arm (PA group) aims to improve family communication and well-being, reduce sedentary behavior and increase physical activity. The programme includes a knowledge and motivation enhancement session at baseline, an experience sharing session at 3 months, a family gathering session at 6 months, and a holistic health session at 12 months after the first session as well as biweekly/monthly mobile messages. The holistic health session is not a part of the cRCT, it aims to collect one-year feedback from participants and provides additional health information to improve dietary habits. |
| Healthy Eating (HE) group | Placebo comparator | Behavioral: Healthy EatingThe control arm (HE group) aims to improve family communication and well-being and enhance healthy eating habits. Participants are required to engage their family members in their activities. The programme includes a knowledge and motivation enhancement session at baseline, an experience sharing session at 3 months, a family gathering session at 6 months, and a holistic health session at 12 months after the first session as well as biweekly/monthly mobile messages. The holistic health session is not a part of the cRCT, it aims to collect one-year feedback from participants and provides additional health information to improve physical activity habit. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Parents with at least on child between 3 and 18;
- Parents with at least primary school educational level:
- Parents who can read and write Chinese.
Key exclusion criteria (2 listed)
- People with a serious health condition that might prevent them from participating in physical activity;
- Parents who do not have a child between 3 and 18.
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 Exercisea knowledge and motivation enhancement session at baseline, an experience sharing session at 3 months, a family gathering session at 6 months, and a holistic health session at 12 months (not a part of cRCT, for the collection of feedback only) as well as biweekly/monthly mobile messages to improve physical activity habit. | Behavioural | Zero-time Exercise (PA) group |
| Healthy Eatinga knowledge and motivation enhancement session at baseline, an experience sharing session at 3 months, a family gathering session at 6 months, and a holistic health session at 12 months (not a part of cRCT, for the collection of feedback only) as well as biweekly/monthly mobile messages to improve dietary habit. | Behavioural | Healthy Eating (HE) group |
Primary outcome
Change in behavior on performing physical activity in relation to Zero-time Exercise, moderate and vigorous exercises
Time frame: baseline, 3 months
Behaviors on performing physical activity will be assessed by outcome-based questionnaire
8 secondary outcomes
Change in behavior on performing physical activity in relation to Zero-time Exercise, moderate and vigorous exercises
Time frame: baseline, 3 months, 6 months, 1 year
Change in behavior on taking healthy diet
Time frame: baseline, 3 months, 6 months, 1 year
Attitude on performing Zero-time Exercise,
Time frame: immediate after training session, 3 months, 6 months, 1 year
Perceived ability and intention to motivate participants themselves and their family to increase Zero-time Exercise
Time frame: baseline, 3 months, 6 months, 1 year
Change in participants' own health and happiness
Time frame: baseline, 3 months, 6 months, 1 year
Change in participants' family harmony
Time frame: baseline, 3 months, 6 months, 1 year
Change in physical fitness performance (Endurance)
Time frame: baseline, 3 months,6 months, 1 year
Family members' behavior on performing physical activity in relation to Zero-time Exercise,
Time frame: 6 months
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 12 Jul 2018.
- Derived from this study: PubMed 33042934Lai AYK, Lam EYW, Fabrizo C, Lee DPK, Wan ANT, Tsang JSY, Ho LM, Stewart SM, Lam TH. A Community-Based Lifestyle-Integrated Physical Activity Intervention to Enhance Physical Activity, Positive Family Communication, and Perceived Health in Deprived Families: A Cluster Randomized Controlled Trial. Front Public Health. 2020 Sep 15;8:434. doi: 10.3389/fpubh.2020.00434. eCollection 2020.
- World Health Organization (2017). Noncommunicable diseases : Fact SheetLink provided by the sponsor.
- Department of Health (2016). Behavioural Risk Factor SurveyLink provided by the sponsor.
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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.
Agnes YK Lai, DN principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zero-time Exercise and Healthy Eating in people with Hypokinesia, run by The University of Hong Kong at 1 site in Hong Kong.
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 3 inclusion and 2 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 12 Jul 2018. 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. Some participants in this study may receive a placebo. 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 behavior on performing physical activity in relation to Zero-time Exercise, moderate and vigorous exercises (time frame: baseline, 3 months). 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 NCT02601534, 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 12 Jul 2018.