- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02601534
Be Healthy, So Easy: FAMILY Education Project
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Hong Kong, Hong Kong, 852
- Caritas integrated Family Service Centre
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Zero-time Exercise (PA) group
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. |
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.
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|
Placebo Comparator: Healthy Eating (HE) group
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. |
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
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baseline, 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Behavior on performing physical activity will be assessed by outcome-based and physical activity questionnaire
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baseline, 3 months, 6 months, 1 year
|
|
Change in behavior on taking healthy diet
Time Frame: baseline, 3 months, 6 months, 1 year
|
Behavior on taking healthy diet will be assessed by outcome-based healthy diet questionnaire
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baseline, 3 months, 6 months, 1 year
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Attitude on performing Zero-time Exercise,
Time Frame: immediate after training session, 3 months, 6 months, 1 year
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Attitude on performing physical activity in relation to Zero-time Exercise will be assessed by outcome-based questionnaire
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immediate after training session, 3 months, 6 months, 1 year
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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
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Perceived ability and intention to motivate participants themselves and their family members on performing Zero-time Exercise will be assessed by outcome-based questionnaire
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baseline, 3 months, 6 months, 1 year
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Change in participants' own health and happiness
Time Frame: baseline, 3 months, 6 months, 1 year
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Personal health and happiness will be assessed by outcome-based questionnaire
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baseline, 3 months, 6 months, 1 year
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Change in participants' family harmony
Time Frame: baseline, 3 months, 6 months, 1 year
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Family harmony will be assessed by outcome-based questionnaire
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baseline, 3 months, 6 months, 1 year
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Change in physical fitness performance (Endurance)
Time Frame: baseline, 3 months,6 months, 1 year
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Endurance will be assessed through a simple fitness test called foot pedaling
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baseline, 3 months,6 months, 1 year
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Family members' behavior on performing physical activity in relation to Zero-time Exercise,
Time Frame: 6 months
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Family members' behavior on performing physical activity in relation to Zero-time Exercise will be assessed by outcome-based questionnaire
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6 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Agnes YK Lai, DN, The University of Hong Kong
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UW 15-330
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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