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Be Healthy, So Easy: FAMILY Education Project

Primary Purpose

Hypokinesia

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Zero-time Exercise
Healthy Eating
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypokinesia focused on measuring sedentary behaviour, physical activity

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Parents with at least on child between 3 and 18;
  2. Parents with at least primary school educational level:
  3. Parents who can read and write Chinese.

Exclusion Criteria:

  1. People with a serious health condition that might prevent them from participating in physical activity;
  2. Parents who do not have a child between 3 and 18.

Sites / Locations

  • Caritas integrated Family Service Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Zero-time Exercise (PA) group

Healthy Eating (HE) group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Change in behavior on taking healthy diet
Behavior on taking healthy diet will be assessed by outcome-based healthy diet questionnaire
Attitude on performing Zero-time Exercise,
Attitude on performing physical activity in relation to Zero-time Exercise will be assessed by outcome-based questionnaire
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
Change in participants' own health and happiness
Personal health and happiness will be assessed by outcome-based questionnaire
Change in participants' family harmony
Family harmony will be assessed by outcome-based questionnaire
Change in physical fitness performance (Endurance)
Endurance will be assessed through a simple fitness test called foot pedaling
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

Full Information

First Posted
November 5, 2015
Last Updated
July 10, 2018
Sponsor
The University of Hong Kong
Collaborators
Caritas Medical Centre, Hong Kong, The Hong Kong Jockey Club Charities Trust
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1. Study Identification

Unique Protocol Identification Number
NCT02601534
Brief Title
Be Healthy, So Easy: FAMILY Education Project
Official Title
Be Healthy, So Easy: FAMILY Education Project
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
July 2015 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong
Collaborators
Caritas Medical Centre, Hong Kong, The Hong Kong Jockey Club Charities Trust

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypokinesia
Keywords
sedentary behaviour, physical activity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
673 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Zero-time Exercise (PA) group
Arm Type
Experimental
Arm Description
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.
Arm Title
Healthy Eating (HE) group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Zero-time Exercise
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Healthy Eating
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in behavior on performing physical activity in relation to Zero-time Exercise, moderate and vigorous exercises
Description
Behaviors on performing physical activity will be assessed by outcome-based questionnaire
Time Frame
baseline, 3 months
Secondary Outcome Measure Information:
Title
Change in behavior on performing physical activity in relation to Zero-time Exercise, moderate and vigorous exercises
Description
Behavior on performing physical activity will be assessed by outcome-based and physical activity questionnaire
Time Frame
baseline, 3 months, 6 months, 1 year
Title
Change in behavior on taking healthy diet
Description
Behavior on taking healthy diet will be assessed by outcome-based healthy diet questionnaire
Time Frame
baseline, 3 months, 6 months, 1 year
Title
Attitude on performing Zero-time Exercise,
Description
Attitude on performing physical activity in relation to Zero-time Exercise will be assessed by outcome-based questionnaire
Time Frame
immediate after training session, 3 months, 6 months, 1 year
Title
Perceived ability and intention to motivate participants themselves and their family to increase Zero-time Exercise
Description
Perceived ability and intention to motivate participants themselves and their family members on performing Zero-time Exercise will be assessed by outcome-based questionnaire
Time Frame
baseline, 3 months, 6 months, 1 year
Title
Change in participants' own health and happiness
Description
Personal health and happiness will be assessed by outcome-based questionnaire
Time Frame
baseline, 3 months, 6 months, 1 year
Title
Change in participants' family harmony
Description
Family harmony will be assessed by outcome-based questionnaire
Time Frame
baseline, 3 months, 6 months, 1 year
Title
Change in physical fitness performance (Endurance)
Description
Endurance will be assessed through a simple fitness test called foot pedaling
Time Frame
baseline, 3 months,6 months, 1 year
Title
Family members' behavior on performing physical activity in relation to Zero-time Exercise,
Description
Family members' behavior on performing physical activity in relation to Zero-time Exercise will be assessed by outcome-based questionnaire
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Agnes YK Lai, DN
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Caritas integrated Family Service Centre
City
Hong Kong
ZIP/Postal Code
852
Country
Hong Kong

12. IPD Sharing Statement

Citations:
PubMed Identifier
33042934
Citation
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.
Results Reference
derived
Links:
URL
http://www.who.int/en/news-room/fact-sheets/detail/noncommunicable-diseases
Description
World Health Organization (2017). Noncommunicable diseases : Fact Sheet
URL
https://www.chp.gov.hk/files/pdf/brfa_report_april_2016_eng.pdf
Description
Department of Health (2016). Behavioural Risk Factor Survey

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Be Healthy, So Easy: FAMILY Education Project

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