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Be Healthy, So Easy: FAMILY Education Project

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ClinicalTrials.gov Identifier: NCT02601534
Recruitment Status : Completed
First Posted : November 10, 2015
Last Update Posted : July 12, 2018
Sponsor:
Collaborators:
Caritas Medical Centre, Hong Kong
The Hong Kong Jockey Club Charities Trust
Information provided by (Responsible Party):
Dr. Agnes Yuen-Kwan Lai, The University of Hong Kong

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.


Condition or disease Intervention/treatment Phase
Hypokinesia Behavioral: Zero-time Exercise Behavioral: Healthy Eating Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 673 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Be Healthy, So Easy: FAMILY Education Project
Actual Study Start Date : July 2015
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine


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.

Behavioral: Zero-time Exercise
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.

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.

Behavioral: Healthy Eating
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 Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Attitude on performing Zero-time Exercise, [ Time Frame: immediate after training session, 3 months, 6 months, 1 year ]
    Attitude on performing physical activity in relation to Zero-time Exercise will be assessed by outcome-based questionnaire

  4. 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 ]
    Perceived ability and intention to motivate participants themselves and their family members on performing Zero-time Exercise will be assessed by outcome-based questionnaire

  5. Change in participants' own health and happiness [ Time Frame: baseline, 3 months, 6 months, 1 year ]
    Personal health and happiness will be assessed by outcome-based questionnaire

  6. Change in participants' family harmony [ Time Frame: baseline, 3 months, 6 months, 1 year ]
    Family harmony will be assessed by outcome-based questionnaire

  7. Change in physical fitness performance (Endurance) [ Time Frame: baseline, 3 months,6 months, 1 year ]
    Endurance will be assessed through a simple fitness test called foot pedaling

  8. Family members' behavior on performing physical activity in relation to Zero-time Exercise, [ Time Frame: 6 months ]
    Family members' behavior on performing physical activity in relation to Zero-time Exercise will be assessed by outcome-based questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02601534


Locations
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Hong Kong
Caritas integrated Family Service Centre
Hong Kong, Hong Kong, 852
Sponsors and Collaborators
The University of Hong Kong
Caritas Medical Centre, Hong Kong
The Hong Kong Jockey Club Charities Trust
Investigators
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Principal Investigator: Agnes YK Lai, DN The University of Hong Kong

Additional Information:
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Responsible Party: Dr. Agnes Yuen-Kwan Lai, Project Manager (Health Communication), The University of Hong Kong
ClinicalTrials.gov Identifier: NCT02601534     History of Changes
Other Study ID Numbers: UW 15-330
First Posted: November 10, 2015    Key Record Dates
Last Update Posted: July 12, 2018
Last Verified: July 2018
Keywords provided by Dr. Agnes Yuen-Kwan Lai, The University of Hong Kong:
sedentary behaviour
physical activity
Additional relevant MeSH terms:
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Hypokinesia
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms