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A Community-based Family Holistic Health Promotion Project in Hong Kong: A Cluster Randomized Controlled Trial (cRCT)

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ClinicalTrials.gov Identifier: NCT02866773
Recruitment Status : Unknown
Verified August 2016 by Professor Lam Tai-Hing, The University of Hong Kong.
Recruitment status was:  Recruiting
First Posted : August 15, 2016
Last Update Posted : August 15, 2016
Sponsor:
Collaborators:
Hong Kong Island Women Association
The Hong Kong Jockey Club Charities Trust
Information provided by (Responsible Party):
Professor Lam Tai-Hing, The University of Hong Kong

Brief Summary:
In Hong Kong, nearly 40% of adults were overweight or obese, and about 60% of total registered deaths were due to four major preventable non-communicable diseases. Many residents are lack of attention to personal healthy lifestyle and family holistic health. This project focuses particularly on the promotion of healthy diet and physical activities enhancement in families through the well-established community network of the Hong Kong Island Women Association (HKIWA). This project includes three major components: Train-the-trainer and -ambassador workshop, community-based family interventions, and public education events. It is expected that knowledge and skills of the community leaders and ambassadors are strengthened through the 'Train-the-trainer and -ambassador' (TTTA) workshops. Furthermore, they are expected to help the implementation of community-based family interventions and public education events on the personal and family holistic health of the community participants.

Condition or disease Intervention/treatment Phase
Family Well-being Physical Activity Healthy Diet Behavioral: PA1: Education sessions, Reminders, Whataps group Behavioral: PA2: Education sessions, Reminders Behavioral: PA3: Education sessions, Whataps group Behavioral: PA4: Education sessions Behavioral: HD1: Education sessions, Reminders, Whataps group Behavioral: HD2: Education sessions, Reminders Behavioral: HD3:Education sessions, Whataps group Behavioral: HD4: Education sessions Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Family Holistic Health Community Promotion, A Community-based Research to Promote Healthy Diet and Physical Activity in Hong Kong Island: A Cluster Randomized Controlled Trial (cRCT)
Study Start Date : January 2016
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : August 2017

Arm Intervention/treatment
Experimental: PA1:Education sessions, Reminders, Whataps group
The intervention includes Physical activity knowledge enhancement session, Physical activity anti-inertia Reminders , Physical activity ambassadors' electronic communication group.
Behavioral: PA2: Education sessions, Reminders

The intervention includes two components:

  • Physical activity knowledge enhancement session: one core session and one booster session on increasing physical activity and reducing sedentary behavior
  • Physical activity Anti-inertia Reminder: souvenirs and electronic healthy messages are sent to participants in this group to promote the awareness of performing regular exercise

Behavioral: PA3: Education sessions, Whataps group

The intervention includes two components:

  • Physical activity knowledge enhancement session: one core session and one booster session on increasing physical activity and reducing sedentary behavior.
  • Physical activity ambassadors' electronic communication group: the community leaders and ambassadors' formed an electronic communication group to share their experience on performing regular physical activity and program implementation.

Behavioral: PA4: Education sessions

The intervention includes one component only:

- Physical activity knowledge enhancement session: one core session and one booster session on increasing physical activity and reducing sedentary behavior


Behavioral: HD1: Education sessions, Reminders, Whataps group

The intervention includes two components:

- Healthy diet knowledge enhancement session: one core session and one booster session on increasing reducing sugary intake.

Healthy diet Anti-inertia Reminder: souvenirs and electronic healthy messages are sent to participants in this group to promote the awareness of reducing sugary intake.

- Healthy diet ambassadors' electronic communication group: the community leaders and ambassadors' formed an electronic communication group to share their experience on reducing sugary intake and program implementation.


Active Comparator: PA2:Education sessions, Reminders
The intervention includes Physical activity knowledge enhancement session and Physical activity anti-inertia Reminders
Behavioral: PA3: Education sessions, Whataps group

The intervention includes two components:

  • Physical activity knowledge enhancement session: one core session and one booster session on increasing physical activity and reducing sedentary behavior.
  • Physical activity ambassadors' electronic communication group: the community leaders and ambassadors' formed an electronic communication group to share their experience on performing regular physical activity and program implementation.

Behavioral: PA4: Education sessions

The intervention includes one component only:

- Physical activity knowledge enhancement session: one core session and one booster session on increasing physical activity and reducing sedentary behavior


Active Comparator: PA3:Education sessions, Whataps group
The intervention includes Physical activity knowledge enhancement session and Physical activity ambassadors' electronic communication group.
Behavioral: PA2: Education sessions, Reminders

The intervention includes two components:

  • Physical activity knowledge enhancement session: one core session and one booster session on increasing physical activity and reducing sedentary behavior
  • Physical activity Anti-inertia Reminder: souvenirs and electronic healthy messages are sent to participants in this group to promote the awareness of performing regular exercise

Behavioral: PA4: Education sessions

The intervention includes one component only:

- Physical activity knowledge enhancement session: one core session and one booster session on increasing physical activity and reducing sedentary behavior


Active Comparator: PA4:Education sessions
The intervention includes Physical activity knowledge enhancement session only.
Behavioral: HD4: Education sessions

The intervention includes one component only:

- Healthy diet knowledge enhancement session: one core session and one booster session on increasing reducing sugary intake.


Experimental: HD1:Education sessions, Reminders, Whataps group
The intervention includes Health diet knowledge enhancement session, Health diet anti-inertia Reminders , Health diet ambassadors' electronic communication group.
Behavioral: PA1: Education sessions, Reminders, Whataps group

The intervention includes three components:

  • Physical activity knowledge enhancement session: one core session and one booster session on increasing physical activity and reducing sedentary behavior
  • Physical activity Anti-inertia Reminder: souvenirs and electronic healthy messages are sent to participants in this group to promote the awareness of performing regular exercise
  • Physical activity ambassadors' electronic communication group: the community leaders and ambassadors' formed an electronic communication group to share their experience on performing regular physical activity and program implementation.

Behavioral: HD2: Education sessions, Reminders

The intervention includes two components:

  • Healthy diet knowledge enhancement session: one core session and one booster session on increasing reducing sugary intake.
  • Healthy diet Anti-inertia Reminder: souvenirs and electronic healthy messages are sent to participants in this group to promote the awareness of reducing sugary intake.

Behavioral: HD3:Education sessions, Whataps group

The intervention includes two components:

  • Healthy diet knowledge enhancement session: one core session and one booster session on increasing reducing sugary intake.
  • Healthy diet ambassadors' electronic communication group: the community leaders and ambassadors' formed an electronic communication group to share their experience on reducing sugary intake and program implementation.

Behavioral: HD4: Education sessions

The intervention includes one component only:

- Healthy diet knowledge enhancement session: one core session and one booster session on increasing reducing sugary intake.


Active Comparator: HD2:Education sessions, Reminders
The intervention includes Health diet knowledge enhancement session, Health diet anti-inertia Reminders , and Health diet ambassadors' electronic communication group.
Behavioral: HD3:Education sessions, Whataps group

The intervention includes two components:

  • Healthy diet knowledge enhancement session: one core session and one booster session on increasing reducing sugary intake.
  • Healthy diet ambassadors' electronic communication group: the community leaders and ambassadors' formed an electronic communication group to share their experience on reducing sugary intake and program implementation.

Behavioral: HD4: Education sessions

The intervention includes one component only:

- Healthy diet knowledge enhancement session: one core session and one booster session on increasing reducing sugary intake.


Active Comparator: HD3:Education sessions, Whataps group
The intervention includes Health diet knowledge enhancement session and Health diet ambassadors' electronic communication group.
Behavioral: HD2: Education sessions, Reminders

The intervention includes two components:

  • Healthy diet knowledge enhancement session: one core session and one booster session on increasing reducing sugary intake.
  • Healthy diet Anti-inertia Reminder: souvenirs and electronic healthy messages are sent to participants in this group to promote the awareness of reducing sugary intake.

Behavioral: HD4: Education sessions

The intervention includes one component only:

- Healthy diet knowledge enhancement session: one core session and one booster session on increasing reducing sugary intake.


Active Comparator: HD4:Education sessions
The intervention includes Health diet knowledge enhancement session only.
Behavioral: HD4: Education sessions

The intervention includes one component only:

- Healthy diet knowledge enhancement session: one core session and one booster session on increasing reducing sugary intake.





Primary Outcome Measures :
  1. Change in behaviour [ Time Frame: baseline and one month ]
    Assessed by outcome-based questionnaire


Secondary Outcome Measures :
  1. Change in behavior [ Time Frame: Baseline, 1 month, 3 months, 6 months, and 9 months ]
    Assessed by outcome-based questionnaire

  2. Change in learning [ Time Frame: Baseline, immediately after core session, 1 month, 3 months, 6 months, and 9 months ]
    Assessed by outcome-based questionnaire

  3. Influence on family members [ Time Frame: Baseline, 1 month, 3 months, 6 months, and 9 months ]
    Assessed by outcome-based questionnaire

  4. Personal physical and psychological health [ Time Frame: Baseline, 1 month, 3 months, 6 months, and 9 months ]
    Assessed by outcome-based questionnaire

  5. Quality of Life [ Time Frame: Baseline, 1 month, 3 months, 6 months, and 9 months ]
    Assessed by a validated questionnaire (SF12)

  6. Family well-being [ Time Frame: Baseline, 1 month, 3 months, 6 months, and 9 months ]
    Assessed by outcome-based questionnaire

  7. Family relationship [ Time Frame: Baseline, 1 month, 3 months, 6 months, and 9 months ]
    Assessed by outcome-based questionnaire

  8. Satisfaction towards the program [ Time Frame: immediately after core session, immediately after booster session at 1 month, 6 months, 9 months ]
    Assessed by outcome-based questionnaire

  9. Response on Anti-inertia Reminder [ Time Frame: 1 months, 3 months, 6 months ]
    Assessed by outcome-based questions

  10. Social network relationship [ Time Frame: 6 months and 9 months ]
    Assessed by outcome-based questions



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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria

  1. Train-the-trainers and ambassador programs:

    • Cantonese speaking
    • Intact verbal and hearing abilities for interpersonal communication
    • Reading and writing abilities for questionnaire completion
    • Community leaders and health ambassadors
    • Aged 18 or above
  2. Community-based family interventions:

    • Cantonese speaking
    • Intact verbal and hearing abilities for interpersonal communication
    • Reading and writing abilities for questionnaire completion
    • Aged 12 or above
  3. Public education events:

    • Reading and writing abilities for questionnaire completion
    • Aged 12 or above

Exclusion criteria

- Participants who fail to meet the inclusion criteria, or are unable to sign the consent form.


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): NCT02866773


Contacts
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Contact: Agnes YK Lai, DN 852-3917-6779 agneslai@hku.hk
Contact: Tai-hing Lam, MD 852-3917-9287 hrmrlth@hku.hk

Locations
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Hong Kong
Hong Kong Island Women Association Recruiting
Hong Kong Island, Hong Kong, 852
Contact: Piana He, MSc    3621-0102    hkiwassoc@yahoo.com.hk   
Sponsors and Collaborators
The University of Hong Kong
Hong Kong Island Women Association
The Hong Kong Jockey Club Charities Trust
Investigators
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Principal Investigator: Tai-hing Lam, MD School of Public Health, The University of Hong Kong
Study Director: Piana He, MSc Hong Kong Island Women Association

Publications:

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Responsible Party: Professor Lam Tai-Hing, Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT02866773     History of Changes
Other Study ID Numbers: UW -1622
First Posted: August 15, 2016    Key Record Dates
Last Update Posted: August 15, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Professor Lam Tai-Hing, The University of Hong Kong:
Family
well-being
Physical activity
Diet