Clinical trial NCT02866773: A Community-based Family Holistic Health Promotion Project in Hong Kong: A Cluster Randomized Controlled Trial (cRCT)
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Family
Well-being
Physical Activity
Healthy Diet
Keywords: Family
well-being
Physical activity
Diet
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Hong Kong Island Women Association
name: The Hong Kong Jockey Club Charities Trust
First posted: 2016-08-15
Enrollment: 1200
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: According to World Health Organization (WHO), the prevalence of obesity among all nations has nearly doubled since 1980. High body mass index (BMI) is one of the major risk factors of many non-communicable diseases (NCD) and is the result of unhealthy diet and physical inactivity. In Hong Kong, the Department of Health (DH) found in 2012, through the telephone surveys, that nearly 40% of adults were overweight or obese. About 60% of total registered deaths in Hong Kong were due to four major preventable NCD, which were cancer, heart diseases, stroke and chronic lower respiratory diseases. Therefore, population-based interventions for collective health benefits, especially regarding weight management, are essential in lowering the risk of NCD in the total population.

Given the high proportion of overweight and obese individuals among the local population, achieving modest or even small behavioral changes in diet or activity could potentially lead to significant improvements in public health. Promotion of healthy diets and physical activity is one of the five recommended cost-effective interventions that have been addressed in The Lancet Series. The implementation of policies to promote healthy diets - reducing sugary beverages, in particular - and physical activity due to the likelihood of wide-ranging health gains, including prevention of overweight and cardiovascular disease, on a population level is advocated.

Facing the same challenges of the rest of the world that many residents are lacking of attention on healthy lifestyle, the Hong Kong SAR Government has a burden to improve the well-being of the general public. The Government has recently established a Committee on 'Reduction of Salt and Sugar in Food'. They will steer the direction, formulate and oversee the Action Plans for Salt and Sugar Reduction in Hong Kong. The aim is to reduce the intake of salt and sugar by residents to meet the WHO recommendations. The Centre for Food Safety showed that carbonated drinks and fruit juices were popular in Hong Kong. However, the added sugar does not have any nutritional value but increases the risk of overweight and obesity. Therefore, the promotion of healthy family diet is appropriate for improving a current public health situation in Hong Kong. On the other hand, the Leisure and Cultural Services Department have been jointed with the Department of Health to launch the 'Healthy Exercise for All Campaign' for raising the public's interest in exercising. However, none of the campaigns have addressed the problems and barriers of the sedentary people and their families. The barriers include myths and wrong perceptions, e.g.; exercise has to be difficult, or one has to find much time, spend much money and do lots of high intensive exercise to be beneficial.

This project is aimed to motivate participants to improve start with 'zero-time exercise' and reduce sugary beverages, which can be incorporated into daily life to reduce day-to-day sedentary time and sugar intake together with family members of all ages, that can then act as a trigger for active and healthy lifestyle. Few exercises can be done by the family members together. The investigators shall motivate participants to share what they have learned with their family members and to do 'zero-time exercise' and reduce sugary beverage's intake together. This project includes three major components: Train-the-trainer and -ambassador workshop, community-based family interventions, and public education events. Knowledge and skills of the community leaders and ambassadors will be strengthened through the 'Train-the-trainer and -ambassador' workshop. The trainees will be 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.

Outcome and process evaluations will be used to assess the engagement, implementation and effectiveness of the project. Focus group and in-depth interviews will be conducted to obtain feedback, and opinion of the community leaders, ambassadors and community participants. Quantitative questionnaire assessments will be conducted at different time points to assess the effectiveness of the project on the key components of personal and family holistic health, and family well-being. The assessment time points are before and immediately after the core session, before and after the booster session at one month, three months, six months for community participants. An additional assessment for the community leaders and ambassadors is nine months.

Eligibility 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.

Primary outcomes:
measure: Change in behaviour
timeFrame: baseline and one month
Secondary outcomes:
measure: Change in behavior
timeFrame: Baseline, 1 month, 3 months, 6 months, and 9 months
measure: Change in learning
timeFrame: Baseline, immediately after core session, 1 month, 3 months, 6 months, and 9 months
measure: Influence on family members
timeFrame: Baseline, 1 month, 3 months, 6 months, and 9 months
measure: Personal physical and psychological health
timeFrame: Baseline, 1 month, 3 months, 6 months, and 9 months
measure: Quality of Life
timeFrame: Baseline, 1 month, 3 months, 6 months, and 9 months
measure: Family well-being
timeFrame: Baseline, 1 month, 3 months, 6 months, and 9 months
measure: Family relationship
timeFrame: Baseline, 1 month, 3 months, 6 months, and 9 months
measure: Satisfaction towards the program
timeFrame: immediately after core session, immediately after booster session at 1 month, 6 months, 9 months
measure: Response on Anti-inertia Reminder
timeFrame: 1 months, 3 months, 6 months
measure: Social network relationship
timeFrame: 6 months and 9 months
Other outcomes:
Locations:
city: Hong Kong Island
country: Hong Kong
facility: Hong Kong Island Women Association
Study officials:
affiliation: School of Public Health, The University of Hong Kong
name: Tai-hing Lam, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hong Kong Island Women Association
name: Piana He, MSc
role: STUDY_DIRECTOR
References:
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