Clinical trial NCT02601534: Be Healthy, So Easy: FAMILY Education Project
Official title: Be Healthy, So Easy: FAMILY Education Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypokinesia
Keywords: sedentary behaviour
physical activity
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Caritas Medical Centre, Hong Kong
name: The Hong Kong Jockey Club Charities Trust
First posted: 2015-11-10
Enrollment: 673
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: Change in behavior on performing physical activity in relation to Zero-time Exercise, moderate and vigorous exercises
timeFrame: baseline, 3 months
Secondary outcomes:
measure: Change in behavior on performing physical activity in relation to Zero-time Exercise, moderate and vigorous exercises
timeFrame: baseline, 3 months, 6 months, 1 year
measure: Change in behavior on taking healthy diet
timeFrame: baseline, 3 months, 6 months, 1 year
measure: Attitude on performing Zero-time Exercise,
timeFrame: immediate after training session, 3 months, 6 months, 1 year
measure: Perceived ability and intention to motivate participants themselves and their family to increase Zero-time Exercise
timeFrame: baseline, 3 months, 6 months, 1 year
measure: Change in participants' own health and happiness
timeFrame: baseline, 3 months, 6 months, 1 year
measure: Change in participants' family harmony
timeFrame: baseline, 3 months, 6 months, 1 year
measure: Change in physical fitness performance (Endurance)
timeFrame: baseline, 3 months,6 months, 1 year
measure: Family members' behavior on performing physical activity in relation to Zero-time Exercise,
timeFrame: 6 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Caritas integrated Family Service Centre
Study officials:
affiliation: The University of Hong Kong
name: Agnes YK Lai, DN
role: PRINCIPAL_INVESTIGATOR
References:
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.