Motor ActivityNCT03146169
Training Program for Community Health Campaign: Fitter Families Project
A study testing Training group in people with Motor Activity, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
In recent years, Hong Kong has been undergoing rapid changes with macro social and economic trends. The increasingly complex and diverse family structure contribute to concerns regarding the well-being of families in Hong Kong, including their health, happiness and harmony (FAMILY 3Hs). Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Motor Activity
- What is being tested?
- Training group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Sep 2015to 31 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Chinese speaking
- able to complete assessments
Who cannot join
- not fit the inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
In recent years, Hong Kong has been undergoing rapid changes with macro social and economic trends. The increasingly complex and diverse family structure contribute to concerns regarding the well-being of families in Hong Kong, including their health, happiness and harmony (FAMILY 3Hs). Family life and health education should be strengthened to meet the increasing needs of promoting healthy active lifestyle among Hong Kong families. In this connection, the FAMILY Project initiates the Fitter Families Project (FFP) with a focus on "FAMILY Holistic Health", will be conducted in order to increase the awareness of the importance of FAMILY 3Hs. FFP is a community-based research project with 3 main components - train-the-trainer program, community-based family interventions and public education events. It is expected that trainees from the train-the-trainer program will acquire adequate skills to organize community-based health education programs effectively. Participants of the community-based family interventions will gain knowledge on family holistic health and live a healthy active lifestyle. Attendees of the public education events will become more aware of the importance of FAMILY 3Hs.
Read the detailed description
In 2011, United Nations (UN) addressed the prevention and control of four non-communicable diseases (NCDs: cancer, cardiovascular disease, chronic respiratory disease, and diabetes mellitus) worldwide. The UN, in its Political Declaration, recognized the critical importance of reducing the exposure to the common modifiable risk factors for NCDs, namely, tobacco use, unhealthy diet, physical inactivity, and the harmful use of alcohol.In Hong Kong, NCDs are responsible for more than 85% of all deaths and most of these are preventable. FAMILY Project Cohort Study (2014) also found that 88.6% of Hong Kong people had inadequate vegetable and fruit intake, 70.6% had inadequate physical exercise, 26.4% were overweight and 5.4% were obese.
Families worldwide have been undergoing rapid changes with macro, social and economic trends. Demographic shifts, economic upheavals, changing societal norms and values, immigration across national borders and migration within nations are creating new and altered structures, processes and relationships within families. The increasingly complex and diverse family structure contributes to concerns regarding the well-being of families in Hong Kong, including their health, happiness and harmony (FAMILY 3Hs). Family life and health education should be strengthened to meet the increasing needs of promoting healthy lifestyle among Hong Kong families.
The Fitter Families Project is developed based on the strong foundation of the Learning Families Project in the previous years. In view of the health challenges locally and globally, the new phase of FAMILY project will put more emphasis on health in the upcoming three years. Following the themes on FAMILY health, happiness and harmony (3Hs), the Fitter Families Project focuses on family holistic health with emphasis on the interaction and integration of both physical and psychosocial health.
As an initial step of this project, the investigators conducted a need assessments before designing and conducting a train-the-trainer program. The train-the-trainer program aimed to prepare the staff and lay volunteers to conduct and or assist to implement a series of community-based activities and interventions for the participants of Fitter Families Project. Focus group interviews were conducted to obtain feedback and opinion from the trainees . Questionnaire assessments were conducted before, immediately after finishing the training, three months after training.
- Conditions
- Motor Activity
- Being tested
- Training group
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training groupBehavioural
The training workshop includes four two-hour sessions:
Session one - a knowledge, self-efficacy, and motivation enhancement session at baseline; Session two - an interpersonal communication and leadership skills session at one week; Session three - a motivation enhancement session at one month Session four - an experience sharing session at three months
| Study group | Role | What they receive |
|---|---|---|
| Training group | Experimental | Four two-hour training sessions were conducted at baseline, and one week, one month and three months after the first session. Receives: Behavioral: Training group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in trainees' learning
Assessed by outcome-based questionnaire
Measured: baseline, immediately after first session "up to 30 min", one month and three months
Secondary outcomes (20)
Trainees' reactions to training content
Assessed by outcome-based questionnaire
Measured: Immediately after the training workshop
Trainees' changes in the frequency and amount on performing physical exercise adn Zero Time Exercise
Assessed by outcome-based questionnaire on performing moderate exercise, vigorous exercise and Zero Time Exercise and walking
Measured: baseline, one month and three months
Trainees' changes in grip strength (kg)
assessed by a hand grip dynamometer
Measured: baseline and one month
Trainees' changes in chair stand (times)
baseline and one month
Measured: Assessed 30s Chair stand test ( a test counting number of times from sitting position to standing position in 30 seconds
Trainees' changes in single-leg standing time (second)
baseline and one month
Measured: Assessed by a single-leg stance test ( a test measuring the longest duration of a single leg in 120 seconds)
Trainees' changes in seat and reach (cm)
Assessed by a ruler
Measured: Baseline and one month
Trainees' changes in body fat (%)
Assessed by a standard body fat and weight measuring scale
Measured: Baseline and one month
Trainees' changes in body weight (kg)
Assessed by a standard body fat and weight measuring scale
Measured: Baseline and one month
Trainees' changes in frequency and amount on performing physical activity and Zero Time Exercise)
Assessed by outcome-based questionnaire on performing moderate exercise, vigorous exercise and Zero Time Exercise and walking
Measured: baseline, one month and three months
Trainees' changes in personal happiness
Assessed by outcome-based questionnaire
Measured: baseline, one month and three months
Trainees' changes in personal health
Assessed by outcome-based questionnaire
Measured: baseline, one month and three months
Trainees' changes in family health
Assessed by outcome-based questionnaire
Measured: baseline, one month and three months
Trainees' changes in family happiness
Assessed by outcome-based questionnaire
Measured: baseline, one month and three months
Trainees' changes in family harmony
Assessed by outcome-based questionnaire
Measured: baseline, one month and three months
Trainees' changes in sharing health knowledge with family members in relation to physical activity
Assessed by outcome-based questionnaire
Measured: baseline, one month and three months
Trainees' changes in doing physical activity and exercise with family
Assessed by outcome-based questionnaire
Measured: baseline, one month and three months
Trainees' comments on the received electronic health messages
Assessed by outcome-based questionnaire
Measured: baseline, one month and three months
Community participants' changes in family health
Assessed by outcome-based questionnaire
Measured: baseline, one month and three months
Community participants' changes in family happiness
Assessed by outcome-based questionnaire
Measured: baseline, one month and three months
Community participants' changes in family harmony
Assessed by outcome-based questionnaire
Measured: baseline, one month and three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2017
- Study start1 Sep 2015
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Motor ActivityStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A four-session training workshop is provided to the trainees in order to enhance their competence and performance for conducing and/or assisting the implementation of community -based interventions and activities.
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Agnes Yuen-Kwan Lai, The University of Hong Kong
- Investigators
- Agnes YK Lai, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03146169
- Sponsor's protocol ID
- UW15 - 401
- Status last verified
- May 2018
- First submitted
- 5 May 2017
- Last updated
- 14 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The minimal anonymized dataset will be available upon request to interested researchers. For interested researchers, please contact, Ms Grace Lau (email gclau@hku.hk), (School of Public Health, The University of Hong Kong) for further information."
Publications
Wacharasin C, Theinpichet S. Family nursing practice, education, and research: what is happening in Thailand? J Fam Nurs. 2008 Nov;14(4):429-35. doi: 10.1177/1074840708327515.
PubMed 19139157Denham SA. Family routines: a structural perspective for viewing family health. ANS Adv Nurs Sci. 2002 Jun;24(4):60-74. doi: 10.1097/00012272-200206000-00010.
PubMed 12699277Yoshikawa H. Integrating methods in the science of family health: new directions from an institute of medicine workshop report. Arch Pediatr Adolesc Med. 2012 Jul 1;166(7):659-61. doi: 10.1001/archpediatrics.2012.510. No abstract available.
PubMed 22751883Anderson KH, Tomlinson PS. The family health system as an emerging paradigmatic view for nursing. Image J Nurs Sch. 1992 Spring;24(1):57-63. doi: 10.1111/j.1547-5069.1992.tb00700.x.
PubMed 1541473Lai AYK, Stewart SM, Wan ANT, Shen C, Ng CKK, Kwok LT, Chan SS, Ho DSY, Lam TH. Training to implement a community program has positive effects on health promoters: JC FAMILY Project. Transl Behav Med. 2018 Nov 21;8(6):838-850. doi: 10.1093/tbm/iby070.
PubMed 29961808
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Training Program for Community Health Campaign: Fitter Families Project
- ClinicalTrials.gov ID
- NCT03146169
- Acronym / sponsor ID
- UW15 - 401
- Conditions
- Motor Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 9 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In recent years, Hong Kong has been undergoing rapid changes with macro social and economic trends. The increasingly complex and diverse family structure contribute to concerns regarding the well-being of families in Hong Kong, including their health, happiness and harmony (FAMILY 3Hs). Family life and health education should be strengthened to meet the increasing needs of promoting healthy active lifestyle among Hong Kong families. In this connection, the FAMILY Project initiates the Fitter Families Project (FFP) with a focus on "FAMILY Holistic Health", will be conducted in order to increase the awareness of the importance of FAMILY 3Hs. FFP is a community-based research project with 3 main components - train-the-trainer program, community-based family interventions and public education events. It is expected that trainees from the train-the-trainer program will acquire adequate skills to organize community-based health education programs effectively. Participants of the community-based family interventions will gain knowledge on family holistic health and live a healthy active lifestyle. Attendees of the public education events will become more aware of the importance of FAMILY 3Hs.
Detailed description
In 2011, United Nations (UN) addressed the prevention and control of four non-communicable diseases (NCDs: cancer, cardiovascular disease, chronic respiratory disease, and diabetes mellitus) worldwide. The UN, in its Political Declaration, recognized the critical importance of reducing the exposure to the common modifiable risk factors for NCDs, namely, tobacco use, unhealthy diet, physical inactivity, and the harmful use of alcohol.In Hong Kong, NCDs are responsible for more than 85% of all deaths and most of these are preventable. FAMILY Project Cohort Study (2014) also found that 88.6% of Hong Kong people had inadequate vegetable and fruit intake, 70.6% had inadequate physical exercise, 26.4% were overweight and 5.4% were obese.
Families worldwide have been undergoing rapid changes with macro, social and economic trends. Demographic shifts, economic upheavals, changing societal norms and values, immigration across national borders and migration within nations are creating new and altered structures, processes and relationships within families. The increasingly complex and diverse family structure contributes to concerns regarding the well-being of families in Hong Kong, including their health, happiness and harmony (FAMILY 3Hs). Family life and health education should be strengthened to meet the increasing needs of promoting healthy lifestyle among Hong Kong families.
The Fitter Families Project is developed based on the strong foundation of the Learning Families Project in the previous years. In view of the health challenges locally and globally, the new phase of FAMILY project will put more emphasis on health in the upcoming three years. Following the themes on FAMILY health, happiness and harmony (3Hs), the Fitter Families Project focuses on family holistic health with emphasis on the interaction and integration of both physical and psychosocial health.
As an initial step of this project, the investigators conducted a need assessments before designing and conducting a train-the-trainer program. The train-the-trainer program aimed to prepare the staff and lay volunteers to conduct and or assist to implement a series of community-based activities and interventions for the participants of Fitter Families Project. Focus group interviews were conducted to obtain feedback and opinion from the trainees . Questionnaire assessments were conducted before, immediately after finishing the training, three months after training.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A four-session training workshop is provided to the trainees in order to enhance their competence and performance for conducing and/or assisting the implementation of community -based interventions and activities.
| Arm | Type | Receives |
|---|---|---|
| Training group | Experimental | Behavioral: Training groupFour two-hour training sessions were conducted at baseline, and one week, one month and three months after the first session. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Chinese speaking
- able to complete assessments
Key exclusion criteria (1 listed)
- not fit the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Training groupThe training workshop includes four two-hour sessions: Session one - a knowledge, self-efficacy, and motivation enhancement session at baseline; Session two - an interpersonal communication and leadership skills session at one week; Session three - a motivation enhancement session at one month Session four - an experience sharing session at three months | Behavioural | Training group |
Primary outcome
Change in trainees' learning
Time frame: baseline, immediately after first session "up to 30 min", one month and three months
Assessed by outcome-based questionnaire
20 secondary outcomes
Trainees' reactions to training content
Time frame: Immediately after the training workshop
Trainees' changes in the frequency and amount on performing physical exercise adn Zero Time Exercise
Time frame: baseline, one month and three months
Trainees' changes in grip strength (kg)
Time frame: baseline and one month
Trainees' changes in chair stand (times)
Time frame: Assessed 30s Chair stand test ( a test counting number of times from sitting position to standing position in 30 seconds
Trainees' changes in single-leg standing time (second)
Time frame: Assessed by a single-leg stance test ( a test measuring the longest duration of a single leg in 120 seconds)
Trainees' changes in seat and reach (cm)
Time frame: Baseline and one month
Trainees' changes in body fat (%)
Time frame: Baseline and one month
Trainees' changes in body weight (kg)
Time frame: Baseline and one month
Trainees' changes in frequency and amount on performing physical activity and Zero Time Exercise)
Time frame: baseline, one month and three months
Trainees' changes in personal happiness
Time frame: baseline, one month and three months
Trainees' changes in personal health
Time frame: baseline, one month and three months
Trainees' changes in family health
Time frame: baseline, one month and three months
Trainees' changes in family happiness
Time frame: baseline, one month and three months
Trainees' changes in family harmony
Time frame: baseline, one month and three months
Trainees' changes in sharing health knowledge with family members in relation to physical activity
Time frame: baseline, one month and three months
Trainees' changes in doing physical activity and exercise with family
Time frame: baseline, one month and three months
Trainees' comments on the received electronic health messages
Time frame: baseline, one month and three months
Community participants' changes in family health
Time frame: baseline, one month and three months
Community participants' changes in family happiness
Time frame: baseline, one month and three months
Community participants' changes in family harmony
Time frame: baseline, one month and three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2018.
- Background: PubMed 19139157Wacharasin C, Theinpichet S. Family nursing practice, education, and research: what is happening in Thailand? J Fam Nurs. 2008 Nov;14(4):429-35. doi: 10.1177/1074840708327515.
- Background: PubMed 12699277Denham SA. Family routines: a structural perspective for viewing family health. ANS Adv Nurs Sci. 2002 Jun;24(4):60-74. doi: 10.1097/00012272-200206000-00010.
- Background: PubMed 22751883Yoshikawa H. Integrating methods in the science of family health: new directions from an institute of medicine workshop report. Arch Pediatr Adolesc Med. 2012 Jul 1;166(7):659-61. doi: 10.1001/archpediatrics.2012.510. No abstract available.
- Background: PubMed 1541473Anderson KH, Tomlinson PS. The family health system as an emerging paradigmatic view for nursing. Image J Nurs Sch. 1992 Spring;24(1):57-63. doi: 10.1111/j.1547-5069.1992.tb00700.x.
- Derived from this study: PubMed 29961808Lai AYK, Stewart SM, Wan ANT, Shen C, Ng CKK, Kwok LT, Chan SS, Ho DSY, Lam TH. Training to implement a community program has positive effects on health promoters: JC FAMILY Project. Transl Behav Med. 2018 Nov 21;8(6):838-850. doi: 10.1093/tbm/iby070.
- Individual participant dataSharing planned: Yes. The minimal anonymized dataset will be available upon request to interested researchers. For interested researchers, please contact, Ms Grace Lau (email gclau@hku.hk), (School of Public Health, The University of Hong Kong) for further information."
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Agnes YK Lai, PhD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training group in people with Motor Activity, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in trainees' learning (time frame: baseline, immediately after first session "up to 30 min", one month and three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03146169, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2018.