Training Program for Community Health Campaign: Fitter Families Project

May 7, 2018 updated by: Dr. Agnes Yuen-Kwan Lai, The University of Hong Kong
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Kwun Tong, Hong Kong, 852
        • Christian Family Service Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Chinese speaking
  • able to complete assessments

Exclusion Criteria:

  • not fit the inclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Training group
Four two-hour training sessions were conducted at baseline, and one week, one month and three months after the first session.
Behavioral: Training group

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
baseline, immediately after first session "up to 30 min", one month and three months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Trainees' reactions to training content
Time Frame: Immediately after the training workshop
Assessed by outcome-based questionnaire
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
Assessed by outcome-based questionnaire on performing moderate exercise, vigorous exercise and Zero Time Exercise and walking
baseline, one month and three months
Trainees' changes in grip strength (kg)
Time Frame: baseline and one month
assessed by a hand grip dynamometer
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
baseline and one month
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)
baseline and one month
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
Assessed by a ruler
Baseline and one month
Trainees' changes in body fat (%)
Time Frame: Baseline and one month
Assessed by a standard body fat and weight measuring scale
Baseline and one month
Trainees' changes in body weight (kg)
Time Frame: Baseline and one month
Assessed by a standard body fat and weight measuring scale
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
Assessed by outcome-based questionnaire on performing moderate exercise, vigorous exercise and Zero Time Exercise and walking
baseline, one month and three months
Trainees' changes in personal happiness
Time Frame: baseline, one month and three months
Assessed by outcome-based questionnaire
baseline, one month and three months
Trainees' changes in personal health
Time Frame: baseline, one month and three months
Assessed by outcome-based questionnaire
baseline, one month and three months
Trainees' changes in family health
Time Frame: baseline, one month and three months
Assessed by outcome-based questionnaire
baseline, one month and three months
Trainees' changes in family happiness
Time Frame: baseline, one month and three months
Assessed by outcome-based questionnaire
baseline, one month and three months
Trainees' changes in family harmony
Time Frame: baseline, one month and three months
Assessed by outcome-based questionnaire
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
Assessed by outcome-based questionnaire
baseline, one month and three months
Trainees' changes in doing physical activity and exercise with family
Time Frame: baseline, one month and three months
Assessed by outcome-based questionnaire
baseline, one month and three months
Trainees' comments on the received electronic health messages
Time Frame: baseline, one month and three months
Assessed by outcome-based questionnaire
baseline, one month and three months
Community participants' changes in family health
Time Frame: baseline, one month and three months
Assessed by outcome-based questionnaire
baseline, one month and three months
Community participants' changes in family happiness
Time Frame: baseline, one month and three months
Assessed by outcome-based questionnaire
baseline, one month and three months
Community participants' changes in family harmony
Time Frame: baseline, one month and three months
Assessed by outcome-based questionnaire
baseline, one month and three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2015

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2017

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 5, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 9, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 14, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UW15 - 401

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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."

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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