Evaluation of Training Program on Promoting Family Holistic Health

July 10, 2018 updated by: Dr. Agnes Yuen-Kwan Lai, The University of Hong Kong

Holistic health is an integration and interaction of physical and psychosocial health. Positive psychology is a science of happiness, which focuses on positive emotions and personal strengths. It also is crucial component in family holistic health. Healthy diet can help to achieve energy balance and healthy weights. Physical activity is believed to contribute to physical and mental health, as well as social well-being. However, physical inactivity was found to be a local and worldwide issue and most Hong Kong people are having a sedentary lifestyle.

In view of the health challenges locally and globally, the new phase of FAMILY project will focus to promote family holistic health with emphasize on the interaction and integration of physical and psychosocial health. The investigator will initiate and develop a series innovative training program with vigorous evaluation in order to evaluate the effectiveness of the programs. The investigator hypothesize that the training programs would promote the health awareness and the health of the participants

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

Holistic health is an integration and interaction of physical and psychosocial health. Positive psychology is a science of happiness, which focuses on positive emotions and personal strengths. It is used as a preventive and complementary medicine, which also is crucial component in family holistic health (happiness, harmony and health). Healthy diet can help to achieve energy balance and healthy weights. Sufficient daily consumption of fruit and vegetables, as well as limitation on the intake of sugar, salt and fat could prevent major diseases, such as cardiovascular diseases and certain cancers. Physical activity is believed to contribute to physical and mental health, as well as social well-being. However, physical inactivity was found to be a local and worldwide issue and most Hong Kong people are having a sedentary lifestyle. Studies show that the increase of physical activity and healthy diet reduce the risk of chronic diseases, and improve cardio-pulmonary functions; whereas sedentary behaviors increase the risk

Although people understand the harmful effect of family disharmony, physical inactivity and unhealthy diet, which may cause different kinds of physical and mental illnesses, healthy living attitudes and behaviours are lacking.

Over the past six years, the FAMILY project has been working on community-based projects to promote FAMILY health, happiness and harmony (3Hs). 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 theme on FAMILY 3Hs, the new work focus is to promote family holistic health with emphasize on the interaction and integration of physical and psychosocial health. The investigator will initiate and develop a series innovative community-based projects and training program with vigorous evaluation in order to evaluate the effectiveness of the programs.

The investigator hypothesize that the training programs would promote the health awareness and the health of the participants. During the training, the investigator will conduct physical fitness test and collect data from the participants. Those participants would conduct community programmes for their own institution to enhance the personal and family well-being of their service users.

In order to assess the effectiveness of the training program on improving individual and family well-being and their capability of community programme implementation, Self-reported questionnaire would be used at baseline, one month and three months after training; and focus group interview would be conducted after participants finishing their community programmes.

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 (Anticipated)

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.
100

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
      • Wan Chai, Hong Kong, 852
        • The Boys' & Girls' Association of Hong Kong

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 study questionnaire
  • aged 18 or above

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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: Health Education
Health information related to physical activity
Behavioral: Health Education
Information on healthy living style in relation to physical activity

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 health behavior in relation to physical activity
Time Frame: Baseline , 1 month
Change in health behavior in relation to physical activity will be assessed by behavior indicator scale
Baseline , 1 month

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
Changes in knowledge and attitude on performing physical activity
Time Frame: Baseline, 1 month and 3 months
Change in knowledge and attitude on performing physical activity will be assessed by outcome-based questionnaire
Baseline, 1 month and 3 months
Change in subjective happiness
Time Frame: Baseline, 1 month and 3 months
Subjective happiness will be assessed by outcome-based questionnaire
Baseline, 1 month and 3 months
Change in family health, happiness and harmony (Family 3Hs)
Time Frame: Baseline, 1 month
Family 3Hs will be assessed by family well-being scale
Baseline, 1 month
Change in Quality of Life
Time Frame: Baseline, 1 month and 3 months
Change in quality of life will be assessed by SF-12 v2 health survey
Baseline, 1 month and 3 months
Changes in physical fitness
Time Frame: Baseline, 1 month and 3 months
Change in physical fitness will be assessed by simple fitness test
Baseline, 1 month and 3 months
Changes in health behavior in relation to physical activity
Time Frame: Baseline, 1 month and 3 months
Change in health behaviour will be assessed by behavior indicator scale
Baseline, 1 month and 3 months
Change in family communication in relation to Zero Time Exercise
Time Frame: Baseline, 1 month, 3 months
Change in family communication will be assessed by behavior indicator scale
Baseline, 1 month, 3 months
Reactions to training content
Time Frame: Immediately after finishing training workshop "up to 30 min"
Assessed by outcome-based questionnaire
Immediately after finishing training workshop "up to 30 min"
Learning in relation to implementing community programmes
Time Frame: Baseline, 1 month, 3 months
Assessed by outcome-based questionnaire
Baseline, 1 month, 3 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

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Hong Kong Jockey Club Charities Trust
Christian Family Service Centre
Social Welfare Department, Hong Kong

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Agnes Lai, DN, 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

Helpful Links

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

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.
October 1, 2014

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.
June 1, 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.
June 1, 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).
November 14, 2015

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.
November 14, 2015

First Posted (Estimate)

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.
November 17, 2015

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.
July 12, 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.
July 10, 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.
July 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.
  • UW 14-601

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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