- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02904174
Healthy Living Programme for Older Adults (HLP)
Healthy Living Programme (HLP): Diet, Drug and Fall Prevention for Community-dwelling Frail Older Adults
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This was a single group pre-post trial. Participants aged 60 or above were recruited from the community elderly centres. A 6-week HLP, which included one 45 minutes weekly session, was offered to the participants.
122 participants were recruited. This study shows that the 6-week HLP has a potential to improve the physical well-being of the participants, and to increase their knowledge in diet, drug management and fall prevention.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- able to communicate and understand Cantonese
- > 1 in frailty score
- members of the Pentecostal Church of Hong Kong
Exclusion Criteria:
- nil
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Healthy Living Programme
6 weeks program, with 45 minutes weekly session over 6 weeks.Week 1 & 2 focused on healthy eating habits including food pyramid, balanced diet for the elderly, food labels, healthy snacks and healthy eating out.
Week 3 & 4 were about fall prevention, which included risk factors and complications of fall among older adults, preventive measures, strengthening exercises and aerobic dance.
Week 5 & 6 focused on drug management, such as knowledge on commonly used drugs, drug storage, use of analgesics and non-pharmacological pain relief strategies.
|
A 6-week Healthy Living Program (HLP) was developed and implemented for all the participants.
There was one 45 minutes weekly session over 6 week.
Week 1 & 2 focused on healthy eating habits including food pyramid, balanced diet for the elderly, food labels, healthy snacks and healthy eating out.
Week 3 & 4 were about fall prevention, which included risk factors and complications of fall among older adults, preventive measures, strengthening exercises and aerobic dance.
Week 5 & 6 focused on drug management, such as knowledge on commonly used drugs, drug storage, use of analgesics and non-pharmacological pain relief strategies.
Interactive activities such as games, puzzles and question & answer session were included in the group education.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in subjective happiness level
Time Frame: Baseline, Week 6
|
Measured by Subjective Happiness Scale (SHS), which consisted of 4 statements answered on a 7-point Likert scale.
Scores for each statement range from 1 to 7 and the scores from the four statements were added, thus the possible range of scores on the SHS is 4 to 28.
Higher scores reflect higher levels of subjective happiness.
|
Baseline, Week 6
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in frailty status
Time Frame: Baseline, Week 6
|
Measured by the FRAIL scale, which includes five items: fatigue, resistance, ambulation, illness, and loss of weight.
The FRAIL scale ranges from 0-5, with a score of 0 regards as normal, 1-2 as pre-frail and 3-5 as frail.
|
Baseline, Week 6
|
Change in pain intensity
Time Frame: Baseline, Week 6
|
Measured using the numerical rating scale, to assess the presence and intensity of pain among participants, which was presented with 0 referring to no pain and 10 referring to the worst pain imaginable
|
Baseline, Week 6
|
Change in Generalized pain self-efficacy beliefs
Time Frame: Baseline, Week 6
|
Measured by the Pain Self-Efficacy Questionnaire.
It consists of 10 statements, and participants were asked to rate their confidence in performing 10 activities or tasks despite experiencing pain, on a 7-point scale.
|
Baseline, Week 6
|
Change in functional mobility
Time Frame: Baseline, Week 6
|
Measured by Timed Up and Go Test.
The participants were required to walk a distance of three meters, turn, walk back to the chair and sit down.
|
Baseline, Week 6
|
Change in hand grip strength
Time Frame: Baseline, Week 6
|
Measured using a dynamometer.
Participants were seated with arms by the trunk, the elbow flexed to 90 and in a neutral position, and the wrist in slight extension.
Participants were told to squeeze the dynamometer as hard as they could
|
Baseline, Week 6
|
Change in knowledge in healthy eating habits
Time Frame: Baseline, Week 6
|
Measured by self-developed questionnaire.
Range of score is 0-12, with higher score indicates having more knowledge.
|
Baseline, Week 6
|
Change in knowledge in drug management
Time Frame: Baseline, Week 6
|
Measured by self-developed questionnaire.
Range of score is 0-10, with higher score indicates having more knowledge.
|
Baseline, Week 6
|
Change in knowledge in fall prevention
Time Frame: Baseline, Week 6
|
Measured by self-developed questionnaire.
Range of score is 0-5, with higher score indicates having more knowledge.
|
Baseline, Week 6
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Mimi Mun Yee Tse, PhD, The Hong Kong Polytechnic University
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- H-ZJJY
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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