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Frail Older AdultsHLPNCT02904174

Healthy Living Programme for Older Adults

A study testing Healthy Living Programme in people with Frail Older Adults, run by The Hong Kong Polytechnic University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Malnutrition, risk of falls and medication incidents are commonly faced by the older adults. This study aimed to provide health education to community-dwelling older adults and to assess the effectiveness of a Healthy Living Program (HLP) to older adults in terms of fall prevention, drug management and healthy eating… Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Frail Older Adults
What is being tested?
Healthy Living Programme
Could I receive a placebo?
No, everyone receives an active treatment
How many people
122 participants
Where
No sites listed yet
Study dates
Dec 2014to Jun 2016
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 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • able to communicate and understand Cantonese
  • > 1 in frailty score
  • members of the Pentecostal Church of Hong Kong

Who cannot join

  • nil

About this study

Official title: Healthy Living Programme (HLP): Diet, Drug and Fall Prevention for Community-dwelling Frail Older Adults

Malnutrition, risk of falls and medication incidents are commonly faced by the older adults. This study aimed to provide health education to community-dwelling older adults and to assess the effectiveness of a Healthy Living Program (HLP) to older adults in terms of fall prevention, drug management and healthy eating habits.

Read the 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.

Being tested
Healthy Living Programme

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Healthy Living ProgrammeBehavioural

    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.

Study groups in NCT02904174
Study groupRoleWhat they receive
Healthy Living ProgrammeExperimental6 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.
Receives: Behavioral: Healthy Living Programme

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in subjective happiness level

    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.

    Measured: Baseline, Week 6

Secondary outcomes (8)

  1. Change in frailty status

    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.

    Measured: Baseline, Week 6

  2. Change in pain intensity

    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

    Measured: Baseline, Week 6

  3. Change in Generalized pain self-efficacy beliefs

    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.

    Measured: Baseline, Week 6

  4. Change in functional mobility

    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.

    Measured: Baseline, Week 6

  5. Change in hand grip strength

    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

    Measured: Baseline, Week 6

  6. Change in knowledge in healthy eating habits

    Measured by self-developed questionnaire. Range of score is 0-12, with higher score indicates having more knowledge.

    Measured: Baseline, Week 6

  7. Change in knowledge in drug management

    Measured by self-developed questionnaire. Range of score is 0-10, with higher score indicates having more knowledge.

    Measured: Baseline, Week 6

  8. Change in knowledge in fall prevention

    Measured by self-developed questionnaire. Range of score is 0-5, with higher score indicates having more knowledge.

    Measured: Baseline, Week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2016 (estimated)
  2. Study startDec 2014
  3. Primary completionMar 2016
  4. Study completionJun 2016

Resources

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
Masking
None (open label)
Enrolment
122 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02904174
Sponsor's protocol ID
H-ZJJY
Acronym
HLP
Status last verified
Sep 2016
First submitted
8 Sep 2016
Last updated
16 Sep 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Healthy Living Programme in people with Frail Older Adults, run by The Hong Kong Polytechnic University.

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 3 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 16 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

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 subjective happiness level (time frame: Baseline, Week 6). 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 NCT02904174.

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 16 Sep 2016.

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