NCT02904174

Brief 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 habits.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 16, 2016

Completed
Last Updated

September 16, 2016

Status Verified

September 1, 2016

Enrollment Period

1.2 years

First QC Date

September 8, 2016

Last Update Submit

September 13, 2016

Conditions

Outcome Measures

Primary Outcomes (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.

    Baseline, Week 6

Secondary Outcomes (8)

  • Change in frailty status

    Baseline, Week 6

  • Change in pain intensity

    Baseline, Week 6

  • Change in Generalized pain self-efficacy beliefs

    Baseline, Week 6

  • Change in functional mobility

    Baseline, Week 6

  • Change in hand grip strength

    Baseline, Week 6

  • +3 more secondary outcomes

Study Arms (1)

Healthy Living Programme

EXPERIMENTAL

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.

Behavioral: Healthy Living Programme

Interventions

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.

Healthy Living Programme

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • nil

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Mimi Mun Yee Tse, PhD

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 8, 2016

First Posted

September 16, 2016

Study Start

December 1, 2014

Primary Completion

March 1, 2016

Study Completion

June 1, 2016

Last Updated

September 16, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share