- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05412251
Smart Integrated Health Promotion Program
May 15, 2023 updated by: National Yang Ming University
Smart Integrated Health Promotion Program and Health Behavior for Older Adult
health promotion behavior is important in older adults.The purpose of this study is to examine the efficacy of smart integrated health promotion intervention among middle age adults and older adults in community.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
There very limited research focused on leisure activity, nutrition status, quality of life and subjective well-being.
In addition, there is lack of research develop smart integrated health promotion intervention to enhance well-being for middle age adults older adults in community and examine the efficacy of the intervention.
The purpose of this study is to examine the efficacy of smart integrated health promotion intervention among middle age adults and older adults in community .
Study Type
Interventional
Enrollment (Anticipated)
160
Phase
- 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 Contact
- Name: Heng-Hsin Tung, PhD
- Phone Number: 886-953005831
- Email: henghsin@nycu.edu.tw
Study Contact Backup
- Name: Li-Yun Lee, PhD
- Phone Number: 886-929008111
- Email: leeliyun@mail.dyu.edu.tw
Study Locations
-
-
-
Taichung, Taiwan, 632
- Recruiting
- WISON Pharmacy
-
Contact:
- George Liao
- Phone Number: 886-987-817-823
-
-
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
Ages Eligible for Study
46 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
(1) age over 50 years
Exclusion Criteria:
- those who could not understanding protocol or communication with search nurses;
- or with cognitive impairment or mental disorders;
- or advance cancer;
- or have been myocardial infarction;
- or congestive heart failure was excluded.
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: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: contrl
provide an irregular nutrition counselling to case by nutritionist
|
|
|
Experimental: intervention
Multi-domain intervention included exercise,cognitive training and diet education was conducted for five hours per week in the first month, second month and third month.
|
Multi-domain intervention 120 minutes cognitive training, 120 ~180 minutes physical exercise per weeks, and 60 minutes diet nutrition education per month
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes from baseline life quality at 3, 6, 9 month
Time Frame: baseline, 3, 6, 9 month
|
measured by the EuroQol- 5 Dimension (EQ-5D), score range 0-1,The higher the score, the better the quality of life
|
baseline, 3, 6, 9 month
|
|
Changes from baseline life quality at 3, 6, 9 month
Time Frame: baseline, 3, 6, 9 month
|
measured by the subjective well-being scale, score range 10-50, The higher the score, the better the quality of life
|
baseline, 3, 6, 9 month
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes from baseline one touch blood sugar in mg/dl at 3, 6, 9 month
Time Frame: baseline, 3, 6, 9 month
|
Changes from baseline one touch blood sugar in mg/dl at 3, 6, 9 month
|
baseline, 3, 6, 9 month
|
|
Changes from baseline one touch urine acid in mg/dl at 3, 6, 9 month
Time Frame: baseline, 3, 6, 9 month
|
Changes from baseline one touch urine acid in mg/dl at 3, 6, 9 month
|
baseline, 3, 6, 9 month
|
|
Changes from baseline one touch total cholesterol in mg/dl at 3, 6, 9 month
Time Frame: baseline, 3, 6, 9 month
|
Changes from baseline one touch total cholesterol in mg/dl at 3, 6, 9 month
|
baseline, 3, 6, 9 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Heng-Hsin Tung, PhD, National Yang Ming University
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)
February 18, 2022
Primary Completion (Anticipated)
February 17, 2024
Study Completion (Anticipated)
February 17, 2024
Study Registration Dates
First Submitted
June 6, 2022
First Submitted That Met QC Criteria
June 6, 2022
First Posted (Actual)
June 9, 2022
Study Record Updates
Last Update Posted (Actual)
May 17, 2023
Last Update Submitted That Met QC Criteria
May 15, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- YM110168-EF
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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