- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04727203
Active and Healthy Ageing for All: a Multi-component Healthy Lifestyle Program (AHAA)
July 18, 2022 updated by: Julie Vanderlinden, KU Leuven
Active and Healthy Ageing for All: a Multi-component Healthy Lifestyle Program (AHAA)
AHAA is a healthy lifestyle program offered to older adults aged 60+ years.
The program is developed based upon co-creation with the target group and implemented and evaluated in several locations.
Study Overview
Detailed Description
- co-creation : all participants will be questioned and included in the co-creation session
- implementation : the developed multicomponent healthy lifestyle program will be enrolled and implemented in 6 locations (community services for older adults in Flanders and Brussels)
- evaluation : the program will be evaluated (effects and process)
Study Type
Interventional
Enrollment (Anticipated)
400
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: Julie Vanderlinden, PHDc
- Phone Number: 003216321861
- Email: julie.vanderlinden@odisee.be
Study Locations
-
-
-
Aalst, Belgium, 9300
- Recruiting
- LDC
-
Contact:
- Julie Vanderlinden
- Phone Number: 003216321861
- Email: julie.vanderlinden@odisee.be
-
Brussel, Belgium, 1000
- Recruiting
- LDC
-
Contact:
- Julie Vanderlinden
- Phone Number: 003216321861
- Email: julie.vanderlinden@odisee.be
-
Gent, Belgium, 9000
- Recruiting
- Regie Ouderenzorg
-
Contact:
- Julie Vanderlinden
- Phone Number: 003216321861
- Email: julie.vanderlinden@odisee.be
-
Mechelen, Belgium, 2800
- Recruiting
- LDC
-
Contact:
- Julie Vanderlinden
- Phone Number: 003216321861
- Email: julie.vanderlinden@odisee.be
-
Sint-Truiden, Belgium, 2800
- Recruiting
- Triamant
-
Contact:
- Julie Vanderlinden
- Phone Number: 003216321861
- Email: julie.vanderlinden@odisee.be
-
-
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
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- age 60+ years
Exclusion Criteria:
- not being able to attend the weekly meetings
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: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
Partcipants in this group will receive the 8 week healthy lifestyle program
|
Multi-component healthy lifestyle program
Other Names:
|
No Intervention: Control
Participants in this group will not receive any intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical activity measured by IPAQ
Time Frame: up to twelve weeks
|
Subjective physical activity
|
up to twelve weeks
|
Physical activity measured by accelerometry
Time Frame: up to twelve weeks
|
Objective physical activity
|
up to twelve weeks
|
Sedentary behaviour measured by accelerometry
Time Frame: up to twelve weeks
|
Objective sedentary behaviour
|
up to twelve weeks
|
Sedentary behaviour measured by IPAQ
Time Frame: up to twelve weeks
|
Subjective sedentary behaviour
|
up to twelve weeks
|
Nutrition questionnaire (self-reported)
Time Frame: up to twelve weeks
|
Nutrition
|
up to twelve weeks
|
Sleep measured by accelerometry
Time Frame: up to twelve weeks
|
Objective sleep
|
up to twelve weeks
|
Sleep measured by PSQI
Time Frame: up to twelve weeks
|
Subjective sleep
|
up to twelve weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
well-being measured by WEMWBS
Time Frame: up to twelve weeks
|
well-being
|
up to twelve weeks
|
Perceived stress measured by the perceived stress scale
Time Frame: up to twelve weeks
|
Perceived stress of participants
|
up to twelve weeks
|
Perceived positive health status measured by a self-reported questionnaire
Time Frame: up to twelve weeks
|
Perceived positive health status
|
up to twelve weeks
|
Health literacy measured by HLSQ self-reported questionnaire
Time Frame: up to twelve weeks
|
Health literacy
|
up to twelve weeks
|
Social support measured by a self-reported questionnaire
Time Frame: up to twelve weeks
|
Social Support
|
up to twelve weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Julie Vanderlinden, PHDc, KU Leuven
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)
September 1, 2019
Primary Completion (Anticipated)
December 31, 2023
Study Completion (Anticipated)
September 30, 2024
Study Registration Dates
First Submitted
January 15, 2021
First Submitted That Met QC Criteria
January 22, 2021
First Posted (Actual)
January 27, 2021
Study Record Updates
Last Update Posted (Actual)
July 21, 2022
Last Update Submitted That Met QC Criteria
July 18, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- AHAA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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