Health PromotionAHAANCT04727203
Active and Healthy Ageing for All: a Multi-component Healthy Lifestyle Program
A study testing AHAA in people with Health Promotion, run by KU Leuven at 5 sites in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Promotion
- What is being tested?
- AHAA
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 5 sitesBelgium
- Study dates
- 1 Sep 2019to 30 Sep 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 60+ years
Who cannot join
- not being able to attend the weekly meetings
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Belgium5 sites, 5 recruiting
- Recruiting
LDC
Aalst, 9300
Julie Vanderlinden, 003216321861, julie.vanderlinden@odisee.be
- Recruiting
LDC
Brussels, 1000
Julie Vanderlinden, 003216321861, julie.vanderlinden@odisee.be
- Recruiting
Regie Ouderenzorg
Ghent, 9000
Julie Vanderlinden, 003216321861, julie.vanderlinden@odisee.be
- Recruiting
LDC
Mechelen, 2800
Julie Vanderlinden, 003216321861, julie.vanderlinden@odisee.be
- Recruiting
Triamant
Sint-Truiden, 2800
Julie Vanderlinden, 003216321861, julie.vanderlinden@odisee.be
About this study
Official title: 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.
Read the 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)
- Conditions
- Health Promotion
- Being tested
- AHAA
- Keywords
- ageing, healthy lifestyle, intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AHAABehavioural
Also called Active and healthy ageing for all
Multi-component healthy lifestyle program
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Partcipants in this group will receive the 8 week healthy lifestyle program Receives: Behavioral: AHAA |
| Control | No intervention | Participants in this group will not receive any intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity measured by IPAQ
Subjective physical activity
Measured: up to twelve weeks
Physical activity measured by accelerometry
Objective physical activity
Measured: up to twelve weeks
Sedentary behaviour measured by accelerometry
Objective sedentary behaviour
Measured: up to twelve weeks
Sedentary behaviour measured by IPAQ
Subjective sedentary behaviour
Measured: up to twelve weeks
Nutrition questionnaire (self-reported)
Nutrition
Measured: up to twelve weeks
Sleep measured by accelerometry
Objective sleep
Measured: up to twelve weeks
Sleep measured by PSQI
Subjective sleep
Measured: up to twelve weeks
Secondary outcomes (5)
well-being measured by WEMWBS
well-being
Measured: up to twelve weeks
Perceived stress measured by the perceived stress scale
Perceived stress of participants
Measured: up to twelve weeks
Perceived positive health status measured by a self-reported questionnaire
Perceived positive health status
Measured: up to twelve weeks
Health literacy measured by HLSQ self-reported questionnaire
Health literacy
Measured: up to twelve weeks
Social support measured by a self-reported questionnaire
Social Support
Measured: up to twelve weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start1 Sep 2019
- Primary completion31 Dec 2023 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health PromotionStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- There are 6 groups in this intervention
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Odisee University college for applied sciences
- Responsible party
- Principal investigator, Julie Vanderlinden, KU Leuven
- Investigators
- Julie Vanderlinden, PHDc, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04727203
- Sponsor's protocol ID
- AHAA
- Acronym
- AHAA
- Status last verified
- Jul 2022
- First submitted
- 15 Jan 2021
- Last updated
- 21 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active and Healthy Ageing for All: a Multi-component Healthy Lifestyle Program (AHAA)
- ClinicalTrials.gov ID
- NCT04727203
- Acronym / sponsor ID
- AHAA / AHAA
- Conditions
- Health Promotion
- Keywords
- ageing, healthy lifestyle, intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- Odisee University college for applied sciences
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 27 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- There are 6 groups in this intervention
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: AHAAPartcipants in this group will receive the 8 week healthy lifestyle program |
| Control | No intervention | –Participants in this group will not receive any intervention |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- age 60+ years
Key exclusion criteria (1 listed)
- not being able to attend the weekly meetings
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AHAAAlso: Active and healthy ageing for allMulti-component healthy lifestyle program | Behavioural | Intervention |
Primary outcome
Physical activity measured by IPAQ
Time frame: up to twelve weeks
Subjective physical activity
Physical activity measured by accelerometry
Time frame: up to twelve weeks
Objective physical activity
Sedentary behaviour measured by accelerometry
Time frame: up to twelve weeks
Objective sedentary behaviour
Sedentary behaviour measured by IPAQ
Time frame: up to twelve weeks
Subjective sedentary behaviour
Nutrition questionnaire (self-reported)
Time frame: up to twelve weeks
Nutrition
Sleep measured by accelerometry
Time frame: up to twelve weeks
Objective sleep
Sleep measured by PSQI
Time frame: up to twelve weeks
Subjective sleep
5 secondary outcomes
well-being measured by WEMWBS
Time frame: up to twelve weeks
Perceived stress measured by the perceived stress scale
Time frame: up to twelve weeks
Perceived positive health status measured by a self-reported questionnaire
Time frame: up to twelve weeks
Health literacy measured by HLSQ self-reported questionnaire
Time frame: up to twelve weeks
Social support measured by a self-reported questionnaire
Time frame: up to twelve weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2022.
- Individual participant dataSharing planned: No
Related trials for Health Promotion
Enrolling by invitation
Randomized Controlled Trial Of Text Messages To Increase Pneumococcal Vaccination In Adults In Chile.
Pneumococcal Infections, Immunization Programs
Not yet recruiting
Cost-Effectiveness Analysis of the Healthy Beat Acupunch Regimen on Physical Fitness, Sleep Quality, and Quality of Life Among Community-Dwelling Older Adults
Healthy Aging, Health Promotion
Not yet recruiting
PURSUIT: A Technologically Augmented School-based Program to Improve Child Coping and Prevent Substance Use.
Pediatric Pain, Anxiety
Recruiting
Teaching Health Resilience in a Hospital Setting: A Peer-led Intervention
Opioid Use Disorder, Harm Reduction
Enrolling by invitation
Controlled Evaluation of an Exercise Program for Overweight Adolescents
Adolescent, Pediatric Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie Vanderlinden, PHDc principal investigator
KU Leuven
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AHAA in people with Health Promotion, run by KU Leuven at 5 sites in Belgium.
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 1 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: status not confirmed, as of the sponsor's last update on 21 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julie Vanderlinden, PHDc (003216321861, julie.vanderlinden@odisee.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity measured by IPAQ (time frame: up to twelve weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jul 2022; AzTrials last refreshed its copy on 2 Nov 2026.