Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06407583
Status:
COMPLETED
Last Update Posted:
2024-05-09
First Post:
2023-07-06
Brief Title:
ProMIO20 A Powerful Lifestyle Intervention for Older Adults From Ethnic Minorities
Sponsor:
Amsterdam University of Applied Sciences
Organization:
Amsterdam University of Applied Sciences
Study Overview
Official Title:
ProMIO 20 A Powerful Lifestyle Intervention for Older Adults From Ethnic Minorities
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ProMIO2
Brief Summary:
Older adults from ethnic minorities show on average a worse disease risk profile compared to the majority populations An important risk factor to develop chronic diseases is the loss of muscle mass and functioning also known as sarcopenia Several randomized controlled trials RCTs showed that the combination of adequate protein intake and physical exercise is most effective to prevent the loss of muscle mass strength and functioning in older adults However until shortly no intervention that included protein and exercise was available that accounted for the special socio-cultural needs of ethnic minority populations Therefore the Amsterdam University of Applied Sciences AUAS and ProMIO project group developed a cultural sensitive lifestyle intervention with protein and exercise carried out by dieticians and physical therapists to provide a tailored treatment for older adults from ethnic minorities This project aims to evaluate the effectiveness of this new intervention on protein intake physical activity behavior muscle mass muscle strength function and quality of life The cost-effectiveness of this new intervention will also be evaluated
Detailed Description:
Primary Objective To investigate the effectiveness of the ProMIO lifestyle intervention targeting protein intake and exercise behavior on physical functioning in older adults from ethnic minorities Surinamese
The intervention will be a lifestyle intervention targeted at changing health behaviors in older adults from ethnic minorities in the Netherlands Methods will be used that target specific behavioral determinants in order to optimize both exercise and dietary behavior We aim to reach the following behavioral outcomes
12gkg BWday 25 - 30 grams of protein per meal 4xday
Reaching the WHO physical activity guidelines for older adults
At least 150-300 minutesweek moderate-intensity aerobic physical activity such as walking
2xweek strength balance and functional exercises
Based on previous research it is expected that by optimizing these health behaviors muscle mass muscle strength and physical functioning will improve
Secondary Objectives
To investigate the effectiveness of the ProMIO lifestyle intervention targeting protein intake and exercise behavior on muscle mass and muscle strength in older adults from ethnic minorities
To investigate the effectiveness of the ProMIO lifestyle intervention on protein intake and physical activity behavior in older adults from ethnic minorities
To investigate the cost-effectiveness of the ProMIO lifestyle intervention in comparison to an health education intervention
The cost-effectiveness of the ProMIO intervention will be investigated using a single blind randomized controlled trial RCT with two parallel arms
First potential participants will be recruited and screened for eligibility Secondly participants will be randomly assigned to one of the two groups the intervention group or the control group
The full study will comprise a 6-month intervention divided in two phases and consisting of a multicomponent exercise training MCE program provided by physical therapists and a protein intervention provided by dieticians Each participant will be supervised and monitored by a physical therapist and a dietician who are providing regular consulting sessions
Exercise activities like group exercise training will be provided by certified trainers and health education will be provided by AUAS graduate students with a background in nutrition andor physical exercise Certified trainers and graduate students are supervised and guided by the physical therapist and dietician The intensity of the professional support during the intervention will be highest in the first phase and taper off during the second phase Participants are expected to adopt most of the desired behavioral activities in daily living without professional help Data will be collected at baseline T1 and after 3 T2 and 6 T3 months
Outcome measures are a combination between quantitative and qualitative outcome
The intervention will be a lifestyle intervention targeted at changing health behaviors in older adults from ethnic minorities in the Netherlands Methods will be used that target specific behavioral determinants in order to optimize both exercise and dietary behavior We aim to reach the following behavioral outcomes
12gkg BWday 25 - 30 grams of protein per meal 4xday
Reaching the WHO physical activity guidelines for older adults
At least 150-300 minutesweek moderate-intensity aerobic physical activity such as walking
2xweek strength balance and functional exercises
Based on previous research it is expected that by optimizing these health behaviors muscle mass muscle strength and physical functioning will improve
Secondary Objectives
To investigate the effectiveness of the ProMIO lifestyle intervention targeting protein intake and exercise behavior on muscle mass and muscle strength in older adults from ethnic minorities
To investigate the effectiveness of the ProMIO lifestyle intervention on protein intake and physical activity behavior in older adults from ethnic minorities
To investigate the cost-effectiveness of the ProMIO lifestyle intervention in comparison to an health education intervention
The cost-effectiveness of the ProMIO intervention will be investigated using a single blind randomized controlled trial RCT with two parallel arms
First potential participants will be recruited and screened for eligibility Secondly participants will be randomly assigned to one of the two groups the intervention group or the control group
The full study will comprise a 6-month intervention divided in two phases and consisting of a multicomponent exercise training MCE program provided by physical therapists and a protein intervention provided by dieticians Each participant will be supervised and monitored by a physical therapist and a dietician who are providing regular consulting sessions
Exercise activities like group exercise training will be provided by certified trainers and health education will be provided by AUAS graduate students with a background in nutrition andor physical exercise Certified trainers and graduate students are supervised and guided by the physical therapist and dietician The intensity of the professional support during the intervention will be highest in the first phase and taper off during the second phase Participants are expected to adopt most of the desired behavioral activities in daily living without professional help Data will be collected at baseline T1 and after 3 T2 and 6 T3 months
Outcome measures are a combination between quantitative and qualitative outcome
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| RAAKMKB12033 | OTHER_GRANT | NWO - SIA Raak | None |