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| ID | Type | Description | Link |
|---|---|---|---|
| RAAK.MKB12.033 | Other Grant/Funding Number | NWO - SIA Raak |
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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.
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:
1.2g/kg BW/day (~25 - 30 grams of protein per meal (4x/day))
Reaching the WHO physical activity guidelines for older adults:
Based on previous research it is expected that by optimizing these health behaviors, muscle mass, muscle strength, and physical functioning will improve.
Secondary Objective(s):
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 and/or 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | Participants receiving regular care in the 6 months period. They receive a brief education session at start about exercise and protein. | |
| ProMIO2.0 intervention group | Experimental | Participants receiving regular care and our newly developed lifestyle intervention for 6 months period. The intervention is culture specific and contains of:
The first 3 months are intensive phase, second 3 months guidance gradually decreases. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ProMIO2.0 program | Behavioral | ProMIO2.0 is a lifestyle intervention carried out by physiotherapy and dietetics. They guide and encourage the participants to achieve the following behavioral goals:
The intervention is divided into 2 phases, which indicate the degree of professional guidance:
|
| Measure | Description | Time Frame |
|---|---|---|
| Physical functioning | change in meters from baseline to 3 months by 6 Minute Walk Test | baseline, 3 months |
| Physical functioning | change in meters from baseline to 6 months by 6 Minute Walk Test | baseline, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 30-sec Chair Stand Test | (frequency) change from baseline to 3 or 6 months | baseline, 3 months, 6 months |
| Balance (Single Leg Stand Test) | (seconds) - change from baseline to 3 or 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Weijs, Prof Dr Ir | Amsterdam University of Applied Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amsterdam University of Applied Sciences, Center of Expertise Urban Vitality | Amsterdam | N-H | 1067SM | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40409139 | Derived | Biersteker EJM, van den Helder J, van der Spek N, Holwerda M, Kruizenga H, Weijs PJM, Tieland M. Culture-sensitive lifestyle intervention tailored to non-Western migrant older adults improves physical performance: A randomized controlled trial. J Nutr Health Aging. 2025 Aug;29(8):100584. doi: 10.1016/j.jnha.2025.100584. Epub 2025 May 22. |
| Label | URL |
|---|---|
| Webpage of our institute | View source |
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Restricted on Figshare following our OpenScience regulations
After study completion
Restricted untill publication.
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| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| D003920 | Diabetes Mellitus |
| D050177 | Overweight |
| D009140 | Musculoskeletal Diseases |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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The design is a single blind parallel RCT with a control group and intervention group. The study duration is 6 months.
Control: no intervention (education only) Intervention: ProMIO2.0 lifestyle program including multicomponent exercise and protein intake counselling.
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|
| baseline, 3 months, 6 months |
| Strenght (1RM with Microfet) | (kg) change from baseline to 3 or 6 months | baseline, 3 months, 6 months |
| Strenght with Hand Grip Strenght | (kg) change from baseline to 3 or 6 months | baseline, 3 months, 6 months |
| Body composition Lenght | (meters) change from baseline to 3 or 6 months | baseline, 3 months, 6 months |
| Body composition Weight | (kg) change from baseline to 3 or 6 months | baseline, 3 months, 6 months |
| Body composition BMI | (kg/m2) change from baseline to 3 or 6 months | baseline, 3 months, 6 months |
| Body composition 2D muscle echo | (cm2) change from baseline to 3 or 6 months | baseline, 3 months, 6 months |
| Behavioral outcome - Dietary intake (48h recall) | macronutrient and micronutrient change from baseline to 3 or 6 months | baseline, 3 months, 6 months |
| Behavioral outcome - Physical Activity | (PAMscore) - change from baseline to 3 or 6 months | baseline, 3 months, 6 months |
| Quality of Life (QoL) | (score) change from baseline to 3 or 6 months | baseline, 3 months, 6 months |
| Sarcopenia screening (SarQoL) | (score) change from baseline to 3 or 6 months | baseline, 3 months, 6 months |
| Frailty | (score) change from baseline to 3 or 6 months | baseline, 3 months, 6 months |
| Activities of Daily Living (ADL) Katz | (score) change from baseline to 3 or 6 months | baseline, 3 months, 6 months |
| Pain (NRS) | (NRS) change from baseline to 3 or 6 months | baseline, 3 months, 6 months |
| Sleep (NRS) | (NRS) change from baseline to 3 or 6 months | baseline, 3 months, 6 months |
| Risk of Falls (NRS) | (NRS) change from baseline to 3 or 6 months | baseline, 3 months, 6 months |
| Efficacy Scale International (sFES-I) | (score) change from baseline to 3 or 6 months | baseline, 3 months, 6 months |
| symptoms of depression (CES-D) | (score) change from baseline to 3 or 6 months | baseline, 3 months, 6 months |
| Cost effectiveness - Productivity Cost Questionnaire (PCQ) | (score) change from baseline to 6 months | baseline, 6 months |
| Cost effectiveness - Cost of Quality (MCQ) | (score) change from baseline to 6 months | baseline, 6 months |
| Process evaluation | Process evaluation questionnaire and focus group sessions | 6 months |
| Social democrafic characteristics | e.g. age (years), gender (f/m), highest education level | screening, baseline |
| Medical history | all medical events and diseases reported | screening |
| Medication use | all medication reported at start and during the trial | screening and during study |
| Adverse events | all adverse events reported during the intervention study | During study |
| Adherence to the intervention | Specified for exercise routine and protein intake; a % of attendance and minimal 1.2 g/kgBW/day protein intake | During study |
| Webpage of our nutrition and exercise platform | View source |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |