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SarcopeniaProMIO2NCT06407583

ProMIO2.0; A Powerful Lifestyle Intervention for Older Adults From Ethnic Minorities

A study testing ProMIO2.0 program in people with Sarcopenia and Diabetes, run by Amsterdam University of Applied Sciences at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 55 years and olderHealthy volunteers can take part
Conditions the study is for
Sarcopenia, Diabetes, Overweight
What is being tested?
ProMIO2.0 program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
1 siteNetherlands
Study dates
24 May 2022to 8 Jun 2023
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 55 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Born in Surinam (or at least one of the parents was born there)
  • Aged ≥55 years
  • Physical ability and willingness to execute an MCE program
  • Ability and willingness to comply with the study protocol
  • Written informed consent
  • Consent of the study physician

Who cannot join

  • Aged <55 years
  • Diagnosed with renal insufficiency (MDRD<30, GP approved)
  • Suffering from physical disabilities causing the inability to perform the main exercises (walking aids or mild visual impairment are not an exclusion criteria)
  • Diagnosed unstable coronary heart disease (CHD), decompensated heart failure, or uncontrolled arrhythmias
  • End stage Chronic Obstructive Pulmonary Disease (COPD) GOLD >3
  • Phase IV cancer
Show all 11Show fewer
  • Diagnosed degenerative neurocognitive disorders
  • Active (para-)medical treatment interfering with this intervention
  • Current enrolment in a fixed rehabilitation program or other intervention studies
  • Palliative treatment or a life expectancy of ≤3 months
  • A trip >2 weeks planned in first three months of study or >2 months during the rest of the intervention period

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Amsterdam University of Applied Sciences, Center of Expertise Urban Vitality

    Amsterdam, N-H, 1067SM

Other trials in Netherlands

About this study

Official title: ProMIO 2.0; A Powerful Lifestyle Intervention for Older Adults From Ethnic Minorities

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.

Read the 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:

  • 1.2g/kg BW/day (~25 - 30 grams of protein per meal (4x/day))
  • Reaching the WHO physical activity guidelines for older adults:
  • At least 150-300 minutes/week moderate-intensity aerobic physical activity (such as walking)
  • 2x/week 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 Objective(s):

  • 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 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.

Being tested
ProMIO2.0 program
Keywords
Lifestyle intervention, Protein, Multicomponent exercise, Older adults, Ethnic minorities
Medical subject headings
Sarcopenia, Diabetes Mellitus, Overweight, Musculoskeletal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ProMIO2.0 programBehavioural

    ProMIO2.0 is a lifestyle intervention carried out by physiotherapy and dietetics. They guide and encourage the participants to achieve the following behavioral goals:

    • moderate/intensive exercise (e.g. walking) for 150-300 minutes per week
    • Muscle-strengthening exercises 2x a week
    • Supplemented with balance and flexibility exercises
    • 1.2 grams of protein per kilogram of body weight per day (~25-30 grams of protein per meal, 4x/day) The combination of consultations, information sessions and on-site training at the physiotherapist should ensure that participants acquire the necessary knowledge, awareness and skills to adopt the health behavior in daily life. Materials such as posters, pedometers and videos are used for support.

    The intervention is divided into 2 phases, which indicate the degree of professional guidance:

    1. intensive guidance (month 0 - 3)
    2. average guidance (months 4 - 6)
Study groups in NCT06407583
Study groupRoleWhat they receive
Control groupNo interventionParticipants receiving regular care in the 6 months period. They receive a brief education session at start about exercise and protein.
ProMIO2.0 intervention groupExperimentalParticipants receiving regular care and our newly developed lifestyle intervention for 6 months period. The intervention is culture specific and contains of: * Dietetic care focused on protein intake (protein counselling) * Multicomponent exercise (physical therapy); a combination between group sessions and home-based exercise The first 3 months are intensive phase, second 3 months guidance gradually decreases.
Receives: Behavioral: ProMIO2.0 program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Physical functioning

    change in meters from baseline to 3 months by 6 Minute Walk Test

    Measured: baseline, 3 months

  2. Physical functioning

    change in meters from baseline to 6 months by 6 Minute Walk Test

    Measured: baseline, 6 months

Secondary outcomes (27)

  1. 30-sec Chair Stand Test

    (frequency) change from baseline to 3 or 6 months

    Measured: baseline, 3 months, 6 months

  2. Balance (Single Leg Stand Test)

    (seconds) - change from baseline to 3 or 6 months

    Measured: baseline, 3 months, 6 months

  3. Strenght (1RM with Microfet)

    (kg) change from baseline to 3 or 6 months

    Measured: baseline, 3 months, 6 months

  4. Strenght with Hand Grip Strenght

    (kg) change from baseline to 3 or 6 months

    Measured: baseline, 3 months, 6 months

  5. Body composition Lenght

    (meters) change from baseline to 3 or 6 months

    Measured: baseline, 3 months, 6 months

  6. Body composition Weight

    (kg) change from baseline to 3 or 6 months

    Measured: baseline, 3 months, 6 months

  7. Body composition BMI

    (kg/m2) change from baseline to 3 or 6 months

    Measured: baseline, 3 months, 6 months

  8. Body composition 2D muscle echo

    (cm2) change from baseline to 3 or 6 months

    Measured: baseline, 3 months, 6 months

  9. Behavioral outcome - Dietary intake (48h recall)

    macronutrient and micronutrient change from baseline to 3 or 6 months

    Measured: baseline, 3 months, 6 months

  10. Behavioral outcome - Physical Activity

    (PAMscore) - change from baseline to 3 or 6 months

    Measured: baseline, 3 months, 6 months

  11. Quality of Life (QoL)

    (score) change from baseline to 3 or 6 months

    Measured: baseline, 3 months, 6 months

  12. Sarcopenia screening (SarQoL)

    (score) change from baseline to 3 or 6 months

    Measured: baseline, 3 months, 6 months

  13. Frailty

    (score) change from baseline to 3 or 6 months

    Measured: baseline, 3 months, 6 months

  14. Activities of Daily Living (ADL) Katz

    (score) change from baseline to 3 or 6 months

    Measured: baseline, 3 months, 6 months

  15. Pain (NRS)

    (NRS) change from baseline to 3 or 6 months

    Measured: baseline, 3 months, 6 months

  16. Sleep (NRS)

    (NRS) change from baseline to 3 or 6 months

    Measured: baseline, 3 months, 6 months

  17. Risk of Falls (NRS)

    (NRS) change from baseline to 3 or 6 months

    Measured: baseline, 3 months, 6 months

  18. Efficacy Scale International (sFES-I)

    (score) change from baseline to 3 or 6 months

    Measured: baseline, 3 months, 6 months

  19. symptoms of depression (CES-D)

    (score) change from baseline to 3 or 6 months

    Measured: baseline, 3 months, 6 months

  20. Cost effectiveness - Productivity Cost Questionnaire (PCQ)

    (score) change from baseline to 6 months

    Measured: baseline, 6 months

  21. Cost effectiveness - Cost of Quality (MCQ)

    (score) change from baseline to 6 months

    Measured: baseline, 6 months

  22. Process evaluation

    Process evaluation questionnaire and focus group sessions

    Measured: 6 months

  23. Social democrafic characteristics

    e.g. age (years), gender (f/m), highest education level

    Measured: screening, baseline

  24. Medical history

    all medical events and diseases reported

    Measured: screening

  25. Medication use

    all medication reported at start and during the trial

    Measured: screening and during study

  26. Adverse events

    all adverse events reported during the intervention study

    Measured: During study

  27. Adherence to the intervention

    Specified for exercise routine and protein intake; a % of attendance and minimal 1.2 g/kgBW/day protein intake

    Measured: During study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2024
  2. Study start24 May 2022
  3. Primary completion8 Jun 2023
  4. Study completion8 Jun 2023

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Investigator
Enrolment
76 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06407583
Sponsor's protocol ID
ProMIO2.0 - NL75885.029.21
Other IDs
RAAK.MKB12.033
Acronym
ProMIO2
Status last verified
May 2024
First submitted
6 Jul 2023
Last updated
9 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Restricted on Figshare following our OpenScience regulations

Publications

  • 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.

    PubMed 40409139

Questions about this trial

What is this clinical trial studying?

A study testing ProMIO2.0 program in people with Sarcopenia and Diabetes, run by Amsterdam University of Applied Sciences at 1 site in Netherlands.

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 6 inclusion and 11 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: finished, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Physical functioning (time frame: baseline, 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06407583, which also lists 1 linked publication.

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 9 May 2024.

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