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Completed

NCT Number: NCT06407583

ProMIO2.0; 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.

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Key information

Conditions

Sarcopenia Atrophy Body Weight Diabetes Diabetes Mellitus Endocrine System Diseases Ethnic Minorities Glucose Metabolism Disorders Metabolic Diseases Muscular Atrophy Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Amsterdam University of Applied Sciences, Center of Expertise Urban Vitality

Amsterdam, N-H, 1067SM, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

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:

  • 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:

  • intensive guidance (month 0 - 3)
  • average guidance (months 4 - 6)

Primary outcomes

  1. Physical functioning

    Time frame: baseline, 3 months

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

  2. Physical functioning

    Time frame: baseline, 6 months

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

Secondary outcomes

  1. 30-sec Chair Stand Test

    Time frame: baseline, 3 months, 6 months

    (frequency) change from baseline to 3 or 6 months

  2. Balance (Single Leg Stand Test)

    Time frame: baseline, 3 months, 6 months

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

  3. Strenght (1RM with Microfet)

    Time frame: baseline, 3 months, 6 months

    (kg) change from baseline to 3 or 6 months

  4. Strenght with Hand Grip Strenght

    Time frame: baseline, 3 months, 6 months

    (kg) change from baseline to 3 or 6 months

  5. Body composition Lenght

    Time frame: baseline, 3 months, 6 months

    (meters) change from baseline to 3 or 6 months

  6. Body composition Weight

    Time frame: baseline, 3 months, 6 months

    (kg) change from baseline to 3 or 6 months

  7. Body composition BMI

    Time frame: baseline, 3 months, 6 months

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

  8. Body composition 2D muscle echo

    Time frame: baseline, 3 months, 6 months

    (cm2) change from baseline to 3 or 6 months

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

    Time frame: baseline, 3 months, 6 months

    macronutrient and micronutrient change from baseline to 3 or 6 months

  10. Behavioral outcome - Physical Activity

    Time frame: baseline, 3 months, 6 months

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

  11. Quality of Life (QoL)

    Time frame: baseline, 3 months, 6 months

    (score) change from baseline to 3 or 6 months

  12. Sarcopenia screening (SarQoL)

    Time frame: baseline, 3 months, 6 months

    (score) change from baseline to 3 or 6 months

  13. Frailty

    Time frame: baseline, 3 months, 6 months

    (score) change from baseline to 3 or 6 months

  14. Activities of Daily Living (ADL) Katz

    Time frame: baseline, 3 months, 6 months

    (score) change from baseline to 3 or 6 months

  15. Pain (NRS)

    Time frame: baseline, 3 months, 6 months

    (NRS) change from baseline to 3 or 6 months

  16. Sleep (NRS)

    Time frame: baseline, 3 months, 6 months

    (NRS) change from baseline to 3 or 6 months

  17. Risk of Falls (NRS)

    Time frame: baseline, 3 months, 6 months

    (NRS) change from baseline to 3 or 6 months

  18. Efficacy Scale International (sFES-I)

    Time frame: baseline, 3 months, 6 months

    (score) change from baseline to 3 or 6 months

  19. symptoms of depression (CES-D)

    Time frame: baseline, 3 months, 6 months

    (score) change from baseline to 3 or 6 months

  20. Cost effectiveness - Productivity Cost Questionnaire (PCQ)

    Time frame: baseline, 6 months

    (score) change from baseline to 6 months

  21. Cost effectiveness - Cost of Quality (MCQ)

    Time frame: baseline, 6 months

    (score) change from baseline to 6 months

  22. Process evaluation

    Time frame: 6 months

    Process evaluation questionnaire and focus group sessions

  23. Social democrafic characteristics

    Time frame: screening, baseline

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

  24. Medical history

    Time frame: screening

    all medical events and diseases reported

  25. Medication use

    Time frame: screening and during study

    all medication reported at start and during the trial

  26. Adverse events

    Time frame: During study

    all adverse events reported during the intervention study

  27. Adherence to the intervention

    Time frame: During study

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

Sponsors and collaborators

Lead sponsor

Amsterdam University of Applied Sciences

Other

Registry information

Official study title

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

Acronym: ProMIO2

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 9, 2024
Registry last updated
May 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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