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

Amsterdam University of Applied Sciences

Status: Completed

Conditions: Overweight; Diabetes; Ethnic Minorities; Musculoskeletal Diseases; Sarcopenia

Treatments: Behavioral: ProMIO2.0 program

Study type: Interventional

Funder types: Other

Identifiers

NCT06407583

ProMIO2.0 - NL75885.029.21

RAAK.MKB12.033 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 76 patients

Sex: All

Ages: 55+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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76 participants in 2 patient groups

Control group

No Intervention group

Description:

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 group

Description:

Participants 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.

Treatment:

Behavioral: ProMIO2.0 program