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

NCT06407583 | Completed

• 2 other identifiers: ProMIO2.0 - NL75885.029.21RAAK.MKB12.033
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcopenia; Diabetes; Overweight; Ethnic Minorities; Musculoskeletal Diseases

Keywords

Lifestyle intervention; Protein; Multicomponent exercise; Older adults; Ethnic minorities

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (27)

• 30-sec Chair Stand Test

  baseline, 3 months, 6 months

• Balance (Single Leg Stand Test)

  baseline, 3 months, 6 months

• Strenght (1RM with Microfet)

  baseline, 3 months, 6 months

• Strenght with Hand Grip Strenght

  baseline, 3 months, 6 months

• Body composition Lenght

  baseline, 3 months, 6 months

Study Arms (2)

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: * 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.

Behavioral: ProMIO2.0 program

Interventions

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: 1. intensive guidance (month 0 - 3) 2. average guidance (months 4 - 6)

ProMIO2.0 intervention group

Eligibility Criteria

• Age: 55 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Aged \<55 years
• Diagnosed with renal insufficiency (MDRD\<30, GP approved)
• 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

Sponsors & Collaborators

• Amsterdam University of Applied Sciences: lead

Study Sites (1)

Amsterdam University of Applied Sciences, Center of Expertise Urban Vitality

Amsterdam, N-H, 1067SM, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 40409139 DERIVED

Related Links

• Webpage of our institute
• Webpage of our nutrition and exercise platform

MeSH Terms

Conditions

Sarcopenia; Diabetes Mellitus; Overweight; Musculoskeletal Diseases

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight

Study Officials

• Peter Weijs, Prof Dr Ir

  Amsterdam University of Applied Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 6, 2023
• First Posted: May 9, 2024
• Study Start: May 24, 2022
• Primary Completion: June 8, 2023
• Study Completion: June 8, 2023
• Last Updated: May 9, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: After study completion
• Access Criteria: Restricted untill publication.

Locations

NL (1)