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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes; Overweight; Musculoskeletal Diseases; Sarcopenia; Ethnic Minorities
• Intervention / Treatment: Behavioral: ProMIO2.0 program

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.

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • N-H
    • Amsterdam, N-H, Netherlands, 1067SM
      • Amsterdam University of Applied Sciences, Center of Expertise Urban Vitality

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; Participants receiving regular care in the 6 months period. They receive a brief education session at start about exercise and protein.
Experimental: ProMIO2.0 intervention group; 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; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Amsterdam University of Applied Sciences
• Investigators: Principal Investigator: Peter Weijs, Prof Dr Ir, Amsterdam University of Applied Sciences

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2022
• Primary Completion (Actual): June 8, 2023
• Study Completion (Actual): June 8, 2023

Study Registration Dates

• First Submitted: July 6, 2023
• First Submitted That Met QC Criteria: May 6, 2024
• First Posted (Actual): May 9, 2024

Study Record Updates

• Last Update Posted (Actual): May 9, 2024
• Last Update Submitted That Met QC Criteria: May 6, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Older adults; Protein; Lifestyle intervention; Multicomponent exercise; Ethnic minorities
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Overnutrition; Nutrition Disorders; Body Weight; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Overweight; Sarcopenia; Musculoskeletal Diseases
• Other Study ID Numbers: ProMIO2.0 - NL75885.029.21; RAAK.MKB12.033 (Other Grant/Funding Number: NWO - SIA Raak)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Restricted on Figshare following our OpenScience regulations
• IPD Sharing Time Frame: After study completion
• IPD Sharing Access Criteria: Restricted untill publication.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No