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

Diabetes Clinical Trial

— ProMIO2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06407583
• Other study ID #: ProMIO2.0 - NL75885.029.21
• Secondary ID: RAAK.MKB12.033
• Status: Completed
• Phase: N/A
• Start date: May 24, 2022
• Est. completion date: June 8, 2023

Study information

• Verified date: May 2024
• Source: Amsterdam University of Applied Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: June 8, 2023
• Est. primary completion date: June 8, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Ethnic Minorities
• Musculoskeletal Diseases
• Overweight
• Sarcopenia

Intervention

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)

Locations

Country	Name	City	State
Netherlands	Amsterdam University of Applied Sciences, Center of Expertise Urban Vitality	Amsterdam	N-H

Sponsors (1)

Lead Sponsor	Collaborator
Amsterdam University of Applied Sciences

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical functioning	change in meters from baseline to 3 months by 6 Minute Walk Test	baseline, 3 months
Primary	Physical functioning	change in meters from baseline to 6 months by 6 Minute Walk Test	baseline, 6 months
Secondary	30-sec Chair Stand Test	(frequency) change from baseline to 3 or 6 months	baseline, 3 months, 6 months
Secondary	Balance (Single Leg Stand Test)	(seconds) - change from baseline to 3 or 6 months	baseline, 3 months, 6 months
Secondary	Strenght (1RM with Microfet)	(kg) change from baseline to 3 or 6 months	baseline, 3 months, 6 months
Secondary	Strenght with Hand Grip Strenght	(kg) change from baseline to 3 or 6 months	baseline, 3 months, 6 months
Secondary	Body composition Lenght	(meters) change from baseline to 3 or 6 months	baseline, 3 months, 6 months
Secondary	Body composition Weight	(kg) change from baseline to 3 or 6 months	baseline, 3 months, 6 months
Secondary	Body composition BMI	(kg/m2) change from baseline to 3 or 6 months	baseline, 3 months, 6 months
Secondary	Body composition 2D muscle echo	(cm2) change from baseline to 3 or 6 months	baseline, 3 months, 6 months
Secondary	Behavioral outcome - Dietary intake (48h recall)	macronutrient and micronutrient change from baseline to 3 or 6 months	baseline, 3 months, 6 months
Secondary	Behavioral outcome - Physical Activity	(PAMscore) - change from baseline to 3 or 6 months	baseline, 3 months, 6 months
Secondary	Quality of Life (QoL)	(score) change from baseline to 3 or 6 months	baseline, 3 months, 6 months
Secondary	Sarcopenia screening (SarQoL)	(score) change from baseline to 3 or 6 months	baseline, 3 months, 6 months
Secondary	Frailty	(score) change from baseline to 3 or 6 months	baseline, 3 months, 6 months
Secondary	Activities of Daily Living (ADL) Katz	(score) change from baseline to 3 or 6 months	baseline, 3 months, 6 months
Secondary	Pain (NRS)	(NRS) change from baseline to 3 or 6 months	baseline, 3 months, 6 months
Secondary	Sleep (NRS)	(NRS) change from baseline to 3 or 6 months	baseline, 3 months, 6 months
Secondary	Risk of Falls (NRS)	(NRS) change from baseline to 3 or 6 months	baseline, 3 months, 6 months
Secondary	Efficacy Scale International (sFES-I)	(score) change from baseline to 3 or 6 months	baseline, 3 months, 6 months
Secondary	symptoms of depression (CES-D)	(score) change from baseline to 3 or 6 months	baseline, 3 months, 6 months
Secondary	Cost effectiveness - Productivity Cost Questionnaire (PCQ)	(score) change from baseline to 6 months	baseline, 6 months
Secondary	Cost effectiveness - Cost of Quality (MCQ)	(score) change from baseline to 6 months	baseline, 6 months
Secondary	Process evaluation	Process evaluation questionnaire and focus group sessions	6 months
Secondary	Social democrafic characteristics	e.g. age (years), gender (f/m), highest education level	screening, baseline
Secondary	Medical history	all medical events and diseases reported	screening
Secondary	Medication use	all medication reported at start and during the trial	screening and during study
Secondary	Adverse events	all adverse events reported during the intervention study	During study
Secondary	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

External Links

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