Clinical trial NCT06407583: ProMIO2.0; A Powerful Lifestyle Intervention for Older Adults From Ethnic Minorities
Official title: ProMIO 2.0; A Powerful Lifestyle Intervention for Older Adults From Ethnic Minorities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenia
Diabetes
Overweight
Ethnic Minorities
Musculoskeletal Diseases
Keywords: Lifestyle intervention
Protein
Multicomponent exercise
Older adults
Ethnic minorities
Lead sponsor: Amsterdam University of Applied Sciences
Sponsor class: OTHER
First posted: 2024-05-09
Enrollment: 76
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Physical functioning
timeFrame: baseline, 3 months
measure: Physical functioning
timeFrame: baseline, 6 months
Secondary outcomes:
measure: 30-sec Chair Stand Test
timeFrame: baseline, 3 months, 6 months
measure: Balance (Single Leg Stand Test)
timeFrame: baseline, 3 months, 6 months
measure: Strenght (1RM with Microfet)
timeFrame: baseline, 3 months, 6 months
measure: Strenght with Hand Grip Strenght
timeFrame: baseline, 3 months, 6 months
measure: Body composition Lenght
timeFrame: baseline, 3 months, 6 months
measure: Body composition Weight
timeFrame: baseline, 3 months, 6 months
measure: Body composition BMI
timeFrame: baseline, 3 months, 6 months
measure: Body composition 2D muscle echo
timeFrame: baseline, 3 months, 6 months
measure: Behavioral outcome - Dietary intake (48h recall)
timeFrame: baseline, 3 months, 6 months
measure: Behavioral outcome - Physical Activity
timeFrame: baseline, 3 months, 6 months
measure: Quality of Life (QoL)
timeFrame: baseline, 3 months, 6 months
measure: Sarcopenia screening (SarQoL)
timeFrame: baseline, 3 months, 6 months
measure: Frailty
timeFrame: baseline, 3 months, 6 months
measure: Activities of Daily Living (ADL) Katz
timeFrame: baseline, 3 months, 6 months
measure: Pain (NRS)
timeFrame: baseline, 3 months, 6 months
measure: Sleep (NRS)
timeFrame: baseline, 3 months, 6 months
measure: Risk of Falls (NRS)
timeFrame: baseline, 3 months, 6 months
measure: Efficacy Scale International (sFES-I)
timeFrame: baseline, 3 months, 6 months
measure: symptoms of depression (CES-D)
timeFrame: baseline, 3 months, 6 months
measure: Cost effectiveness - Productivity Cost Questionnaire (PCQ)
timeFrame: baseline, 6 months
measure: Cost effectiveness - Cost of Quality (MCQ)
timeFrame: baseline, 6 months
measure: Process evaluation
timeFrame: 6 months
measure: Social democrafic characteristics
timeFrame: screening, baseline
measure: Medical history
timeFrame: screening
measure: Medication use
timeFrame: screening and during study
measure: Adverse events
timeFrame: During study
measure: Adherence to the intervention
timeFrame: During study
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam University of Applied Sciences, Center of Expertise Urban Vitality
state: N-H
Study officials:
affiliation: Amsterdam University of Applied Sciences
name: Peter Weijs, Prof Dr Ir
role: PRINCIPAL_INVESTIGATOR
References: