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

May 6, 2024 updated by: Amsterdam University of Applied Sciences

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
76

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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:

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Physical functioning
Time Frame: baseline, 3 months
change in meters from baseline to 3 months by 6 Minute Walk Test
baseline, 3 months
Physical functioning
Time Frame: baseline, 6 months
change in meters from baseline to 6 months by 6 Minute Walk Test
baseline, 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
30-sec Chair Stand Test
Time Frame: baseline, 3 months, 6 months
(frequency) change from baseline to 3 or 6 months
baseline, 3 months, 6 months
Balance (Single Leg Stand Test)
Time Frame: baseline, 3 months, 6 months
(seconds) - change from baseline to 3 or 6 months
baseline, 3 months, 6 months
Strenght (1RM with Microfet)
Time Frame: baseline, 3 months, 6 months
(kg) change from baseline to 3 or 6 months
baseline, 3 months, 6 months
Strenght with Hand Grip Strenght
Time Frame: baseline, 3 months, 6 months
(kg) change from baseline to 3 or 6 months
baseline, 3 months, 6 months
Body composition Lenght
Time Frame: baseline, 3 months, 6 months
(meters) change from baseline to 3 or 6 months
baseline, 3 months, 6 months
Body composition Weight
Time Frame: baseline, 3 months, 6 months
(kg) change from baseline to 3 or 6 months
baseline, 3 months, 6 months
Body composition BMI
Time Frame: baseline, 3 months, 6 months
(kg/m2) change from baseline to 3 or 6 months
baseline, 3 months, 6 months
Body composition 2D muscle echo
Time Frame: baseline, 3 months, 6 months
(cm2) change from baseline to 3 or 6 months
baseline, 3 months, 6 months
Behavioral outcome - Dietary intake (48h recall)
Time Frame: baseline, 3 months, 6 months
macronutrient and micronutrient change from baseline to 3 or 6 months
baseline, 3 months, 6 months
Behavioral outcome - Physical Activity
Time Frame: baseline, 3 months, 6 months
(PAMscore) - change from baseline to 3 or 6 months
baseline, 3 months, 6 months
Quality of Life (QoL)
Time Frame: baseline, 3 months, 6 months
(score) change from baseline to 3 or 6 months
baseline, 3 months, 6 months
Sarcopenia screening (SarQoL)
Time Frame: baseline, 3 months, 6 months
(score) change from baseline to 3 or 6 months
baseline, 3 months, 6 months
Frailty
Time Frame: baseline, 3 months, 6 months
(score) change from baseline to 3 or 6 months
baseline, 3 months, 6 months
Activities of Daily Living (ADL) Katz
Time Frame: baseline, 3 months, 6 months
(score) change from baseline to 3 or 6 months
baseline, 3 months, 6 months
Pain (NRS)
Time Frame: baseline, 3 months, 6 months
(NRS) change from baseline to 3 or 6 months
baseline, 3 months, 6 months
Sleep (NRS)
Time Frame: baseline, 3 months, 6 months
(NRS) change from baseline to 3 or 6 months
baseline, 3 months, 6 months
Risk of Falls (NRS)
Time Frame: baseline, 3 months, 6 months
(NRS) change from baseline to 3 or 6 months
baseline, 3 months, 6 months
Efficacy Scale International (sFES-I)
Time Frame: baseline, 3 months, 6 months
(score) change from baseline to 3 or 6 months
baseline, 3 months, 6 months
symptoms of depression (CES-D)
Time Frame: baseline, 3 months, 6 months
(score) change from baseline to 3 or 6 months
baseline, 3 months, 6 months
Cost effectiveness - Productivity Cost Questionnaire (PCQ)
Time Frame: baseline, 6 months
(score) change from baseline to 6 months
baseline, 6 months
Cost effectiveness - Cost of Quality (MCQ)
Time Frame: baseline, 6 months
(score) change from baseline to 6 months
baseline, 6 months
Process evaluation
Time Frame: 6 months
Process evaluation questionnaire and focus group sessions
6 months
Social democrafic characteristics
Time Frame: screening, baseline
e.g. age (years), gender (f/m), highest education level
screening, baseline
Medical history
Time Frame: screening
all medical events and diseases reported
screening
Medication use
Time Frame: screening and during study
all medication reported at start and during the trial
screening and during study
Adverse events
Time Frame: During study
all adverse events reported during the intervention study
During study
Adherence to the intervention
Time Frame: During study
Specified for exercise routine and protein intake; a % of attendance and minimal 1.2 g/kgBW/day protein intake
During study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Amsterdam University of Applied Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Peter Weijs, Prof Dr Ir, Amsterdam University of Applied Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 24, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 8, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 8, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 6, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 9, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 9, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes

Clinical Trials on ProMIO2.0 program

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings