Primary objective:Can a personalised lifestyle intervention (LEEV!-intervention) support healthcare professionals in achieving effective and long-term lifestyle improvement (increased physical activity) for adults with ID to improve their lifestyle-…
ID
Source
Brief title
Condition
- Other condition
- Appetite and general nutritional disorders
Synonym
Health condition
Kwetsbaarheid en sarcopenie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study outcome is change in physical activity.
Secondary outcome
Study outcomes on an intrapersonal level
Anthropometry/body composition
• Height (cm from standing position, or using knee height)
• Body weight (kg) [calibrated weighing scale]
• Body Mass Index (kg/m2)
• Waist circumference (cm, standing up or in supine position)
• Hip circumference (cm)
• Waist to hip (ratio)
• Muscle mass (%, kg), fat mass (%, kg), fat free mass and total body water
(BIA)
Physical performance: ID-fit scan (mild-moderate ID) and test battery
(severe-profound ID)
• 30 seconds Chair stand and 5 times Chair stand
• Grip strength (kg)
• Static balance test
• Comfortable walking speed
• 6MWT
Questionnaires:
• Dietary quality
• ID-Frailty Index Short Form
• Anxiety, Depression And Mood Scale
• The Aberrant Behaviour Checklist
Study outcomes an interpersonal level
Questionnaires:
• ADSP-HENU
• ADSP-HEPA
• The Usefulness, Satisfaction, and Ease of Use Questionnaire
• The System Usability Scale
Study outcomes on an organisational level
Questionnaire:
• DIHASID
• MIDI-ID
Background summary
People with intellectual disabilities (ID) are living longer due to
improvements in healthcare, but often not in good health. They face health
issues like chronic disease, frailty, sarcopenia, sensory impairments, and
limited mobility at a young age. Unhealthy habits like inactivity and poor diet
choices contribute to these problems. Improving the lifestyle of people with ID
is complex due to their physical and cognitive limitations, making existing
interventions less suitable. Currently, there are no interventions for adults
with ID that consider nutrition & physical activity, and intrapersonal,
interpersonal, and location factors. We hypothesise that a personalised
approach targeting all these aspects will increase physical activity and
improve diet quality in adults with ID, and thereby an improvement of their
health.
Study objective
Primary objective:
Can a personalised lifestyle intervention (LEEV!-intervention) support
healthcare professionals in achieving effective and long-term lifestyle
improvement (increased physical activity) for adults with ID to improve their
lifestyle-related health?
Secondary objectives:
1. What is the feasibility of the LEEV!-intervention for adults with ID, the
healthcare professionals, and the location/care organisation?
2. What is the effectiveness of the LEEV!-intervention for adults with ID on
nutrition, physical activity levels, and lifestyle-related health outcomes, for
the healthcare professional on their knowledge and skill acquisition, and for
the location/care organisation on environment related to healthy living and
efficiency of work processes?
Study design
We will conduct a feasibility study and a one-arm multiple baseline trial.
Intervention
Participants will follow a 9 month personalised lifestyle intervention
targeting physical activity and diet quality. The intervention involves changes
at an intrapersonal, interpersonal and location level
Study burden and risks
The possible benefits for participants include improvements in lifestyle and
health through the personalised lifestyle intervention. This could lead to
enhancements such as an improved nutritional status, better body composition,
increased vitality, and an improved quality of life. The risks involved in
participating in the study are minimal. Performed measurements within this
study are similar to typical diagnostic activities during visits to a
healthcare professional such as a physician, nutritionist, physiotherapist,
lifestyle coach or behavioural specialist. Within the study, we strive to
gather comprehensive information while minimising the burden on participants.
In total we will perform five study visits. Three in the baseline period, one
at the end of the intervention and one follow-up measurement after three
months. The five study visits each last 45 minutes. Direct support
professionals assist in fulfilling questionnaires with participants, which
leads to a total time investment of 35 minutes (chapter 6, table 2). Over the
intervention period of 9 months there will be biweekly coaching sessions, each
lasting 30 minutes.Participation in an intervention can be experienced as
burdensome, for example due to dietary restrictions and the time investment.
Petrus Driessenstraat 3
Groningen 9714 CA
NL
Petrus Driessenstraat 3
Groningen 9714 CA
NL
Listed location countries
Age
Inclusion criteria
• Having an intellectual disability according to the international definition
• Eighteen years of age or older
• Having a lifestyle-related query
• Residing at or receiving support from one of the participating healthcare
organisations
• Written informed consent from the participants themselves or a legal
representative
Exclusion criteria
Participants will be excluded if they exhibit any of the following exclusion
criteria shortly prior to entering the study:
- Severe mental or physical health issues that prevent the participant from
taking part. The physicians, and behavioural scientists of the potential
participant will evaluate whether the health condition of the potential
participant requires exclusion from the study. In the end, the decision about
in- or exclusion will be made in consultation between the physicians,
behavioural scientist, representatives and principal researchers.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | Het onderzoek zal worden geregistreerd op clinicaltrials.gov wanneer het onderzoek is goedgekeurd. |
| CCMO | NL85438.042.23 |