The main objectives of this monitoring study are: To asses 1) the number of potential participants, selected by the health care professionals, that are actually included in the Beweegkuur; 2) the number of participants that follow the complete…
ID
Source
Brief title
Condition
- Diabetic complications
- Lifestyle issues
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study outcome indicators are:
- dietary behavior and physical activity level, both measured by self reportage
through a short version of the Vet-lijst and the International Physical
Activity Questionnaire (IPAQ)
- participation, attrition and compliance, measured with the digital
registration file of the LSA. To yield a more detailed view on compliance, it
will additionally be measured with a number of questions in the proces
evaluation questionnaire. The researchers will visit teh articiapting practices
on a regular basis to observe helath care professionals in their compliance to
the protocol.
Secondary outcome
Secundary study outcome indicators are:
- Motivation to maintain a healthier dietary behavior and a higher level of of
physical activity
- Participants' experiences with the Beweegkuur
- Quality of life (QoL)
- Physical fitness
- Health risk related factors:
o Antropometry: physical height, body weight, fat percentage, waist
circumference
o Bloodvalues: bloodpressure, HbA1c
Motivation is measured with a set of validated questionnaires. Experiences will
be measured with an adjusted version of the questionnaire that has been used in
the pilotstudy of the Beweegkuur. QoL i smeasured with the Euroqol 6d. These
questionnaires wil be presented to the participants together with the
previously mentioned questionnaires.
Physical fitness of package 1 and 2 participans is assessed by the
physical therapist with the Astrand test. This is a submaximal aerobic capacity
test that belongs to the routine protocol of the Beweegkuur. If necessary
(suspicion for cardiac diseaese), the participant will be referred to the GP.
The participant will only be included after permission of the GP.
Measurements of health risk related factors belong to the routine
protocol of the Beweegkuur. They are performed by the LSA. Test results are
recorded in the digital registration file.
Background summary
The BeweegKuur has been developed by NISB (Dutch Institute for Sports and
Physical Activity) to help people with an increased, lifestyle related health
risk to adapt a healthier lifestyle. Within the BeweegKuur three lifestyle
intervention programs exist that differ with respect to the intensity of the
support provided to adapt physical activity. For people with relative minor
limitations, package 1 or 2 will be offered. A study by RIVM has proven
effectiveness and cost effectiveness of these two packages for the populations
that they have been developed for. However, little is known about the extent of
application of the Beweegkuur for the target group of people with overweight
and obesity, about the number of participants that follow the complete program
and about the extent of compliance to the Beweegkuur protocol by the health
care professionals as well as by the participants. It is also unclear if this
compliance is related to a shift towards a more favorable motivation to engage
in and maintain a healthier dietary behavior (lower energy and fat intake) and
a higher level of physical activity, and to a reduction of body weight..
Study objective
The main objectives of this monitoring study are: To asses 1) the number of
potential participants, selected by the health care professionals, that are
actually included in the Beweegkuur; 2) the number of participants that follow
the complete program; 3) the extent to which health care professionals apply
the Beweegkuur protocol as intended, and participants comply to the
recommendations and advice, and 4) explore the effectiviness of the Beweegkuur
concerning a change towards a more favorable motivation for healthier dietary
behavior and a higher level of physical activity, towards the actual change in
and maintenance of these behaviors.
Study design
The monitoring study is a prospective cohortstudy without control condition.
The complete study covers a time episode of 39 months. Measurments wil be
performed at baseline (T0: the moment the participant is included in the
study), within one week after a participant in package 2 has ended the
physiotherapy intevention (T2 - about 12 weeks after T0) at the end of the
Beweegkuur (T3: 12 months after T0) and at follow up (T4: 24 months after T0).
measuremnts mainly consist of self reportage through questionnaires; monitoring
the digital registration file of the LSA and observations on location. In the
registration file the LSA records the results of the routine measurements of
the Beweegkuur (e.g. physical height, body weight, Body Mass Index; blood
sugar, HbA1c; submaximal aerobic capacity test). Participants will be recruited
form 29 GP practices who are familiar with a former version of the Beweegkuur
for DM2 patients.
Study burden and risks
Measurements will elicit a limited burden to the participant Part of the data
gathered for this study are part of the routine Beweegkuur protocol, and will
consequently be performed in all Beweegkuur participants at T0 and T3,
irrespective of their participation in the study. Extra measurements for the
study at T1 and T3 are:
- a short version of the Vet-lijst
- the IPAQ activity quetsionnaire
- the questionnaire for motivational factors
- the Euroqol 6d
- the process-evaluation questionnaire
The estimated completion time for the quetionnaires is one hour per measurement
moment . No risks are associated with these measurements. Participants in the
study have no benefits compared to those who follow the Beweegkuur without
participation in the study. The extra consultation of the LSA after 24 months
can be seen as a smal burden for the patient, since only the regular
measurements are executed.
Peter Debeyeplein 1
6229 HA Maastricht
NL
Peter Debeyeplein 1
6229 HA Maastricht
NL
Listed location countries
Age
Inclusion criteria
The inclusioncriteria for participation in the distinct packages of the Beweegkuur match the categorization of the Partnership Overgewicht Nederland (PON) and the Nederlands Huisartsen Genootschap (NHG).
Package 1:
• BMI 25-30 and a too large waist circumference (>= 88 cm for women; >= 102 cm for men)
• BMI 30-35 and a normal or too large waist circumference
Package 2:
• BMI 25-35 with an enhanced risk for DM2 or Cardio-Vascular Diseases (CVD)
Package 3:
• BMI 25-35 with comorbidity such as sleepapneu, arthrosis deformans, DM and/or CVD
• BMI 35-40 and a normal or too large waist circumference and an enhanced risk for DM2 or (CVD);For the monitoring study only participants of package 1 and 2 are included;Additional inclusion criteria, irrespective of the package are:
1. being motivated to change their behavior
2. inactive lifestyle (not meeting the Nederlandse Norm Gezond Bewegen)
Exclusion criteria
Counterindications:
- DM2 with 3 or more complications limiting routine functioning (CVS, nephropathy, retinopathy, neuropathy, diabetic ulceration)
- DM2 with severe polyfarmacy (> 5 therapeutic categories)
- DM2 with hypertension level 3 (RR >180/110 mmHG)
- Severe limitations for physical exercize (< 70% of the expected exercize capacity)
- Limitations for participation in the Beweegkuur, assessed by the GP
- BMI < 25 with DM2
- BMI > 35 with comorbidity
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 |
|---|---|
| CCMO | NL32615.068.10 |