Diabetes Mellitus Type 2SLIMMERNCT02094911
(Cost-)Effectiveness of SLIMMER Diabetes Prevention Intervention
A study testing Combined lifestyle intervention in people with Diabetes Mellitus Type 2, run by Wageningen University at 1 site in Netherlands.
Trial summary
The overall aim of the project is to evaluate the (cost-)effectiveness of the SLIMMER diabetes prevention intervention in Dutch primary health care. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Diabetes Mellitus Type 2
- What is being tested?
- Combined lifestyle intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 316 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2011to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 40-70 years
- Impaired fasting glucose (IFG; i.e. venous plasma glucose concentration ≥6.1 and
- ≤6.9 mmol/l) during the past 5 years, according to the GP registration database OR diabetes risk score ≥7 as calculated from the Diabetes Risk Test
- Willing and able to participate in the intervention for at least 1.5 years
- Dutch speaking
Who cannot join
- Known diabetes mellitus
- Any chronic illness that makes 1.5-years survival improbable, interferes with glucose tolerance, or makes participation in a lifestyle intervention impossible
- Patients with any severe cardiovascular disease (this also includes history of cardiac dysrhythmia), unless GP gives agreement
- Medication known to interfere with glucose tolerance
- Any mental or physical disability that will hinder participation in the lifestyle intervention
- Severe psychiatric disease
Show all 10Show fewer
- Patients who showed bad compliance in the past
- Participation in another regular vigorous exercise and/or diet programme, i.e.:
- Intensive exercise programme: any exercise programme offered by a physiotherapist and/or patients sporting at least 3 times a week at their own initiative.
- Intensive diet programme: patients who visited a dietician at least 3 times during the last year.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implementation and (Cost-)Effectiveness of Diabetes Prevention in Dutch Primary Health Care: From SLIM to SLIMMER
The overall aim of the project is to evaluate the (cost-)effectiveness of the SLIMMER diabetes prevention intervention in Dutch primary health care.
Read the detailed description
This is a randomised controlled trial, conducted in a real-life setting (Dutch primary health care).
- Conditions
- Diabetes Mellitus Type 2
- Being tested
- Combined lifestyle intervention, Usual care group
- Keywords
- Prevention, Combined lifestyle intervention, Primary health care
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined lifestyle interventionBehavioural
Also called SLIMMER intervention
10-month intervention period with:
- weekly group-based sports lessons supervised by a physiotherapist
- individual dietary advice by a dietician
- case management by practice nurse
- maintenance programme to guide subjects to maintain lifestyle behaviour change
Usual care groupOther
Written information on healthy lifestyle was provided at baseline, no individual advice or programme was provided. No additional appointments were scheduled, apart from the visits for follow-up measurements
| Study group | Role | What they receive |
|---|---|---|
| Combined lifestyle intervention | Experimental | Lifestyle counselling (nutrition and physical activity) by dietician and physiotherapist during 10-month intervention period Receives: Behavioral: Combined lifestyle intervention |
| Usual care group | Other | Subjects receive brochures on healthy lifestyle at baseline, and during the 10-month intervention period only usual care as provided by their own general practitioner. Receives: Other: Usual care group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fasting insulin
Measured: Baseline, end of intervention (12 months), after follow-up (18 months)
Secondary outcomes (11)
Glucose tolerance
fasting glucose, 2h glucose, 2h insulin, HbA1c
Measured: Baseline, end of intervention (12 months), after follow-up (18 months)
Serum lipids
total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides
Measured: Baseline, end of intervention (12 months), after follow-up (18 months)
Body fatness
body weight, BMI, waist and hip circumference, body fat
Measured: Baseline, end of intervention (12 months), after follow-up (18 months)
Physical fitness
measured with six-minute walk test
Measured: Baseline, end of intervention (12 months), after follow-up (18 months)
Blood pressure
Measured: Baseline, end of intervention (12 months), after follow-up (18 months)
Medication use
Measured: Baseline, end of intervention (12 months), after follow-up (18 months)
Quality of Life
Measured: Baseline, end of intervention (12 months), after follow-up (18 months)
Eating behaviour
Measured as nutrient intake and food intake, with a Food Frequency Questionnaire
Measured: Baseline, end of intervention (12 months), after follow-up (18 months)
Physical activity behaviour
Measured with questionnaire
Measured: Baseline, end of intervention (12 months), after follow-up (18 months)
Behavioural determinants
Determinants of nutrition and physical activity behaviour, measured with questionnaire
Measured: Baseline, end of intervention (12 months), after follow-up (18 months)
Process indicators
Indicators to investigate how the intervention was delivered and received, measured with quantitative and qualitative methods
Measured: Baseline, end of intervention (12 months), after follow-up (18 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2014 (estimated)
- Study startOct 2011
- Primary completionMay 2014 (estimated)
- Study completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 316 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, Dutch Diabetes Research Foundation
- Responsible party
- Sponsor
- Investigators
- Edith Feskens, PhD, Principal investigator, Wageningen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02094911
- Sponsor's protocol ID
- NL37994.081.11
- Acronym
- SLIMMER
- Status last verified
- Mar 2014
- First submitted
- 19 Mar 2014
- Last updated
- 24 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Duijzer G, Bukman AJ, Meints-Groenveld A, Haveman-Nies A, Jansen SC, Heinrich J, Hiddink GJ, Feskens EJM, de Wit GA. Cost-effectiveness of the SLIMMER diabetes prevention intervention in Dutch primary health care: economic evaluation from a randomised controlled trial. BMC Health Serv Res. 2019 Nov 11;19(1):824. doi: 10.1186/s12913-019-4529-8.
PubMed 31711499den Braver NR, de Vet E, Duijzer G, Ter Beek J, Jansen SC, Hiddink GJ, Feskens EJM, Haveman-Nies A. Determinants of lifestyle behavior change to prevent type 2 diabetes in high-risk individuals. Int J Behav Nutr Phys Act. 2017 Jun 12;14(1):78. doi: 10.1186/s12966-017-0532-9.
PubMed 28606146Duijzer G, Haveman-Nies A, Jansen SC, ter Beek J, Hiddink GJ, Feskens EJ. SLIMMER: a randomised controlled trial of diabetes prevention in Dutch primary health care: design and methods for process, effect, and economic evaluation. BMC Public Health. 2014 Jun 14;14:602. doi: 10.1186/1471-2458-14-602.
PubMed 24928217
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation and (Cost-)Effectiveness of Diabetes Prevention in Dutch Primary Health Care: From SLIM to SLIMMER
- ClinicalTrials.gov ID
- NCT02094911
- Acronym / sponsor ID
- SLIMMER / NL37994.081.11
- Conditions
- Diabetes Mellitus Type 2
- Keywords
- Prevention, Combined lifestyle intervention, Primary health care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 316 participants (estimated)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, Dutch Diabetes Research Foundation
- Study start
- Oct 2011
- Primary completion
- May 2014 (estimated)
- Study completion
- May 2015 (estimated)
- First posted
- 24 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall aim of the project is to evaluate the (cost-)effectiveness of the SLIMMER diabetes prevention intervention in Dutch primary health care.
Detailed description
This is a randomised controlled trial, conducted in a real-life setting (Dutch primary health care).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined lifestyle intervention | Experimental | Behavioral: Combined lifestyle interventionLifestyle counselling (nutrition and physical activity) by dietician and physiotherapist during 10-month intervention period |
| Usual care group | Other | Other: Usual care groupSubjects receive brochures on healthy lifestyle at baseline, and during the 10-month intervention period only usual care as provided by their own general practitioner. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 40-70 years
- Impaired fasting glucose (IFG; i.e. venous plasma glucose concentration ≥6.1 and
- ≤6.9 mmol/l) during the past 5 years, according to the GP registration database OR diabetes risk score ≥7 as calculated from the Diabetes Risk Test
- Willing and able to participate in the intervention for at least 1.5 years
- Dutch speaking
Key exclusion criteria (10 listed)
- Known diabetes mellitus
- Any chronic illness that makes 1.5-years survival improbable, interferes with glucose tolerance, or makes participation in a lifestyle intervention impossible
- Patients with any severe cardiovascular disease (this also includes history of cardiac dysrhythmia), unless GP gives agreement
- Medication known to interfere with glucose tolerance
- Any mental or physical disability that will hinder participation in the lifestyle intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined lifestyle interventionAlso: SLIMMER intervention10-month intervention period with: * weekly group-based sports lessons supervised by a physiotherapist * individual dietary advice by a dietician * case management by practice nurse * maintenance programme to guide subjects to maintain lifestyle behaviour change | Behavioural | Combined lifestyle intervention |
| Usual care groupWritten information on healthy lifestyle was provided at baseline, no individual advice or programme was provided. No additional appointments were scheduled, apart from the visits for follow-up measurements | Other | Usual care group |
Primary outcome
Change in fasting insulin
Time frame: Baseline, end of intervention (12 months), after follow-up (18 months)
11 secondary outcomes
Glucose tolerance
Time frame: Baseline, end of intervention (12 months), after follow-up (18 months)
Serum lipids
Time frame: Baseline, end of intervention (12 months), after follow-up (18 months)
Body fatness
Time frame: Baseline, end of intervention (12 months), after follow-up (18 months)
Physical fitness
Time frame: Baseline, end of intervention (12 months), after follow-up (18 months)
Blood pressure
Time frame: Baseline, end of intervention (12 months), after follow-up (18 months)
Medication use
Time frame: Baseline, end of intervention (12 months), after follow-up (18 months)
Quality of Life
Time frame: Baseline, end of intervention (12 months), after follow-up (18 months)
Eating behaviour
Time frame: Baseline, end of intervention (12 months), after follow-up (18 months)
Physical activity behaviour
Time frame: Baseline, end of intervention (12 months), after follow-up (18 months)
Behavioural determinants
Time frame: Baseline, end of intervention (12 months), after follow-up (18 months)
Process indicators
Time frame: Baseline, end of intervention (12 months), after follow-up (18 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2014.
- Derived from this study: PubMed 31711499Duijzer G, Bukman AJ, Meints-Groenveld A, Haveman-Nies A, Jansen SC, Heinrich J, Hiddink GJ, Feskens EJM, de Wit GA. Cost-effectiveness of the SLIMMER diabetes prevention intervention in Dutch primary health care: economic evaluation from a randomised controlled trial. BMC Health Serv Res. 2019 Nov 11;19(1):824. doi: 10.1186/s12913-019-4529-8.
- Derived from this study: PubMed 28606146den Braver NR, de Vet E, Duijzer G, Ter Beek J, Jansen SC, Hiddink GJ, Feskens EJM, Haveman-Nies A. Determinants of lifestyle behavior change to prevent type 2 diabetes in high-risk individuals. Int J Behav Nutr Phys Act. 2017 Jun 12;14(1):78. doi: 10.1186/s12966-017-0532-9.
- Derived from this study: PubMed 24928217Duijzer G, Haveman-Nies A, Jansen SC, ter Beek J, Hiddink GJ, Feskens EJ. SLIMMER: a randomised controlled trial of diabetes prevention in Dutch primary health care: design and methods for process, effect, and economic evaluation. BMC Public Health. 2014 Jun 14;14:602. doi: 10.1186/1471-2458-14-602.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edith Feskens, PhD principal investigator
Wageningen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined lifestyle intervention in people with Diabetes Mellitus Type 2, run by Wageningen University at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in fasting insulin (time frame: Baseline, end of intervention (12 months), after follow-up (18 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02094911, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2014.