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Doelbewust diabetes.


- candidate number9124
- NTR NumberNTR2765
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-feb-2011
- Secondary IDs07-303  METC University Utrecht
- Public TitleDoelbewust diabetes.
- Scientific TitleBeyond expectations: The effectiveness of a theory driven intervention to achieve and sustain optimal self-management in patients with type 2 diabetes.
- ACRONYMBeyond Expectations
- hypothesisIt is expected that the intervention will increase participants' proactive coping skills, which will in turn lead to improved self-care behavior and medical outcomes.
- Healt Condition(s) or Problem(s) studiedDiabetes Mellitus Type 2 (DM type II)
- Inclusion criteria1. Recently (< 5 years) diagnosed with type 2 diabetes;
2. Sufficient mastery of Dutch language.
- Exclusion criteria1. Serious physical and psychiatric comorbidities;
2. Currently involved in another diabetes-related self-management program;
3. Insufficient mastery of the Dutch language.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-feb-2009
- planned closingdate1-jul-2011
- Target number of participants300
- InterventionsAll participants are included in a behavioral intervention program targeting proactive coping skills (Beyond Good Intentions). The program comprises one invidivual session and 4 group sessions over a period of 2 months. Using a practical 5-step plan, participants are taught to set concrete goals, recognize conditions and barriers to goal achievement, identify potential difficult situations, formulate necessary actions, and consider how to evaluate their progress.

After the basis intervention, two different booster session programs are delivered. Participants are randomly assigned to a follow-up program that continues to target small concrete goals, or a follow-up program in which the focus is on large abstract goals.

Proactive coping skills and self-care behavior will be assessed at baseline, after the basis intervention, after the booster sessions, and at follow-up 6 months after the last booster session. Medical outcomes will be assessed at baseline and at follow-up.
- Primary outcomeSelf-management behaviors as assessed through questionnaires (diet, exercise, lifestyle adherence, medication adherence), corroborated by medical outcomes that will be assessed through blood samples (Hba1c, blood glucose levels).
- Secondary outcomePsychological measures, assessed by questionnaires (proactive coping skills, self-efficacy, self-control).
- TimepointsT0 (week 0): Baseline, before intervention;
T1 (week 6): After basis intervention;
T2 (week 36): After booster sessions;
T3 (week 62): 6 month follow-up.
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESProf. dr. D.T.D. Ridder, de
- CONTACT for SCIENTIFIC QUERIESProf. dr. D.T.D. Ridder, de
- Sponsor/Initiator Linschoten Institute for Psychology, Faculty of Social Sciences, Utrecht University
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryThe study aims to test the effectiveness of a behavioral intervention program targeting proactive coping skills in type 2 diabetes patients. The program comprises one invidivual session and 4 group sessions over a period of 2 months. Using a practical 5-step plan, participants are taught to set concrete goals, recognize conditions and barriers to goal achievement, identify potential difficult situations, formulate necessary actions, and consider how to evaluate their progress. It is expected that the intervention will increase participants' proactive coping skills, which will in turn lead to improved self-care behavior and medical outcomes.
- Main changes (audit trail)
- RECORD16-feb-2011 - 4-mrt-2011


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