This trial is active, not recruiting.

Conditions diabetes type 2, obesity
Treatment cognitive behavior therapy (cbt)
Sponsor Oslo and Akershus University College of Applied Sciences
Collaborator University of Oslo
Start date April 2010
End date July 2015
Trial size 15 participants
Trial identifier NCT01297049, 2010/427b


The overall objective of this pilot study is to develop a cost-effective treatment methodology delivered outside of traditional clinical setting, and based on modern technology for patients with diabetes type 2 also suffering from obesity. This study will investigate the feasibility of web based counselling and situational feedback through mobile supervising. The intention is to treat 10-15 patients. All participants will receive standard treatment delivered by their general practitioners. In addition the participants will fill in and send diaries to the supervisors each evening for 4 weeks reduced to a weekly frequency for the next two months period. The diary's schedule will be an evaluation of the day activities related to meals and food, medication management as well as the performed physical activities. The diary's schedule will also include blood glucose sample, and plans for the next day especially regarding physical activity. The participants will be able to view their own registrations on a web page. Daily/weekly situational feedback will be given to the participants within a cognitive behavioural framework to stimulate self-management. The primary outcome will be the HbA1c levels. Secondary outcomes will include evaluation of lifestyle outcomes such as physical activity levels and eating behaviour, and skills such as self-management of medication. In addition, the interventions effectiveness will examine mental health outcomes such as emotional distress and health-related quality of life.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose supportive care
cognitive behavior therapy (cbt) Life style counselling
All patients will receive standard care (reassurance, education, physiotherapy, and necessary medication). Complementary to this standard care, the participants will be required to closely monitor their blood glucose levels, weight, eating behavior and daily activities, and to relay this information to the nurse specialist trained in treating somatic patients with CBT. The nurse will then suggest appropriate treatment decisions, the patients will receive situational feedback based on the electronic diary during 3 months (daily during 4 weeks intensive treatment and weekly during 2 months as a complement).

Primary Outcomes

Blood glucose control with changes in Glycated hemoglobin (HbA1c) values
time frame: At the baseline and at the end of the intervention (3 months)

Secondary Outcomes

Health Education Impact Questionnaire (heiQ);
time frame: At the baseline and after the end of the intervention (3 months)
Problem Areas in Diabetes (PAID)
time frame: At the baseline and after the end of the intervention (3 months)
Food frequency questionnaire FFQ
time frame: At the baseline and after the end of the intervention (3 months)
Audit of Diabetes Dependence Quality of Life (ADDQoL-19)
time frame: At the baseline and after the end of the intervention (3months)

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

Inclusion Criteria: - age 18-70 years old - T2DM diagnosed > 3 months prior to study - HbA1c 7,5-10% - capability of filling in Norwegian questionnaires - BMI ≥ 25 - able and willing to give signed informed consent - willing to attend the full treatment schedule including ability to use mobile phones, computers and pocket computers Exclusion Criteria: - change in weight > 5kg during the last 3 months - any mental or physical condition interfering with the protocol - not having easy access to computers - having reading problems

Additional Information

Official title I-care: Stimulating Self-management in Patients With Type 2-diabetes Through Web-based Situational Feedback. A Pilot Study.
Principal investigator Andréa AG Nes, Mc
Description Diabetes and overweight have become a world health epidemic. The number of people suffering of these diseases is increasing due to population growth, aging, urbanization, and increasing prevalence of obesity and physical inactivity. The costs of diabetes affect health services, national productivity as well as individuals and families. Hospital in-patient costs for the treatment of complications are the largest single contributor to direct healthcare costs. Many of these complications and, therefore, their costs, are preventable. Intensive therapy, directed at the control of blood glucose, blood pressure etc, has been shown to be cost-effective in that, although initial costs are increased, it decreases longer term costs as a result of delayed or prevented complications . Diabetes self-management education is a multi-faceted process involving much more than helping people with diabetes to monitor their blood glucose, or take their medication as prescribed. Diabetes education must be an ongoing process rather than a one-time event because a person's health status and need for support change over time.
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by Oslo and Akershus University College of Applied Sciences.