'Diabetescoach' – personal health coaching in patients with type 2 diabetes mellitus
| ISRCTN | ISRCTN79457541 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN79457541 |
| Secondary identifying numbers | 1 |
- Submission date
- 13/02/2021
- Registration date
- 17/02/2021
- Last edited
- 11/06/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Type 2 diabetes mellitus (DT2) is a common condition that causes the level of sugar (glucose) in the blood to become too high. Risk factors for DT2 include a high-calorie diet, physical inactivity and the resulting obesity. In view of the increasing number of DT2 patients and the associated costs for the health care system, there is an urgent need to further develop interventions for the treatment of DT2 in addition to standard treatment. Due to the different course of DT2 and the emergence and severity of the associated illness, treatment of DT2 should be based on a tailored approach to support lifestyle change.
This Diabetescoach (dbcoach) study is based on the need to develop a lifestyle intervention to implement the exercise and nutrition recommendations and to establish appropriate health behavior for DT2 patients. The aim of this study is to evaluate an individual personal health coach intervention to promote an active lifestyle and healthy eating behavior in addition to the existing treatment methods. It is assumed that the investigated intervention has a positive effect on HbA1c, physical activity, nutritional and dietary behavior and other examined parameters.
Who can participate?
Patients between 18-65 years old with type 2 diabetes
What does the study involve?
Participants are randomly allocated to the intervention group or the control group. Patients assigned to the intervention group will receive a 12-month, individually-tailored counselling to promote physical activity and healthy eating during medical treatment. Lifestyle counselling is provided through telephone calls in 24 sessions. The frequency of the telephone calls depends on the time of the intervention: in the first 6 weeks the telephone calls take place weekly, in the following 24 weeks every 2 weeks and in the last 24 weeks every 4 weeks. In addition, patients have access to an application for monitoring their health behavior and for communicating with their personal health coach. The intervention is based on the MoVo-concept, behavior change techniques and physical activity and nutritional recommendations of the American College of Sports Medicine and the American Diabetes Association. The researchers expect to achieve long-term lifestyle changes in patients with type 2 diabetes through individualized, ongoing support via telephone counseling and the app.
In addition to the standard treatment of diabetes type 2, patients in the control group receive a one-time written diet and exercise recommendation. This recommendation is based on the current standard recommendation of the American College of Sports Medicine and the American Diabetes Association. The control group also gets access to the application and should follow the standard treatment.
What are the possible benefits and risks of participating?
There are no disadvantages to participating in the study. Participation is on a voluntary basis and can be stopped at any time. Medical treatment will continue even if the patient participates in the program. Therefore the standard treatment is independent of participation. There are no risks associated with participation in the study.
By participating in the study, patients have the opportunity to change their lifestyle in the long term and thus slow down the progression of DT2. The program also takes place regardless of location.
Where is the study run from?
University of Basel (Switzerland)
When is the study starting and how long is it expected to run for?
July 2019 to February 2024
Who is funding the study?
Innosuisse (Switzerland)
Who is the main contact?
1. Dr Oliver Faude
oliver.faude@unibas.ch
2. Vivien Hohberg
vivien.hohberg@unibas.ch
Contact information
Scientific
University of Basel
Department for Sport, Exercise and Health
Birsstrasse 320B
Basel
4052
Switzerland
| Phone | +41 (0)61 207 4735 |
|---|---|
| oliver.faude@unibas.ch |
Scientific
University of Basel
Department for Sport, Exercise and Health
Birsstrasse 320B
Basel
4052
Switzerland
| Phone | +41 (0)61 207 47 24 |
|---|---|
| vivien.hohberg@unibas.ch |
Study information
| Study design | Interventional single-blind monocentric pragmatic randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | 'Diabetescoach' – personal health coaching in patients with type 2 diabetes mellitus: a randomized controlled trial |
| Study acronym | dbcoach |
| Study objectives | 1. The HbA1c level of the intervention group can be reduced in the long term compared to the control group. 2. The physical activity of the intervention group will be increased and maintained compared to the control group. |
| Ethics approval(s) | Approved 12/02/2021, Ethikkommission Nordwest- und Zentralschweiz (Hebelstrasse 53, 4056 Basel CH, Switzerland; +41 (0)61 268 13 50; eknz@bs.ch), ref: 2020-02755 |
| Health condition(s) or problem(s) studied | Type 2 diabetes |
| Intervention | Patients will be randomly assigned to the intervention group or the control group by an independent person, stratified by age, sex, and BMI. Randomization will be conducted as permuted block randomization with variable block sizes of 2, 4, and 6 (randomly arranged) in a 1:1 ratio. Patients assigned to the intervention group will receive 12 months of individualized counseling to promote physical activity and healthy eating in addition to standard therapy for type 2 diabetes. Lifestyle counselling is provided through telephone calls in 24 sessions. The frequency of the telephone calls depends on the time of the intervention: in the first 6 weeks the telephone calls take place weekly, in the following 24 weeks every 2 weeks and in the last 24 weeks every 4 weeks. In addition, patients have access to an app to monitor their health behaviors and communicate with their personal health coach. The intervention is based on the Movo concept, behavior change techniques, and exercise and nutrition recommendations from the American College of Sports Medicine and the American Diabetes Association. This theory- and evidence-based intervention has the potential to achieve long-term lifestyle changes in patients with type 2 diabetes through individualized, ongoing support via telephone counseling and the app. In addition to the standard treatment of type 2 diabetes, patients in the control group receive a one-time written diet and exercise recommendation. This recommendation is based on the current standard recommendation of the American College of Sports Medicine and the American Diabetes Association. The control group also gets access to the application and should follow the standard therapy. |
| Intervention type | Behavioural |
| Primary outcome measure | Measured at baseline (T0), after study inclusion, 6 months after study inclusion (T1), and 12 months after study inclusion (T2): 1. Chronic glycemic control over the last 3 months measured using HbA1c blood marker 2. Duration and intensity of daily physical activity measured using a triaxial accelerometer (ActiGraph wGT3X-BT) around the waist for 7 days |
| Secondary outcome measures | Measured at baseline (T0), after study inclusion, 6 months after study inclusion (T1), and 12 months after study inclusion (T2): 1. Subjective physical activity measured using SIMPAQ questionnaire 2. Nutrition and dietary behavior measured using Nutrition Diary, SEV questionnaire 3. Sport-related cognitive mediators of behavior change measured using questionnaires 4. Quality of life measured using SF-8 questionnaire 5. Neuropathy measured using FACT questionnaire 6. Medication measured using medical report 7. Food supplements measured using medical report 8. Anthropometry (abdominal circumference, hip circumference, height, weight) measured using medical report 9. Blood levels (cholesterol, LDL, non-HDL, Chol/HDL, CRP, IFG) measured using medical report 10. Comorbidities measured using medical report 11. Demographic variables measured using a demographic questionnaire 12. Cost-effectiveness measured using Swiss Medical Association, Tarmed V.1.09 at the end of the study |
| Overall study start date | 01/07/2019 |
| Completion date | 29/02/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 90 |
| Key inclusion criteria | Current inclusion criteria as of 15/06/2021: Type 2 diabetes patients will be included in the study if they: 1. Have an HbA1c value above 7.5 2. Have type 2 diabetes as defined by the American Diabetes Association 3. Are able to understand German at a sufficient level to comprehend instructions and information 4. Have access to ongoing treatment for type 2 diabetes by a primary care physician or diabetologist 5. Have an Internet connection 6. Have an activity level of less than 150 minutes of moderate or 75 minutes of intensive physical activity per week Previous inclusion criteria: Type 2 diabetes patients will be included in the study if they: 1. Are between 18-65 years old 2. Have an HbA1c value above 7.5 3. Have type 2 diabetes as defined by the American Diabetes Association 4. Are able to understand German at a sufficient level to comprehend instructions and information 5. Have access to ongoing treatment for type 2 diabetes by a primary care physician or diabetologist 6. Have an Internet connection 7. Have an activity level of less than 150 minutes of moderate or 75 minutes of intensive physical activity per week |
| Key exclusion criteria | Patients with type 2 diabetes must be excluded from the study if: 1. They have chronic or acute contraindications to physical activity or cannot be physically active for other medical reasons 2. They suffer from psychiatric or addiction disorders 3. They are pregnant 4. Insulin therapy is being used 5. If the HbA1c value cannot be reliably determined due to medical conditions (in the case of hemoglobinopathy, hemolytic anemia, blood transfusion, HIV, liver or kidney failure requiring dialysis) |
| Date of first enrolment | 01/05/2021 |
| Date of final enrolment | 28/02/2023 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
Birsstrasse 320 B
Basel
4052
Switzerland
Sponsor information
University/education
Department for Sport, Exercise and Health
Birsstrasse 320B
Basel
4052
Switzerland
| Phone | +41 (0)61 207 4735 |
|---|---|
| dbcoach-dsbg@unibas.ch | |
| Website | https://www.unibas.ch/de |
"ROR" |
https://ror.org/02s6k3f65 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Innosuisse - Swiss Innovation Agency, Innosuisse - Agence suisse pour l’encouragement de l’innovation, Innosuisse - Agenzia svizzera per la promozione dell’innovazione, Swiss Innovation Agency, Innosuisse, Innosuisse
- Location
- Switzerland
Results and Publications
| Intention to publish date | 30/09/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository |
| Publication and dissemination plan | The study protocol will be published as an additional document. The dissemination of the results will take place in a peer-reviewed journal and will be coordinated by the principal investigator. |
| IPD sharing plan | Current IPD sharing statement as of 04/01/2022: The statistical analysis code as well as the final data will be provided by the corresponding author in a scientific repository. The final data set does not contain any demographic or personal information that could lead to the identification of the study participants. _____ Previous IPD sharing statement: The data-sharing plans for the current study are unknown and will be made available at a later date. The researchers would like to publish the data-sharing plans with the study protocol. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 01/06/2022 | 08/06/2022 | Yes | No |
Editorial Notes
11/06/2024: The intention to publish date was changed from 01/06/2024 to 30/09/2024.
11/09/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/10/2022 to 28/02/2023.
2. The overall end date was changed from 01/10/2023 to 29/02/2024.
3. The intention to publish date was changed from 01/09/2023 to 01/06/2024.
4. The plain English summary was updated to reflect these changes.
08/06/2022: Publication reference added.
10/05/2022: The following changes have been made:
1. The recruitment end date has been changed from 01/05/2022 to 01/10/2022.
2. The overall trial end date has been changed from 01/03/2023 to 01/10/2023 and the plain English summary has been updated to reflect this change.
04/01/2022: The following changes have been made:
1. The trial website has been added.
2. The IPD sharing statement and summary have been updated.
15/06/2021: The following changes were made to the trial record:
1. The inclusion criteria were updated.
2. The recruitment start date was changed from 01/03/2021 to 01/05/2021.
3. The recruitment end date was changed from 01/03/2022 to 01/05/2022.
16/02/2021: Trial's existence confirmed by the Ethikkommission Nordwest- und Zentralschweiz.
