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| ID | Type | Description | Link |
|---|---|---|---|
| SDAM_FOR555606 | Other Grant/Funding Number | The DAM foundation |
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| Name | Class |
|---|---|
| University of Tromso | OTHER |
| Abel Technologies AS | UNKNOWN |
| The Dam Foundation | OTHER |
| Diabetes Wellness Norway |
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This registration covers a pilot for a 3-armed parallel-group randomized controlled trial (RCT) that will evaluate the efficacy of DiaMester, a Norwegian e-health programme designed to improve self-management and induce clinically meaningful weight loss, and thereby potential remission in adults with type 2 diabetes (T2D).
The aim of this pilot RCT is to test the feasibility of the program and to investigate to what extent the program contributes to the intended improvement in lifestyle, self-management, metabolic risk factors and body weight. We also aim to investigate if participants in the e-health program achieve a clinically meaningful weight loss in each of the two intervention arms: one including a low-calorie diet (LCD) total diet replacement (TDR) induction phase and one without the use of a LCD.
The DiaMester app serves as a secure communication platform between each participant and an assigned health coach, who provides individually tailored advice on diet and physical activity and monitors progress towards agreed weight-loss targets. Six health coaches (clinical dietitians or diabetes nurses) will deliver the intervention, each having completed the same standardized training prior to study start.
Hypotheses:
Primary objective: To test whether participation in the DiaMester e-health program with an LCD induction phase results in greater weight loss compared to usual care after 12 months.
H1: The e-health + LCD group will achieve greater weight loss after 12 months than the control group
Secondary objectives:
A. To test whether participation in the DiaMester e-health program alone (without LCD) results in greater weight loss compared to usual care after 12 months.
H2: The e-health-only group will achieve greater weight loss than the control group after 12 months
B. Secondary outcomes include diet quality, lifestyle, physical activity, metabolic risk factors, and health related quality of life (HRQoL), self-management, eating disorder symptoms and diabetes distress. Both the LCD and no LCD intervention groups will be compared with the control group (usual care).
We hypothesize that compared to usual care, the e-health program supported lifestyle interventions will H3: Improve diet quality (in line with dietary recommendations), lifestyle index score and increase participants' physical activity H4: Improve the metabolic risk factors HbA1c, blood lipids, and blood pressure, H5: Reduce the use of blood glucose/lipid lowering drugs and/or blood pressure lowering drugs H5: Increase HRQoL and self-management and lower the level of diabetes distress.
H6: Not increase eating disorder symptoms
C: To examine possible mediating and moderating factors for the effect on body weight and metabolic risk factors H6: The intervention's effect on bodyweight is mediated by change in diet quality and physical activity H7: The intervention's effect on HbA1c, blood lipids and blood pressure is mediated by change in bodyweight, diet quality and physical activity H8: The effect of weight loss on HbA1c is moderated by diabetes duration, BMI and age
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | E-health program with LCD |
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| 2 | Experimental | E-health program without LCD |
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| 3 | No Intervention | Standard care, but with continuous glucose monitoring (CGM) for 10 days at baseline and 1 year. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| e-health lifestyle program | Behavioral | The e-health lifestyle program consists of three parts:
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in body weight from baseline (weight loss) | Body weight (kg) will be measured by the participants' GPs. Change in body weight will be reported as percentage weight loss and will be analysed as a continuous variable. | Body weight will be assessed at baseline, 3 months, 6 months, 9 months and 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c from baseline | HbA1c (mmol/mol) will be measured by the participants GPs and will be analysed as a continuous variable. | HbA1c will be measured at baseline, 3 months, 6 months, 9 months and 12 months. |
| Change in blood lipids from baseline |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anne-Marie Aas, PhD | Contact | +47 47302912 | a.m.aas@medisin.uio.no | |
| Lise M Østli, MSc | Contact | +47 97180196 | l.m.ostli@medisin.uio.no |
| Name | Affiliation | Role |
|---|---|---|
| Anne-Marie Aas, PhD | Oslo University Hospital and University of Oslo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo University Hospital | Recruiting | Oslo | 0424 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7866415 | Background | Fairburn CG, Beglin SJ. Assessment of eating disorders: interview or self-report questionnaire? Int J Eat Disord. 1994 Dec;16(4):363-70. | |
| 12716841 | Background | Anderson RM, Fitzgerald JT, Gruppen LD, Funnell MM, Oh MS. The Diabetes Empowerment Scale-Short Form (DES-SF). Diabetes Care. 2003 May;26(5):1641-2. doi: 10.2337/diacare.26.5.1641-a. No abstract available. |
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Individual participant data will not be shared, as participants have not consented to data sharing beyond the purposes of the present study, and the data contain sensitive health information protected under GDPR.
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| D015431 | Weight Loss |
| D001068 | Feeding and Eating Disorders |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D031204 | Caloric Restriction |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D002149 | Energy Intake |
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| UNKNOWN |
| Norwegian Diabetes Association | OTHER |
| University of Oslo | OTHER |
This registration covers a three-arm, parallel-group pilot RCT. Participants will be randomized in a 1:1:1 ratio to one of the two e-health lifestyle intervention arms or to the control group. The intervention and follow-up period is 1 year.
The three arms include:
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|
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| Low calorie diet | Behavioral | Participants will use a low calorie diet (LCD) total diet replacement (TDR) for the first 3 months of the 1 year intervention period, before gradual reintroduction of food. |
|
Lipids (mmol/L) (total cholesterol, low density cholesterol, high density cholesterol, triglycerides, non-high density cholesterol) will be measured by the participants GPs and will be analysed as a continuous variable. |
| Lipids will be measured at baseline, 6 months and 12 months |
| Change in blood pressure from baseline | Change in blood pressure (mmHg) will be measured by the participants GPs and will be analysed as a continuous variable. | Blood pressure will be measured at baseline, 3 months, 6 months, 9 months and 12 months. |
| Change in blood glucose time in range from baseline | Average blood glucose will be collected form continuous glucose monitors (CGM). | Participants' in the control group will wear a CGM for 10 days at baseline and 1 year, while participants' in the two intervention groups will wear a CGM for 40 days at baseline, 40 days at 6 months and 10 days at one year. |
| Change in average blood glucose baseline | Average blood glucose will be collected form continuous glucose monitors (CGM). | Participants' in the control group will wear a CGM for 10 days at baseline and 1 year, while participants' in the two intervention groups will wear a CGM for 40 days at baseline, 40 days at 6 months and 10 days at one year. |
| Change in use of medications from baseline | Type of blood glucose lowering drugs, lipid lowering drugs and blood pressure lowering drugs. We will report how many participants that are using zero, one and more than one glucose lowering drug, lipid lowering drug and blood pressure lowering drug. In addition, we will report the number of participants that are using GLP-1 analogues. | Use of medications will be assessed at baseline, 3 months, 6 months, 9 months and 12 months. |
| Change in diet quality from baseline | Data on diet quality will be collected using 24 hour recall for 3 separate days at each time point. The Norwegian Diet Index (1) will be adapted to create a new index reflecting the Norwegian dietary guidelines for diabetes and the European recommendations for the dietary management of diabetes (The Diabetes and Nutrition Study Group of the EASD 2023). In addition, intake of nutrients and key food groups will be evaluated. | Diet quality will be assessed at baseline, 6 months and 1 year. |
| Change in physical activity from baseline | Physical activity will be scored on the short form of the International physical activity questionnaire (IPAQ-SF) (2). For participants in the intervention groups physical activity (energy expenditure and steps) will be recorded with smart watches. | Physical activity will be assessed at baseline and 1 year follow up. |
| Change in health related quality (HRQoL) of life from baseline | HRQoL will be measured using the EQ-5D-5L (3). | Measured at baseline and 1 year follow-up |
| Change in diabetes distress of life from baseline | Diabetes distress will be measured using the problem Areas in Diabetes Scale (PAID) (4) and/or the Diabetes Distress Scale (DDS) (5). Time frame: Measured at baseline and 1 year follow-up | Measured at baseline and 1 year follow-up |
| Change in diabetes self-management from baseline | Diabetes self-management will be measured using the problem Diabetes Empowerment Scale-Short Form (DES-SF) (6). | Measured at baseline and 1 year follow-up |
| Change in eating disorder symptoms from baseline | Eating disorder symptoms will be measured using the Eating Disorder Examination Questionnaire (EDE-Q) (7, 8). Individuals with a score indicating high likelihood of ED at baseline will undergo an interview evaluating diagnostic criteria. | Measured at baseline and 1 year follow-up |
| Prevalence of likely eating disorder at baseline | Eating disorder symptoms will be measured using the problem EDE-Q. Individuals with a score indicating high likelihood of ED at baseline will undergo an interview evaluating diagnostic criteria. | Measured at baseline |
| 15735199 | Background | Polonsky WH, Fisher L, Earles J, Dudl RJ, Lees J, Mullan J, Jackson RA. Assessing psychosocial distress in diabetes: development of the diabetes distress scale. Diabetes Care. 2005 Mar;28(3):626-31. doi: 10.2337/diacare.28.3.626. |
| 7555499 | Background | Polonsky WH, Anderson BJ, Lohrer PA, Welch G, Jacobson AM, Aponte JE, Schwartz CE. Assessment of diabetes-related distress. Diabetes Care. 1995 Jun;18(6):754-60. doi: 10.2337/diacare.18.6.754. |
| 21479777 | Background | Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9. |
| 12900694 | Background | Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB. |
| 37808205 | Background | Henriksen HB, Berg HB, Andersen LF, Weedon-Fekjaer H, Blomhoff R. Development of the Norwegian diet index and the Norwegian lifestyle index and evaluation in a national survey. Food Nutr Res. 2023 Sep 29;67. doi: 10.29219/fnr.v67.9217. eCollection 2023. |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
| D001523 | Mental Disorders |
| D004032 |
| Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |