NCT Number: NCT07361640
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).
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Oslo, 0424, Norway
Location status: Recruiting
Anne-Marie Aas, Phd
CONTACT
Eirik Årsand, PhD
SUB_INVESTIGATOR
Kirsti Bjerkan, MSc
SUB_INVESTIGATOR
Kåre I Birkeland, PhD
SUB_INVESTIGATOR
Line Wisting, PhD
SUB_INVESTIGATOR
Lise M Østli, MSc
CONTACT
Milada Hagen, PhD
SUB_INVESTIGATOR
Monica H Carlsen, PhD
SUB_INVESTIGATOR
Tina Rishaug, MSc
SUB_INVESTIGATOR
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The e-health lifestyle program consists of three parts:
Other names: Lifestyle intervention, e-health based intervention, m-health intervention, digital behavioural intervention, weight loss intervention, total diet replacement low caloric diet
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.
Time frame: Body weight will be assessed at baseline, 3 months, 6 months, 9 months and 12 months.
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.
Time frame: HbA1c will be measured at baseline, 3 months, 6 months, 9 months and 12 months.
HbA1c (mmol/mol) will be measured by the participants GPs and will be analysed as a continuous variable.
Time frame: Lipids will be measured at baseline, 6 months and 12 months
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.
Time frame: Blood pressure will be measured at baseline, 3 months, 6 months, 9 months and 12 months.
Change in blood pressure (mmHg) will be measured by the participants GPs and will be analysed as a continuous variable.
Time frame: 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.
Average blood glucose will be collected form continuous glucose monitors (CGM).
Time frame: 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.
Average blood glucose will be collected form continuous glucose monitors (CGM).
Time frame: Use of medications will be assessed at baseline, 3 months, 6 months, 9 months and 12 months.
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.
Time frame: Diet quality will be assessed at baseline, 6 months and 1 year.
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.
Time frame: Physical activity will be assessed at baseline and 1 year follow up.
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.
Time frame: Measured at baseline and 1 year follow-up
HRQoL will be measured using the EQ-5D-5L (3).
Time frame: Measured at baseline and 1 year follow-up
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
Time frame: Measured at baseline and 1 year follow-up
Diabetes self-management will be measured using the problem Diabetes Empowerment Scale-Short Form (DES-SF) (6).
Time frame: Measured at baseline and 1 year follow-up
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.
Time frame: Measured 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.
Contact information is provided by the study sponsor or research team.
Anne-Marie Aas, PhD
CONTACT
Lise M Østli, MSc
CONTACT
Oslo University Hospital
Other
DiaMester: E-health Lifestyle Program for Improved Self-management and Remission of Type 2 Diabetes - a Pilot RCT
Acronym: DiaMester
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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