DiaMester Pilot RCT: E-health Lifestyle Program for Type 2 Diabetes (DiaMester)

DiaMester: E-health Lifestyle Program for Improved Self-management and Remission of Type 2 Diabetes - a Pilot RCT

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).

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Behavioral: e-health lifestyle program; Behavioral: Low calorie diet

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 99
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anne-Marie Aas, Phd; Phone Number: +47 47302912; Email: a.m.aas@medisin.uio.no
• Study Contact Backup: Name: Lise M Østli, MSc; Phone Number: +47 97180196; Email: l.m.ostli@medisin.uio.no

Study Locations

• Norway
  • Oslo, Norway, 0424
    • Recruiting
    • Oslo University Hospital
    • Contact: Anne-Marie Aas, Phd; Phone Number: +47 47302912; Email: a.m.aas@medisin.uio.no
    • Contact: Lise M Østli, MSc; Phone Number: +47 97180196; Email: l.m.ostli@medisin.uio.no
    • Sub-Investigator: Kåre I Birkeland, PhD
    • Sub-Investigator: Line Wisting, PhD
    • Sub-Investigator: Kirsti Bjerkan, MSc
    • Sub-Investigator: Monica H Carlsen, PhD
    • Sub-Investigator: Milada Hagen, PhD
    • Sub-Investigator: Eirik Årsand, PhD
    • Sub-Investigator: Tina Rishaug, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Written informed consent
• Men and women aged ≥ 18 years
• Type 2 diabetes of duration 0-6 years (diagnosis based on 2 recorded diagnostic-level tests, HbA1c and/or blood glucose)
• HbA1c ≥ 48 mmol/mol at the last routine clinical check, within last 12 months if on diet alone
• HbA1c ≥ 43 mmol/mol if on treatment with oral hypoglycaemic agents or GLP-1 RA treatment
• Body Mass Index (BMI) >27 kg/m2
• Stable body weight during the last 6 months with or without the use of weight-reducing drugs
• Self-reported desire to lose weight
• Owns a smartphone

Exclusion criteria:

• Current insulin use
• > 5% weight change or started treatment with weight reducing drugs* within the last 6 months. *orlistat (Xenical), bupropion-naltrekson (Mysimba), fenteramin-topiramat (Qsimba), semaglutid (Wegovy, Ozempic), tirzepatid (Mounjaro), liraglutid (Saxenda, Victoza), dulaglutid (Truicity).
• Recent routine HbA1c ≥108 mmol/mol
• Recent eGFR <30 ml/min/1.73 m^2
• Known cancer
• Myocardial infarction within previous 6 months
• Severe heart failure defined as equivalent to the New York Heart Association grade 3 (NYHA)
• Pregnancy/considering pregnancy or exclusively breastfeeding
• Substance abuse (drugs, alcohol)
• Diagnosed eating disorders or suspected ED based on screening questionnaire
• Learning difficulties or unable to understand, speak and read Norwegian or English
• Patients who have required hospitalization for depression or are on antipsychotic drugs
• People currently participating in another clinical research trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; E-health program with LCD	Behavioral: e-health lifestyle program; The e-health lifestyle program consists of three parts: an educational digital course module that can be tailored to the users' individual needs and preferences. This will include videos and interactive webinars accessible through the program, hosted by health specialists with users as guests.; individual and group-based digital lifestyle coaching by trained health care personnel through secure video-conference and chat solutions.; a mobile-phone-based self-management app. This app will offer the user relevant data and information from glucometer and smart watch according to the users' needs and preferences as well as easy ways for recording dietary intake, physical activity and other relevant parameters.; Other Names: Lifestyle intervention; weight loss intervention; e-health based intervention; m-health intervention; digital behavioural intervention; total diet replacement low caloric diet; Behavioral: Low calorie 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.
Experimental: 2; E-health program without LCD	Behavioral: e-health lifestyle program; The e-health lifestyle program consists of three parts: an educational digital course module that can be tailored to the users' individual needs and preferences. This will include videos and interactive webinars accessible through the program, hosted by health specialists with users as guests.; individual and group-based digital lifestyle coaching by trained health care personnel through secure video-conference and chat solutions.; a mobile-phone-based self-management app. This app will offer the user relevant data and information from glucometer and smart watch according to the users' needs and preferences as well as easy ways for recording dietary intake, physical activity and other relevant parameters.; Other Names: Lifestyle intervention; weight loss intervention; e-health based intervention; m-health intervention; digital behavioural intervention; total diet replacement low caloric diet
No Intervention: 3; Standard care, but with continuous glucose monitoring (CGM) for 10 days at baseline and 1 year.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: University of Oslo; The Dam Foundation; University of Tromso; Norwegian Diabetes Association; Abel Technologies AS; Diabetes Wellness Norway
• Investigators: Principal Investigator: Anne-Marie Aas, PhD, Oslo University hospital and University of Oslo

Publications and helpful links

General Publications

• 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.
• 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.
• Fairburn CG, Beglin SJ. Assessment of eating disorders: interview or self-report questionnaire? Int J Eat Disord. 1994 Dec;16(4):363-70.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): January 14, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: January 15, 2026
• First Submitted That Met QC Criteria: January 15, 2026
• First Posted (Actual): January 23, 2026

Study Record Updates

• Last Update Posted (Actual): January 23, 2026
• Last Update Submitted That Met QC Criteria: January 15, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: diabetes; self-management; weight loss; diabetes mellitus type 2; e-health; caloric restriction; eating disorder; diet therapy; remission induction; low calorie diet; health psychology; total diet replacement
• Additional Relevant MeSH Terms: Endocrine System Diseases; Mental Disorders; Metabolic Diseases; Body Weight; Signs and Symptoms, Digestive; Body Weight Changes; Glucose Metabolism Disorders; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Weight Loss; Diabetes Mellitus, Type 2; Diabetes Mellitus; Feeding and Eating Disorders; Therapeutics; Diet, Food, and Nutrition; Physiological Phenomena; Nutritional Physiological Phenomena; Diet Therapy; Nutrition Therapy; Diet; Energy Intake; Caloric Restriction
• Other Study ID Numbers: 891668; SDAM_FOR555606 (Other Grant/Funding Number: The DAM foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No