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

NCT07361640 | Recruiting

• 2 other identifiers: 891668SDAM_FOR555606
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Diabetes Mellitus, Type 2

Keywords

diabetes; diabetes mellitus type 2; e-health; self-management; weight loss; low calorie diet; remission induction; total diet replacement; caloric restriction; diet therapy; health psychology; eating disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Change in HbA1c from baseline

  HbA1c will be measured at baseline, 3 months, 6 months, 9 months and 12 months.

• Change in blood lipids from baseline

  Lipids will be measured at baseline, 6 months and 12 months

• Change in blood pressure from baseline

  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

  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

  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.

Study Arms (3)

1

EXPERIMENTAL

E-health program with LCD

Behavioral: e-health lifestyle program; Behavioral: Low calorie diet

2

EXPERIMENTAL

E-health program without LCD

Behavioral: e-health lifestyle program

3

NO INTERVENTION

Standard care, but with continuous glucose monitoring (CGM) for 10 days at baseline and 1 year.

Interventions

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.

1

e-health lifestyle program BEHAVIORAL

The e-health lifestyle program consists of three parts: 1. 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. 2. individual and group-based digital lifestyle coaching by trained health care personnel through secure video-conference and chat solutions. 3. 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.

Also known as: Lifestyle intervention, e-health based intervention, m-health intervention, digital behavioural intervention, weight loss intervention, total diet replacement low caloric diet

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oslo University Hospital: lead
• University of Tromso: collaborator
• Abel Technologies AS: collaborator
• The Dam Foundation: collaborator
• Diabetes Wellness Norway: collaborator
• Norwegian Diabetes Association: collaborator
• University of Oslo: collaborator

Study Sites (1)

Oslo University Hospital

Oslo, 0424, Norway

RECRUITING

Related Publications (7)

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

  PMID: 7866415 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.

  PMID: 12716841 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.

  PMID: 15735199 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.

  PMID: 7555499 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.

  PMID: 21479777 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.

  PMID: 12900694 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.

  PMID: 37808205 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus; Weight Loss; Feeding and Eating Disorders

Interventions

Caloric Restriction

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Mental Disorders

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Energy Intake; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Anne-Marie Aas, PhD

  Oslo University Hospital and University of Oslo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor and Clinical Dietitian

Model Details: 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: 1. e-health program with an LCD TDR of 750-900 kcal/day for a 3-month induction phase, aiming at 10-15% weight loss within 12 months, 2. e-health program alone (without LCD) aiming at 10-15% weight loss within 12 months, 3. control group

Study Record Dates

• First Submitted: January 15, 2026
• First Posted: January 23, 2026
• Study Start: January 14, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)