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

Official title

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

Overview

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).

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

Interventions

• Behavioral e-health lifestyle program
  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
• 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.

Primary outcome measures

• Change in body weight from baseline (weight loss) [Time frame: Body weight will be assessed at baseline, 3 months, 6 months, 9 months and 12 months.]

Secondary outcome measures (12)

• Change in HbA1c from baseline [Time frame: HbA1c will be measured at baseline, 3 months, 6 months, 9 months and 12 months.]
• Change in blood lipids from baseline [Time frame: Lipids will be measured at baseline, 6 months and 12 months]
• Change in blood pressure from baseline [Time frame: 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 [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.]
• Change in average blood glucose baseline [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.]
• Change in use of medications from baseline [Time frame: Use of medications will be assessed at baseline, 3 months, 6 months, 9 months and 12 months.]
• Change in diet quality from baseline [Time frame: Diet quality will be assessed at baseline, 6 months and 1 year.]
• Change in physical activity from baseline [Time frame: Physical activity will be assessed at baseline and 1 year follow up.]
• Change in health related quality (HRQoL) of life from baseline [Time frame: Measured at baseline and 1 year follow-up]
• Change in diabetes distress of life from baseline [Time frame: Measured at baseline and 1 year follow-up]
• Change in diabetes self-management from baseline [Time frame: Measured at baseline and 1 year follow-up]
• Change in eating disorder symptoms from baseline [Time frame: Measured at baseline and 1 year follow-up]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Norway · 1 center

• Oslo University Hospital — Oslo

Publications

• 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
• 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
• 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
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT07361640 · 891668 · SDAM_FOR555606

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗