Digital, Blended Lifestyle Intervention for Type 2 Diabetes Remission

NCT ID: NCT05346614

Last Updated: 2022-07-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 410 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2025-03-01

Brief Summary

410 Dutch type 2 diabetes patients will be randomized using a 5:1 ratio to intervention group versus control, to a lifestyle intervention program given via a mobile application and digital platform. Active participants will undergo diabetyping, where blood glucose and c-peptide responses to a glucose challenge are measured, and be recommended to follow a calorie-restricted (minimum 500 kcal deficit) low-carbohydrate, or restricted carbohydrate (120g) Mediterranean diet and customized exercise program for a period of 24 weeks. Individuals will then be followed for a period of 2 years following the intervention.

Detailed Description

Patients will partake in a 24-week intervention followed by a two-year follow-up period. The intervention will consist of diabetic phenotyping (diabetyping), and a personalized app-based lifestyle intervention, done in conjunction with usual care, the so-called blended care model. Individuals will be allocated to either a high (unsaturated) fat, low-carbohydrate Mediterranean (50 g), or the Mediterranean with limited carbohydrates (120 g) diet based on their diabetype, insulin use, and personal preference. This will be given in conjunction with physical activity program, which will focus more on aerobic activity or resistance training depending on diabetype. All participants will be provided with additional coaching to support behavioral change, which will include aspects of diet, physical activity but also aspects of mindfulness, and emotion regulation. The participants will be assessed at screening, before the start of the maintenance phase, and at follow-ups one, two, and three. Control patients will follow the usual care and will also be followed up, following the same schedule. The treatment is further clarified below:

Prior to commencing the study, participants in the active intervention group will receive a kit containing all the necessary products (i.e. wearable, smart scale, and glucose monitor), information, and instructions (where applicable) for participating in the study. Moreover, they will be carefully informed about the types of personalisations available to them. The participants will have either a whole food type diet or a low carbohydrate diet recommended to them based on their metabolic profiles. In addition, they will also have specific types of exercise recommended to them. Participants' treating physicians and coaches will be informed about their choices, and will receive supporting medication adjustment documents, based on those made in previous studies. It will remain the responsibility of the treating physicians to adjust any medications the participants are receiving.

The control group is required to meet the same criteria as the intervention group. The control group only receives health assessments (with the exception of the diabetyping), and will not receive any health intervention. They will continue to receive standard diabetes care.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Active lifestyle intervention

Individuals in the active intervention group will undergo diabetyping (diabetes type 2 phenotyping: glucose, and C-peptide responses to a glucose challenge). Based on the diabetype, individuals will receive recommendations to follow either a calorie-restricted (500kcal deficit minimum) low carbohydrate or a modified Mediterranean diet for a period of 18 weeks (total intervention is 24 weeks). Secondly, individuals will follow a personalized exercise program. Guidance and coaching (individual and small group) will be given via mobile app and digital platform. Individuals will receive real-time feedback based on their diet, exercise, and glucose levels (via continuous glucose monitoring for 4 weeks). Medications will be slowly withdrawn over the intervention period, with a focus on the first phase of the intervention.

Group Type: EXPERIMENTAL

Lifestyle intervention

Intervention Type: BEHAVIORAL

Lifestyle coaching will be given on a digital app-based platform. Individuals will receive real-time feedback via a smart scale, activity monitor, and continuous glucose monitor (first 4 weeks, longer if required). Coaching will be focused on gradual behavior change, assisted by digital nudges, one-on-one, and small group coaching sessions. Coaching will include education regarding lifestyle to improve health literacy with respect to diet and diabetes management. Additionally, coaches will guide participants in the implementation of individualized diet and exercise program with varying levels of carbohydrate restriction and caloric deficit.

Usual care group

Individuals in the usual care group will receive standard diabetes care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Lifestyle intervention

Lifestyle coaching will be given on a digital app-based platform. Individuals will receive real-time feedback via a smart scale, activity monitor, and continuous glucose monitor (first 4 weeks, longer if required). Coaching will be focused on gradual behavior change, assisted by digital nudges, one-on-one, and small group coaching sessions. Coaching will include education regarding lifestyle to improve health literacy with respect to diet and diabetes management. Additionally, coaches will guide participants in the implementation of individualized diet and exercise program with varying levels of carbohydrate restriction and caloric deficit.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Diabetes: Diagnosis of T2DM without physician defined end-organ failure
• BMI: 25 to 45 kg/m²
• Age: 18 to 75 years
• Most recent HbA1c value should be greater than 6.0% (>43 mmol/mol); if less than 6.5% (<48 mmol/mol), individuals should still be receiving anti-diabetic medication
• Tech-savvy (patients are required to be able to fully use smartphone or tablet)
• Display interest and motivation to enroll in a digital, lifestyle intervention for diabetes

Exclusion Criteria

• Weight loss of more than five kg or greater than 10% within the past six months
• Serious co-morbidities, for example, a severe form of chronic obstructive pulmonary disease (Gold III or IV), bariatric surgery, heart failure (classes 2-4) kidney failure, or another medically determined end-stage organ failure
• Substance abuse
• Learning difficulties limiting the participation in a digital health intervention and or limiting the comprehension of trial goals or coaching curriculum.
• Current treatment with anti-obesity drugs
• Pregnancy, consideration of pregnancy within the study period, lactation or having given birth within the previous nine months
• Hospital admission for depression
• Major psychiatric disorder (e.g., schizophrenia, bipolar disorder) or use of antipsychotic drugs.
• Currently uncontrolled or eating disorder or purging behavior
• Type 1 diabetes
• History of keto-acidosis
• Myocardial infarction, stroke, angina, or coronary insufficiency within the previous six months
• Diabetic retinopathy requiring treatment
• Creatinine > 2.0 mg·dL-1 or > 152.5 µmol·L-1
• Urinary albumin > 1 g·dL-1 or > 10 g·L-1
• Cancer requiring treatment in the past five years, with the exception of non-melanoma skin cancer
• Chronic infectious disease requiring ongoing treatment
• Other chronic diseases or conditions likely to limit lifespan to less than six years
• Severe visual impairment or other impairment preventing interaction with digital content
• Non-English or Non-Dutch speaking
• Excessive alcohol intake (acute or chronic) defined as the average consumption of three or more alcohol-containing beverages daily or consumption of more than 14 alcoholic beverages per week
• Cholelithiasis or biliary dysfunction
• Use of an insulin pump
• Participation in diabetes therapy within the preceding three years; participation in concurrent weight management or interventional research protocol,
• Untreated thyroid disease,
• Requirement of a prescribed medical diet
• A recent on-record estimated glomerular filtration rate of less than 30 mL/min per 1.732 m²
• Incapacitated patients, and thus unable to fully participate in the trial.
• uncontrolled blood pressure (SBP > 170 mmHg and/or DBP > 100 mmHg)
• For nutritional ketosis specifically: impaired hepatic function (Bilirubin >2 mg·dL-1 or >34.2 µmol·L-1, Albumin < 3.5 g·dL-1 or <35 g·L-1)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Groningen

OTHER

Sponsor Role: collaborator

Universiteit Leiden

OTHER

Sponsor Role: collaborator

TNO

OTHER

Sponsor Role: collaborator

Ancora Health B.V.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Suzan Wopereis, PhD

Role: PRINCIPAL_INVESTIGATOR

TNO

Maarten van Aken, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Haga Ziekenhuis

Elly Vogelzang, MD

Role: PRINCIPAL_INVESTIGATOR

Center Medische Kwartier Eindhoven

Janet Kist, MD

Role: PRINCIPAL_INVESTIGATOR

Huisartsenpraktijk Zonneoord

Jan Hoogsteen, MD

Role: PRINCIPAL_INVESTIGATOR

Ancora Health

Rimke Vos, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Public Health and Primary Care / LUMC-Campus Den Haag

Locations

St. Anna Ziekenhuis

Eindhoven, Limburg, Netherlands

Center Medische Kwartier Eindhoven

Eindhoven, North Brabant, Netherlands

Huisartsenpraktijk Zonneoord

The Hague, South Holland, Netherlands

Haga Ziekenhuis

The Hague, South Holland, Netherlands

Countries

Netherlands

Central Contacts

José Castela Forte, MSc.

Role: CONTACT

Jose@Ancora.health

+316 28218360

Sarah Mount, PhD

Role: CONTACT

Sarah@Ancora.health

Facility Contacts

Arno Toorians, MD

Role: primary

a.toorians@st-anna.nl

+31 40 286 4040

Elly Vogelzang, MD

Role: primary

e.vogelzang@medischkwartiereindhoven.nl

+31040 211 51 79

Janet Kist, MD

Role: primary

j.m.kist@lumc.nl

+31070 321 4567

Maarten van Aken, PhD, MD

Role: primary

m.vanaken@hagaziekenhuis.nl

+31070 210 0000

Other Identifiers

NL77688.056.21

Identifier Type: -

Identifier Source: org_study_id