An interventional study of Lifestyle intervention in Diabetes Mellitus, Type 2, sponsored by Ancora Health B.V.. Status unknown at 4 sites in Netherlands. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-07-20.
Sponsored by Ancora Health B.V. · Not applicable, Interventional, and Treatment
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.
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's planned enrollment of 410 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
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Exclusion Criteria:
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.
Behavioral: Lifestyle intervention
Individuals in the usual care group will receive standard diabetes care.
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.
Rate of diabetes remission
Percentage of patients achieving complete diabetes remission. Diabetes remission rates amongst the active intervention group will be reported as the number of participants who have achieved fasting glucose \< 7 mmol/L or HbA1c \< 6.5% (48 mmol/mol) on two separate occasions 6 months apart, and glucose-lowering therapy has been stopped.
Time frame: 1 year
Rates of improved glycaemic control
Percentage of patients achieving improved glycaemic control. This will be defined as the number of individuals who achieve a reduction in glycated hemoglobin (HbA1c), and or reduced dependence on glucose-lowering medications, defined as the number of medications or dose.
Time frame: Will be reported at all follow-up moments (6 months, 1 year, and 2 years)
Blood lipids
Changes in blood lipids, namely triglycerides, total cholesterol, LDL, and HDL will be measured as an indicator of health status
Time frame: Will be reported at all follow-up moments (6 months, 1 year, and 2 years)
Weight loss
Weight loss will be measured as change in weight compared to baseline. It will be measured as an indicator of participant compliance and feasibility of the program.
Time frame: Will be reported at all follow-up moments (6 months, 1 year, and 2 years)
Remission versus diabetype
The association between diabetype\* as determined by response to an oral glucose tolerance test with remission will be determined \* de Hoogh IM, Oosterman JE, Otten W, et al. The Effect of a Lifestyle Intervention on Type 2 Diabetes Pathophysiology and Remission: The Stevenshof Pilot Study. Nutrients 2021;13(7):2193.
Time frame: Will be reported at all follow-up moments (6 months, 1 year, and 2 years)
Cost effectiveness
The cost of the intervention will be analyzed in comparison with that of usual care, in terms of doctor and hospital visits, as well as the use of supportive medical care ex. physiotherapy.
Time frame: Will be reported at all follow-up moments (6 months, 1 year, and 2 years)
Digital engagement as measured by the Engagement Index
Digital engagement will be digitally recorded as an engagement index, which is based on the frequency of user engagement with the app and digital content.
Time frame: Up to 1 year
Compliance
Compliance will be assessed as a score based on the user's participation and success in coaching activities, educational sessions, and diet, physical activity and blood sugar measurement logging goals.
Time frame: Up to 1 year
Plan to share: Yes — The data will be made available to researchers upon motivated request. Moreover, all supporting documents will be submitted upon publication of the study protocol and results.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
No publications or documents are linked to this record.
This study is status unknown, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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