The Effects of a Novel Lifestyle Intervention Program on Insulin Sensitivity in Type 2 Diabetes (CH_DDZ)

German Diabetes Center

Status: Completed

Conditions: Fatty Liver, Nonalcoholic; Type 2 Diabetes

Treatments: Behavioral: Low-calorie diet supported by an app-guided digital education program, nutritional coaching calls via phone

Study type: Interventional

Funder types: Other

Identifiers

NCT04509245

Changing_Health_DDZ

Details and patient eligibility

About

Moderate weight reduction by a moderately hypocaloric very-low-fat diet resulted in normalization of fasting hyperglycemia and reversal of hepatic insulin resistance in patients with poorly controlled type 2 diabetes. The Diabetes Remission Clinical Trial (DiRECT) revealed that utilizing a total diet replacement by a low-energy formula diet for 3 months led to a 15 kg or more weight loss in 24% participants and diabetes remission 46% of the participants. To date it remains unknown whether similar results can be achieved with a natural, non-formula based diet in connection with an educative smartphone application and telephone coaching

Full description

24 patients with type 2 diabetes from the German Diabetes Study (GDS) with less than 4 years disease duration and not receiving insulin were included in this study. Before the start of the intervention, participants documented their dietary intake by recording a food diary. During the 12-week intervention participants were asked to adhere to a real food-based low-calorie diet supported by an app-guided digital education program as well as a low-calorie recipe book and received weekly coaching calls by nutritionists. Patients were instructed to adhere to a balanced low calorie diet during the intervention. Nutritionists provided structured behavior change focusing on dietary advice, adherence to logging dietary intake and tracking weight. At first visit, patients installed the Changing Health App (Changing Health, Newcastle, UK) and completed an app-based digital education program. This program focused on type 2 diabetes education and behavioral change in combination with weight tracking and dietary monitoring. Patients used the app throughout the study and adherence was monitored via logins. Comprehensive testing before and after the intervention comprised a mixed-meal tolerance test and liver fat.

Enrollment: 24 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age between 18 and 65 years
• Existing diagnosis of type 2 diabetes
• Individuals who use a smartphone or PC to install the app
• Individuals who are able to communicate in German

Exclusion criteria

• Physical disability that leads to a significant lack of mobility (wheelchair, walking aid, walking stick, cane or crutches)
• Insulin therapy

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Effects of a digitally assisted lifestyle intervention

Experimental group

Description:

Testing the effects of a low-calorie diet in connection with app-based digital education and behavioral change program on glucose metabolism and disease management.

Treatment:

Behavioral: Low-calorie diet supported by an app-guided digital education program, nutritional coaching calls via phone