Weight Reduction With the Low-Insulin-Method (WeR-LIM)

West German Center of Diabetes and Health

Status: Completed

Conditions: Overweight and Obesity

Treatments: Behavioral: Telemedical coaching; Behavioral: Low-Insulin-Method

Study type: Interventional

Funder types: Other

Identifiers

NCT05933759

WeR-LIM

Details and patient eligibility

About

Background: Overweight and obesity affect health, quality of life and ability to work. Therefore, the Low-Insulin-Method was developed to support overweight and obese people in weight loss.

Method: In a randomized controlled clinical trial, the effect of the lifestyle intervention program 'Low-Insulin-Method', delivered by the Low-Insulin-App including low-carb diet, self monitoring of weight, physical activity and telemedical coaching is examined compared to a control group without coaching. The learning contents are taught in 30 videos and 5 online meetings. The intervention group additionally gets 4 individual care calls. The state of health is examined at the beginning and after 12 weeks.

Objective: The aim is to develop a training and counseling program for overweight or obese individuals with diabetes risk or type 2 diabetes, which can be used both for primary and for tertiary prevention of overweight-related diseases.

Enrollment: 65 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Body Mass Index 25 kg/m2

Exclusion criteria

• none

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

65 participants in 2 patient groups

Intervention group

Experimental group

Description:

Lifestyle intervention with education via the Low-Insulin-App, low-carb diet, self-monitoring of weight and steps, and telemedical coaching.

Treatment:

Behavioral: Low-Insulin-Method

Behavioral: Telemedical coaching

Control group

Active Comparator group

Description:

Lifestyle intervention with education via the Low-Insulin-App, low-carb diet, self-monitoring of weight and steps.

Treatment:

Behavioral: Low-Insulin-Method