Weight Reduction With the Low-Insulin-Method

Overweight and Obesity Clinical Trial

— WeR-LIM  

Official title:

Weight Reduction With the Low-Insulin-Method in an Occupational Health Setting

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05933759
• Other study ID #: WeR-LIM
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 15, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: July 2023
• Source: West German Center of Diabetes and Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: June 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Body Mass Index 25 kg/m2

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity
• Weight Loss

Intervention

Behavioral:
• Telemedical coaching
Individual telemedical coaching delivered by a nutritional consultant
• Low-Insulin-Method
Lifestyle intervention with education via the Low-Insulin-App, low-carb diet, self-monitoring of weight and steps

Locations

Country	Name	City	State
Germany	West German Centre of Diabetes and Health	Düsseldorf

Sponsors (2)

Lead Sponsor	Collaborator
West German Center of Diabetes and Health	University of Bonn

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	gut microbiome composition in percent	difference between groups	12 weeks
Primary	Weight change in kg	Estimated treatment difference	12 weeks
Secondary	body mass index in kg/m2	Estimated treatment difference	12 weeks
Secondary	waist circumference in cm	Estimated treatment difference	12 weeks
Secondary	hip circumference in cm	Estimated treatment difference	12 weeks
Secondary	fat mass in kg	Estimated treatment difference	12 weeks
Secondary	lean body mass in kg	Estimated treatment difference	12 weeks
Secondary	muscle mass in kg	Estimated treatment difference	12 weeks
Secondary	energy expenditure in kcal	Estimated treatment difference	12 weeks
Secondary	blood pressure in mmHg	Estimated treatment difference	12 weeks
Secondary	quality of life (short form questionnaire) in units on a scale	Estimated treatment difference minimum 0, maximum 100 higher scores mean a better outcome	12 weeks
Secondary	depression (German version of the Center for Epidemiological Studies-Depression Scale) in units on a scale	Estimated treatment difference minimum 0, maximum 100 higher scores mean a worse outcome	12 weeks
Secondary	physical activity in min/day	Estimated treatment difference	12 weeks
Secondary	physical activity in steps/day	Estimated treatment difference	12 weeks
Secondary	eating behaviour (German version of the Three-factor Eating Questionnaire) in units on a scale	Estimated treatment difference minimum 0, maximum 100 higher scores mean a better outcome	12 weeks
Secondary	total cholesterol in mg/dl	Estimated treatment difference	12 weeks
Secondary	HDL cholesterol in mg/dl	Estimated treatment difference	12 weeks
Secondary	LDL cholesterol in mg/dl	Estimated treatment difference	12 weeks
Secondary	triglycerides in mg/dl	Estimated treatment difference	12 weeks
Secondary	fasting blood glucose in mg/dl	Estimated treatment difference	12 weeks
Secondary	insulin in µU/ml	Estimated treatment difference	12 weeks
Secondary	HbA1c in %	Estimated treatment difference	12 weeks
Secondary	food frequency (German version of the food frequency questionnaire) in units on a scale	Estimated treatment difference minimum 0, maximum 100 higher scores mean a better outcome	12 weeks