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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Overweight and Obesity
• Intervention / Treatment: Behavioral: Telemedical coaching; Behavioral: Low-Insulin-Method

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Düsseldorf, Germany, 40591
    • West German Centre of Diabetes and Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Body Mass Index 25 kg/m2

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Lifestyle intervention with education via the Low-Insulin-App, low-carb diet, self-monitoring of weight and steps, and telemedical coaching.	Behavioral: Telemedical coaching; Individual telemedical coaching delivered by a nutritional consultant; Behavioral: Low-Insulin-Method; Lifestyle intervention with education via the Low-Insulin-App, low-carb diet, self-monitoring of weight and steps
Active Comparator: Control group; Lifestyle intervention with education via the Low-Insulin-App, low-carb diet, self-monitoring of weight and steps.	Behavioral: Low-Insulin-Method; Lifestyle intervention with education via the Low-Insulin-App, low-carb diet, self-monitoring of weight and steps

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight change in kg	Estimated treatment difference	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
body mass index in kg/m2	Estimated treatment difference	12 weeks
waist circumference in cm	Estimated treatment difference	12 weeks
hip circumference in cm	Estimated treatment difference	12 weeks
fat mass in kg	Estimated treatment difference	12 weeks
lean body mass in kg	Estimated treatment difference	12 weeks
muscle mass in kg	Estimated treatment difference	12 weeks
energy expenditure in kcal	Estimated treatment difference	12 weeks
blood pressure in mmHg	Estimated treatment difference	12 weeks
physical activity in min/day	Estimated treatment difference	12 weeks
physical activity in steps/day	Estimated treatment difference	12 weeks
total cholesterol in mg/dl	Estimated treatment difference	12 weeks
HDL cholesterol in mg/dl	Estimated treatment difference	12 weeks
LDL cholesterol in mg/dl	Estimated treatment difference	12 weeks
triglycerides in mg/dl	Estimated treatment difference	12 weeks
fasting blood glucose in mg/dl	Estimated treatment difference	12 weeks
insulin in µU/ml	Estimated treatment difference	12 weeks
HbA1c in %	Estimated treatment difference	12 weeks
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
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
gut microbiome composition in percent	difference between groups	12 weeks

Collaborators and Investigators

• Sponsor: West German Center of Diabetes and Health
• Collaborators: University of Bonn

Study record dates

Study Major Dates

• Study Start (Estimated): July 15, 2023
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: June 27, 2023
• First Submitted That Met QC Criteria: June 27, 2023
• First Posted (Actual): July 6, 2023

Study Record Updates

• Last Update Posted (Actual): July 12, 2023
• Last Update Submitted That Met QC Criteria: July 10, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Body Weight Changes; Weight Loss; Overweight; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin
• Other Study ID Numbers: WeR-LIM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No