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

Primary Purpose

Overweight and Obesity

Status
Not yet recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Telemedical coaching
Low-Insulin-Method
Sponsored by
West German Center of Diabetes and Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Overweight and Obesity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Body Mass Index 25 kg/m2 Exclusion Criteria: none

Sites / Locations

  • West German Centre of Diabetes and Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention group

Control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Weight change in kg
Estimated treatment difference

Secondary Outcome Measures

body mass index in kg/m2
Estimated treatment difference
waist circumference in cm
Estimated treatment difference
hip circumference in cm
Estimated treatment difference
fat mass in kg
Estimated treatment difference
lean body mass in kg
Estimated treatment difference
muscle mass in kg
Estimated treatment difference
energy expenditure in kcal
Estimated treatment difference
blood pressure in mmHg
Estimated treatment difference
quality of life (short form questionnaire) in units on a scale
Estimated treatment difference minimum 0, maximum 100 higher scores mean a better outcome
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
physical activity in min/day
Estimated treatment difference
physical activity in steps/day
Estimated treatment difference
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
total cholesterol in mg/dl
Estimated treatment difference
HDL cholesterol in mg/dl
Estimated treatment difference
LDL cholesterol in mg/dl
Estimated treatment difference
triglycerides in mg/dl
Estimated treatment difference
fasting blood glucose in mg/dl
Estimated treatment difference
insulin in µU/ml
Estimated treatment difference
HbA1c in %
Estimated treatment difference
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

Full Information

First Posted
June 27, 2023
Last Updated
July 10, 2023
Sponsor
West German Center of Diabetes and Health
Collaborators
University of Bonn
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1. Study Identification

Unique Protocol Identification Number
NCT05933759
Brief Title
Weight Reduction With the Low-Insulin-Method
Acronym
WeR-LIM
Official Title
Weight Reduction With the Low-Insulin-Method in an Occupational Health Setting
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 15, 2023 (Anticipated)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
West German Center of Diabetes and Health
Collaborators
University of Bonn

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Lifestyle intervention with education via the Low-Insulin-App, low-carb diet, self-monitoring of weight and steps, and telemedical coaching.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Lifestyle intervention with education via the Low-Insulin-App, low-carb diet, self-monitoring of weight and steps.
Intervention Type
Behavioral
Intervention Name(s)
Telemedical coaching
Intervention Description
Individual telemedical coaching delivered by a nutritional consultant
Intervention Type
Behavioral
Intervention Name(s)
Low-Insulin-Method
Intervention Description
Lifestyle intervention with education via the Low-Insulin-App, low-carb diet, self-monitoring of weight and steps
Primary Outcome Measure Information:
Title
Weight change in kg
Description
Estimated treatment difference
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
body mass index in kg/m2
Description
Estimated treatment difference
Time Frame
12 weeks
Title
waist circumference in cm
Description
Estimated treatment difference
Time Frame
12 weeks
Title
hip circumference in cm
Description
Estimated treatment difference
Time Frame
12 weeks
Title
fat mass in kg
Description
Estimated treatment difference
Time Frame
12 weeks
Title
lean body mass in kg
Description
Estimated treatment difference
Time Frame
12 weeks
Title
muscle mass in kg
Description
Estimated treatment difference
Time Frame
12 weeks
Title
energy expenditure in kcal
Description
Estimated treatment difference
Time Frame
12 weeks
Title
blood pressure in mmHg
Description
Estimated treatment difference
Time Frame
12 weeks
Title
quality of life (short form questionnaire) in units on a scale
Description
Estimated treatment difference minimum 0, maximum 100 higher scores mean a better outcome
Time Frame
12 weeks
Title
depression (German version of the Center for Epidemiological Studies-Depression Scale) in units on a scale
Description
Estimated treatment difference minimum 0, maximum 100 higher scores mean a worse outcome
Time Frame
12 weeks
Title
physical activity in min/day
Description
Estimated treatment difference
Time Frame
12 weeks
Title
physical activity in steps/day
Description
Estimated treatment difference
Time Frame
12 weeks
Title
eating behaviour (German version of the Three-factor Eating Questionnaire) in units on a scale
Description
Estimated treatment difference minimum 0, maximum 100 higher scores mean a better outcome
Time Frame
12 weeks
Title
total cholesterol in mg/dl
Description
Estimated treatment difference
Time Frame
12 weeks
Title
HDL cholesterol in mg/dl
Description
Estimated treatment difference
Time Frame
12 weeks
Title
LDL cholesterol in mg/dl
Description
Estimated treatment difference
Time Frame
12 weeks
Title
triglycerides in mg/dl
Description
Estimated treatment difference
Time Frame
12 weeks
Title
fasting blood glucose in mg/dl
Description
Estimated treatment difference
Time Frame
12 weeks
Title
insulin in µU/ml
Description
Estimated treatment difference
Time Frame
12 weeks
Title
HbA1c in %
Description
Estimated treatment difference
Time Frame
12 weeks
Title
food frequency (German version of the food frequency questionnaire) in units on a scale
Description
Estimated treatment difference minimum 0, maximum 100 higher scores mean a better outcome
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
gut microbiome composition in percent
Description
difference between groups
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Body Mass Index 25 kg/m2 Exclusion Criteria: none
Facility Information:
Facility Name
West German Centre of Diabetes and Health
City
Düsseldorf
ZIP/Postal Code
40591
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Weight Reduction With the Low-Insulin-Method

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