Skip to main content
OpenTrials
Completed

NCT Number: NCT05933759

Weight Reduction With the Low-Insulin-Method

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Overweight and Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

West German Centre of Diabetes and Health

Düsseldorf, 40591, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Body Mass Index 25 kg/m2

Exclusion criteria

  • none

Treatment and study plan

Telemedical coaching

Behavioral

Individual telemedical coaching delivered by a nutritional consultant

Low-Insulin-Method

Behavioral

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

Primary outcomes

  1. Weight change in kg

    Time frame: 12 weeks

    Estimated treatment difference

Secondary outcomes

  1. body mass index in kg/m2

    Time frame: 12 weeks

    Estimated treatment difference

  2. waist circumference in cm

    Time frame: 12 weeks

    Estimated treatment difference

  3. hip circumference in cm

    Time frame: 12 weeks

    Estimated treatment difference

  4. fat mass in kg

    Time frame: 12 weeks

    Estimated treatment difference

  5. lean body mass in kg

    Time frame: 12 weeks

    Estimated treatment difference

  6. muscle mass in kg

    Time frame: 12 weeks

    Estimated treatment difference

  7. energy expenditure in kcal

    Time frame: 12 weeks

    Estimated treatment difference

  8. blood pressure in mmHg

    Time frame: 12 weeks

    Estimated treatment difference

  9. quality of life (short form questionnaire) in units on a scale

    Time frame: 12 weeks

    Estimated treatment difference minimum 0, maximum 100 higher scores mean a better outcome

  10. depression (German version of the Center for Epidemiological Studies-Depression Scale) in units on a scale

    Time frame: 12 weeks

    Estimated treatment difference minimum 0, maximum 100 higher scores mean a worse outcome

  11. physical activity in min/day

    Time frame: 12 weeks

    Estimated treatment difference

  12. physical activity in steps/day

    Time frame: 12 weeks

    Estimated treatment difference

  13. eating behaviour (German version of the Three-factor Eating Questionnaire) in units on a scale

    Time frame: 12 weeks

    Estimated treatment difference minimum 0, maximum 100 higher scores mean a better outcome

  14. total cholesterol in mg/dl

    Time frame: 12 weeks

    Estimated treatment difference

  15. HDL cholesterol in mg/dl

    Time frame: 12 weeks

    Estimated treatment difference

  16. LDL cholesterol in mg/dl

    Time frame: 12 weeks

    Estimated treatment difference

  17. triglycerides in mg/dl

    Time frame: 12 weeks

    Estimated treatment difference

  18. fasting blood glucose in mg/dl

    Time frame: 12 weeks

    Estimated treatment difference

  19. insulin in µU/ml

    Time frame: 12 weeks

    Estimated treatment difference

  20. HbA1c in %

    Time frame: 12 weeks

    Estimated treatment difference

  21. food frequency (German version of the food frequency questionnaire) in units on a scale

    Time frame: 12 weeks

    Estimated treatment difference minimum 0, maximum 100 higher scores mean a better outcome

Other outcomes

  1. gut microbiome composition in percent

    Time frame: 12 weeks

    difference between groups

Sponsors and collaborators

Lead sponsor

West German Center of Diabetes and Health

Other

Collaborators

  • University of Bonn

Registry information

Official study title

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

Acronym: WeR-LIM

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Jul 6, 2023
Registry last updated
Jul 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.