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Weight Reduction With the Low-Insulin-Method

NCT05933759 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2024-07-11

No results posted yet for this study

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.

Conditions

  • Overweight and Obesity

Interventions

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

Sponsors & Collaborators

  • University of Bonn

    collaborator OTHER

  • West German Center of Diabetes and Health

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-07-15
Primary Completion
2023-12-31
Completion
2024-06-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05933759 on ClinicalTrials.gov