Weight Reduction With the Low-Insulin-Method

NCT ID: NCT05933759

Last Updated: 2024-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-15

Study Completion Date

2024-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Overweight and Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Intervention group

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

Group Type EXPERIMENTAL

Telemedical coaching

Intervention Type BEHAVIORAL

Individual telemedical coaching delivered by a nutritional consultant

Low-Insulin-Method

Intervention Type BEHAVIORAL

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

Control group

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

Group Type ACTIVE_COMPARATOR

Low-Insulin-Method

Intervention Type BEHAVIORAL

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

Interventions

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Telemedical coaching

Individual telemedical coaching delivered by a nutritional consultant

Intervention Type BEHAVIORAL

Low-Insulin-Method

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Body Mass Index 25 kg/m2

Exclusion Criteria

* none
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Bonn

OTHER

Sponsor Role collaborator

West German Center of Diabetes and Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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West German Centre of Diabetes and Health

Düsseldorf, , Germany

Site Status

Countries

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Germany

Other Identifiers

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WeR-LIM

Identifier Type: -

Identifier Source: org_study_id

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