Weight Reduction With the Low-Insulin-Method
WeR-LIM
1 other identifier
interventional
65
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 27, 2023
CompletedFirst Posted
Study publicly available on registry
July 6, 2023
CompletedStudy Start
First participant enrolled
July 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2024
CompletedJuly 11, 2024
July 1, 2024
6 months
June 27, 2023
July 10, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Weight change in kg
Estimated treatment difference
12 weeks
Secondary Outcomes (21)
body mass index in kg/m2
12 weeks
waist circumference in cm
12 weeks
hip circumference in cm
12 weeks
fat mass in kg
12 weeks
lean body mass in kg
12 weeks
- +16 more secondary outcomes
Other Outcomes (1)
gut microbiome composition in percent
12 weeks
Study Arms (2)
Intervention group
EXPERIMENTALLifestyle intervention with education via the Low-Insulin-App, low-carb diet, self-monitoring of weight and steps, and telemedical coaching.
Control group
ACTIVE COMPARATORLifestyle intervention with education via the Low-Insulin-App, low-carb diet, self-monitoring of weight and steps.
Interventions
Individual telemedical coaching delivered by a nutritional consultant
Lifestyle intervention with education via the Low-Insulin-App, low-carb diet, self-monitoring of weight and steps
Eligibility Criteria
You may qualify if:
- Body Mass Index 25 kg/m2
You may not qualify if:
- none
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- West German Center of Diabetes and Healthlead
- University of Bonncollaborator
Study Sites (1)
West German Centre of Diabetes and Health
Düsseldorf, 40591, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2023
First Posted
July 6, 2023
Study Start
July 15, 2023
Primary Completion
December 31, 2023
Study Completion
June 30, 2024
Last Updated
July 11, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share