Clinical trial NCT05933759: Weight Reduction With the Low-Insulin-Method
Official title: Weight Reduction With the Low-Insulin-Method in an Occupational Health Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Lead sponsor: West German Center of Diabetes and Health
Sponsor class: OTHER
Collaborators: name: University of Bonn
First posted: 2023-07-06
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: Inclusion Criteria:

* Body Mass Index 25 kg/m2

Exclusion Criteria:

* none

Primary outcomes:
measure: Weight change in kg
timeFrame: 12 weeks
Secondary outcomes:
measure: body mass index in kg/m2
timeFrame: 12 weeks
measure: waist circumference in cm
timeFrame: 12 weeks
measure: hip circumference in cm
timeFrame: 12 weeks
measure: fat mass in kg
timeFrame: 12 weeks
measure: lean body mass in kg
timeFrame: 12 weeks
measure: muscle mass in kg
timeFrame: 12 weeks
measure: energy expenditure in kcal
timeFrame: 12 weeks
measure: blood pressure in mmHg
timeFrame: 12 weeks
measure: quality of life (short form questionnaire) in units on a scale
timeFrame: 12 weeks
measure: depression (German version of the Center for Epidemiological Studies-Depression Scale) in units on a scale
timeFrame: 12 weeks
measure: physical activity in min/day
timeFrame: 12 weeks
measure: physical activity in steps/day
timeFrame: 12 weeks
measure: eating behaviour (German version of the Three-factor Eating Questionnaire) in units on a scale
timeFrame: 12 weeks
measure: total cholesterol in mg/dl
timeFrame: 12 weeks
measure: HDL cholesterol in mg/dl
timeFrame: 12 weeks
measure: LDL cholesterol in mg/dl
timeFrame: 12 weeks
measure: triglycerides in mg/dl
timeFrame: 12 weeks
measure: fasting blood glucose in mg/dl
timeFrame: 12 weeks
measure: insulin in µU/ml
timeFrame: 12 weeks
measure: HbA1c in %
timeFrame: 12 weeks
measure: food frequency (German version of the food frequency questionnaire) in units on a scale
timeFrame: 12 weeks
Other outcomes:
measure: gut microbiome composition in percent
timeFrame: 12 weeks
Locations:
city: Düsseldorf
country: Germany
facility: West German Centre of Diabetes and Health
Study officials:
References: