An interventional study of Telemedical coaching and Low-Insulin-Method in Overweight and Obesity, sponsored by West German Center of Diabetes and Health. Completed at 1 site in Germany. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-11.
Sponsored by West German Center of Diabetes and Health · Not applicable, Interventional, and Supportive care
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.
3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.
This study's enrollment of 65 is below the median of 73 across 3,175 interventional studies indexed under Overweight.
Browse Overweight studies →West German Center of Diabetes and Health is the lead sponsor of 18 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Lifestyle intervention with education via the Low-Insulin-App, low-carb diet, self-monitoring of weight and steps, and telemedical coaching.
Behavioral: Telemedical coaching · Behavioral: Low-Insulin-Method
Lifestyle intervention with education via the Low-Insulin-App, low-carb diet, self-monitoring of weight and steps.
Behavioral: Low-Insulin-Method
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
Weight change in kg
Estimated treatment difference
Time frame: 12 weeks
body mass index in kg/m2
Estimated treatment difference
Time frame: 12 weeks
waist circumference in cm
Estimated treatment difference
Time frame: 12 weeks
hip circumference in cm
Estimated treatment difference
Time frame: 12 weeks
fat mass in kg
Estimated treatment difference
Time frame: 12 weeks
lean body mass in kg
Estimated treatment difference
Time frame: 12 weeks
muscle mass in kg
Estimated treatment difference
Time frame: 12 weeks
energy expenditure in kcal
Estimated treatment difference
Time frame: 12 weeks
blood pressure in mmHg
Estimated treatment difference
Time frame: 12 weeks
quality of life (short form questionnaire) in units on a scale
Estimated treatment difference minimum 0, maximum 100 higher scores mean a better outcome
Time frame: 12 weeks
depression (German version of the Center for Epidemiological Studies-Depression Scale) in units on a scale
Estimated treatment difference minimum 0, maximum 100 higher scores mean a worse outcome
Time frame: 12 weeks
physical activity in min/day
Estimated treatment difference
Time frame: 12 weeks
physical activity in steps/day
Estimated treatment difference
Time frame: 12 weeks
eating behaviour (German version of the Three-factor Eating Questionnaire) in units on a scale
Estimated treatment difference minimum 0, maximum 100 higher scores mean a better outcome
Time frame: 12 weeks
total cholesterol in mg/dl
Estimated treatment difference
Time frame: 12 weeks
HDL cholesterol in mg/dl
Estimated treatment difference
Time frame: 12 weeks
LDL cholesterol in mg/dl
Estimated treatment difference
Time frame: 12 weeks
triglycerides in mg/dl
Estimated treatment difference
Time frame: 12 weeks
fasting blood glucose in mg/dl
Estimated treatment difference
Time frame: 12 weeks
insulin in µU/ml
Estimated treatment difference
Time frame: 12 weeks
HbA1c in %
Estimated treatment difference
Time frame: 12 weeks
food frequency (German version of the food frequency questionnaire) in units on a scale
Estimated treatment difference minimum 0, maximum 100 higher scores mean a better outcome
Time frame: 12 weeks
gut microbiome composition in percent
difference between groups
Time frame: 12 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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West German Center of Diabetes and Health