Study Results
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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COMPLETED
NA
30 participants
INTERVENTIONAL
2018-02-10
2020-12-31
Brief Summary
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Method: In a randomized controlled clinical trial, the effect of a lifestyle intervention with meal replacement by formula diet, exercise stimulation, and telemedicine coaching is examined compared to a control group with routine care. The learning contents are taught in 7 group trainings, a practical unit with shopping and cooking training, as well as in 4 individual telephone conversations. The state of health is examined at the beginning, after 12 and 26 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
PREVENTION
SINGLE
Study Groups
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Intervention group
Lifestyle intervention with meal replacement by formula diet, exercise stimulation, and telemedicine coaching.
Lifestyle intervention
Meal replacement by formula diet, exercise stimulation, and telemedicine coaching.
Control group
Routine care.
No interventions assigned to this group
Interventions
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Lifestyle intervention
Meal replacement by formula diet, exercise stimulation, and telemedicine coaching.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* severe diseases such as tumors, chronic obstructive pulmonary disease (COPD), asthma, dementia, chronic bowel disease, psychosis, liver cirrhosis, (macro) nephropathy, renal insufficiency with glomerular filtration rate (GFR) \<30
* ongoing chemotherapy, chron. Cortisone treatment
18 Years
ALL
Yes
Sponsors
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West German Center of Diabetes and Health
OTHER
Responsible Party
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Principal Investigators
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Stephan Martin, MD
Role: PRINCIPAL_INVESTIGATOR
West-German Centre of Diabetes and Health
Locations
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West-German Centre of Diabetes and Health
Düsseldorf, , Germany
Countries
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Other Identifiers
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FORM UND BEWEGUNG
Identifier Type: -
Identifier Source: org_study_id
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