SHAPE AND MOTION - Medical Accompanied Slimming

NCT ID: NCT03417674

Last Updated: 2021-10-12

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-10

Study Completion Date

2020-12-31

Brief Summary

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Background: Overweight and obesity affect health, quality of life and ability to work. Therefore, the scientifically evaluated program "SHAPE AND MOTION - medically ◦ accompanied ◦ slimming" was developed to support overweight and obese people in weight loss.

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.

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

SEQUENTIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention group

Lifestyle intervention with meal replacement by formula diet, exercise stimulation, and telemedicine coaching.

Group Type EXPERIMENTAL

Lifestyle intervention

Intervention Type COMBINATION_PRODUCT

Meal replacement by formula diet, exercise stimulation, and telemedicine coaching.

Control group

Routine care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Lifestyle intervention

Meal replacement by formula diet, exercise stimulation, and telemedicine coaching.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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Inclusion Criteria

* Body mass index ≥ 25 kg/m2

Exclusion Criteria

* acute diseases such as respiratory or gastrointestinal infections
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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West German Center of Diabetes and Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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Germany

Other Identifiers

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FORM UND BEWEGUNG

Identifier Type: -

Identifier Source: org_study_id

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