Clinical trial NCT03417674: SHAPE AND MOTION - Medical Accompanied Slimming
Official title: SHAPE AND MOTION - Medical Accompanied Slimming
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Lead sponsor: West German Center of Diabetes and Health
Sponsor class: OTHER
First posted: 2018-01-31
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Weight loss in kg
timeFrame: 26 weeks
Secondary outcomes:
measure: body mass index in kg/m2
timeFrame: 26 weeks
measure: waist circumference in cm
timeFrame: 26 weeks
measure: hip circumference in cm
timeFrame: 26 weeks
measure: fat mass in kg
timeFrame: 26 weeks
measure: lean body mass in kg
timeFrame: 26 weeks
measure: muscle mass in kg
timeFrame: 26 weeks
measure: energy expenditure in kcal
timeFrame: 26 weeks
measure: blood pressure in mmHg
timeFrame: 26 weeks
measure: quality of life (sf-12 questionnaire) in units on a scale
timeFrame: 26 weeks
measure: depression (German version of the Center for Epidemiological Studies-Depression [CES-D] Scale) in units on a scale
timeFrame: 26 weeks
measure: physical activity in min/day
timeFrame: 26 weeks
measure: physical activity in steps/day
timeFrame: 26 weeks
measure: eating behaviour (German version of the Three-factor Eating Questionnaire [TFEQ]) in units on a scale
timeFrame: 26 weeks
measure: total cholesterol in mg/dl
timeFrame: 26 weeks
measure: HDL cholesterol in mg/dl
timeFrame: 26 weeks
measure: LDL cholesterol in mg/dl
timeFrame: 26 weeks
measure: triglycerides in mg/dl
timeFrame: 26 weeks
measure: fasting blood glucose in mg/dl
timeFrame: 26 weeks
measure: insulin in µU/ml
timeFrame: 26 weeks
measure: HbA1c in %
timeFrame: 26 weeks
measure: uric acid in mg/dl
timeFrame: 26 weeks
measure: creatinin in mg/dl
timeFrame: 26 weeks
measure: medication in mg/day
timeFrame: 26 weeks
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: West-German Centre of Diabetes and Health
Study officials:
affiliation: West-German Centre of Diabetes and Health
name: Stephan Martin, MD
role: PRINCIPAL_INVESTIGATOR
References: