Investigating the success of an app-led weight loss program

Not Applicable

• Conditions: Overweight; E65-E68; Obesity and other hyperalimentation

• Registration Number: DRKS00033498
• Lead Sponsor: pfit GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Written informed consent of the study participants after detailed verbal and written explanation of the study content, requirements and risks
- Ability and willingness to follow the investigator's instructions
- BMI: 28.0-35.0 kg/m2

Exclusion Criteria

- Severe chronic diseases (diagnosed diabetes, cardiovascular diseases, liver diseases, renal insufficiency, cancer)
- Chronic diseases of the gastrointestinal tract (especially small intestine, liver, pancreas) and condition following surgery on the gastrointestinal tract; e.g. gastrectomy, sprue, enterocolitis, chronic pancreatitis, cholestasis, short bowel syndrome, chronic inflammatory bowel disease, not: appendicitis, gallstone surgery
- Surgical procedures to reduce the size of the stomach, gastric banding, gastric balloon
- Autoimmune diseases (e.g. Crohn's disease, ulcerative colitis, rheumatoid arthritis, multiple sclerosis)
- Regular intake of laxatives
- Regular use of immunosuppressive medication (e.g. corticosteroids (except inhaled))
- Pregnancy, breastfeeding period
- Alcohol, drug and/or medication abuse
- Immediate need for surgical intervention in the next 3 months
- Simultaneous participation in another clinical trial or participation within the last 30 days
- Study participants not capable of giving informed consent
- Refusal or withdrawal of consent by study participants

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Body-Mass-Index, measured at t0 and t12

Secondary Outcome Measures

Name	Time	Method
At t0 and t12:<br>- Waist circumference (measurement with measuring tape)<br>- Body composition (BIA measurement) <br><br>Blood sampling and laboratory determination of:<br>- Parameters of glucose metabolism (fasting glucose, insulin, HbA1c, HOMA index)<br>- Parameters of lipid metabolism (LDL, HDL, total cholesterol, triglycerides)<br>- Inflammation parameters (hsCRP)<br>- CBC <br><br>At t0, t6 and t12:<br>- Survey of the consumption pattern using the modified FFQ<br>- Survey of activity using the Freiburg questionnaire