Interdisciplinary therapy for obesity management
Pilot Project on Interdisciplinary Therapy of Obesity and Its Consequences on Body Weight, Quality of Life and Gastrointestinal Parameters
NA · University of Hohenheim · NCT01344525
This study is testing different weight loss methods, like special diets and surgery, to see how they affect obesity and gut health over three years.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 480 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Hohenheim (other) |
| Locations | 3 sites (Heidelberg and 2 other locations) |
| Trial ID | NCT01344525 on ClinicalTrials.gov |
What this trial studies
This project involves obese individuals who undergo significant interventions, such as a low-calorie formula diet or bariatric surgery, with a focus on substantial weight loss of over 10%. Participants will be monitored for at least three years, with regular follow-ups every six months to assess weight changes, quality of life, and various gastrointestinal parameters. A database and biomaterial bank will be established to analyze the relationship between obesity and gastrointestinal health, comparing outcomes of surgical and non-surgical interventions. The study aims to identify gastrointestinal factors that could predict the success of different obesity treatments.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with a BMI over 30 who are undergoing significant weight loss interventions.
Not a fit: Patients who do not achieve at least a 10% weight loss after intervention or have insufficient follow-up may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for obesity and better long-term outcomes for patients.
How similar studies have performed: Other studies have shown promise in understanding the relationship between obesity and gastrointestinal health, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults (18-65 years at time of inclusion) * Obesity defined as BMI \> 30 kg/m2 * Obesity treatment (multidisciplinary life style intervention with LCD or bariatric surgery) resulting in an estimated body weight loss of \>10% of the initial body weight within 6 month Exclusion Criteria: * Body weight loss after intervention \< 10% * Follow-up period \< 1 year or number of consultations within 3 years \< 3
Where this trial is running
Heidelberg and 2 other locations
- University of Heidelberg — Heidelberg, Germany (RECRUITING)
- University of Hohenheim — Stuttgart, Germany (RECRUITING)
- University of Tübingen — Tübingen, Germany (RECRUITING)
Study contacts
- Principal investigator: Stephan C. Bischoff, Prof. Dr. — University of Hohenheim, Institute of Nutritional Medicine
- Study coordinator: Antje Damms-Machado, Dipl. troph.
- Email: antje.machado@uni-hohenheim.de
- Phone: +49 711 451017707
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Obesity, Weight Loss, obesity therapy, metabolic syndrome, gastrointestinal tract, microbiota, metabolomics, micronutrients