Investigating the success of an app-led weight loss program
Organizational Data
- DRKS-ID:
- DRKS00033498
- Recruitment Status:
- Recruiting planned
- Date of registration in DRKS:
- 2024-03-01
- Last update in DRKS:
- 2024-03-01
- Registration type:
- Prospective
Acronym/abbreviation of the study
No Entry
URL of the study
No Entry
Brief summary in lay language
This nutrition study investigates the extent to which the use of a nutrition app has an influence on weight loss for overweight people. Two groups are being compared: One group uses the app for 12 weeks, which creates an individualized nutrition plan based on the information provided by the study participants. The second group initially uses recipe collections, checklists and other materials to organize their diet according to the principles of a healthy and energy-reduced diet. At the end of the study, the second group will also have access to the app.
Brief summary in scientific language
This nutritional-physiological study is a monocentric, randomized, comparative intervention study with a waiting control group. The aim of the study is to investigate whether the use of an app-guided weight loss program with individual nutrition plans leads to greater weight loss than the provision of written nutritional information to promote a balanced and energy-restricted diet (waiting control group). Participants are randomized and assigned to one of two groups stratified by gender, age and BMI. Group 1 uses the app-guided weight loss program and eats according to the individual, app-generated nutrition plan for twelve weeks. Group 2 will follow the principles of a balanced, energy-reduced diet for a period of twelve weeks. Information on this is provided to the participants once at the beginning in the form of checklists, recipes and explanations. At the end of the study, the participants in group 2 will also receive the nutrition app for twelve weeks (waiting group design).
Health condition or problem studied
- Free text:
- Overweight
- ICD10:
- E65-E68 - Obesity and other hyperalimentation
- Healthy volunteers:
- Yes
Interventions, Observational Groups
- Arm 1:
- Group 1 uses the app-guided weight loss program (Upfit) and eats according to the individual, app-generated nutrition plan for twelve weeks.
- Arm 2:
- Group 2 is to follow the principles of a balanced, energy-reduced diet for a period of twelve weeks. Information on this is provided to the participants once at the beginning in the form of checklists, recipes and explanations. At the end of the study, the participants in group 2 will also receive the nutrition app Upfit for twelve weeks (waiting group design).
Endpoints
- Primary outcome:
- Body-Mass-Index, measured at t0 and t12
- Secondary outcome:
- At t0 and t12: - Waist circumference (measurement with measuring tape) - Body composition (BIA measurement) Blood sampling and laboratory determination of: - Parameters of glucose metabolism (fasting glucose, insulin, HbA1c, HOMA index) - Parameters of lipid metabolism (LDL, HDL, total cholesterol, triglycerides) - Inflammation parameters (hsCRP) - CBC At t0, t6 and t12: - Survey of the consumption pattern using the modified FFQ - Survey of activity using the Freiburg questionnaire
Study Design
- Purpose:
- Prevention
- Allocation:
- Randomized controlled study
- Control:
-
- Active control (effective treatment of control group)
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- Randomization by uninvolved employees of the university
- Blinding:
- No
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting planned
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- Other Institut für Lebensmittelwissenschaft und Humanernährung Gottfried Wilhelm Leibniz Universität Hannover Hannover
Recruitment period and number of participants
- Planned study start date:
- 2024-03-01
- Actual study start date:
- No Entry
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 60
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 30 Years
- Maximum Age:
- 65 Years
- Additional 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
Addresses
Primary Sponsor
- Address:
- Upfit GmbH & Co. KGLeverkusenstr. 5422761 HamburgGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://upfit.de
- Investigator Sponsored/Initiated Trial (IST/IIT):
- No
Contact for Scientific Queries
- Address:
- Institut für Lebensmittelwissenschaft und Humanernährung Gottfried Wilhelm Leibniz Universität HannoverTessa DeutschAm Kleinen Felde 3030167 HannoverGermany
- Telephone:
- +491624234619
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- Institut für Lebensmittelwissenschaft und Humanernährung Gottfried Wilhelm Leibniz Universität HannoverTessa DeutschAm Kleinen Felde 3030167 HannoverGermany
- Telephone:
- +401624234619
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Institut für Lebensmittelwissenschaft und Humanernährung Gottfried Wilhelm Leibniz Universität HannoverProf. Dr Andreas HahnAm Kleinen Felde 3030167 HannoverGermany
- Telephone:
- +49 5117625093
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.lw.uni-hannover.de/de/institut
Sources of Monetary or Material Support
Commercial (pharmaceutical industry, medical engineering industry, etc.)
- Address:
- Upfit GmbH & Co. KGLeverkusenstr. 5422761 HamburgGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission bei der Ärztekammer Niedersachsen, Unterkommission zur Beurteilung medizinischer Forschung am MenschenKarl-Wiechert-Allee 18-2230625 HannoverGermany
- Telephone:
- +49-511-3802208
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.aekn.de/aekn/kommissionen/ethikkommission
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2024-01-04
- Ethics committee number:
- Bo/01/2024
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2024-01-26
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry