Personalized Nutrition and EHealth: Lifestyle Intervention (LION) Study for Weight Loss Maintenance
LION
Lifestyle Intervention Study
1 other identifier
interventional
272
1 country
1
Brief Summary
Despite standardized intervention strategies, weight loss and weight loss maintenance largely differ from person to person. Factors which may contribute to these individual differences is current object of research. In order to investigate predictors and barriers for weight management and to investigate two different dietary interventions and two different digital tools for weight maintenance, the LION-Study was designed as follows: Step I (screening, baseline phenotyping), step II (weight loss intervention with formula diet), step III (weight maintenance intervention with 4 intervention groups: low carb/newsletter; low carb/app; low fat/newsletter; low fat/app) and step IV (follow-up). Participants are required to attend visits at seven time points. At screening (month 0) a telephone-based screening interview takes place, in order to test eligibility of the potential participant. If the person is eligible, two consecutive baseline face-to-face visits are planned during step I. After completion of the eight weeks weight loss intervention (month 3), an additional visit takes place followed by three consecutive visits in the weight maintenance step (month 6, 9 and 15). The study ends with a final visit after the follow-up (month 27). Additional contacts (face-to-face and telephone) take place during the weight loss intervention step. Participants will regularly receive a bag with the required formula diet meals. During these "pick up" appointments, the study team actively get in face-to-face contact with participants. At the different visits, data are collected by questionnaires, medical investigations (e.g. MRI, motor function, resting metabolic rate), blood withdrawal as well as urine, feces and saliva sampling. Primary objective is to evaluate the effect of two diets (low carb/low fat) and two digital tools (app/newsletter) on long-term weight loss maintenance 12 months after weight loss. Secondary objective is to identify genetic, epigenetic, physiological, psychological and lifestyle factors that predict the success of weight loss and weight loss maintenance.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable obesity
Started Jul 2019
Longer than P75 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 11, 2019
CompletedStudy Start
First participant enrolled
July 17, 2019
CompletedFirst Posted
Study publicly available on registry
July 18, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 19, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 29, 2024
CompletedDecember 4, 2024
August 1, 2024
3.5 years
July 11, 2019
November 29, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Weight maintenance 12 months after weight loss intervention
Body weight change in kg and % (from baseline weight)
15 months
Secondary Outcomes (10)
Weight change after eight weeks of formula diet
month 3
Glucose
month 0, 3, 6, 9, 12, 15, 27
Insulin
month 0, 3, 6, 9, 12, 15, 27
Lipids
month 0, 3, 6, 9, 12, 15, 27
Leptin
month 0, 3, 6, 9, 12, 15, 27
- +5 more secondary outcomes
Study Arms (4)
Low carb - App-based group
ACTIVE COMPARATORLow carb is defined as 30 energy percent from carbs and consist of 20 energy percent from protein. The daily energy requirement is calculated for each participant individually, based on his/hers resting metabolic rate and physical activity level. Daily energy intake should be 10% lower than the calculated daily energy requirement. Participants assigned to the app-based group works together with a personal coach via app, providing nutritional guidance and support during the 12-month weight maintenance step.
Low carb - Newsletter-based group
ACTIVE COMPARATORLow carb is defined as 30 energy percent from carbs and consist of 20 energy percent from protein. The daily energy requirement is calculated for each participant individually, based on his/hers resting metabolic rate and physical activity level. Daily energy intake should be 10% lower than the calculated daily energy requirement. The newsletter intervention group gets regularly digital newsletters, in the same frequency as "contacts" take place in the app-based group.
Low fat - App-based group
ACTIVE COMPARATORLow fat is defined as 25 energy percent from fat and consist of 20 energy percent from protein. The daily energy requirement is calculated for each participant individually, based on his/hers resting metabolic rate and physical activity level. Daily energy intake should be 10% lower than the calculated daily energy requirement. Participants assigned to the app-based group works together with a personal coach via app, providing nutritional guidance and support during the 12-month weight maintenance step.
Low fat - Newsletter-based group
ACTIVE COMPARATORLow fat is defined as 25 energy percent from fat and consist of 20 energy percent from protein. The daily energy requirement is calculated for each participant individually, based on his/hers resting metabolic rate and physical activity level. Daily energy intake should be 10% lower than the calculated daily energy requirement. The newsletter intervention group gets regularly digital newsletters, in the same frequency as "contacts" take place in the app-based group.
Interventions
Weight maintenance intervention (52 weeks): After randomization, participants will follow either a low carb or a low fat diet and get nutritional assistance either by an app or a newsletter, based on the group they got randomized to (low carb/app, low carb/newsletter, low fat/app, low fat/newsletter).
Eligibility Criteria
You may qualify if:
- Age: 18 - 65 years
- BMI: 30,0 - 39,9 kg/m2
- Owner of a smartphone
- Caucasian
- No severe diseases
- Informed written consent
You may not qualify if:
- Diabetes mellitus
- Severe cardiovascular and/or respiratory disease
- Untreated high blood pressure
- Severe kidney disease
- Active cancer (or in remission)
- Inflammatory bowel disease
- Severe chronic infections and/or inflammations
- Severe mental-health disorders
- Neurodegenerative disorders
- Endocrine diseases
- Lipedema
- Pregnancy and lactation
- Vigorous weight fluctuations (\> 5 kg) in the last 3 months
- Immobility
- Surgery in the last 3 months
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute for Nutritional Medicine, Technical University of Munich
Munich, Bavaria, 80992, Germany
Related Publications (4)
Reik A, Schauberger G, Wiechert M, Hauner H, Holzapfel C. Association Between the Postprandial Response to an Oral Glucose Tolerance Test and Anthropometric Changes After an 8-Week Low-Calorie Formula Diet - Results From the Lifestyle Intervention (LION) Study. Mol Nutr Food Res. 2024 Jun;68(12):e2400106. doi: 10.1002/mnfr.202400106. Epub 2024 Jun 8.
PMID: 38850172BACKGROUNDReik A, Holzapfel C. Randomized Controlled Lifestyle Intervention (LION) Study for Weight Loss and Maintenance in Adults With Obesity-Design and Methods. Front Nutr. 2020 Nov 10;7:586985. doi: 10.3389/fnut.2020.586985. eCollection 2020.
PMID: 33240920BACKGROUNDJunker D, Wu M, Reik A, Raspe J, Rupp S, Han J, Nabauer SM, Wiechert M, Somasundaram A, Burian E, Waschulzik B, Makowski MR, Hauner H, Holzapfel C, Karampinos DC. Impact of baseline adipose tissue characteristics on change in adipose tissue volume during a low calorie diet in people with obesity-results from the LION study. Int J Obes (Lond). 2024 Sep;48(9):1332-1341. doi: 10.1038/s41366-024-01568-6. Epub 2024 Jun 26.
PMID: 38926461BACKGROUNDSomasundaram A, Wu M, Reik A, Rupp S, Han J, Naebauer S, Junker D, Patzelt L, Wiechert M, Zhao Y, Rueckert D, Hauner H, Holzapfel C, Karampinos DC. Evaluating Sex-specific Differences in Abdominal Fat Volume and Proton Density Fat Fraction at MRI Using Automated nnU-Net-based Segmentation. Radiol Artif Intell. 2024 Jul;6(4):e230471. doi: 10.1148/ryai.230471.
PMID: 38809148BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christina Holzapfel, PhD
TUM School of Medicine, Technical University of Munich
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
July 11, 2019
First Posted
July 18, 2019
Study Start
July 17, 2019
Primary Completion
January 19, 2023
Study Completion
February 29, 2024
Last Updated
December 4, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Immediately following publication. No end date.
- Access Criteria
- On request participant data collected during the trial, after deidentification and according to informed consent. Researches who provide a methodologically sound proposal. On request to principle investigator (Christina Holzapfel, christina.holzapfel@tum.de).
We will apply principles which meet standards of findability, accessibility, interoperability, and reusability (FAIR) in the management of data in our project. The owner of the data will be the Institute for Nutritional Medicine at TUM School of Medicine, Technical University of Munich. The data and samples will be safely stored for long term and can be easily accessed and/or downloaded by the study team. For collaboration partners defined dataset and samples will be provided with well-defined license and access conditions.