Clinical trial NCT04023942: Personalized Nutrition and EHealth: Lifestyle Intervention (LION) Study for Weight Loss Maintenance
Official title: Lifestyle Intervention Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Obesity
Weight loss
Weight maintenance
Lifestyle intervention
Dietary intervention
Formula diet
App
Newsletter
Digital tool
Low carb
Low fat
Meal challenges
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2019-07-18
Enrollment: 272
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This clinical study is a single-center 2\*2 factorial randomized trial. For the weight maintenance step, participants will be randomized into one of the four weight maintenance intervention arms.
Primary purpose: TREATMENT

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.

Detailed description: Step I - Screening and baseline phenotyping When a potential suitable participant is interested, a screening interview to check eligibility will take place by phone after oral agreement is given. The structured screening interview is carried out by means of a questionnaire in the format of a Case Report Form (CRF). Suitable persons are provided with participant´s information and data protection sheet and with the "declaration of consent". Sufficient time for consideration is given between the screening interview and visit 1A, where written consent is signed.

After the telephone-based screening interview, eligible participants are required to provide written consent. Participants will undergo clinical examinations at two visits (V1A + V1B), serving primarily for phenotyping as well as for detection of potentially unknown exclusion criteria. The order of some measurements carried out during V1A and V1B as well as the type of lipid challenge is randomized.

Data collection V1A:

* Resting metabolic rate
* Metabolic response to meal challenge
* Anthropometry
* Vital parameters
* Blood parameters
* Clinical, lifestyle (nutrition, physical activity), psychological, environmental and social factors (questionnaires and protocols)
* Sampling of blood samples for further research questions

Data collection V1B:

* Metabolic response to meal challenge
* Vital parameters
* Blood parameters
* Urine parameters
* Hand Strength Measurement
* Clinical, lifestyle (nutrition, physical activity), psychological, environmental and social factors (questionnaires and protocols)
* Sampling of blood, urine and saliva
* Optional: Adipose tissue distribution by MRI measurement; parameters for physical strength, motor function and body static condition; 24h urine collection; fecal samples

Step II - Weight loss intervention Once participant is still deemed eligible after V1A and V1B, the formula-based low calorie diet (LCD) starts as weight loss intervention. Formula products will be provided once per week. An additional daily intake of 200 g raw or cooked non-starchy vegetables is allowed. Participants fulfill a food diary to record eaten products including drinks and vegetables and to record well-being or side effects. Furthermore, participants are phenotyped by a continuous glucose measurement during the first four weeks of intervention.

Data collection V2:

* Anthropometry
* Vital parameters
* Blood and urine parameters
* Clinical, lifestyle (nutrition, physical activity), psychological, environmental and social factors (questionnaires and protocols)
* Resting metabolic rate
* Hand strength measurement
* Documentation of safety
* Continuous glucose measurement
* Sampling of blood, urine, and saliva
* Optional: Adipose tissue distribution by MRI measurement; parameters for physical strength, motor function and body static condition; 24h urine collection; fecal samples Step III - Weight maintenance intervention

If weight loss is \> 4 kg after eight weeks, the participant is eligible for randomization into one of the following four weight maintenance intervention arms:

Low carb - App-based group Low carb - Newsletter-based group Low fat - App-based group Low fat - Newsletter-based group

Data collection V3A:

* Anthropometry
* Blood and urine parameters
* Clinical, lifestyle (nutrition, physical activity), psychological, environmental and social factors (questionnaires and protocols)
* Documentation of safety
* Sampling of blood and urine samples for further research questions, e.g. metabolic profile (to be confirmed)
* Optional: 24h urine collection

Data collection V3B:

* Anthropometry
* Blood parameters
* Clinical, lifestyle (nutrition, physical activity), psychological, environmental and social factors (questionnaires and protocols)
* Documentation of safety
* Sampling of blood samples for further research questions, e.g. metabolic profile (to be confirmed)

Data collection V3C:

* Anthropometry
* Blood and urine parameters
* Resting metabolic rate
* Vital parameters
* Clinical, lifestyle (nutrition, physical activity), psychological, environmental and social factors (questionnaires and protocols)
* Documentation of safety
* Hand strength measurement
* Sampling of blood, urine, and saliva
* Optional: Adipose tissue distribution by MRI measurement; parameters for physical strength, motor function and body static condition; 24h urine collection; fecal samples Step IV - Follow-up During follow-up, all participants receive the same newsletters with nutritional information every 3 months (independent of weight maintenance intervention group). Further weight management is carried out by "self-help".

Data collection V4:

* Anthropometry
* Vital parameters
* Blood parameters (
* Clinical, lifestyle (nutrition, physical activity), psychological, environmental and social factors (questionnaires and protocols)
* Resting metabolic rate
* Sampling of blood

Eligibility criteria: Inclusion Criteria:

* Age: 18 - 65 years
* BMI: 30,0 - 39,9 kg/m2
* Owner of a smartphone
* Caucasian
* No severe diseases
* Informed written consent

Exclusion Criteria:

* 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
* Participation in other intervention studies
* Carrier of pace makers
* Blood donation or transfusion in the last 3 months

Primary outcomes:
measure: Weight maintenance 12 months after weight loss intervention
timeFrame: 15 months
Secondary outcomes:
measure: Weight change after eight weeks of formula diet
timeFrame: month 3
measure: Glucose
timeFrame: month 0, 3, 6, 9, 12, 15, 27
measure: Insulin
timeFrame: month 0, 3, 6, 9, 12, 15, 27
measure: Lipids
timeFrame: month 0, 3, 6, 9, 12, 15, 27
measure: Leptin
timeFrame: month 0, 3, 6, 9, 12, 15, 27
measure: Resting metabolic rate
timeFrame: month 0, 3, 15, 27
measure: Magnetic resonance imaging (MRI)
timeFrame: month 0, 3, 15, 27
measure: Insulin response on meal challenges
timeFrame: month 0
measure: Glucose response on meal challenges
timeFrame: month 0
measure: Lipid response on meal challenges
timeFrame: month 0
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Institute for Nutritional Medicine, Technical University of Munich
state: Bavaria
Study officials:
affiliation: TUM School of Medicine, Technical University of Munich
name: Christina Holzapfel, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Reik 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.
citation: Junker 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.
citation: Somasundaram 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.