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Trial record 1 of 1 for:    Holzapfel | Obesity
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Personalized Nutrition and eHealth: Lifestyle Intervention (LION) Study for Weight Loss Maintenance (LION)

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ClinicalTrials.gov Identifier: NCT04023942
Recruitment Status : Recruiting
First Posted : July 18, 2019
Last Update Posted : July 22, 2019
Sponsor:
Information provided by (Responsible Party):
Christina Holzapfel, Technische Universität München

Tracking Information
First Submitted Date  ICMJE July 11, 2019
First Posted Date  ICMJE July 18, 2019
Last Update Posted Date July 22, 2019
Actual Study Start Date  ICMJE July 17, 2019
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 15, 2019)
Weight maintenance 12 months after weight loss intervention [ Time Frame: 15 months ]
Body weight change in kg and % (from baseline weight)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT04023942 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 15, 2019)
  • Weight change after eight weeks of formula diet [ Time Frame: month 3 ]
    Body weight in kg and % (from baseline weight)
  • Glucose [ Time Frame: month 0, 3, 6, 9, 12, 15, 27 ]
    Change in glucose in mg/dl
  • Insulin [ Time Frame: month 0, 3, 6, 9, 12, 15, 27 ]
    Change in insulin in µU/ml
  • Lipids [ Time Frame: month 0, 3, 6, 9, 12, 15, 27 ]
    Change in blood lipids (total cholesterin, triglyzeride, HDL cholesterin, LDL cholesterin - highly correlated to each other) in mg/dl
  • Leptin [ Time Frame: month 0, 3, 6, 9, 12, 15, 27 ]
    Change in leptin in ng/ml
  • Resting metabolic rate [ Time Frame: month 0, 3, 15, 27 ]
    Resting metabolic rate in kilocalories / 24 hours
  • Magnetic resonance imaging (MRI) [ Time Frame: month 0, 3, 15, 27 ]
    MRI data (organ volume, proton density fat fraction)
  • Insulin response on meal challenges [ Time Frame: month 0 ]
    Insulin response at different time points during meal challenge in µU/ml
  • Glucose response on meal challenges [ Time Frame: month 0 ]
    Glucose response at different time points during meal challenge in mg/dl
  • Lipid response on meal challenges [ Time Frame: month 0 ]
    Lipid (total cholesterin, triglyzeride, HDL cholesterin, LDL cholesterin - highly correlated to each other) response at different time points during meal challenge in mg/dl
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Personalized Nutrition and eHealth: Lifestyle Intervention (LION) Study for Weight Loss Maintenance
Official Title  ICMJE Lifestyle Intervention Study
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Obesity
Intervention  ICMJE Behavioral: Weight maintenance intervention
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).
Other Name: Dietary Intervention
Study Arms  ICMJE
  • Active Comparator: Low carb - App-based group
    Low 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.
    Intervention: Behavioral: Weight maintenance intervention
  • Active Comparator: Low carb - Newsletter-based group
    Low 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.
    Intervention: Behavioral: Weight maintenance intervention
  • Active Comparator: Low fat - App-based group
    Low 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.
    Intervention: Behavioral: Weight maintenance intervention
  • Active Comparator: Low fat - Newsletter-based group
    Low 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.
    Intervention: Behavioral: Weight maintenance intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 15, 2019)
252
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Christina Holzapfel, PhD +49 89 28924923 christina.holzapfel@tum.de
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04023942
Other Study ID Numbers  ICMJE 01EA1709
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: 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.
Responsible Party Christina Holzapfel, Technische Universität München
Study Sponsor  ICMJE Technische Universität München
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Christina Holzapfel, PhD TUM School of Medicine, Technical University of Munich
PRS Account Technische Universität München
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP