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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

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.


Condition or disease Intervention/treatment Phase
Obesity Behavioral: Weight maintenance intervention Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 252 participants
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
Official Title: Lifestyle Intervention Study
Actual Study Start Date : July 17, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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

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.
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

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.
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

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.
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




Primary Outcome Measures :
  1. Weight maintenance 12 months after weight loss intervention [ Time Frame: 15 months ]
    Body weight change in kg and % (from baseline weight)


Secondary Outcome Measures :
  1. Weight change after eight weeks of formula diet [ Time Frame: month 3 ]
    Body weight in kg and % (from baseline weight)

  2. Glucose [ Time Frame: month 0, 3, 6, 9, 12, 15, 27 ]
    Change in glucose in mg/dl

  3. Insulin [ Time Frame: month 0, 3, 6, 9, 12, 15, 27 ]
    Change in insulin in µU/ml

  4. 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

  5. Leptin [ Time Frame: month 0, 3, 6, 9, 12, 15, 27 ]
    Change in leptin in ng/ml

  6. Resting metabolic rate [ Time Frame: month 0, 3, 15, 27 ]
    Resting metabolic rate in kilocalories / 24 hours

  7. Magnetic resonance imaging (MRI) [ Time Frame: month 0, 3, 15, 27 ]
    MRI data (organ volume, proton density fat fraction)

  8. Insulin response on meal challenges [ Time Frame: month 0 ]
    Insulin response at different time points during meal challenge in µU/ml

  9. Glucose response on meal challenges [ Time Frame: month 0 ]
    Glucose response at different time points during meal challenge in mg/dl

  10. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04023942


Contacts
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Contact: Christina Holzapfel, PhD +49 89 28924923 christina.holzapfel@tum.de

Locations
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Germany
Institute for Nutritional Medicine, Technical University of Munich Recruiting
Munich, Bavaria, Germany, 80992
Contact: Christina Holzapfel    0049 89 289 249 23    christina.holzapfel@tum.de   
Sponsors and Collaborators
Technische Universität München
Investigators
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Principal Investigator: Christina Holzapfel, PhD TUM School of Medicine, Technical University of Munich

Additional Information:
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Responsible Party: Christina Holzapfel, Principal investigator, Technische Universität München
ClinicalTrials.gov Identifier: NCT04023942     History of Changes
Other Study ID Numbers: 01EA1709
First Posted: July 18, 2019    Key Record Dates
Last Update Posted: July 22, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Christina Holzapfel, Technische Universität München:
Obesity
Weight loss
Weight maintenance
Lifestyle intervention
Dietary intervention
Formula diet
App
Newsletter
Digital tool
Low carb
Low fat
Meal challenges
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms