<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03241121</url>
  </required_header>
  <id_info>
    <org_study_id>2017-00487</org_study_id>
    <secondary_id>PZ00P3-167826</secondary_id>
    <secondary_id>SSED-YI 2017</secondary_id>
    <nct_id>NCT03241121</nct_id>
  </id_info>
  <brief_title>Study of Eating Patterns With a Smartphone App and the Effects of Time Restricted Feeding in the Metabolic Syndrome</brief_title>
  <official_title>Study of Eating Patterns With a Smartphone App and the Metabolic Effects of Time Restricted Feeding (TRF) in the Metabolic Syndrome - An Open-label Randomized Controlled Trial of TRF vs Regular Dietary Advices</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Lausanne Hospitals</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Salk Institute for Biological Studies</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Lausanne Hospitals</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      SwissChronoFood - Study of eating patterns with a smartphone app and the metabolic effects of&#xD;
      time restricted feeding in metabolic syndrome&#xD;
&#xD;
      The purpose of this study is to assess eating patterns among teenagers and adults with a new&#xD;
      method, going beyond the pen-and-paper food diaries, and to investigate whether time&#xD;
      restricted feeding leads to weight loss, improvement in lipid and glucose metabolism in&#xD;
      individuals with components of the metabolic syndrome&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The prevalence of the metabolic syndrome (MS) is increasing worldwide, due to the progression&#xD;
      of its different components (central obesity, elevated blood pressure, impaired glucose&#xD;
      tolerance and dyslipidemia), as well as the often associated liver steatosis. One way to&#xD;
      tackle the obesity epidemic is to intervene early at the onset in childhood and teenage years&#xD;
      - before cardio-metabolic complications have occurred. However, lifestyle programs targeting&#xD;
      this age group had limited success in the current obesogenic environment. In particular,&#xD;
      weight loss is a key factor in controlling all MS components, yet it is difficult to maintain&#xD;
      over time.&#xD;
&#xD;
      Time restricted feeding (TRF) is an approach that emphasizes energy intake limited to certain&#xD;
      windows of time within the 24-hour cycle without restrictions on calories or macronutrients.&#xD;
      This has emerged as an appealing approach to reduce body weight while improving lipid profile&#xD;
      and glucose metabolism. However, TRF has been mostly studied in animals and long-term&#xD;
      prospective data on its efficacy and mechanisms in humans is lacking.&#xD;
&#xD;
      Prior to the intervention, the investigators will assess the eating patterns of participants&#xD;
      with an innovative smartphone application ('app') which is less intrusive and more reliable&#xD;
      than food diaries/questionnaires to assess eating behavior and patterns.&#xD;
&#xD;
      In this project, the investigators will assess eating patterns among teenagers and adults,&#xD;
      and investigate whether a controlled TRF intervention leads to beneficial changes in MS&#xD;
      components. Study Part 1 uses an epidemiological approach to establish baseline daily eating&#xD;
      behavior, physical activity patterns and sleeping habits over 2 weeks (teenagers) and 4 weeks&#xD;
      (adults) using the smartphone app. Those individuals meeting criteria for at least one&#xD;
      component of MS and who have eaten for &gt;14 hours per 24-hour cycle will be recruited for&#xD;
      Study Part 2. In Part 2, participants will be assigned to TRF or active control groups, and&#xD;
      followed in this pragmatic randomized controlled trial for 6 weeks (teenagers) and 6 months&#xD;
      (adults) to assess the change in their weight and MS components, as well as liver fat&#xD;
      deposits. Study Part 3 will investigate the underlying mechanisms of improved metabolic&#xD;
      profile with TRF.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 29, 2017</start_date>
  <completion_date type="Actual">March 31, 2022</completion_date>
  <primary_completion_date type="Actual">March 31, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Study Part 1: Prospective longitudinal observational study. Study Part 2/3: Open-label randomized controlled trial.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Eating duration</measure>
    <time_frame>From baseline visit to end of observation phase (Part 1: 4 weeks for adults, 2 weeks for teenagers)</time_frame>
    <description>Duration from the first to last caloric intake over 24-hour cycle, collected via the smartphone app.&#xD;
Note: Key inclusion criterion for the intervention phase (Part 2).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of metabolic syndrome components</measure>
    <time_frame>From baseline visit to close-out visit (Part 1: 4 weeks for adults, 2 weeks for teenagers; followed by Part 2: 6 months for adults, 6 weeks for teenagers)</time_frame>
    <description>Number of participants with changes in weight and/or lipid profile and/or glucose metabolism in the intervention phase (Part 2).&#xD;
Note: Changes of the different components will be analyzed separately as secondary outcomes.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adherence to TRF intervention</measure>
    <time_frame>From randomization visit to close-out visit (Part 2: 6 months for adults, 6 weeks for teenagers)</time_frame>
    <description>After allocation to the TRF arm, assessment of the adherence to the intervention, as measured by eating duration from the first to last caloric intake over 24-hour cycle.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight change</measure>
    <time_frame>From baseline visit to close-out visit (Part 1: 4 weeks for adults, 2 weeks for teenagers; followed by Part 2: 6 months for adults, 6 weeks for teenagers)</time_frame>
    <description>Part of the composite primary outcome in the intervention phase (Part 2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in lipid profile</measure>
    <time_frame>From baseline visit to close-out visit (Part 1: 4 weeks for adults, 2 weeks for teenagers; followed by Part 2: 6 months for adults, 6 weeks for teenagers)</time_frame>
    <description>Part of the composite primary outcome in the intervention phase (Part 2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in glucose metabolism</measure>
    <time_frame>From baseline visit to close-out visit (Part 1: 4 weeks for adults, 2 weeks for teenagers; followed by Part 2: 6 months for adults, 6 weeks for teenagers)</time_frame>
    <description>Part of the composite primary outcome in the intervention phase (Part 2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in blood pressure</measure>
    <time_frame>From baseline visit to close-out visit (Part 1: 4 weeks for adults, 2 weeks for teenagers; followed by Part 2: 6 months for adults, 6 weeks for teenagers)</time_frame>
    <description>Systolic and diastolic blood pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in hepatic steatosis / fibrosis score</measure>
    <time_frame>From randomization visit to close-out visit (Part 2: 6 months for adults, 6 weeks for teenagers)</time_frame>
    <description>As measured by the Fibroscan device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in number of meals per day</measure>
    <time_frame>From baseline visit to close-out visit (Part 1: 4 weeks for adults, 2 weeks for teenagers; followed by Part 2: 6 months for adults, 6 weeks for teenagers)</time_frame>
    <description>Temporal analysis of caloric intake events collected by the smartphone app</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in meal intervals</measure>
    <time_frame>From baseline visit to close-out visit (Part 1: 4 weeks for adults, 2 weeks for teenagers; followed by Part 2: 6 months for adults, 6 weeks for teenagers)</time_frame>
    <description>Temporal analysis of caloric intake events collected by the smartphone app</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fraction of calories consumed after noon</measure>
    <time_frame>From baseline visit to close-out visit (Part 1: 4 weeks for adults, 2 weeks for teenagers; followed by Part 2: 6 months for adults, 6 weeks for teenagers)</time_frame>
    <description>Estimation of caloric content from food pictures collected by the smartphone app</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fraction of calories consumed after 6pm</measure>
    <time_frame>From baseline visit to close-out visit (Part 1: 4 weeks for adults, 2 weeks for teenagers; followed by Part 2: 6 months for adults, 6 weeks for teenagers)</time_frame>
    <description>Estimation of caloric content from food pictures collected by the smartphone app</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in eating pattern difference between weekdays and weekends</measure>
    <time_frame>From baseline visit to close-out visit (Part 1: 4 weeks for adults, 2 weeks for teenagers; followed by Part 2: 6 months for adults, 6 weeks for teenagers)</time_frame>
    <description>Indirect assessment of different lifestyle habits during weekdays and weekends</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in fat mass</measure>
    <time_frame>From randomization visit to close-out visit (Part 3: 6 months, only adults)</time_frame>
    <description>Body composition as measured by dual energy X-ray absorptiometry (DEXA)</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in fat free mass</measure>
    <time_frame>From randomization visit to close-out visit (Part 3: 6 months, only adults)</time_frame>
    <description>Body composition as measured by dual energy X-ray absorptiometry (DEXA)</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in diurnal rhythms of cortisol secretion</measure>
    <time_frame>From randomization visit to close-out visit (Part 3: 6 months, only adults)</time_frame>
    <description>Repeated measurements of cortisol over a 24-hour cycle</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in diurnal rhythms of melatonin secretion</measure>
    <time_frame>From randomization visit to close-out visit (Part 3: 6 months, only adults)</time_frame>
    <description>Repeated measurements of melatonin over a 24-hour cycle</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in physical activity</measure>
    <time_frame>From randomization visit to close-out visit (Part 3: 6 months, only adults)</time_frame>
    <description>As measured by actigraphy</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in sleep/wake cycles</measure>
    <time_frame>From randomization visit to close-out visit (Part 3: 6 months, only adults)</time_frame>
    <description>As measured by actigraphy</description>
  </other_outcome>
  <other_outcome>
    <measure>Eating duration - alternative definition of the primary outcome</measure>
    <time_frame>From baseline visit to end of observation phase (Part 1: 4 weeks for adults, 2 weeks for teenagers)</time_frame>
    <description>Alternative definition of eating duration accounting for 2.5-97.5th percentiles of caloric intake over 24 hours, presumably less sensitive to the occasionally forgotten food picture event</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">235</enrollment>
  <condition>Eating Behavior</condition>
  <condition>Metabolic Syndrome</condition>
  <condition>Obesity</condition>
  <condition>Dyslipidemias</condition>
  <condition>Glucose Intolerance</condition>
  <condition>Steatosis of Liver</condition>
  <arm_group>
    <arm_group_label>Time restricted feeding</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>For those in the intervention phase (Part 2)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Regular dietary advices</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>For those in the intervention phase (Part 2)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Time restricted feeding</intervention_name>
    <description>To eat only during a self-selected window of 12 hours, with no advice on nutrition quality, quantity or caloric intake</description>
    <arm_group_label>Time restricted feeding</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Regular dietary advices</intervention_name>
    <description>Regular dietary advices by a trained dietitian or research nurse according to current nutrition guidelines</description>
    <arm_group_label>Regular dietary advices</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Eating patterns</intervention_name>
    <description>Data collection on eating patterns via the smartphone app</description>
    <arm_group_label>Regular dietary advices</arm_group_label>
    <arm_group_label>Time restricted feeding</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key inclusion criteria for both observation and intervention phases (Part 1+2):&#xD;
&#xD;
          -  Age ≥ 12 years&#xD;
&#xD;
          -  Body mass index ≥ 20 kg/m2 and stable weight (previous 3 months) in adults; BMI ≥ 25th&#xD;
             percentile in teenagers&#xD;
&#xD;
          -  Smartphone compatible with the app (iOS or Android systems)&#xD;
&#xD;
        Additional inclusion criteria for the intervention phase (Part 2):&#xD;
&#xD;
          -  Any component of the metabolic syndrome following the International Diabetes&#xD;
             Federation consensus definition&#xD;
&#xD;
          -  Eating duration &gt;14h during the observation phase&#xD;
&#xD;
        Additional inclusion criteria for the mechanistic study (Part 3):&#xD;
&#xD;
          -  Age 18-40 years, men and pre-menopausal women&#xD;
&#xD;
          -  BMI 30-40 kg/m2&#xD;
&#xD;
          -  In the fasting state (at least 8 hours)&#xD;
&#xD;
        Key exclusion criteria for both observation and intervention phases (Part 1+2):&#xD;
&#xD;
          -  Pregnant and breastfeeding women, plans for maternity during the study&#xD;
&#xD;
          -  Major illness/fever over the previous month, active cancer&#xD;
&#xD;
          -  Eating disorder, on a diet / weight management, prior bariatric surgery&#xD;
&#xD;
          -  Major mental illness, unable to give informed consent&#xD;
&#xD;
          -  Current shift work or travel abroad planned in the next month&#xD;
&#xD;
        Additional exclusion criteria for the intervention phase (Part 2):&#xD;
&#xD;
          -  Prior cardiovascular event&#xD;
&#xD;
          -  Major liver, gastrointestinal, renal or endocrine disorder, diabetes mellitus with&#xD;
             hypoglycemic drug(s)&#xD;
&#xD;
          -  Major sleep disorder, centrally acting medication&#xD;
&#xD;
          -  Lipid lowering drug, hypoglycemic drug, medication affecting the gut&#xD;
&#xD;
        Additional exclusion criteria for the mechanistic study (Part 3):&#xD;
&#xD;
          -  Impaired glucose tolerance (pre-diabetes) or diabetes mellitus&#xD;
&#xD;
          -  Positive pregnancy test&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tinh-Hai Collet, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Lausanne Hospitals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Inselspital, Klinik für Allgemeine Innere Medizin</name>
      <address>
        <city>Bern</city>
        <state>BE</state>
        <zip>3010</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital of Lausanne (CHUV)</name>
      <address>
        <city>Lausanne</city>
        <zip>1011</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <link>
    <url>http://www.swisschronofood.ch</url>
    <description>Study website</description>
  </link>
  <results_reference>
    <citation>Phillips NE, Mareschal J, Schwab N, Manoogian ENC, Borloz S, Ostinelli G, Gauthier-Jaques A, Umwali S, Gonzalez Rodriguez E, Aeberli D, Hans D, Panda S, Rodondi N, Naef F, Collet TH. The Effects of Time-Restricted Eating versus Standard Dietary Advice on Weight, Metabolic Health and the Consumption of Processed Food: A Pragmatic Randomised Controlled Trial in Community-Based Adults. Nutrients. 2021 Mar 23;13(3):1042. doi: 10.3390/nu13031042.</citation>
    <PMID>33807102</PMID>
  </results_reference>
  <results_reference>
    <citation>Borloz S, Bucher Della Torre S, Collet TH, Jotterand Chaparro C. Consumption of Ultraprocessed Foods in a Sample of Adolescents With Obesity and Its Association With the Food Educational Style of Their Parent: Observational Study. JMIR Pediatr Parent. 2021 Nov 15;4(4):e28608. doi: 10.2196/28608.</citation>
    <PMID>34779776</PMID>
  </results_reference>
  <results_reference>
    <citation>Papageorgiou M, Biver E, Mareschal J, Phillips NE, Hemmer A, Biolley E, Schwab N, Manoogian ENC, Gonzalez Rodriguez E, Aeberli D, Hans D, Pot C, Panda S, Rodondi N, Ferrari SL, Collet TH. The effects of time-restricted eating and weight loss on bone metabolism and health: a 6-month randomized controlled trial. Obesity (Silver Spring). 2023 Feb;31 Suppl 1(Suppl 1):85-95. doi: 10.1002/oby.23577. Epub 2022 Oct 14.</citation>
    <PMID>36239695</PMID>
  </results_reference>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>April 2, 2017</study_first_submitted>
  <study_first_submitted_qc>August 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <last_update_submitted>October 20, 2022</last_update_submitted>
  <last_update_submitted_qc>October 20, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 24, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Lausanne Hospitals</investigator_affiliation>
    <investigator_full_name>Tinh-Hai Collet, MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Time Restricted Feeding</keyword>
  <keyword>Eating patterns</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fatty Liver</mesh_term>
    <mesh_term>Metabolic Syndrome</mesh_term>
    <mesh_term>Dyslipidemias</mesh_term>
    <mesh_term>Glucose Intolerance</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Anonymized dataset of selected variables that underlie results in a publication. Some data may not be amenable to complete anonymization and will not be shared to ensure appropriate confidentiality of participant's data.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>Starting 6 months after publication</ipd_time_frame>
    <ipd_access_criteria>Upon appropriate data request by other scientists</ipd_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03241121
org study id: 2017-00487
secondary id: PZ00P3-167826
secondary id: SSED-YI 2017
nct id: NCT03241121
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
SwissChronoFood - Study of eating patterns with a smartphone app and the metabolic effects of
      time restricted feeding in metabolic syndrome

      The purpose of this study is to assess eating patterns among teenagers and adults with a new
      method, going beyond the pen-and-paper food diaries, and to investigate whether time
      restricted feeding leads to weight loss, improvement in lipid and glucose metabolism in
      individuals with components of the metabolic syndrome
The prevalence of the metabolic syndrome (MS) is increasing worldwide, due to the progression
      of its different components (central obesity, elevated blood pressure, impaired glucose
      tolerance and dyslipidemia), as well as the often associated liver steatosis. One way to
      tackle the obesity epidemic is to intervene early at the onset in childhood and teenage years
      - before cardio-metabolic complications have occurred. However, lifestyle programs targeting
      this age group had limited success in the current obesogenic environment. In particular,
      weight loss is a key factor in controlling all MS components, yet it is difficult to maintain
      over time.

      Time restricted feeding (TRF) is an approach that emphasizes energy intake limited to certain
      windows of time within the 24-hour cycle without restrictions on calories or macronutrients.
      This has emerged as an appealing approach to reduce body weight while improving lipid profile
      and glucose metabolism. However, TRF has been mostly studied in animals and long-term
      prospective data on its efficacy and mechanisms in humans is lacking.

      Prior to the intervention, the investigators will assess the eating patterns of participants
      with an innovative smartphone application ('app') which is less intrusive and more reliable
      than food diaries/questionnaires to assess eating behavior and patterns.

      In this project, the investigators will assess eating patterns among teenagers and adults,
      and investigate whether a controlled TRF intervention leads to beneficial changes in MS
      components. Study Part 1 uses an epidemiological approach to establish baseline daily eating
      behavior, physical activity patterns and sleeping habits over 2 weeks (teenagers) and 4 weeks
      (adults) using the smartphone app. Those individuals meeting criteria for at least one
      component of MS and who have eaten for >14 hours per 24-hour cycle will be recruited for
      Study Part 2. In Part 2, participants will be assigned to TRF or active control groups, and
      followed in this pragmatic randomized controlled trial for 6 weeks (teenagers) and 6 months
      (adults) to assess the change in their weight and MS components, as well as liver fat
      deposits. Study Part 3 will investigate the underlying mechanisms of improved metabolic
      profile with TRF.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Study Part 1: Prospective longitudinal observational study. Study Part 2/3: Open-label randomized controlled trial.
primary purpose: Treatment
masking: None (Open Label)
measure: Eating duration
time frame: From baseline visit to end of observation phase (Part 1: 4 weeks for adults, 2 weeks for teenagers)
description: Duration from the first to last caloric intake over 24-hour cycle, collected via the smartphone app.
Note: Key inclusion criterion for the intervention phase (Part 2).
measure: Change of metabolic syndrome components
time frame: From baseline visit to close-out visit (Part 1: 4 weeks for adults, 2 weeks for teenagers; followed by Part 2: 6 months for adults, 6 weeks for teenagers)
description: Number of participants with changes in weight and/or lipid profile and/or glucose metabolism in the intervention phase (Part 2).
Note: Changes of the different components will be analyzed separately as secondary outcomes.
measure: Adherence to TRF intervention
time frame: From randomization visit to close-out visit (Part 2: 6 months for adults, 6 weeks for teenagers)
description: After allocation to the TRF arm, assessment of the adherence to the intervention, as measured by eating duration from the first to last caloric intake over 24-hour cycle.
measure: Weight change
time frame: From baseline visit to close-out visit (Part 1: 4 weeks for adults, 2 weeks for teenagers; followed by Part 2: 6 months for adults, 6 weeks for teenagers)
description: Part of the composite primary outcome in the intervention phase (Part 2)
measure: Change in lipid profile
time frame: From baseline visit to close-out visit (Part 1: 4 weeks for adults, 2 weeks for teenagers; followed by Part 2: 6 months for adults, 6 weeks for teenagers)
description: Part of the composite primary outcome in the intervention phase (Part 2)
measure: Change in glucose metabolism
time frame: From baseline visit to close-out visit (Part 1: 4 weeks for adults, 2 weeks for teenagers; followed by Part 2: 6 months for adults, 6 weeks for teenagers)
description: Part of the composite primary outcome in the intervention phase (Part 2)
measure: Change in blood pressure
time frame: From baseline visit to close-out visit (Part 1: 4 weeks for adults, 2 weeks for teenagers; followed by Part 2: 6 months for adults, 6 weeks for teenagers)
description: Systolic and diastolic blood pressure
measure: Change in hepatic steatosis / fibrosis score
time frame: From randomization visit to close-out visit (Part 2: 6 months for adults, 6 weeks for teenagers)
description: As measured by the Fibroscan device
measure: Change in number of meals per day
time frame: From baseline visit to close-out visit (Part 1: 4 weeks for adults, 2 weeks for teenagers; followed by Part 2: 6 months for adults, 6 weeks for teenagers)
description: Temporal analysis of caloric intake events collected by the smartphone app
measure: Change in meal intervals
time frame: From baseline visit to close-out visit (Part 1: 4 weeks for adults, 2 weeks for teenagers; followed by Part 2: 6 months for adults, 6 weeks for teenagers)
description: Temporal analysis of caloric intake events collected by the smartphone app
measure: Change in fraction of calories consumed after noon
time frame: From baseline visit to close-out visit (Part 1: 4 weeks for adults, 2 weeks for teenagers; followed by Part 2: 6 months for adults, 6 weeks for teenagers)
description: Estimation of caloric content from food pictures collected by the smartphone app
measure: Change in fraction of calories consumed after 6pm
time frame: From baseline visit to close-out visit (Part 1: 4 weeks for adults, 2 weeks for teenagers; followed by Part 2: 6 months for adults, 6 weeks for teenagers)
description: Estimation of caloric content from food pictures collected by the smartphone app
measure: Change in eating pattern difference between weekdays and weekends
time frame: From baseline visit to close-out visit (Part 1: 4 weeks for adults, 2 weeks for teenagers; followed by Part 2: 6 months for adults, 6 weeks for teenagers)
description: Indirect assessment of different lifestyle habits during weekdays and weekends
measure: Change in fat mass
time frame: From randomization visit to close-out visit (Part 3: 6 months, only adults)
description: Body composition as measured by dual energy X-ray absorptiometry (DEXA)
measure: Change in fat free mass
time frame: From randomization visit to close-out visit (Part 3: 6 months, only adults)
description: Body composition as measured by dual energy X-ray absorptiometry (DEXA)
measure: Change in diurnal rhythms of cortisol secretion
time frame: From randomization visit to close-out visit (Part 3: 6 months, only adults)
description: Repeated measurements of cortisol over a 24-hour cycle
measure: Change in diurnal rhythms of melatonin secretion
time frame: From randomization visit to close-out visit (Part 3: 6 months, only adults)
description: Repeated measurements of melatonin over a 24-hour cycle
measure: Change in physical activity
time frame: From randomization visit to close-out visit (Part 3: 6 months, only adults)
description: As measured by actigraphy
measure: Change in sleep/wake cycles
time frame: From randomization visit to close-out visit (Part 3: 6 months, only adults)
description: As measured by actigraphy
measure: Eating duration - alternative definition of the primary outcome
time frame: From baseline visit to end of observation phase (Part 1: 4 weeks for adults, 2 weeks for teenagers)
description: Alternative definition of eating duration accounting for 2.5-97.5th percentiles of caloric intake over 24 hours, presumably less sensitive to the occasionally forgotten food picture event
arm group label: Time restricted feeding
arm group type: Experimental
description: For those in the intervention phase (Part 2)
arm group label: Regular dietary advices
arm group type: Active Comparator
description: For those in the intervention phase (Part 2)
intervention type: Behavioral
intervention name: Time restricted feeding
description: To eat only during a self-selected window of 12 hours, with no advice on nutrition quality, quantity or caloric intake
arm group label: Time restricted feeding
intervention type: Behavioral
intervention name: Regular dietary advices
description: Regular dietary advices by a trained dietitian or research nurse according to current nutrition guidelines
arm group label: Regular dietary advices
intervention type: Device
intervention name: Eating patterns
description: Data collection on eating patterns via the smartphone app
arm group label: Regular dietary advices
arm group label: Time restricted feeding
criteria: 
gender: All
minimum age: 12 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Tinh-Hai Collet, MD
role: Principal Investigator
affiliation: University of Lausanne Hospitals
facility: 
facility: 
country: Switzerland
url: http://www.swisschronofood.ch
description: Study website
citation: Phillips NE, Mareschal J, Schwab N, Manoogian ENC, Borloz S, Ostinelli G, Gauthier-Jaques A, Umwali S, Gonzalez Rodriguez E, Aeberli D, Hans D, Panda S, Rodondi N, Naef F, Collet TH. The Effects of Time-Restricted Eating versus Standard Dietary Advice on Weight, Metabolic Health and the Consumption of Processed Food: A Pragmatic Randomised Controlled Trial in Community-Based Adults. Nutrients. 2021 Mar 23;13(3):1042. doi: 10.3390/nu13031042.
PMID: 33807102
citation: Borloz S, Bucher Della Torre S, Collet TH, Jotterand Chaparro C. Consumption of Ultraprocessed Foods in a Sample of Adolescents With Obesity and Its Association With the Food Educational Style of Their Parent: Observational Study. JMIR Pediatr Parent. 2021 Nov 15;4(4):e28608. doi: 10.2196/28608.
PMID: 34779776
citation: Papageorgiou M, Biver E, Mareschal J, Phillips NE, Hemmer A, Biolley E, Schwab N, Manoogian ENC, Gonzalez Rodriguez E, Aeberli D, Hans D, Pot C, Panda S, Rodondi N, Ferrari SL, Collet TH. The effects of time-restricted eating and weight loss on bone metabolism and health: a 6-month randomized controlled trial. Obesity (Silver Spring). 2023 Feb;31 Suppl 1(Suppl 1):85-95. doi: 10.1002/oby.23577. Epub 2022 Oct 14.
PMID: 36239695
responsible party type: Principal Investigator
investigator affiliation: University of Lausanne Hospitals
investigator full name: Tinh-Hai Collet, MD
investigator title: Principal Investigator
mesh term: Fatty Liver
mesh term: Metabolic Syndrome
mesh term: Dyslipidemias
mesh term: Glucose Intolerance
mesh term: Syndrome
sharing ipd: Yes
ipd description: Anonymized dataset of selected variables that underlie results in a publication. Some data may not be amenable to complete anonymization and will not be shared to ensure appropriate confidentiality of participant's data.
ipd info type: Study Protocol
ipd time frame: Starting 6 months after publication
ipd access criteria: Upon appropriate data request by other scientists