xml: <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/NCT06022887</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY2023-0498</org_study_id>
      <nct_id>NCT06022887</nct_id>
    </id_info>
    <brief_title>Time-Restricted Eating and Mindfulness-Based Stress Reduction to Reduce the Risk of Early-Onset Colorectal Cancer</brief_title>
    <acronym>MBSR&amp;TRE</acronym>
    <official_title>Feasibility and Acceptability of a Remote Time-Restricted Eating and Mindfulness-Based Stress Reduction Intervention to Reduce Risk Factors Associated With Early-Onset Colorectal Cancer Development Among Young Adults</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Lisa Tussing-Humphreys</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of Illinois at Chicago</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Illinois at Chicago</source>
    <oversight_info>
      <has_dmc>Yes</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>
        The goal of this clinical trial is to evaluate the feasibility of remote time-restricted&#xD;
        eating (TRE) and mindfulness-based stress reduction (MBSR) interventions and the preliminary&#xD;
        effect on EOCRC-related markers. The main question[s] it aims to answer are:&#xD;
  &#xD;
          -  Is it feasible and acceptable to conduct 8-week remote interventions of TRE, MBSR, and&#xD;
             combined TRE+MBSR among young adults with excess adiposity and moderate-to-severe&#xD;
             perceived stress?&#xD;
  &#xD;
          -  Will participants in the combined group lose more body weight and reduce their stress&#xD;
             levels than those in the remaining groups?&#xD;
  &#xD;
          -  Will participants in the combined group experience better body composition changes and&#xD;
             improve their cardiometabolic health compared to those in the remaining groups?&#xD;
  &#xD;
          -  Will participants in the combined group exhibit changes in the microbiome compared to&#xD;
             those in the remaining groups?&#xD;
  &#xD;
        Participants will:&#xD;
  &#xD;
          -  Complete 8 weeks of a TRE intervention&#xD;
  &#xD;
          -  Complete 8 weeks of a remote MBSR intervention&#xD;
  &#xD;
        Researchers will compare 1. TRE alone; 2. MBSR alone; 3. TRE + MBSR; and 4. Control to see if&#xD;
        the study is feasible and acceptable; to see if individuals lose body weight; to see if&#xD;
        individual stress levels reduce; to see changes in the microbiome.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Early onset colorectal cancer (EOCRC) is defined as a diagnosis of colorectal cancer (CRC) in&#xD;
        patients younger than 50 years old. The American Cancer Society reported that 12% of all CRC&#xD;
        diagnoses as occurring in individuals younger than 50 years old. Worldwide, a steady increase&#xD;
        in EOCRC cases is observed among Westernized countries, which suggests that similar risk&#xD;
        factors and exposures within these developed countries are contributors to EOCRC. In&#xD;
        particular, increased adiposity from an early age that persists through adulthood and chronic&#xD;
        psychosocial stress are under investigation as drivers of the recent uptick in EOCRC in the&#xD;
        United States (US) and other Westernized countries. Obesity in early adulthood is strongly&#xD;
        associated with increased risk of EOCRC; in the US, obesity affects 42% of adults. In&#xD;
        addition, obesity is associated with metabolic, hormonal, and immune perturbations that can&#xD;
        promote gene mutations that drive EOCRC tumorigenesis. Chronic stress can negatively impact&#xD;
        several different systems of the human body including the sympathetic nervous system&#xD;
        (SNS)-related catecholamines, epinephrine and norepinephrine, and&#xD;
        hypothalamic-pituitary-adrenal (HPA)-axis related hormones including adrenocorticotropic&#xD;
        hormone and the glucocorticoid, cortisol. Due to the broad impact that exposure to chronic&#xD;
        stress has in the human body, chronic stress has been linked to several diseases, including&#xD;
        cancer. The gut and the brain are connected through a bidirectional system coined the&#xD;
        gut-microbiota-brain axis (GMBA). Chronic stress can disrupt the SNS, HPA-axis and immune&#xD;
        system, leading to a shift in gut microbial ecology and metabolic function that tips the&#xD;
        balance to a more pro-inflammatory colonic state conducive to the formation of EOCRC. This&#xD;
        study will examine if mitigating chronic stress and weight loss can modify EOCRC risk in&#xD;
        young adults at risk of EOCRC. Accumulating evidence suggests that time-restricted eating&#xD;
        (TRE), a type of intermittent fasting, produces a ~300-500 kcal/d energy deficit by limiting&#xD;
        an individual's daily eating window to 4-8 hours each day. Mindfulness meditation is the&#xD;
        practice of cultivating a moment-to-moment awareness of internal and external experience in&#xD;
        an accepting and open manner. In 1990, Kabat-Zinn developed Mindfulness Based Stress&#xD;
        Reduction (MBSR): an intervention with a goal of reducing stress, pain, and suffering. MBSR&#xD;
        is associated with lower perceived stress and decreased circulating cortisol concentrations.&#xD;
        Existing evidence suggests that MBSR also yields EOCRC preventive effects specific to body&#xD;
        weight reduction, increase of insulin sensitivity and reduction of inflammation. We propose&#xD;
        to conduct an 8-week 4-arm randomized-controlled study of 1. TRE alone; 2. MBSR alone; 3. TRE&#xD;
        + MBSR; and 4. Control among 40 young adults with obesity (BMI ≥ 30 kg/m2) and moderate to&#xD;
        severe perceived stress (Perceived Stress Score ≥14) to evaluate the feasibility of the&#xD;
        interventions and preliminary effect on EOCRC-related markers. Data generated from this&#xD;
        preliminary trial would serve in developing a fully powered efficacy trial testing TRE+MBSR&#xD;
        for EOCRC prevention among young adults in the Chicagoland area.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">May 2024</completion_date>
    <primary_completion_date type="Anticipated">May 2024</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>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Feasibility of the study</measure>
      <time_frame>Baseline; through study completion, an average of 9 weeks</time_frame>
      <description>the number of people interested in the study, those who pass phone and in-person screenings, and those who decline enrollment and their reasons. Once enrolled, we will closely monitor attendance, data completeness, session attendance, asynchronous intervention usage, and loss to follow-up/withdrawal. To monitor participant progress, we will update the CONSORT participant flow diagram every week. Participants who withdraw voluntarily will be asked for their reasons.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Acceptability of the study</measure>
      <time_frame>Week 4 of the intervention; through study completion, an average of 9 weeks</time_frame>
      <description>Participants will complete the acceptability of intervention measure (scores range from 4-20 points with higher scores reflecting higher acceptability).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Hair cortisol</measure>
      <time_frame>Baseline; through study completion, an average of 9 weeks</time_frame>
      <description>Objective stress markers will be measured via hair cortisol</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Serum adrenocorticotropic hormone (ACTH)</measure>
      <time_frame>Baseline; through study completion, an average of 9 weeks</time_frame>
      <description>Objective stress markers will be measured via serum ACTH.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Serum cortisol</measure>
      <time_frame>Baseline; through study completion, an average of 9 weeks</time_frame>
      <description>Objective stress markers will be measured via serum cortisol.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Serum norepinephrine</measure>
      <time_frame>Baseline; through study completion, an average of 9 weeks</time_frame>
      <description>Objective stress markers will be measured via serum norepinephrine</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Perceived Stress Scale.</measure>
      <time_frame>Screening; through study completion, an average of 9 weeks</time_frame>
      <description>The Perceived Stress Scale queries participants' perceptions of feeling stress during the last month. Responses were on a 5-point scale from &quot;never&quot; to &quot;very often.&quot; Scores will be summed to indicate current stress levels, with higher scores suggesting greater perceived stress (≥ 14 indicates moderate to high perceived stress).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Body fat mass</measure>
      <time_frame>Baseline; through study completion, an average of 9 weeks</time_frame>
      <description>Body fat mass will be measured via whole body dual energy x-ray absorptiometry (DEXA) scan.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Body lean mass</measure>
      <time_frame>Baseline; through study completion, an average of 9 weeks</time_frame>
      <description>Body lean mass will be measured via whole body dual energy x-ray absorptiometry (DEXA) scan.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Body bone density</measure>
      <time_frame>Baseline; through study completion, an average of 9 weeks</time_frame>
      <description>Body bone density will be measured via whole body dual energy x-ray absorptiometry (DEXA) scan.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Triglycerides</measure>
      <time_frame>Baseline; through study completion, an average of 9 weeks</time_frame>
      <description>Will be measured from plasma by a commercial lab.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>High sensitivity C-reactive protein.</measure>
      <time_frame>Baseline; through study completion, an average of 9 weeks</time_frame>
      <description>Will be measured from plasma by a commercial lab.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>homeostasis model assessment-insulin resistance (HOMA-IR)</measure>
      <time_frame>Baseline; through study completion, an average of 9 weeks</time_frame>
      <description>calculated from fasting glucose and insulin using a standard formula.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Microbial Deoxyribonucleic acid (DNA) isolation: 16S on V4 region</measure>
      <time_frame>Baseline; through study completion, an average of 9 weeks</time_frame>
      <description>performed on stool using Microbial DNA isolation</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">48</enrollment>
    <condition>Obesity</condition>
    <condition>Colorectal Cancer</condition>
    <condition>Microbial Colonization</condition>
    <condition>Time Restricted Feeding</condition>
    <condition>Stress, Psychological</condition>
    <arm_group>
      <arm_group_label>TRE alone</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will be instructed to eat ad libitum from noon - 8:00pm daily and fast from 8:00pm - noon (16-h fast) for 8 weeks. During the 8-h eating window, there will be no restrictions on types or quantities of foods consumed. Participants will meet with a registered dietitian (RD) for 30 minutes at the start of the intervention to review instructions and goals and weekly thereafter. Adherence to the TRE intervention will be assessed as the number of adherent days per week.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>MBSR alone</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants in this study will be granted access to a remote mindfulness-based stress reductions (MBSR) protocol. Participants will have access to the MBSR course, consisting of 30 audio lessons, each ranging from 9 to 14 minutes long. During the study, participants will be asked to complete four lessons per week during weeks 1-7 and two lessons during week 8.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>TRE + MBSR</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>This group will follow a combined protocol of the TRE and MBSR interventions as described above.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>The control group will not receive any of the interventions previously described. To maintain a relationship with each participant in the control group, we will contact them once a week via text message to engage them to finalize the intervention period. At the end of the intervention period and after all data is collected, the RD will meet with the participant for 30 minutes and will educate them regarding the TRE protocol and provide access to the MBSR web-based program.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>TRE</intervention_name>
      <description>daily ad libitum food intake, 8-h 12pm - 8pm, 8 wks active weight loss phase;</description>
      <arm_group_label>TRE + MBSR</arm_group_label>
      <arm_group_label>TRE alone</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>MBSR</intervention_name>
      <description>Completed 30 sessions of a Mindfulness-Based Stress Reduction (MBSR) interventions for 8 weeks</description>
      <arm_group_label>MBSR alone</arm_group_label>
      <arm_group_label>TRE + MBSR</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. 18-39 years old.&#xD;
  &#xD;
            2. BMI 30-49.99 kg/m2.&#xD;
  &#xD;
            3. Own and use a smartphone, computer, or tablet with access to the Internet.&#xD;
  &#xD;
            4. Score ≥ 14 on the Perceived Stress Score (PSS) at screening.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Have a personal or family history of EOCRC.&#xD;
  &#xD;
            2. Have taken antibiotics in the previous 2 months.&#xD;
  &#xD;
            3. Have an inflammatory bowel disease or genetic predisposition to EOCRC or CRC (e.g.,&#xD;
               Lynch syndrome);.&#xD;
  &#xD;
            4. Any cancer diagnosis or cancer treatment in the past 12 months.&#xD;
  &#xD;
            5. Consume &gt;50 grams ethanol daily (approximately 4-5, 12 ounces beers).&#xD;
  &#xD;
            6. Use combustible tobacco.&#xD;
  &#xD;
            7. Have history of bariatric surgery or bowel resection.&#xD;
  &#xD;
            8. Have an active infection.&#xD;
  &#xD;
            9. Have type 1 or type 2 diabetes, immunodeficiency/autoimmune disorder, or inflammatory&#xD;
               bowel disease.&#xD;
  &#xD;
           10. Use fiber or pre-/probiotic supplements &gt;3 days per week.&#xD;
  &#xD;
           11. Currently taking corticosteroids medication - inhaled, topical, or oral in the past 2&#xD;
               months (affects cortisol measures).&#xD;
  &#xD;
           12. Are on a weight-loss diet or involved in a formal weight-loss program or are not&#xD;
               weight stable for 3 months (+/- 4.5 kg) prior to the study.&#xD;
  &#xD;
           13. Females who are pregnant/trying to become pregnant.&#xD;
  &#xD;
           14. Have schizophrenia (medication can affect study outcomes).&#xD;
  &#xD;
           15. Have an eating window of &lt;10 hours/day or are currently following an intermittent&#xD;
               fasting pattern.&#xD;
  &#xD;
           16. Night shift workers (shift passes midnight).&#xD;
  &#xD;
           17. Present a history of eating disorder.&#xD;
  &#xD;
           18. Currently taking weight loss medication.&#xD;
  &#xD;
           19. Illegal drug use in the past month (not marijuana).&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>39 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Manoela Lima Oliveira, MS, RD, LDN</last_name>
      <role>Principal Investigator</role>
      <affiliation>PhD Candidate</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Lisa M Tussing-Humphreys, PHD, RD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Associate Professor, Kinesiology and Nutrition</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Manoela Lima Oliveira, MS, RD, LDN</last_name>
      <phone>6189775345</phone>
      <email>mlimao2@uic.edu</email>
    </overall_contact>
    <link>
      <url>https://redcap.link/mbsrandtre</url>
      <description>If you are interested in this research, please answer some eligibility questions in the survey linked here.</description>
    </link>
    <reference>
      <citation>Sinicrope FA. Increasing Incidence of Early-Onset Colorectal Cancer. N Engl J Med. 2022 Apr 21;386(16):1547-1558. doi: 10.1056/NEJMra2200869. No abstract available.</citation>
      <PMID>35443109</PMID>
    </reference>
    <reference>
      <citation>Doubeni CA, Major JM, Laiyemo AO, Schootman M, Zauber AG, Hollenbeck AR, Sinha R, Allison J. Contribution of behavioral risk factors and obesity to socioeconomic differences in colorectal cancer incidence. J Natl Cancer Inst. 2012 Sep 19;104(18):1353-62. doi: 10.1093/jnci/djs346. Epub 2012 Sep 5.</citation>
      <PMID>22952311</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 23, 2023</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>University of Illinois at Chicago</investigator_affiliation>
      <investigator_full_name>Lisa Tussing-Humphreys</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>obesity; Time Restricted Feeding; microbiome; chronic stress</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Communicable Diseases</mesh_term>
      <mesh_term>Infections</mesh_term>
      <mesh_term>Colorectal Neoplasms</mesh_term>
      <mesh_term>Stress, Psychological</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06022887
  org study id: STUDY2023-0498
  nct id: NCT06022887
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to evaluate the feasibility of remote time-restricted
        eating (TRE) and mindfulness-based stress reduction (MBSR) interventions and the preliminary
        effect on EOCRC-related markers. The main question[s] it aims to answer are:
  
          -  Is it feasible and acceptable to conduct 8-week remote interventions of TRE, MBSR, and
             combined TRE+MBSR among young adults with excess adiposity and moderate-to-severe
             perceived stress?
  
          -  Will participants in the combined group lose more body weight and reduce their stress
             levels than those in the remaining groups?
  
          -  Will participants in the combined group experience better body composition changes and
             improve their cardiometabolic health compared to those in the remaining groups?
  
          -  Will participants in the combined group exhibit changes in the microbiome compared to
             those in the remaining groups?
  
        Participants will:
  
          -  Complete 8 weeks of a TRE intervention
  
          -  Complete 8 weeks of a remote MBSR intervention
  
        Researchers will compare 1. TRE alone; 2. MBSR alone; 3. TRE + MBSR; and 4. Control to see if
        the study is feasible and acceptable; to see if individuals lose body weight; to see if
        individual stress levels reduce; to see changes in the microbiome.
  Early onset colorectal cancer (EOCRC) is defined as a diagnosis of colorectal cancer (CRC) in
        patients younger than 50 years old. The American Cancer Society reported that 12% of all CRC
        diagnoses as occurring in individuals younger than 50 years old. Worldwide, a steady increase
        in EOCRC cases is observed among Westernized countries, which suggests that similar risk
        factors and exposures within these developed countries are contributors to EOCRC. In
        particular, increased adiposity from an early age that persists through adulthood and chronic
        psychosocial stress are under investigation as drivers of the recent uptick in EOCRC in the
        United States (US) and other Westernized countries. Obesity in early adulthood is strongly
        associated with increased risk of EOCRC; in the US, obesity affects 42% of adults. In
        addition, obesity is associated with metabolic, hormonal, and immune perturbations that can
        promote gene mutations that drive EOCRC tumorigenesis. Chronic stress can negatively impact
        several different systems of the human body including the sympathetic nervous system
        (SNS)-related catecholamines, epinephrine and norepinephrine, and
        hypothalamic-pituitary-adrenal (HPA)-axis related hormones including adrenocorticotropic
        hormone and the glucocorticoid, cortisol. Due to the broad impact that exposure to chronic
        stress has in the human body, chronic stress has been linked to several diseases, including
        cancer. The gut and the brain are connected through a bidirectional system coined the
        gut-microbiota-brain axis (GMBA). Chronic stress can disrupt the SNS, HPA-axis and immune
        system, leading to a shift in gut microbial ecology and metabolic function that tips the
        balance to a more pro-inflammatory colonic state conducive to the formation of EOCRC. This
        study will examine if mitigating chronic stress and weight loss can modify EOCRC risk in
        young adults at risk of EOCRC. Accumulating evidence suggests that time-restricted eating
        (TRE), a type of intermittent fasting, produces a ~300-500 kcal/d energy deficit by limiting
        an individual's daily eating window to 4-8 hours each day. Mindfulness meditation is the
        practice of cultivating a moment-to-moment awareness of internal and external experience in
        an accepting and open manner. In 1990, Kabat-Zinn developed Mindfulness Based Stress
        Reduction (MBSR): an intervention with a goal of reducing stress, pain, and suffering. MBSR
        is associated with lower perceived stress and decreased circulating cortisol concentrations.
        Existing evidence suggests that MBSR also yields EOCRC preventive effects specific to body
        weight reduction, increase of insulin sensitivity and reduction of inflammation. We propose
        to conduct an 8-week 4-arm randomized-controlled study of 1. TRE alone; 2. MBSR alone; 3. TRE
        + MBSR; and 4. Control among 40 young adults with obesity (BMI ≥ 30 kg/m2) and moderate to
        severe perceived stress (Perceived Stress Score ≥14) to evaluate the feasibility of the
        interventions and preliminary effect on EOCRC-related markers. Data generated from this
        preliminary trial would serve in developing a fully powered efficacy trial testing TRE+MBSR
        for EOCRC prevention among young adults in the Chicagoland area.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Feasibility of the study
  time frame: Baseline; through study completion, an average of 9 weeks
  description: the number of people interested in the study, those who pass phone and in-person screenings, and those who decline enrollment and their reasons. Once enrolled, we will closely monitor attendance, data completeness, session attendance, asynchronous intervention usage, and loss to follow-up/withdrawal. To monitor participant progress, we will update the CONSORT participant flow diagram every week. Participants who withdraw voluntarily will be asked for their reasons.
  measure: Acceptability of the study
  time frame: Week 4 of the intervention; through study completion, an average of 9 weeks
  description: Participants will complete the acceptability of intervention measure (scores range from 4-20 points with higher scores reflecting higher acceptability).
  measure: Hair cortisol
  time frame: Baseline; through study completion, an average of 9 weeks
  description: Objective stress markers will be measured via hair cortisol
  measure: Serum adrenocorticotropic hormone (ACTH)
  time frame: Baseline; through study completion, an average of 9 weeks
  description: Objective stress markers will be measured via serum ACTH.
  measure: Serum cortisol
  time frame: Baseline; through study completion, an average of 9 weeks
  description: Objective stress markers will be measured via serum cortisol.
  measure: Serum norepinephrine
  time frame: Baseline; through study completion, an average of 9 weeks
  description: Objective stress markers will be measured via serum norepinephrine
  measure: Perceived Stress Scale.
  time frame: Screening; through study completion, an average of 9 weeks
  description: The Perceived Stress Scale queries participants' perceptions of feeling stress during the last month. Responses were on a 5-point scale from "never" to "very often." Scores will be summed to indicate current stress levels, with higher scores suggesting greater perceived stress (≥ 14 indicates moderate to high perceived stress).
  measure: Body fat mass
  time frame: Baseline; through study completion, an average of 9 weeks
  description: Body fat mass will be measured via whole body dual energy x-ray absorptiometry (DEXA) scan.
  measure: Body lean mass
  time frame: Baseline; through study completion, an average of 9 weeks
  description: Body lean mass will be measured via whole body dual energy x-ray absorptiometry (DEXA) scan.
  measure: Body bone density
  time frame: Baseline; through study completion, an average of 9 weeks
  description: Body bone density will be measured via whole body dual energy x-ray absorptiometry (DEXA) scan.
  measure: Triglycerides
  time frame: Baseline; through study completion, an average of 9 weeks
  description: Will be measured from plasma by a commercial lab.
  measure: High sensitivity C-reactive protein.
  time frame: Baseline; through study completion, an average of 9 weeks
  description: Will be measured from plasma by a commercial lab.
  measure: homeostasis model assessment-insulin resistance (HOMA-IR)
  time frame: Baseline; through study completion, an average of 9 weeks
  description: calculated from fasting glucose and insulin using a standard formula.
  measure: Microbial Deoxyribonucleic acid (DNA) isolation: 16S on V4 region
  time frame: Baseline; through study completion, an average of 9 weeks
  description: performed on stool using Microbial DNA isolation
  arm group label: TRE alone
  arm group type: Experimental
  description: Participants will be instructed to eat ad libitum from noon - 8:00pm daily and fast from 8:00pm - noon (16-h fast) for 8 weeks. During the 8-h eating window, there will be no restrictions on types or quantities of foods consumed. Participants will meet with a registered dietitian (RD) for 30 minutes at the start of the intervention to review instructions and goals and weekly thereafter. Adherence to the TRE intervention will be assessed as the number of adherent days per week.
  arm group label: MBSR alone
  arm group type: Experimental
  description: Participants in this study will be granted access to a remote mindfulness-based stress reductions (MBSR) protocol. Participants will have access to the MBSR course, consisting of 30 audio lessons, each ranging from 9 to 14 minutes long. During the study, participants will be asked to complete four lessons per week during weeks 1-7 and two lessons during week 8.
  arm group label: TRE + MBSR
  arm group type: Experimental
  description: This group will follow a combined protocol of the TRE and MBSR interventions as described above.
  arm group label: Control
  arm group type: No Intervention
  description: The control group will not receive any of the interventions previously described. To maintain a relationship with each participant in the control group, we will contact them once a week via text message to engage them to finalize the intervention period. At the end of the intervention period and after all data is collected, the RD will meet with the participant for 30 minutes and will educate them regarding the TRE protocol and provide access to the MBSR web-based program.
  intervention type: Behavioral
  intervention name: TRE
  description: daily ad libitum food intake, 8-h 12pm - 8pm, 8 wks active weight loss phase;
  arm group label: TRE + MBSR
  arm group label: TRE alone
  intervention type: Behavioral
  intervention name: MBSR
  description: Completed 30 sessions of a Mindfulness-Based Stress Reduction (MBSR) interventions for 8 weeks
  arm group label: MBSR alone
  arm group label: TRE + MBSR
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 39 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Manoela Lima Oliveira, MS, RD, LDN
  role: Principal Investigator
  affiliation: PhD Candidate
  last name: Lisa M Tussing-Humphreys, PHD, RD
  role: Principal Investigator
  affiliation: Associate Professor, Kinesiology and Nutrition
  last name: Manoela Lima Oliveira, MS, RD, LDN
  phone: 6189775345
  email: mlimao2@uic.edu
  url: https://redcap.link/mbsrandtre
  description: If you are interested in this research, please answer some eligibility questions in the survey linked here.
  citation: Sinicrope FA. Increasing Incidence of Early-Onset Colorectal Cancer. N Engl J Med. 2022 Apr 21;386(16):1547-1558. doi: 10.1056/NEJMra2200869. No abstract available.
  PMID: 35443109
  citation: Doubeni CA, Major JM, Laiyemo AO, Schootman M, Zauber AG, Hollenbeck AR, Sinha R, Allison J. Contribution of behavioral risk factors and obesity to socioeconomic differences in colorectal cancer incidence. J Natl Cancer Inst. 2012 Sep 19;104(18):1353-62. doi: 10.1093/jnci/djs346. Epub 2012 Sep 5.
  PMID: 22952311
  responsible party type: Sponsor-Investigator
  investigator affiliation: University of Illinois at Chicago
  investigator full name: Lisa Tussing-Humphreys
  investigator title: Professor
  mesh term: Communicable Diseases
  mesh term: Infections
  mesh term: Colorectal Neoplasms
  mesh term: Stress, Psychological
  sharing ipd: No