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/NCT05966870</url>
    </required_header>
    <id_info>
      <org_study_id>1908757318</org_study_id>
      <secondary_id>P30DK097512</secondary_id>
      <nct_id>NCT05966870</nct_id>
    </id_info>
    <brief_title>Unsweetened Sparkling Water and Changes in Sweetness Perception in Adolescents</brief_title>
    <official_title>Reducing Added Sugar Intake on Sweetness Perception in Adolescents by Substituting Unsweetened Sparkling Water for Sugar Sweetened Beverages</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Indiana University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>Indiana University</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>
        The study design is a prospective observational study in adolescents who are at risk for&#xD;
        developing Type 2 Diabetes (T2D), to evaluate the effectiveness of sparkling water to reduce&#xD;
        dietary intake of added sugars and thereby improve glycemia. Study data on consumption and&#xD;
        the flavor profile of sparkling water will serve as a measure of acceptability. The study&#xD;
        intervention will be to provide carbonated flavored sparkling water for 12 weeks to&#xD;
        adolescents (and their families) who have a usual intake of 2 or more servings of sugar&#xD;
        sweetened beverages (SSB) per day and are at a high risk for developing type 2 diabetes.&#xD;
        Study measures will be obtained before and after the exposure to carbonated flavored&#xD;
        sparkling water and each participant will serve as his/her own control. To encourage the&#xD;
        participants to substitute the carbonated flavored sparkling water, study personnel will send&#xD;
        them weekly iMessages through the Technology Assisted Dietary Assessment (TADA) app. In&#xD;
        addition, investigators will monitor the participants' diet, using the TADA app, every two&#xD;
        weeks, for 4 days. Study measurements will be obtained at baseline, before the intervention,&#xD;
        during and at the end of the 12 week intervention.&#xD;
  &#xD;
        Objective: Determine the effect of reducing added sugars intake by substituting carbonated&#xD;
        sparkling water on T2D risk in adolescents.&#xD;
  &#xD;
        Hypothesis: Adolescents who decrease consumption of SSB by substituting sparkling water will&#xD;
        experience decreased blood glucose concentrations and increased insulin sensitivity during an&#xD;
        oral glucose tolerance test and decreased glucose excursions during continued glucose&#xD;
        monitoring, compared to those who do not decrease consumption of SSB.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Importance of studying added sugars in adolescents. Research that leads to nutritional&#xD;
        strategies to prevent T2D in adolescents is an urgent pursuit. One particular contributing&#xD;
        factor to the growth of T2D and prediabetes in adolescents is the increased consumption of&#xD;
        added sugars. Adolescents in the U.S. have high intakes of added sugars which could have poor&#xD;
        health implications. Added sugars are found in sugar sweetened beverages and desserts and&#xD;
        snacks, top sources of energy for adolescents, and calories from added sugars contribute to&#xD;
        16% of the total energy intake. Levels are well above recommendations from leading scientific&#xD;
        organizations, which suggest limiting added sugars to less than 10% of energy. However, it is&#xD;
        not clear whether sugar reduction to less than 10% of energy is palatable for an adolescent&#xD;
        population that prefers sweetened foods and beverages. Moreover, uncertainty about the&#xD;
        evidence linking added sugar consumption to risk of disease has made policies that seek to&#xD;
        reduce dietary intake of added sugar controversial. The controversy impairs large-scale&#xD;
        implementation of recommendations to reduce intake of added sugars by individuals,&#xD;
        clinicians, policy makers and industry stakeholders.&#xD;
  &#xD;
        Evidence linking added sugars and risk of type 2 diabetes and cardiovascular disease lacks&#xD;
        information on adolescents. Many epidemiological studies in adults, but not all show the&#xD;
        concept that after controlling for energy intake, high consumption of sugar-sweetened foods&#xD;
        is a risk factor for T2D. Epidemiological studies also associate high consumption of added&#xD;
        sugars, particularly from sugar sweetened beverages (SSB), with increased adiposity&#xD;
        (including central adiposity) and dyslipidemia. These studies formed the basis of&#xD;
        recommendations to limit added sugar consumption from the American Heart Organization. The&#xD;
        data in youth is limited. Two small randomized studies compared the effects of glucose versus&#xD;
        fructose beverages on insulin sensitivity in adolescents and findings were mixed. One&#xD;
        longitudinal cohort study showed that higher consumption of added sugars, from SSB, was&#xD;
        associated with hyperglycemia and impaired insulin sensitivity in youth aged 8 - 12 years.&#xD;
        One study showed that high amounts of added sugars may induce insulin resistance and&#xD;
        beta-cell dysfunction and such effects can occur independent of adiposity. The literature&#xD;
        lacks evidence linking high consumption of added sugars to risk of developing youth-onset&#xD;
        T2D.&#xD;
  &#xD;
        Substituting Flavored Sparkling Water for Sugar Sweetened Beverages. Instead of sugar, food&#xD;
        manufacturers typically sweeten foods beverages using low-calorie or artificial sweeteners.&#xD;
        &quot;Diet&quot; versions of SSB have been available for several decades and are widely used by adults&#xD;
        and children. However the safety of low calorie sweeteners is controversial and many in the&#xD;
        scientific and lay communities do not promote their use as a substitute for SSB. We propose&#xD;
        that an alternative to SSB may be found in sparkling waters (carbonated water with flavoring,&#xD;
        completely unsweetened), which are commercially available in soda-like flavors like cola or&#xD;
        Dr. Pepper™. The rationale for the current project is the urgent need for an effective&#xD;
        strategy to combat adolescent T2D which investigators will address by demonstrating the&#xD;
        benefit of an intervention to reduce added sugars. The objective of the study is to&#xD;
        demonstrate whether substituting sparkling water for SSB has benefits for in vivo&#xD;
        physiological measures of glycemia while maintaining flavor acceptability to adolescents who&#xD;
        are at risk for diabetes.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">March 9, 2020</start_date>
    <completion_date type="Actual">June 26, 2023</completion_date>
    <primary_completion_date type="Actual">December 20, 2022</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>Prospective, before and after, cohort study</intervention_model_description>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in 2 hour glucose concentration</measure>
      <time_frame>0, 12 weeks</time_frame>
      <description>Oral glucose tolerance testing; 1.75 g/kg body weight</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Dietary consumption of SSB and Sparkling water</measure>
      <time_frame>0, 2, 4, 6, 8, 10, 12 weeks</time_frame>
      <description>Using Technology Assisted Dietary Assessment (TADA) system, a mobile food record</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Insulin sensitivity</measure>
      <time_frame>0, 12 weeks</time_frame>
      <description>Whole body insulin sensitivity index (WBISI); Calculated as described by Matsuda et al., 1999. Units are 1/mg/dL*mU/ML*mg/dL*mU/ML; higher values indicate more insulin sensitivity</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Glycemic variability</measure>
      <time_frame>0, 12 weeks</time_frame>
      <description>Continuous Glucose Monitoring will be measured usingFreeStyle Libre Pro System; Abbott; Abbott Park, IL. The instrument records glucose excursions during a 24 hour period as glycemic variability.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in Flavor perception of beverage sweetness</measure>
      <time_frame>0, 12 weeks</time_frame>
      <description>Sensory testing of 6 levels of sweetness in beverages.Participants will rate the samples for their sweetness using a &quot;just about right&quot; visual analog scale, with anchors at: -100, &quot;Not sweet enough&quot;; -50, &quot;Slightly not sweet enough&quot;; 0, &quot;Just about right&quot;; +50, &quot;Slightly too sweet&quot;; and +100 &quot;Too sweet.&quot; Samples will also be rated for liking using a hedonic visual analog scale, with anchors at: -100, &quot;Worst ever&quot;; -50, &quot;Dislike&quot;; 0, &quot;Neutral&quot;; +50, &quot;Like&quot;; +100, &quot;Best ever.&quot;</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Blood Pressure</measure>
      <time_frame>0, 12 weeks</time_frame>
      <description>Systolic blood pressure in the morning with participant in the fasting condition</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Blood Triglycerides</measure>
      <time_frame>0, 12 weeks</time_frame>
      <description>Triglycerides concentrations in the morning with participant in the fasting condition.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in waist circumference</measure>
      <time_frame>0, 12 weeks</time_frame>
      <description>measured per instructions from National Health and Nutrition Examination Survay (NHANES). Anthropometry Procedures Manual</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Change in Dietary intake behaviors</measure>
      <time_frame>0, 2, 4, 6, 8, 10, 12 weeks</time_frame>
      <description>Using Technology Assisted Dietary Assessment (TADA) system, a mobile food record. Total intake of calories and added sugars will be assessed.</description>
    </other_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Actual">11</enrollment>
    <condition>Obesity, Adolescent</condition>
    <condition>PreDiabetes</condition>
    <arm_group>
      <arm_group_label>Replacement of SSB with Unsweetened Sparkling Beverage</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>To encourage participants to substitute sparkling water flavored water for SSB intake, we will provide enough supplies of the drinks to adolescents (and their families) each month. We will also provide iPhones with the TADA app to the adolescent participants. Study staff will remind participants to consume the sparkling water through iMessages sent through the TADA app.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Unsweetened flavored sparkling water</intervention_name>
      <description>Unsweetened sparkling waters are carbonated water with flavoring, completely unsweetened, which are commercially available in soda-like flavors like cola</description>
      <arm_group_label>Replacement of SSB with Unsweetened Sparkling Beverage</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Male and female adolescents (age 10-21 years)&#xD;
  &#xD;
            -  Overweight and Obese (body mass index ≥ 85 percentile for age and sex)&#xD;
  &#xD;
            -  High consumers of SSB, defined as &gt;2 or more servings per day&#xD;
  &#xD;
            -  Family history of diabetes in a first or second degree relative OR prediabetes (i.e.,&#xD;
               evidence of either impaired glucose tolerance (HbA1c 5.7 - 6.4%, or plasma glucose&#xD;
               between 140-199 mg/dL at 2 hours on oral glucose tolerance testing) or impaired&#xD;
               fasting plasma glucose (≥ 100 mg/dL))&#xD;
  &#xD;
          Exclusion Criteria:• Pregnancy&#xD;
  &#xD;
            -  Use of medications that affect glucose metabolism (such as glucocorticoid-containing&#xD;
               medications or atypical antipsychotics). We will not exclude female participants who&#xD;
               currently use, are planning to use, or planning to stop taking oral contraceptives.&#xD;
  &#xD;
            -  Syndromic obesity (such as Prader Willi, hypothalamic obesity, or Laurence-Moon-Biedl)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <gender_based>Yes</gender_based>
      <gender_description>participant eligibility is based on self-representation of gender identity</gender_description>
      <minimum_age>10 Years</minimum_age>
      <maximum_age>21 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Nana Gletsu Miller, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Indiana University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Indiana University School of Public Health</name>
        <address>
          <city>Bloomington</city>
          <state>Indiana</state>
          <zip>47405</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <reference>
      <citation>Andes LJ, Cheng YJ, Rolka DB, Gregg EW, Imperatore G. Prevalence of Prediabetes Among Adolescents and Young Adults in the United States, 2005-2016. JAMA Pediatr. 2020 Feb 1;174(2):e194498. doi: 10.1001/jamapediatrics.2019.4498. Epub 2020 Feb 3.</citation>
      <PMID>31790544</PMID>
    </reference>
    <reference>
      <citation>Banfield EC, Liu Y, Davis JS, Chang S, Frazier-Wood AC. Poor Adherence to US Dietary Guidelines for Children and Adolescents in the National Health and Nutrition Examination Survey Population. J Acad Nutr Diet. 2016 Jan;116(1):21-27. doi: 10.1016/j.jand.2015.08.010. Epub 2015 Sep 26.</citation>
      <PMID>26391469</PMID>
    </reference>
    <reference>
      <citation>Reedy J, Krebs-Smith SM. Dietary sources of energy, solid fats, and added sugars among children and adolescents in the United States. J Am Diet Assoc. 2010 Oct;110(10):1477-84. doi: 10.1016/j.jada.2010.07.010.</citation>
      <PMID>20869486</PMID>
    </reference>
    <reference>
      <citation>Bailey RL, Fulgoni VL, Cowan AE, Gaine PC. Sources of Added Sugars in Young Children, Adolescents, and Adults with Low and High Intakes of Added Sugars. Nutrients. 2018 Jan 17;10(1):102. doi: 10.3390/nu10010102.</citation>
      <PMID>29342109</PMID>
    </reference>
    <reference>
      <citation>Boushey CJ, Kerr DA, Wright J, Lutes KD, Ebert DS, Delp EJ. Use of technology in children's dietary assessment. Eur J Clin Nutr. 2009 Feb;63 Suppl 1(Suppl 1):S50-7. doi: 10.1038/ejcn.2008.65.</citation>
      <PMID>19190645</PMID>
    </reference>
    <reference>
      <citation>Running, C.A. Desensitization but not sensitization from commercial chemesthetic beverages. Food Quality and Preference 2018 Vol. 69 Pages 21-27; DOI: 10.1016/j.foodqual.2018.05.001</citation>
    </reference>
    <reference>
      <citation>Wang J, Light K, Henderson M, O'Loughlin J, Mathieu ME, Paradis G, Gray-Donald K. Consumption of added sugars from liquid but not solid sources predicts impaired glucose homeostasis and insulin resistance among youth at risk of obesity. J Nutr. 2014 Jan;144(1):81-6. doi: 10.3945/jn.113.182519. Epub 2013 Nov 6.</citation>
      <PMID>24198307</PMID>
    </reference>
    <reference>
      <citation>Matsuda M, DeFronzo RA. Insulin sensitivity indices obtained from oral glucose tolerance testing: comparison with the euglycemic insulin clamp. Diabetes Care. 1999 Sep;22(9):1462-70. doi: 10.2337/diacare.22.9.1462.</citation>
      <PMID>10480510</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 10, 2023</study_first_submitted>
    <study_first_submitted_qc>July 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Indiana University</investigator_affiliation>
      <investigator_full_name>Nana Gletsu Miller</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pediatric Obesity</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/NCT05966870
  org study id: 1908757318
  secondary id: P30DK097512
  nct id: NCT05966870
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The study design is a prospective observational study in adolescents who are at risk for
        developing Type 2 Diabetes (T2D), to evaluate the effectiveness of sparkling water to reduce
        dietary intake of added sugars and thereby improve glycemia. Study data on consumption and
        the flavor profile of sparkling water will serve as a measure of acceptability. The study
        intervention will be to provide carbonated flavored sparkling water for 12 weeks to
        adolescents (and their families) who have a usual intake of 2 or more servings of sugar
        sweetened beverages (SSB) per day and are at a high risk for developing type 2 diabetes.
        Study measures will be obtained before and after the exposure to carbonated flavored
        sparkling water and each participant will serve as his/her own control. To encourage the
        participants to substitute the carbonated flavored sparkling water, study personnel will send
        them weekly iMessages through the Technology Assisted Dietary Assessment (TADA) app. In
        addition, investigators will monitor the participants' diet, using the TADA app, every two
        weeks, for 4 days. Study measurements will be obtained at baseline, before the intervention,
        during and at the end of the 12 week intervention.
  
        Objective: Determine the effect of reducing added sugars intake by substituting carbonated
        sparkling water on T2D risk in adolescents.
  
        Hypothesis: Adolescents who decrease consumption of SSB by substituting sparkling water will
        experience decreased blood glucose concentrations and increased insulin sensitivity during an
        oral glucose tolerance test and decreased glucose excursions during continued glucose
        monitoring, compared to those who do not decrease consumption of SSB.
  Importance of studying added sugars in adolescents. Research that leads to nutritional
        strategies to prevent T2D in adolescents is an urgent pursuit. One particular contributing
        factor to the growth of T2D and prediabetes in adolescents is the increased consumption of
        added sugars. Adolescents in the U.S. have high intakes of added sugars which could have poor
        health implications. Added sugars are found in sugar sweetened beverages and desserts and
        snacks, top sources of energy for adolescents, and calories from added sugars contribute to
        16% of the total energy intake. Levels are well above recommendations from leading scientific
        organizations, which suggest limiting added sugars to less than 10% of energy. However, it is
        not clear whether sugar reduction to less than 10% of energy is palatable for an adolescent
        population that prefers sweetened foods and beverages. Moreover, uncertainty about the
        evidence linking added sugar consumption to risk of disease has made policies that seek to
        reduce dietary intake of added sugar controversial. The controversy impairs large-scale
        implementation of recommendations to reduce intake of added sugars by individuals,
        clinicians, policy makers and industry stakeholders.
  
        Evidence linking added sugars and risk of type 2 diabetes and cardiovascular disease lacks
        information on adolescents. Many epidemiological studies in adults, but not all show the
        concept that after controlling for energy intake, high consumption of sugar-sweetened foods
        is a risk factor for T2D. Epidemiological studies also associate high consumption of added
        sugars, particularly from sugar sweetened beverages (SSB), with increased adiposity
        (including central adiposity) and dyslipidemia. These studies formed the basis of
        recommendations to limit added sugar consumption from the American Heart Organization. The
        data in youth is limited. Two small randomized studies compared the effects of glucose versus
        fructose beverages on insulin sensitivity in adolescents and findings were mixed. One
        longitudinal cohort study showed that higher consumption of added sugars, from SSB, was
        associated with hyperglycemia and impaired insulin sensitivity in youth aged 8 - 12 years.
        One study showed that high amounts of added sugars may induce insulin resistance and
        beta-cell dysfunction and such effects can occur independent of adiposity. The literature
        lacks evidence linking high consumption of added sugars to risk of developing youth-onset
        T2D.
  
        Substituting Flavored Sparkling Water for Sugar Sweetened Beverages. Instead of sugar, food
        manufacturers typically sweeten foods beverages using low-calorie or artificial sweeteners.
        "Diet" versions of SSB have been available for several decades and are widely used by adults
        and children. However the safety of low calorie sweeteners is controversial and many in the
        scientific and lay communities do not promote their use as a substitute for SSB. We propose
        that an alternative to SSB may be found in sparkling waters (carbonated water with flavoring,
        completely unsweetened), which are commercially available in soda-like flavors like cola or
        Dr. Pepper™. The rationale for the current project is the urgent need for an effective
        strategy to combat adolescent T2D which investigators will address by demonstrating the
        benefit of an intervention to reduce added sugars. The objective of the study is to
        demonstrate whether substituting sparkling water for SSB has benefits for in vivo
        physiological measures of glycemia while maintaining flavor acceptability to adolescents who
        are at risk for diabetes.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Prospective, before and after, cohort study
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: Change in 2 hour glucose concentration
  time frame: 0, 12 weeks
  description: Oral glucose tolerance testing; 1.75 g/kg body weight
  measure: Change in Dietary consumption of SSB and Sparkling water
  time frame: 0, 2, 4, 6, 8, 10, 12 weeks
  description: Using Technology Assisted Dietary Assessment (TADA) system, a mobile food record
  measure: Change in Insulin sensitivity
  time frame: 0, 12 weeks
  description: Whole body insulin sensitivity index (WBISI); Calculated as described by Matsuda et al., 1999. Units are 1/mg/dL*mU/ML*mg/dL*mU/ML; higher values indicate more insulin sensitivity
  measure: Change in Glycemic variability
  time frame: 0, 12 weeks
  description: Continuous Glucose Monitoring will be measured usingFreeStyle Libre Pro System; Abbott; Abbott Park, IL. The instrument records glucose excursions during a 24 hour period as glycemic variability.
  measure: Change in Flavor perception of beverage sweetness
  time frame: 0, 12 weeks
  description: Sensory testing of 6 levels of sweetness in beverages.Participants will rate the samples for their sweetness using a "just about right" visual analog scale, with anchors at: -100, "Not sweet enough"; -50, "Slightly not sweet enough"; 0, "Just about right"; +50, "Slightly too sweet"; and +100 "Too sweet." Samples will also be rated for liking using a hedonic visual analog scale, with anchors at: -100, "Worst ever"; -50, "Dislike"; 0, "Neutral"; +50, "Like"; +100, "Best ever."
  measure: Change in Blood Pressure
  time frame: 0, 12 weeks
  description: Systolic blood pressure in the morning with participant in the fasting condition
  measure: Change in Blood Triglycerides
  time frame: 0, 12 weeks
  description: Triglycerides concentrations in the morning with participant in the fasting condition.
  measure: Change in waist circumference
  time frame: 0, 12 weeks
  description: measured per instructions from National Health and Nutrition Examination Survay (NHANES). Anthropometry Procedures Manual
  measure: Change in Dietary intake behaviors
  time frame: 0, 2, 4, 6, 8, 10, 12 weeks
  description: Using Technology Assisted Dietary Assessment (TADA) system, a mobile food record. Total intake of calories and added sugars will be assessed.
  arm group label: Replacement of SSB with Unsweetened Sparkling Beverage
  arm group type: Experimental
  description: To encourage participants to substitute sparkling water flavored water for SSB intake, we will provide enough supplies of the drinks to adolescents (and their families) each month. We will also provide iPhones with the TADA app to the adolescent participants. Study staff will remind participants to consume the sparkling water through iMessages sent through the TADA app.
  intervention type: Other
  intervention name: Unsweetened flavored sparkling water
  description: Unsweetened sparkling waters are carbonated water with flavoring, completely unsweetened, which are commercially available in soda-like flavors like cola
  arm group label: Replacement of SSB with Unsweetened Sparkling Beverage
  criteria: 
  gender: All
  gender based: Yes
  gender description: participant eligibility is based on self-representation of gender identity
  minimum age: 10 Years
  maximum age: 21 Years
  healthy volunteers: No
  last name: Nana Gletsu Miller, PhD
  role: Principal Investigator
  affiliation: Indiana University
  facility: 
  country: United States
  citation: Andes LJ, Cheng YJ, Rolka DB, Gregg EW, Imperatore G. Prevalence of Prediabetes Among Adolescents and Young Adults in the United States, 2005-2016. JAMA Pediatr. 2020 Feb 1;174(2):e194498. doi: 10.1001/jamapediatrics.2019.4498. Epub 2020 Feb 3.
  PMID: 31790544
  citation: Banfield EC, Liu Y, Davis JS, Chang S, Frazier-Wood AC. Poor Adherence to US Dietary Guidelines for Children and Adolescents in the National Health and Nutrition Examination Survey Population. J Acad Nutr Diet. 2016 Jan;116(1):21-27. doi: 10.1016/j.jand.2015.08.010. Epub 2015 Sep 26.
  PMID: 26391469
  citation: Reedy J, Krebs-Smith SM. Dietary sources of energy, solid fats, and added sugars among children and adolescents in the United States. J Am Diet Assoc. 2010 Oct;110(10):1477-84. doi: 10.1016/j.jada.2010.07.010.
  PMID: 20869486
  citation: Bailey RL, Fulgoni VL, Cowan AE, Gaine PC. Sources of Added Sugars in Young Children, Adolescents, and Adults with Low and High Intakes of Added Sugars. Nutrients. 2018 Jan 17;10(1):102. doi: 10.3390/nu10010102.
  PMID: 29342109
  citation: Boushey CJ, Kerr DA, Wright J, Lutes KD, Ebert DS, Delp EJ. Use of technology in children's dietary assessment. Eur J Clin Nutr. 2009 Feb;63 Suppl 1(Suppl 1):S50-7. doi: 10.1038/ejcn.2008.65.
  PMID: 19190645
  citation: Running, C.A. Desensitization but not sensitization from commercial chemesthetic beverages. Food Quality and Preference 2018 Vol. 69 Pages 21-27; DOI: 10.1016/j.foodqual.2018.05.001
  citation: Wang J, Light K, Henderson M, O'Loughlin J, Mathieu ME, Paradis G, Gray-Donald K. Consumption of added sugars from liquid but not solid sources predicts impaired glucose homeostasis and insulin resistance among youth at risk of obesity. J Nutr. 2014 Jan;144(1):81-6. doi: 10.3945/jn.113.182519. Epub 2013 Nov 6.
  PMID: 24198307
  citation: Matsuda M, DeFronzo RA. Insulin sensitivity indices obtained from oral glucose tolerance testing: comparison with the euglycemic insulin clamp. Diabetes Care. 1999 Sep;22(9):1462-70. doi: 10.2337/diacare.22.9.1462.
  PMID: 10480510
  responsible party type: Principal Investigator
  investigator affiliation: Indiana University
  investigator full name: Nana Gletsu Miller
  investigator title: Associate Professor
  mesh term: Pediatric Obesity
  sharing ipd: No