<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/NCT04445740</url>
  </required_header>
  <id_info>
    <org_study_id>H-47369</org_study_id>
    <secondary_id>R00HD091396</secondary_id>
    <nct_id>NCT04445740</nct_id>
  </id_info>
  <brief_title>The i Heart Rhythm Project: Healthy Sleep and Behavioral Rhythms for Obesity Prevention</brief_title>
  <official_title>Feasibility, Acceptability, and Preliminary Efficacy of the i Heart Rhythm Project</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Baylor College of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Baylor College of Medicine</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>
      This pilot study will examine the feasibility, acceptability, and preliminary efficacy of the&#xD;
      intervention. This will ensure that all aspects of the research protocol and procedures work&#xD;
      as desired and are acceptable to families in preparation for the fully powered randomized&#xD;
      controlled trial. The proposed study will assess our ability to: 1)recruit, consent, and&#xD;
      retain participants, 2) deliver the intervention, 3) implement study and assessment&#xD;
      procedures 4) assess the reliability of the proposed measures in this sample, 5) determine&#xD;
      whether modifications to the intervention, procedures, and measures are needed prior to&#xD;
      conducting a fully powered study, and 6) willingness of participants to participate in the&#xD;
      intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The current study employs a 2 group randomized control design (treatment and no-treatment&#xD;
      control) with randomization occurring after baseline (time 0) and 3 additional evaluation&#xD;
      periods (end of intervention (time 1), and 9 months (time 2) and 12 months post intervention&#xD;
      (time 3)). Because the the i♥rhythm project is intended to prevent children from beginning a&#xD;
      trajectory toward overweight/obesity in elementary school, the impact of the intervention on&#xD;
      change in standardized BMI (BMIz) during the following summer (time 2 and 3) will be&#xD;
      explored, identifying whether a maintenance intervention is needed. Following the&#xD;
      intervention and final data assessment (time 1 and 3), qualitative interviews will explore&#xD;
      the acceptability of the intervention, treatment barriers and facilitators, difficulties with&#xD;
      study procedures, maintenance of improvements, and self-efficacy to maintain improvements. A&#xD;
      third treatment condition controlling for the effect of attention was beyond the scope of the&#xD;
      current feasibility study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">March 15, 2021</start_date>
  <completion_date type="Anticipated">August 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">August 30, 2023</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>Single (Investigator)</masking>
    <masking_description>key personnel will be masked</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility Criteria: ability to recruit the needed sample size</measure>
    <time_frame>3 months</time_frame>
    <description>The feasibility of the intervention will be established by our ability to recruit the needed sample size and retain at least 80% at Time 1 and 60% at Time 3; favorable acceptability ratings by 80% of the sample, participation in greater than 60% of daily diaries, views of intervention materials by 80% of participants. Decisions regarding changes to the intervention will be made based on the attainment of feasibility criteria and post-assessment interviews. Decisions regarding changes to the intervention will be made based on the attainment of feasibility criteria and post-assessment interviews.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Treatment Acceptability</measure>
    <time_frame>3 months</time_frame>
    <description>Treatment Acceptability Report Form-Revised(TARF-R) 185 is a 20-item global measure of treatment acceptability for behavioral interventions. The TARF-R has demonstrated good internal consistency (αs&gt;.69) and evidence of construct validity. A favorable rating is considered 4 or greater.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Anthropometrics</measure>
    <time_frame>0 months, 3 months, 12 months and 15 months</time_frame>
    <description>Body Mass Index (BMI) is the most common indicator of body size and has been consistently correlated with metabolic problems in children. Participants' height and weight will be measured using established protocols. BMI (kg/m2) will be computed and BMI %ile and BMIz will be calculated from age and gender normative data. BMI %ile will determine weight status group. Change in BMI and BMIz are the best proxy measures for change in fat mass and standardized fat mass and will assess exploratory hypotheses. Change in BMI will serve as the primary outcome for the fully powered randomized controlled trial. For the current application, feasibility criteria will serve as the primary outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measurement of endogenous circadian rhythms</measure>
    <time_frame>0 months, 3 months, 12 months and 15 months</time_frame>
    <description>Circadian phase can be examined by measuring the circadian timing of melatonin onset under dim light conditions (dim light melatonin onset; DLMO). Compared to markers of endogenous circadian rhythms, melatonin is relatively robust. Salivary DLMO measures have demonstrated high intraclass correlations (.93) with plasma and sensitivity and specificity comparable to plasma assays. Following established procedures with children, salivary DLMO will be collected on a weekday evening in the laboratory under dim light conditions (&lt;40 lux), via a cheek swab every hour beginning 5 hours prior to and ending 1 hour following typical bedtime. Saliva samples will be centrifuged, frozen, and assayed using radioimmunoassay test kits. DLMO phase will be determined using linear interpolation across the time points before and after melatonin concentration increased to and remained above 4pg/mL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Actigraphy for the measurement of sleep, sleep/wake patterns, physical activity, and light exposure.</measure>
    <time_frame>0 months, 3 months, 12 months and 15 months</time_frame>
    <description>Actigraphs (GT3X-BT, Pensacola, FL) worn on the wrist of the dominant hand 24 hours a day for 7 days will measure sleep duration and timing of sleep onset and waking. Wrist placement reliably measures sleep duration in adolescents. Sleep diaries will be completed. Monitor-wear logs will identify times the accelerometer is removed and the activity engaged in while the monitor is off. The photocell contained in the Actigraph GT3X-BT will be used to measure ambient light exposure. Accelerometers have been extensively used to assess children's physical activity (PA). Five days of monitoring had 0.8 reliability of accurately capturing the habitual PA of children. Activity counts captured in 5-second epochs will be categorized into sedentary, light, moderate, and vigorous PA using established cut points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body composition</measure>
    <time_frame>0 months, 3 months, 12 months and 15 months</time_frame>
    <description>Since BMI can misrepresent adiposity among muscular and slender children, use of additional body fat indicators has been recommended. Investigators will assess percent body fat using Bod Pod.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dietary Assessment</measure>
    <time_frame>0 months, 3 months, 12 months and 15 months</time_frame>
    <description>The Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA-24)174 will be used to assess children's dietary intake (e.g., total daily caloric intake, timing of intake, timing of the last eating episode of the day). As recommended, parents will complete the adult version of the ASA-24, providing proxy report of their child's dietary intake. Investigators will use 3 days of diet assessment as 3 days optimize the prediction of doubly labeled water estimated energy expenditure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parenting Structure</measure>
    <time_frame>0 months, 3 months, 12 months and 15 months</time_frame>
    <description>Comprehensive General Parenting Questionnaire (CGPQ) is a parent report of parenting practices among parents of 5-13 year olds. Investigators will assess subscales related to parenting structure (inconsistent discipline, consistency, organization, and scaffolding). There is support for the construct validity of the CGPQ. Parenting structure subscales have demonstrated acceptable to good internal reliability (ranging from .67-.74). Subscale scores range from 5 to 25. Higher scores indicate higher levels of structure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bedtime Routines</measure>
    <time_frame>0 months, 3 months, 12 months and 15 months</time_frame>
    <description>The Bedtimes Routines Questionnaire (BRQ), is a 31-item parent report measure of children's bedtime routines, comprised of three scales measuring consistency of bedtime routines (weekday &amp; weekend), reactivity to changes in bedtime routines, and frequency of adaptive and maladaptive activities. The BRQ scales had good internal consistency ranging from α = 0.69 to 0.90. Scores on the consistency and adaptive behavior subscales range from 10 to 50 with higher scores reflecting more consistent bedtime routines and higher. The reactivity scale scores range from 5 to 25 with higher scores reflecting greater reactivity. The maladaptive behavior scale has possible scores ranging from 6 to 30 with higher scores reflecting more maladaptive behaviors.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Summer Care Arrangements</measure>
    <time_frame>0 months, 3 months, 12 months and 15 months</time_frame>
    <description>How Children Spend their Summer (e.g., children's involvement in summer school, child care, entertainment programs, as well as day or overnight camps) will be assessed by a parent report survey based on a modified version of the Early Childhood Longitudinal Program Kindergarten Class' parent interview on summer activities. The Girl's Health Enrichment Multisite Studies demographic protocol will be employed with parents.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stress (Parent)</measure>
    <time_frame>0 months, 3 months, 12 months and 15 months</time_frame>
    <description>Perceived Stress Scale (PSS-10) is a 10-item self-report measure of perceived stress with established acceptable psychometric properties(α's &gt;.70, test-retest criterion coefficient &gt;.7, validated factor structure and evidence of convergent validity). Scores range from 0 to 40 with higher scores reflecting higher levels of perceived stress.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Social Support (Parent)</measure>
    <time_frame>0 months, 3 months, 12 months and 15 months</time_frame>
    <description>Interpersonal Support Evaluation List (ISEL) is a 12-item self-report measure of the perceived availability of social support (i.e. Tangible, appraisal, and belonging). The ISEL has demonstrated good reliability. The &quot;tangible&quot; subscale assesses perceived availability of resources and material aid; the &quot;appraisal&quot; subscale assesses the perceived availability of another individual(s) to discuss one's problems; the &quot;self-esteem&quot; subscale assesses the perceived availability of someone to compare one's self to in a positive manner; and the &quot;belonging&quot; subscale, the perceived availability of having others to socialize and do things with. Scores range from 0-30 on each scale with greater scores indicating higher levels of social support.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Motivation to Continue in the Program</measure>
    <time_frame>3 months</time_frame>
    <description>The Treatment Questionnaire Concerning Continued Program Participation was originally developed to assess reasons for continuing to participate in a weight-loss program. We have adapted it assess reasons for continuing to participate focused on addressing children's sleep during summer. Scores in the Autonomous Regulation scale range from 5 to 35 and scores on the Controlled Regulation range from 8 to 56. Higher scores reflect higher levels of Autonomous and Controlled regulation.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Obesity Prevention</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive an intervention and will participate in assessments</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants will not receive an intervention, but will participate in assessments</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>i♥rhythm project</intervention_name>
    <description>behavioral mobile health intervention, targeting parents of 5-8 year olds, designed to promote consistent behavioral rhythms in children through consistent bedtimes, light exposure, meal timing, and physical activity.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The index child is 5-8 years old and currently enrolled in kindergarten, first, or&#xD;
             second grade&#xD;
&#xD;
          -  Parent reports being a daily user of social media&#xD;
&#xD;
          -  Parent willing to engage in an mobile health intervention that includes social media&#xD;
&#xD;
          -  Parent owns a smart phone&#xD;
&#xD;
          -  At least 1 parent is comfortable participating in the intervention and responding to&#xD;
             questionnaires in English&#xD;
&#xD;
          -  Index child has a BMI &gt;50th percentile&#xD;
&#xD;
          -  families live in the greater Houston area and able to attend in-person data collection&#xD;
             at the Children's Nutrition Research Center.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Per parent report, the child does not have a chronic medical condition affecting&#xD;
             sleep, eating behaviors, weight status, or behavioral rhythms (e.g., obstructive sleep&#xD;
             apnea, attention deficit hyperactivity disorder, autism). The inclusion and exclusion&#xD;
             criteria will be assessed using a screening questionnaire and assessments which will&#xD;
             be administered following the consenting procedures.&#xD;
&#xD;
          -  Per parent report, the child is not being treated with a medication or supplement&#xD;
             known to affect sleep.&#xD;
&#xD;
          -  Child has not participated in an obesity prevention or obesity treatment program in&#xD;
             the last 6 months&#xD;
&#xD;
          -  Child had not been retaine 2 or more grades for academic reason or has intellectual&#xD;
             difficulities that would influence their ability to complet questionnaires or&#xD;
             participate in interviews.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jennette Moreno</last_name>
    <role>Principal Investigator</role>
    <affiliation>Baylor College of Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hafza Dadabhoy, MS</last_name>
    <role>Study Director</role>
    <affiliation>Baylor College of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's Nutrition Research Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Moreno JP, Dadabhoy H, Musaad S, Baranowski T, Thompson D, Alfano CA, Crowley SJ. Evaluation of a Circadian Rhythm and Sleep-Focused Mobile Health Intervention for the Prevention of Accelerated Summer Weight Gain Among Elementary School-Age Children: Protocol for a Randomized Controlled Feasibility Study. JMIR Res Protoc. 2022 May 16;11(5):e37002. doi: 10.2196/37002.</citation>
    <PMID>35576573</PMID>
  </reference>
  <reference>
    <citation>Moreno JP, Hannay KM, Walch O, Dadabhoy H, Christian J, Puyau M, El-Mubasher A, Bacha F, Grant SR, Park RJ, Cheng P. Estimating circadian phase in elementary school children: leveraging advances in physiologically informed models of circadian entrainment and wearable devices. Sleep. 2022 Jun 13;45(6):zsac061. doi: 10.1093/sleep/zsac061.</citation>
    <PMID>35275213</PMID>
  </reference>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>March 25, 2023</last_update_submitted>
  <last_update_submitted_qc>March 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 28, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Baylor College of Medicine</investigator_affiliation>
    <investigator_full_name>Jennette P. Moreno</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>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>


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/NCT04445740
org study id: H-47369
secondary id: R00HD091396
nct id: NCT04445740
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This pilot study will examine the feasibility, acceptability, and preliminary efficacy of the
      intervention. This will ensure that all aspects of the research protocol and procedures work
      as desired and are acceptable to families in preparation for the fully powered randomized
      controlled trial. The proposed study will assess our ability to: 1)recruit, consent, and
      retain participants, 2) deliver the intervention, 3) implement study and assessment
      procedures 4) assess the reliability of the proposed measures in this sample, 5) determine
      whether modifications to the intervention, procedures, and measures are needed prior to
      conducting a fully powered study, and 6) willingness of participants to participate in the
      intervention.
The current study employs a 2 group randomized control design (treatment and no-treatment
      control) with randomization occurring after baseline (time 0) and 3 additional evaluation
      periods (end of intervention (time 1), and 9 months (time 2) and 12 months post intervention
      (time 3)). Because the the i♥rhythm project is intended to prevent children from beginning a
      trajectory toward overweight/obesity in elementary school, the impact of the intervention on
      change in standardized BMI (BMIz) during the following summer (time 2 and 3) will be
      explored, identifying whether a maintenance intervention is needed. Following the
      intervention and final data assessment (time 1 and 3), qualitative interviews will explore
      the acceptability of the intervention, treatment barriers and facilitators, difficulties with
      study procedures, maintenance of improvements, and self-efficacy to maintain improvements. A
      third treatment condition controlling for the effect of attention was beyond the scope of the
      current feasibility study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Investigator)
masking description: key personnel will be masked
measure: Feasibility Criteria: ability to recruit the needed sample size
time frame: 3 months
description: The feasibility of the intervention will be established by our ability to recruit the needed sample size and retain at least 80% at Time 1 and 60% at Time 3; favorable acceptability ratings by 80% of the sample, participation in greater than 60% of daily diaries, views of intervention materials by 80% of participants. Decisions regarding changes to the intervention will be made based on the attainment of feasibility criteria and post-assessment interviews. Decisions regarding changes to the intervention will be made based on the attainment of feasibility criteria and post-assessment interviews.
measure: Treatment Acceptability
time frame: 3 months
description: Treatment Acceptability Report Form-Revised(TARF-R) 185 is a 20-item global measure of treatment acceptability for behavioral interventions. The TARF-R has demonstrated good internal consistency (αs>.69) and evidence of construct validity. A favorable rating is considered 4 or greater.
measure: Anthropometrics
time frame: 0 months, 3 months, 12 months and 15 months
description: Body Mass Index (BMI) is the most common indicator of body size and has been consistently correlated with metabolic problems in children. Participants' height and weight will be measured using established protocols. BMI (kg/m2) will be computed and BMI %ile and BMIz will be calculated from age and gender normative data. BMI %ile will determine weight status group. Change in BMI and BMIz are the best proxy measures for change in fat mass and standardized fat mass and will assess exploratory hypotheses. Change in BMI will serve as the primary outcome for the fully powered randomized controlled trial. For the current application, feasibility criteria will serve as the primary outcome.
measure: Measurement of endogenous circadian rhythms
time frame: 0 months, 3 months, 12 months and 15 months
description: Circadian phase can be examined by measuring the circadian timing of melatonin onset under dim light conditions (dim light melatonin onset; DLMO). Compared to markers of endogenous circadian rhythms, melatonin is relatively robust. Salivary DLMO measures have demonstrated high intraclass correlations (.93) with plasma and sensitivity and specificity comparable to plasma assays. Following established procedures with children, salivary DLMO will be collected on a weekday evening in the laboratory under dim light conditions (<40 lux), via a cheek swab every hour beginning 5 hours prior to and ending 1 hour following typical bedtime. Saliva samples will be centrifuged, frozen, and assayed using radioimmunoassay test kits. DLMO phase will be determined using linear interpolation across the time points before and after melatonin concentration increased to and remained above 4pg/mL.
measure: Actigraphy for the measurement of sleep, sleep/wake patterns, physical activity, and light exposure.
time frame: 0 months, 3 months, 12 months and 15 months
description: Actigraphs (GT3X-BT, Pensacola, FL) worn on the wrist of the dominant hand 24 hours a day for 7 days will measure sleep duration and timing of sleep onset and waking. Wrist placement reliably measures sleep duration in adolescents. Sleep diaries will be completed. Monitor-wear logs will identify times the accelerometer is removed and the activity engaged in while the monitor is off. The photocell contained in the Actigraph GT3X-BT will be used to measure ambient light exposure. Accelerometers have been extensively used to assess children's physical activity (PA). Five days of monitoring had 0.8 reliability of accurately capturing the habitual PA of children. Activity counts captured in 5-second epochs will be categorized into sedentary, light, moderate, and vigorous PA using established cut points.
measure: Body composition
time frame: 0 months, 3 months, 12 months and 15 months
description: Since BMI can misrepresent adiposity among muscular and slender children, use of additional body fat indicators has been recommended. Investigators will assess percent body fat using Bod Pod.
measure: Dietary Assessment
time frame: 0 months, 3 months, 12 months and 15 months
description: The Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA-24)174 will be used to assess children's dietary intake (e.g., total daily caloric intake, timing of intake, timing of the last eating episode of the day). As recommended, parents will complete the adult version of the ASA-24, providing proxy report of their child's dietary intake. Investigators will use 3 days of diet assessment as 3 days optimize the prediction of doubly labeled water estimated energy expenditure.
measure: Parenting Structure
time frame: 0 months, 3 months, 12 months and 15 months
description: Comprehensive General Parenting Questionnaire (CGPQ) is a parent report of parenting practices among parents of 5-13 year olds. Investigators will assess subscales related to parenting structure (inconsistent discipline, consistency, organization, and scaffolding). There is support for the construct validity of the CGPQ. Parenting structure subscales have demonstrated acceptable to good internal reliability (ranging from .67-.74). Subscale scores range from 5 to 25. Higher scores indicate higher levels of structure.
measure: Bedtime Routines
time frame: 0 months, 3 months, 12 months and 15 months
description: The Bedtimes Routines Questionnaire (BRQ), is a 31-item parent report measure of children's bedtime routines, comprised of three scales measuring consistency of bedtime routines (weekday & weekend), reactivity to changes in bedtime routines, and frequency of adaptive and maladaptive activities. The BRQ scales had good internal consistency ranging from α = 0.69 to 0.90. Scores on the consistency and adaptive behavior subscales range from 10 to 50 with higher scores reflecting more consistent bedtime routines and higher. The reactivity scale scores range from 5 to 25 with higher scores reflecting greater reactivity. The maladaptive behavior scale has possible scores ranging from 6 to 30 with higher scores reflecting more maladaptive behaviors.
measure: Summer Care Arrangements
time frame: 0 months, 3 months, 12 months and 15 months
description: How Children Spend their Summer (e.g., children's involvement in summer school, child care, entertainment programs, as well as day or overnight camps) will be assessed by a parent report survey based on a modified version of the Early Childhood Longitudinal Program Kindergarten Class' parent interview on summer activities. The Girl's Health Enrichment Multisite Studies demographic protocol will be employed with parents.
measure: Stress (Parent)
time frame: 0 months, 3 months, 12 months and 15 months
description: Perceived Stress Scale (PSS-10) is a 10-item self-report measure of perceived stress with established acceptable psychometric properties(α's >.70, test-retest criterion coefficient >.7, validated factor structure and evidence of convergent validity). Scores range from 0 to 40 with higher scores reflecting higher levels of perceived stress.
measure: Social Support (Parent)
time frame: 0 months, 3 months, 12 months and 15 months
description: Interpersonal Support Evaluation List (ISEL) is a 12-item self-report measure of the perceived availability of social support (i.e. Tangible, appraisal, and belonging). The ISEL has demonstrated good reliability. The "tangible" subscale assesses perceived availability of resources and material aid; the "appraisal" subscale assesses the perceived availability of another individual(s) to discuss one's problems; the "self-esteem" subscale assesses the perceived availability of someone to compare one's self to in a positive manner; and the "belonging" subscale, the perceived availability of having others to socialize and do things with. Scores range from 0-30 on each scale with greater scores indicating higher levels of social support.
measure: Motivation to Continue in the Program
time frame: 3 months
description: The Treatment Questionnaire Concerning Continued Program Participation was originally developed to assess reasons for continuing to participate in a weight-loss program. We have adapted it assess reasons for continuing to participate focused on addressing children's sleep during summer. Scores in the Autonomous Regulation scale range from 5 to 35 and scores on the Controlled Regulation range from 8 to 56. Higher scores reflect higher levels of Autonomous and Controlled regulation.
arm group label: Intervention
arm group type: Experimental
description: Participants will receive an intervention and will participate in assessments
arm group label: Control
arm group type: No Intervention
description: Participants will not receive an intervention, but will participate in assessments
intervention type: Behavioral
intervention name: i♥rhythm project
description: behavioral mobile health intervention, targeting parents of 5-8 year olds, designed to promote consistent behavioral rhythms in children through consistent bedtimes, light exposure, meal timing, and physical activity.
arm group label: Intervention
criteria: 
gender: All
minimum age: 5 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jennette Moreno
role: Principal Investigator
affiliation: Baylor College of Medicine
last name: Hafza Dadabhoy, MS
role: Study Director
affiliation: Baylor College of Medicine
facility: 
country: United States
citation: Moreno JP, Dadabhoy H, Musaad S, Baranowski T, Thompson D, Alfano CA, Crowley SJ. Evaluation of a Circadian Rhythm and Sleep-Focused Mobile Health Intervention for the Prevention of Accelerated Summer Weight Gain Among Elementary School-Age Children: Protocol for a Randomized Controlled Feasibility Study. JMIR Res Protoc. 2022 May 16;11(5):e37002. doi: 10.2196/37002.
PMID: 35576573
citation: Moreno JP, Hannay KM, Walch O, Dadabhoy H, Christian J, Puyau M, El-Mubasher A, Bacha F, Grant SR, Park RJ, Cheng P. Estimating circadian phase in elementary school children: leveraging advances in physiologically informed models of circadian entrainment and wearable devices. Sleep. 2022 Jun 13;45(6):zsac061. doi: 10.1093/sleep/zsac061.
PMID: 35275213
responsible party type: Principal Investigator
investigator affiliation: Baylor College of Medicine
investigator full name: Jennette P. Moreno
investigator title: Assistant Professor
mesh term: Obesity
sharing ipd: No