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The i Heart Rhythm Project: Healthy Sleep and Behavioral Rhythms for Obesity Prevention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04445740
Recruitment Status : Active, not recruiting
First Posted : June 24, 2020
Last Update Posted : March 28, 2023
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Jennette P. Moreno, Baylor College of Medicine

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Obesity Prevention Behavioral: i♥rhythm project Not Applicable

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Masking Description: key personnel will be masked
Primary Purpose: Prevention
Official Title: Feasibility, Acceptability, and Preliminary Efficacy of the i Heart Rhythm Project
Actual Study Start Date : March 15, 2021
Estimated Primary Completion Date : August 30, 2023
Estimated Study Completion Date : August 30, 2023
Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention
Participants will receive an intervention and will participate in assessments
 Behavioral: i♥rhythm project
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.
No Intervention: Control
Participants will not receive an intervention, but will participate in assessments


Outcome Measures
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Primary Outcome Measures :
  1. Feasibility Criteria: ability to recruit the needed sample size [ Time Frame: 3 months ]
    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.

  2. Treatment Acceptability [ Time Frame: 3 months ]
    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.


Secondary Outcome Measures :
  1. Anthropometrics [ Time Frame: 0 months, 3 months, 12 months and 15 months ]
    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.

  2. Measurement of endogenous circadian rhythms [ Time Frame: 0 months, 3 months, 12 months and 15 months ]
    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.

  3. 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 ]
    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.

  4. Body composition [ Time Frame: 0 months, 3 months, 12 months and 15 months ]
    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.

  5. Dietary Assessment [ Time Frame: 0 months, 3 months, 12 months and 15 months ]
    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.

  6. Parenting Structure [ Time Frame: 0 months, 3 months, 12 months and 15 months ]
    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.

  7. Bedtime Routines [ Time Frame: 0 months, 3 months, 12 months and 15 months ]
    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.

  8. Summer Care Arrangements [ Time Frame: 0 months, 3 months, 12 months and 15 months ]
    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.

  9. Stress (Parent) [ Time Frame: 0 months, 3 months, 12 months and 15 months ]
    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.

  10. Social Support (Parent) [ Time Frame: 0 months, 3 months, 12 months and 15 months ]
    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.

  11. Motivation to Continue in the Program [ Time Frame: 3 months ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   5 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • The index child is 5-8 years old and currently enrolled in kindergarten, first, or second grade
  • Parent reports being a daily user of social media
  • Parent willing to engage in an mobile health intervention that includes social media
  • Parent owns a smart phone
  • At least 1 parent is comfortable participating in the intervention and responding to questionnaires in English
  • Index child has a BMI >50th percentile
  • families live in the greater Houston area and able to attend in-person data collection at the Children's Nutrition Research Center.

Exclusion Criteria:

  • Per parent report, the child does not have a chronic medical condition affecting sleep, eating behaviors, weight status, or behavioral rhythms (e.g., obstructive sleep apnea, attention deficit hyperactivity disorder, autism). The inclusion and exclusion criteria will be assessed using a screening questionnaire and assessments which will be administered following the consenting procedures.
  • Per parent report, the child is not being treated with a medication or supplement known to affect sleep.
  • Child has not participated in an obesity prevention or obesity treatment program in the last 6 months
  • Child had not been retaine 2 or more grades for academic reason or has intellectual difficulities that would influence their ability to complet questionnaires or participate in interviews.
Contacts and Locations
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Information from the National Library of Medicine

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

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04445740


Locations
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United States, Texas
Children's Nutrition Research Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Jennette Moreno Baylor College of Medicine
Study Director: Hafza Dadabhoy, MS Baylor College of Medicine
More Information
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Publications:

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Responsible Party: Jennette P. Moreno, Assistant Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT04445740    
Other Study ID Numbers: H-47369
R00HD091396 ( U.S. NIH Grant/Contract )
First Posted: June 24, 2020    Key Record Dates
Last Update Posted: March 28, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight