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

Obesity Prevention Clinical Trial

Official title:

Feasibility, Acceptability, and Preliminary Efficacy of the i Heart Rhythm Project

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04445740
• Other study ID #: H-47369
• Secondary ID: R00HD091396
• Status: Completed
• Phase: N/A
• Start date: March 15, 2021
• Est. completion date: August 18, 2023

Study information

• Verified date: October 2023
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: August 18, 2023
• Est. primary completion date: August 18, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Obesity Prevention

Intervention

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.

Locations

Country	Name	City	State
United States	Children's Nutrition Research Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Baylor College of Medicine	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility Criteria: ability to recruit the needed sample size	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.	3 months
Primary	Treatment Acceptability	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 (as>.69) and evidence of construct validity. A favorable rating is considered 4 or greater.	3 months
Secondary	Anthropometrics	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.	0 months, 3 months, 12 months and 15 months
Secondary	Measurement of endogenous circadian rhythms	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.	0 months, 3 months, 12 months and 15 months
Secondary	Actigraphy for the measurement of sleep, sleep/wake patterns, physical activity, and light exposure.	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.	0 months, 3 months, 12 months and 15 months
Secondary	Body composition	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.	0 months, 3 months, 12 months and 15 months
Secondary	Dietary Assessment	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.	0 months, 3 months, 12 months and 15 months
Secondary	Parenting Structure	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.	0 months, 3 months, 12 months and 15 months
Secondary	Bedtime Routines	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 a = 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.	0 months, 3 months, 12 months and 15 months
Secondary	Summer Care Arrangements	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.	0 months, 3 months, 12 months and 15 months
Secondary	Stress (Parent)	Perceived Stress Scale (PSS-10) is a 10-item self-report measure of perceived stress with established acceptable psychometric properties(a'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.	0 months, 3 months, 12 months and 15 months
Secondary	Social Support (Parent)	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.	0 months, 3 months, 12 months and 15 months
Secondary	Motivation to Continue in the Program	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.	3 months