Clinical trial NCT04445740: The i Heart Rhythm Project: Healthy Sleep and Behavioral Rhythms for Obesity Prevention
Official title: Feasibility, Acceptability, and Preliminary Efficacy of the i Heart Rhythm Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity Prevention
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2020-06-24
Enrollment: 92
Sex: ALL
Minimum age (years): 5
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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.

Primary outcomes:
measure: Feasibility Criteria: ability to recruit the needed sample size
timeFrame: 3 months
measure: Treatment Acceptability
timeFrame: 3 months
Secondary outcomes:
measure: Anthropometrics
timeFrame: 0 months, 3 months, 12 months and 15 months
measure: Measurement of endogenous circadian rhythms
timeFrame: 0 months, 3 months, 12 months and 15 months
measure: Actigraphy for the measurement of sleep, sleep/wake patterns, physical activity, and light exposure.
timeFrame: 0 months, 3 months, 12 months and 15 months
measure: Body composition
timeFrame: 0 months, 3 months, 12 months and 15 months
measure: Dietary Assessment
timeFrame: 0 months, 3 months, 12 months and 15 months
measure: Parenting Structure
timeFrame: 0 months, 3 months, 12 months and 15 months
measure: Bedtime Routines
timeFrame: 0 months, 3 months, 12 months and 15 months
measure: Summer Care Arrangements
timeFrame: 0 months, 3 months, 12 months and 15 months
measure: Stress (Parent)
timeFrame: 0 months, 3 months, 12 months and 15 months
measure: Social Support (Parent)
timeFrame: 0 months, 3 months, 12 months and 15 months
measure: Motivation to Continue in the Program
timeFrame: 3 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: Children's Nutrition Research Center
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Jennette Moreno
role: PRINCIPAL_INVESTIGATOR
affiliation: Baylor College of Medicine
name: Hafza Dadabhoy, MS
role: STUDY_DIRECTOR
References:
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: 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.