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

NCT ID: NCT04445740

Last Updated: 2023-10-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-15
• Study Completion Date: 2023-08-18

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.

Conditions

Obesity Prevention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Intervention

Participants will receive an intervention and will participate in assessments

Group Type: EXPERIMENTAL

i♥rhythm project

Intervention Type: BEHAVIORAL

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.

Control

Participants will not receive an intervention, but will participate in assessments

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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 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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Baylor College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Jennette P. Moreno

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jennette Moreno

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Hafza Dadabhoy, MS

Role: STUDY_DIRECTOR

Baylor College of Medicine

Locations

Children's Nutrition Research Center

Houston, Texas, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 35576573 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 35275213 (View on PubMed)

Other Identifiers

R00HD091396

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H-47369

Identifier Type: -

Identifier Source: org_study_id