NCT04445740

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Baylor College of Medicine · Academic / Other
• Sex: All
• Age: 5 Years – 60 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-03-15
• Primary completion: 2023-08-18
• Completion: 2023-08-18
• First posted: 2020-06-24
• Last updated: 2023-10-25

Locations

1 site across 1 country: United States