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

Baylor College of Medicine

Status

Completed

Conditions

Obesity Prevention

Treatments

Behavioral: i♥rhythm project

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT04445740

H-47369

R00HD091396 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

92 patients

Sex

All

Ages

5 to 60 years old

Volunteers

Accepts Healthy Volunteers

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.