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

NCT04445740 | Completed

• 2 other identifiers: H-47369R00HD091396
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity Prevention

Outcome Measures

Primary Outcomes (2)

• 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

• 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 (αs\>.69) and evidence of construct validity. A favorable rating is considered 4 or greater.

  3 months

Secondary Outcomes (11)

• Anthropometrics

  0 months, 3 months, 12 months and 15 months

• Measurement of endogenous circadian rhythms

  0 months, 3 months, 12 months and 15 months

• Actigraphy for the measurement of sleep, sleep/wake patterns, physical activity, and light exposure.

  0 months, 3 months, 12 months and 15 months

• Body composition

  0 months, 3 months, 12 months and 15 months

• Dietary Assessment

  0 months, 3 months, 12 months and 15 months

Study Arms (2)

Intervention

EXPERIMENTAL

Participants will receive an intervention and will participate in assessments

Behavioral: i♥rhythm project

Control

NO INTERVENTION

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

Interventions

i♥rhythm project 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.

Intervention

Eligibility Criteria

• Age: 5 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baylor College of Medicine: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Children's Nutrition Research Center

Houston, Texas, 77030, United States

Location

Related 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.

  PMID: 35576573 BACKGROUND

• 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.

  PMID: 35275213 BACKGROUND

Study Officials

• Jennette Moreno

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

• Hafza Dadabhoy, MS

  Baylor College of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: key personnel will be masked
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 26, 2020
• First Posted: June 24, 2020
• Study Start: March 15, 2021
• Primary Completion: August 18, 2023
• Study Completion: August 18, 2023
• Last Updated: October 25, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)