Status:
COMPLETED
The i Heart Rhythm Project: Healthy Sleep and Behavioral Rhythms for Obesity Prevention
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Obesity Prevention
Eligibility:
All Genders
5-60 years
Phase:
NA
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 an...
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 inte...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 18 2023
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT04445740
Start Date
March 15 2021
End Date
August 18 2023
Last Update
October 25 2023
Active Locations (1)
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1
Children's Nutrition Research Center
Houston, Texas, United States, 77030