Obesity PreventionNCT04445740
The i Heart Rhythm Project: Healthy Sleep and Behavioral Rhythms for Obesity Prevention
A study testing i♥rhythm project in people with Obesity Prevention, run by Baylor College of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity Prevention
- What is being tested?
- i♥rhythm project
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2021to 18 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Nutrition Research Center
Houston, Texas, 77030
About this study
Official title: Feasibility, Acceptability, and Preliminary Efficacy of the i Heart Rhythm Project
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.
Read the 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
- Being tested
- i♥rhythm project
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
i♥rhythm projectBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants will receive an intervention and will participate in assessments Receives: Behavioral: i♥rhythm project |
| Control | No intervention | Participants will not receive an intervention, but will participate in assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 3 months
Secondary outcomes (11)
Anthropometrics
Body Mass Index (BMI) is the most common indicator of body size and has been consistently correlated with metabolic problems in children. Participants' height and weight will be measured using established protocols. BMI (kg/m2) will be computed and BMI %ile and BMIz will be calculated from age and gender normative data. BMI %ile will determine weight status group. Change in BMI and BMIz are the best proxy measures for change in fat mass and standardized fat mass and will assess exploratory hypotheses. Change in BMI will serve as the primary outcome for the fully powered randomized controlled trial. For the current application, feasibility criteria will serve as the primary outcome.
Measured: 0 months, 3 months, 12 months and 15 months
Measurement of endogenous circadian rhythms
Circadian phase can be examined by measuring the circadian timing of melatonin onset under dim light conditions (dim light melatonin onset; DLMO). Compared to markers of endogenous circadian rhythms, melatonin is relatively robust. Salivary DLMO measures have demonstrated high intraclass correlations (.93) with plasma and sensitivity and specificity comparable to plasma assays. Following established procedures with children, salivary DLMO will be collected on a weekday evening in the laboratory under dim light conditions (<40 lux), via a cheek swab every hour beginning 5 hours prior to and ending 1 hour following typical bedtime. Saliva samples will be centrifuged, frozen, and assayed using radioimmunoassay test kits. DLMO phase will be determined using linear interpolation across the time points before and after melatonin concentration increased to and remained above 4pg/mL.
Measured: 0 months, 3 months, 12 months and 15 months
Actigraphy for the measurement of sleep, sleep/wake patterns, physical activity, and light exposure.
Actigraphs (GT3X-BT, Pensacola, FL) worn on the wrist of the dominant hand 24 hours a day for 7 days will measure sleep duration and timing of sleep onset and waking. Wrist placement reliably measures sleep duration in adolescents. Sleep diaries will be completed. Monitor-wear logs will identify times the accelerometer is removed and the activity engaged in while the monitor is off. The photocell contained in the Actigraph GT3X-BT will be used to measure ambient light exposure. Accelerometers have been extensively used to assess children's physical activity (PA). Five days of monitoring had 0.8 reliability of accurately capturing the habitual PA of children. Activity counts captured in 5-second epochs will be categorized into sedentary, light, moderate, and vigorous PA using established cut points.
Measured: 0 months, 3 months, 12 months and 15 months
Body composition
Since BMI can misrepresent adiposity among muscular and slender children, use of additional body fat indicators has been recommended. Investigators will assess percent body fat using Bod Pod.
Measured: 0 months, 3 months, 12 months and 15 months
Dietary Assessment
The Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA-24)174 will be used to assess children's dietary intake (e.g., total daily caloric intake, timing of intake, timing of the last eating episode of the day). As recommended, parents will complete the adult version of the ASA-24, providing proxy report of their child's dietary intake. Investigators will use 3 days of diet assessment as 3 days optimize the prediction of doubly labeled water estimated energy expenditure.
Measured: 0 months, 3 months, 12 months and 15 months
Parenting Structure
Comprehensive General Parenting Questionnaire (CGPQ) is a parent report of parenting practices among parents of 5-13 year olds. Investigators will assess subscales related to parenting structure (inconsistent discipline, consistency, organization, and scaffolding). There is support for the construct validity of the CGPQ. Parenting structure subscales have demonstrated acceptable to good internal reliability (ranging from .67-.74). Subscale scores range from 5 to 25. Higher scores indicate higher levels of structure.
Measured: 0 months, 3 months, 12 months and 15 months
Bedtime Routines
The Bedtimes Routines Questionnaire (BRQ), is a 31-item parent report measure of children's bedtime routines, comprised of three scales measuring consistency of bedtime routines (weekday \& weekend), reactivity to changes in bedtime routines, and frequency of adaptive and maladaptive activities. The BRQ scales had good internal consistency ranging from α = 0.69 to 0.90. Scores on the consistency and adaptive behavior subscales range from 10 to 50 with higher scores reflecting more consistent bedtime routines and higher. The reactivity scale scores range from 5 to 25 with higher scores reflecting greater reactivity. The maladaptive behavior scale has possible scores ranging from 6 to 30 with higher scores reflecting more maladaptive behaviors.
Measured: 0 months, 3 months, 12 months and 15 months
Summer Care Arrangements
How Children Spend their Summer (e.g., children's involvement in summer school, child care, entertainment programs, as well as day or overnight camps) will be assessed by a parent report survey based on a modified version of the Early Childhood Longitudinal Program Kindergarten Class' parent interview on summer activities. The Girl's Health Enrichment Multisite Studies demographic protocol will be employed with parents.
Measured: 0 months, 3 months, 12 months and 15 months
Stress (Parent)
Perceived Stress Scale (PSS-10) is a 10-item self-report measure of perceived stress with established acceptable psychometric properties(α's >.70, test-retest criterion coefficient >.7, validated factor structure and evidence of convergent validity). Scores range from 0 to 40 with higher scores reflecting higher levels of perceived stress.
Measured: 0 months, 3 months, 12 months and 15 months
Social Support (Parent)
Interpersonal Support Evaluation List (ISEL) is a 12-item self-report measure of the perceived availability of social support (i.e. Tangible, appraisal, and belonging). The ISEL has demonstrated good reliability. The "tangible" subscale assesses perceived availability of resources and material aid; the "appraisal" subscale assesses the perceived availability of another individual(s) to discuss one's problems; the "self-esteem" subscale assesses the perceived availability of someone to compare one's self to in a positive manner; and the "belonging" subscale, the perceived availability of having others to socialize and do things with. Scores range from 0-30 on each scale with greater scores indicating higher levels of social support.
Measured: 0 months, 3 months, 12 months and 15 months
Motivation to Continue in the Program
The Treatment Questionnaire Concerning Continued Program Participation was originally developed to assess reasons for continuing to participate in a weight-loss program. We have adapted it assess reasons for continuing to participate focused on addressing children's sleep during summer. Scores in the Autonomous Regulation scale range from 5 to 35 and scores on the Controlled Regulation range from 8 to 56. Higher scores reflect higher levels of Autonomous and Controlled regulation.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2020
- Study start15 Mar 2021
- Primary completion18 Aug 2023
- Study completion18 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Obesity PreventionStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Jennette P. Moreno, Baylor College of Medicine
- Investigators
- Jennette Moreno, Principal investigator, Baylor College of MedicineHafza Dadabhoy, MS, Study director, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04445740
- Sponsor's protocol ID
- H-47369
- Other IDs
- R00HD091396
- Status last verified
- Oct 2023
- First submitted
- 26 May 2020
- Last updated
- 25 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35576573Moreno 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.
PubMed 35275213
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Acceptability, and Preliminary Efficacy of the i Heart Rhythm Project
- ClinicalTrials.gov ID
- NCT04445740
- Acronym / sponsor ID
- H-47369
- Conditions
- Obesity Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 18 Aug 2023 (actual)
- Study completion
- 18 Aug 2023 (actual)
- First posted
- 24 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: i♥rhythm projectParticipants will receive an intervention and will participate in assessments |
| Control | No intervention | –Participants will not receive an intervention, but will participate in assessments |
Who may qualify
- Ages
- 5 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| i♥rhythm projectbehavioral 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. | Behavioural | Intervention |
Primary outcome
Feasibility Criteria: ability to recruit the needed sample size
Time frame: 3 months
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.
Treatment Acceptability
Time frame: 3 months
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.
11 secondary outcomes
Anthropometrics
Time frame: 0 months, 3 months, 12 months and 15 months
Measurement of endogenous circadian rhythms
Time frame: 0 months, 3 months, 12 months and 15 months
Actigraphy for the measurement of sleep, sleep/wake patterns, physical activity, and light exposure.
Time frame: 0 months, 3 months, 12 months and 15 months
Body composition
Time frame: 0 months, 3 months, 12 months and 15 months
Dietary Assessment
Time frame: 0 months, 3 months, 12 months and 15 months
Parenting Structure
Time frame: 0 months, 3 months, 12 months and 15 months
Bedtime Routines
Time frame: 0 months, 3 months, 12 months and 15 months
Summer Care Arrangements
Time frame: 0 months, 3 months, 12 months and 15 months
Stress (Parent)
Time frame: 0 months, 3 months, 12 months and 15 months
Social Support (Parent)
Time frame: 0 months, 3 months, 12 months and 15 months
Motivation to Continue in the Program
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2023.
- Background: PubMed 35576573Moreno 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.
- Background: PubMed 35275213Moreno 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennette Moreno principal investigator
Baylor College of Medicine
Hafza Dadabhoy, MS study director
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing i♥rhythm project in people with Obesity Prevention, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility Criteria: ability to recruit the needed sample size (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04445740, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2023.