- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04364282
Stay In Treatment for Pediatric Weight Management (SIT)
May 24, 2023 updated by: Wake Forest University Health Sciences
War of Attrition: Predicting Dropout From Pediatric Weight Management
Attrition from pediatric weight management programs is unacceptably high, with dropout ranging from 27-73%.
This project will utilize a model that predicts dropout from treatment, increasing its power and accuracy through a multi-site observational study.
This will result in a powerful tool that will be used to decrease attrition from pediatric weight management, with the potential for widespread dissemination to improve treatment outcomes.
Study Overview
Status
Recruiting
Conditions
Detailed Description
The obesity epidemic is one of the foremost threats to the health of children and adults in the U.S today.
Multidisciplinary pediatric weight management programs have been deemed effective, with increased access to these programs strongly advocated.
However, the effectiveness of these programs is limited by attrition, with dropout ranging from 27-73%, limiting health benefits to children and inefficiently utilizing already scarce resources.
In addition to better understanding the drivers of attrition, being able to predict or forecast dropout holds great potential to improve adherence and outcomes, and modify treatment approaches to best serve the needs of families.
Using a model that isolates variables associated with attrition from pediatric weight management to forecast participant dropout, this prospective, longitudinal observational study will collect comprehensive data on child and family-, obesity-, and treatment-related variables In Stage 1, investigators will install an attrition forecasting model, the Outcomes Forecasting System (OFS), in 3 pediatric weight management programs, and build its precision and calibration using a conceptual model of adherence.
In Stage 2, we will establish external validation, installing the OFS in a fourth weight management program, and temporal validation through continued use of the OFS within the 3 original sites.
The overall goal of this project is to increase the accuracy and power of an attrition prediction model through its installation in weight management programs and to demonstrate its internal, external, and temporal validity.
A greater understanding of patient, family, and disease-specific factors that predict dropout from pediatric weight management can be utilized to prevent attrition.
By identifying the most pertinent factors driving attrition across weight management sites, new avenues for treatment and prevention will be identified.
This project will result in a valuable tool, available for dissemination across a diverse array of clinical programs to improve adherence, decrease costs, and improve outcomes.
Study Type
Observational
Enrollment (Estimated)
1100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Caroline B Young, BS
- Phone Number: 336 713 4061
- Email: cblackwe@wakehealth.edu
Study Contact Backup
- Name: Charlie D Mitchell, BS
- Phone Number: 336 716 4597
- Email: cdmitche@wakehealth.edu
Study Locations
-
-
Missouri
-
Kansas City, Missouri, United States, 64108
- Recruiting
- Children's Mercy Hospital
-
Contact:
- Kelly Dunlap, RDN
- Phone Number: 816-302-3210
- Email: kdunlap@cmh.edu
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-
North Carolina
-
Winston-Salem, North Carolina, United States, 27157
- Recruiting
- Brenner Children's Hospital
-
Contact:
- Charlie D Mitchell
- Phone Number: 336-715-4597
- Email: cdmitche@wakehealth.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Recruitment will be through existing pediatric weight management clinics.
A total of 100 child-parent dyads at each site over 2 years (300 dyads across all three sites; total of 600 participants) will be recruited.
An additional 50 dyads across sites (150 dyads total; 300 total participants) will be recruited in year 3 for temporal validation and a 4th site will also be added for external validation (100 dyads, 200 total participants).
Children ages 7-18 years, and a legal parent/guardian referred to a participating pediatric weight management program, are eligible.
Description
Inclusion Criteria:
- Child is 7-18 years of age
- Participating child has been referred to one of the participating weight management programs, and the family (child-parent dyad) has chosen to participate in said program.
- Participating child is obese (BMI ≥95th percentile for age and sex).
- Participating child provides assent to participation in the research study.
- At least one parent/guardian consents to participate (and consent to child participation).
The parent should be the primary parent accompanying the child to treatment, and the child's primary residence must be with that parent.
- Both members of the parent-child dyad must speak either English or Spanish.
Exclusion Criteria:
- Participating child cannot complete measures and study activities (non-verbal, significant developmental and behavioral challenges).
- Participating child has a chronic illness that impacts weight (i.e. cancer).
- Participating child with a genetic condition (i.e. Prader-Willi) that is associated with excessive weight.
- One member of the parent-child dyad refuses to participate in the study or does not wish to complete 6 months of treatment.
- One member of the parent-child dyad is unable to participate in 6 month follow-up data collection.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
---|
Parent-Child Dyads Taking Part in Weight-Management Programs
Participants in this study will be children and their parents taking part in existing pediatric weight-management programs at participating sites.
All participants will be seen at baseline and 6-months for data collection visits.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Attrition from weight management
Time Frame: 6 months
|
Completion of treatment is defined as completing 6 months of participation in weight-management program (attending the recommended number of visits, and still considered active after 6 months)
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body mass index (BMI) z score
Time Frame: 6 months
|
Measured in child only
|
6 months
|
Percent of the 95th percentile BMI
Time Frame: 6 months
|
Measured in child only
|
6 months
|
Body weight
Time Frame: 6 months
|
Measured in parent only
|
6 months
|
Family Health Habits
Time Frame: 6 months
|
The Family Nutrition and Physical Activity (FNPA) Screening tool will be completed by the parent and used to assess eating, activity, and other habits within the family and home environment.
No cut points or threshold have been established for determining Healthy vs Unhealthy home environments.
Researchers and practitioners should use their own discretion when interpreting scores on the FNPA.
|
6 months
|
General and psychosocial health (Parent)
Time Frame: 6 months
|
The PROMIS-29 Profile 2.0- short forms for adults will be used to assess anxiety, depression, fatigue, pain, physical function, sleep, and ability to participate in social activities.
|
6 months
|
General and psychosocial health (Child)
Time Frame: 6 months
|
The Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric/Parent Proxy Profile 25- will be used to assess anxiety, depression, fatigue, pain, physical function/mobility, and peer relationships.
Child self-report and Parent Proxy Report.
|
6 months
|
Family function (Parent report)
Time Frame: 6 months
|
Parents will complete the Family Assessment Device (FAD), General Functioning subscale (12 item) as a proxy for an overall picture of family function.
This self-report questionnaire asks a series of questions on family function and dynamics and parents will be asked to rate their response on a 4-point Likert scale where 1=strongly agree and 4=strongly disagree.
|
6 months
|
Family function (Child report)
Time Frame: 6 months
|
Child will complete the PROMIS Pediatric Family Relationships measure (short form).
This self-report questionnaire assesses the child's perception of family interactions.
Participants will be asked to respond to questions on a five-point Likert scale ranging from 1 = never to 5 = always.
|
6 months
|
Household environment (Parent report)
Time Frame: 6 months
|
Parents will be asked to complete the Confusion, Hubbub, and Order Scale (CHAOS).
The CHAOS measure is a 15-item instrument specifically designed to be administered to parents for assessing chaos in the child's home environment.
This 15-item scale is measured using a 4-point Likert scale where 1= very much like your own home and 4=not at all like your own home.
Positive items are reverse scored and higher total scores indicate higher levels of chaos and disruption in the home.
|
6 months
|
Household environment (Child report)
Time Frame: 6 months
|
Children will be asked to complete the Children's Report of Parent Behavior Inventory (CRPBI).
The CRPBI is a questionnaire that assesses three factors of parenting: acceptance vs. rejection, psychological control vs. autonomy, and firm vs. lax control.
Responses are given on a three-point scale, indicating whether an item is like, somewhat like, or not like the parent.
|
6 months
|
Stress (Parent report)
Time Frame: 6 months
|
Parents will complete the Perceived Stress Scale (PSS).
The PSS is a 14-item scale that provides a global appraisal of stress by asking respondents to report whether their lives seem to be unpredictable, uncontrollable, or overloaded.
Each item is rated on a 5-point scale ranging from never (0) to almost always (4).
Positively worded items are reverse scored, and the ratings are summed, with higher scores indicating more perceived stress.
|
6 months
|
Stress (Child report)
Time Frame: 6 months
|
Children will complete the PROMIS Psychological Stress Experience Short Form 4a.
This form is designed to capture psychological stress reactions: feeling overwhelmed, perceived lack of control of one's life, and cognitive-perceptual disruption.
Items are scored on a 5-point Likert scale where 0=never and 4=always.
Higher scores indicate worse psychological stress.
|
6 months
|
Motivation/self-efficacy
Time Frame: 6 months
|
Both parents and children will complete the Importance, Confidence, and Readiness measure.
A self-report questionnaire will assess motivation (importance, confidence, and readiness) and participants will be asked to respond to questions on a five-point Likert scale ranging from 1 = not at all to 5 = very.
|
6 months
|
Health Literacy
Time Frame: 6 months
|
Data collectors will administer the Newest Vital Sign (NVS), a health literacy tool, to parents at baseline and follow-up.
The NVS is used to measure health literacy and evaluate the impact of low health literacy on a variety of health outcomes.
The NVS is based on a nutrition label from an ice cream container.
Parents will be given the label and then asked 6 questions about it.
The number of correct responses is totaled and higher scores indicate higher levels of health literacy.
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Joseph A Skelton, MD, MS, Wake Forest University Health Sciences
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 6, 2020
Primary Completion (Estimated)
June 1, 2024
Study Completion (Estimated)
June 1, 2024
Study Registration Dates
First Submitted
April 21, 2020
First Submitted That Met QC Criteria
April 23, 2020
First Posted (Actual)
April 28, 2020
Study Record Updates
Last Update Posted (Actual)
May 25, 2023
Last Update Submitted That Met QC Criteria
May 24, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00062191
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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