Pediatric ObesitySITNCT04364282
Stay In Treatment for Pediatric Weight Management
A study testing Care team informed in people with Pediatric Obesity and Attrition, run by Wake Forest University Health Sciences at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Pediatric Obesity, Attrition, Family Research
- What is being tested?
- Care team informed
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,216 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Jul 2020to 26 Mar 2025
- 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 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Children's Mercy Hospital
Kansas City, Missouri, 64108
Brenner Children's Hospital
Winston-Salem, North Carolina, 27157
About this study
Official title: 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.
Read the 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.
- Conditions
- Pediatric Obesity, Attrition, Family Research, Weight Loss
- Being tested
- Care team informed, Control
- Medical subject headings
- Pediatric Obesity, Tooth Wear, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Care team informedOther
Members of the weight-management care team will be informed of the family's risk profile for attrition and may employ additional contacts to enhance chances of retention.
ControlOther
Members of the weight-management care team will not be aware of the family's risk profile for attrition.
| Study group | Role | What they receive |
|---|---|---|
| Care team informed | Active comparator | Participants in this study will be children and their parents taking part in existing pediatric weight-management programs at participating sites. In this group, members of the weight-management care team will be informed of the family's risk profile for attrition. Receives: Other: Care team informed |
| Control | Placebo comparator | Participants in this study will be children and their parents taking part in existing pediatric weight-management programs at participating sites. In this group, members of the weight-management care team will not be informed of the family's risk profile for attrition. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attrition from weight management
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)
Measured: 6 months
Secondary outcomes (14)
Body mass index (BMI) z score
Measured in child only
Measured: 6 months
Percent of the 95th percentile BMI
Measured in child only
Measured: 6 months
Body weight
Measured in parent only
Measured: 6 months
Family Health Habits
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.
Measured: 6 months
General and psychosocial health (Parent)
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.
Measured: 6 months
General and psychosocial health (Child)
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.
Measured: 6 months
Family function (Parent report)
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.
Measured: 6 months
Family function (Child report)
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.
Measured: 6 months
Household environment (Parent report)
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.
Measured: 6 months
Household environment (Child report)
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.
Measured: 6 months
Stress (Parent report)
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.
Measured: 6 months
Stress (Child report)
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.
Measured: 6 months
Motivation/self-efficacy
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.
Measured: 6 months
Health Literacy
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start6 Jul 2020
- Primary completion26 Mar 2025
- Study completion26 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pediatric ObesityStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill, Boston Children's Hospital, Children's Mercy Hospital Kansas City, Nationwide Children's Hospital
- Responsible party
- Sponsor
- Investigators
- Joseph A Skelton, MD, MS, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04364282
- Sponsor's protocol ID
- IRB00062191
- Acronym
- SIT
- Status last verified
- Mar 2026
- First submitted
- 21 Apr 2020
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Skelton JA, Rhodes ET, Hampl SE, Eneli I, Ip EH; SIT Study Research Group. Proximal and Distal Factors Associated With Obesity in Childhood: An Exploratory Structural Equation Model. Obes Sci Pract. 2026 Feb 27;12(2):e70124. doi: 10.1002/osp4.70124. eCollection 2026 Apr.
PubMed 41767161Fleischman A, Hampl S, Rhodes ET, Sweeney B, Eneli I, Skelton JA. Implementation of recommended treatment for children in weight management programs: Lessons from the stay in treatment study sites. Prev Med. 2024 May;182:107949. doi: 10.1016/j.ypmed.2024.107949. Epub 2024 Apr 5.
PubMed 38583602Berry DC, Rhodes ET, Hampl S, Young CB, Cohen G, Eneli I, Fleischman A, Ip E, Sweeney B, Houle TT, Skelton J. Stay in treatment: Predicting dropout from pediatric weight management study protocol. Contemp Clin Trials Commun. 2021 Jun 9;22:100799. doi: 10.1016/j.conctc.2021.100799. eCollection 2021 Jun.
PubMed 34169176
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- War of Attrition: Predicting Dropout From Pediatric Weight Management
- ClinicalTrials.gov ID
- NCT04364282
- Acronym / sponsor ID
- SIT / IRB00062191
- Conditions
- Pediatric Obesity, Attrition, Family Research, Weight Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,216 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill, Boston Children's Hospital, Children's Mercy Hospital Kansas City, Nationwide Children's Hospital
- Study start
- 6 Jul 2020 (actual)
- Primary completion
- 26 Mar 2025 (actual)
- Study completion
- 26 Mar 2025 (actual)
- First posted
- 28 Apr 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.
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.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Care team informed | Active comparator | Other: Care team informedParticipants in this study will be children and their parents taking part in existing pediatric weight-management programs at participating sites. In this group, members of the weight-management care team will be informed of the family's risk profile for attrition. |
| Control | Placebo comparator | Other: ControlParticipants in this study will be children and their parents taking part in existing pediatric weight-management programs at participating sites. In this group, members of the weight-management care team will not be informed of the family's risk profile for attrition. |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Care team informedMembers of the weight-management care team will be informed of the family's risk profile for attrition and may employ additional contacts to enhance chances of retention. | Other | Care team informed |
| ControlMembers of the weight-management care team will not be aware of the family's risk profile for attrition. | Other | Control |
Primary outcome
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)
14 secondary outcomes
Body mass index (BMI) z score
Time frame: 6 months
Percent of the 95th percentile BMI
Time frame: 6 months
Body weight
Time frame: 6 months
Family Health Habits
Time frame: 6 months
General and psychosocial health (Parent)
Time frame: 6 months
General and psychosocial health (Child)
Time frame: 6 months
Family function (Parent report)
Time frame: 6 months
Family function (Child report)
Time frame: 6 months
Household environment (Parent report)
Time frame: 6 months
Household environment (Child report)
Time frame: 6 months
Stress (Parent report)
Time frame: 6 months
Stress (Child report)
Time frame: 6 months
Motivation/self-efficacy
Time frame: 6 months
Health Literacy
Time frame: 6 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 15 Jun 2026.
- Background: PubMed 41767161Skelton JA, Rhodes ET, Hampl SE, Eneli I, Ip EH; SIT Study Research Group. Proximal and Distal Factors Associated With Obesity in Childhood: An Exploratory Structural Equation Model. Obes Sci Pract. 2026 Feb 27;12(2):e70124. doi: 10.1002/osp4.70124. eCollection 2026 Apr.
- Background: PubMed 38583602Fleischman A, Hampl S, Rhodes ET, Sweeney B, Eneli I, Skelton JA. Implementation of recommended treatment for children in weight management programs: Lessons from the stay in treatment study sites. Prev Med. 2024 May;182:107949. doi: 10.1016/j.ypmed.2024.107949. Epub 2024 Apr 5.
- Background: PubMed 34169176Berry DC, Rhodes ET, Hampl S, Young CB, Cohen G, Eneli I, Fleischman A, Ip E, Sweeney B, Houle TT, Skelton J. Stay in treatment: Predicting dropout from pediatric weight management study protocol. Contemp Clin Trials Commun. 2021 Jun 9;22:100799. doi: 10.1016/j.conctc.2021.100799. eCollection 2021 Jun.
- 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.
Joseph A Skelton, MD, MS principal investigator
Wake Forest University Health Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Care team informed in people with Pediatric Obesity and Attrition, run by Wake Forest University Health Sciences at 2 sites 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 5 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 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
Attrition from weight management (time frame: 6 months). 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 NCT04364282, which also lists 3 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 15 Jun 2026.