Childhood ObesityFBT 2NCT06728800
Leveraging Interactive Digital Technology to Increase Access to Family-Based Behavioral Treatment for Childhood Obesity
A study testing FBT 2.0 in people with Childhood Obesity, run by 3-C Institute for Social Development at 1 site in United States.
Trial summary
The primary goal of this SBIR Direct to Phase II is to expand upon the existing training platform to create an "all-in-one" digital product, FBT 2.0, that offers an integrated suite of intervention components, including (a) dynamic, personalized, self-paced program for children and parent/caregivers; (b) e-training… Read more about this study
- Who is it for?
- Ages 6 years and olderHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- FBT 2.0
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- must be youth between the ages of 6 and 17
- must have a body mass index (BMI) percentile greater than or equal to the 85th BMI percentile for age and sex
- must have one caregiver participate, who is at least 18 years of age and lives with the child at least 50% of the time.
- the participating caregiver must have a body mass index (BMI) of 25 or greater
- youth and caregiver must be English proficient
- family must have reliable internet access and a working scale in the home
Who cannot join
- co-morbid disorders that contraindicate weight loss (e.g., eating disorder).
- caregiver has a medical or psychiatric condition in which weight loss is contraindicated (e.g., pregnancy)
- youth is unable to provide assent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
3C Institute
Durham, North Carolina, 27713
Melissa DeRosier, PhD
Melissa DeRosier, PhD
About this study
The primary goal of this SBIR Direct to Phase II is to expand upon the existing training platform to create an "all-in-one" digital product, FBT 2.0, that offers an integrated suite of intervention components, including (a) dynamic, personalized, self-paced program for children and parent/caregivers; (b) e-training and ongoing support for interventionists; and (c) family engagement and monitoring tools for interventionists. Investigators will create a comprehensive, e-learning digital intervention with engaging, interactive, and personalized online tools for youth and their parents/caregivers that are integrated into the broader interventionist platform.
Read the detailed description
The primary goal of this SBIR Direct to Phase II is to expand upon the existing training platform to create an "all-in-one" digital product, FBT 2.0, that offers an integrated suite of intervention components, including (a) dynamic, personalized, self-paced program for children and parent/caregivers; (b) e-training and ongoing support for interventionists; and (c) family engagement and monitoring tools for interventionists. Investigators will create a comprehensive, e-learning digital intervention with engaging, interactive, and personalized online tools for youth and their parents/caregivers that are integrated into the broader interventionist platform. For the Pilot test , investigators will randomize enrolled caregiver-youth dyads (stratified by age group, i.e., 6 to 12, > 12) to one of three delayed-start cohorts with a 1-, 2-, or 3-month control period, after which all dyads receive FBT 2.0. Dyads assigned to receive FBT 2.0 will receive all eight modules over the 4-month treatment period, completing approximately one module every two weeks. Dyads will have free access to all completed modules for the duration of the treatment period, until the 6-month follow-up. Each module is expected to take approximately two to three sessions to complete, each session lasting approximately 45 minutes. At least one interventionist-led session (20-30 minutes) will occur per week, with additional sessions or coach support as needed via text exchange and/or videoconferencing supported on the website. Families will be able to engage with the software for as long as desired during the trial.
All caregiver-youth dyads receive the FBT 2.0 intervention. At enrollment, dyads are randomized to one of three delayed-start cohorts that begin treatment after a 1-, 2-, or 3-month control period. During the control period, dyads receive a link to American Academy of Pediatrics educational materials on healthy eating, physical activity, screen time, and sleep, and complete weight measurements; no treatment components are delivered. Prior to enrollment, dyads complete a 1-week run-in during which the caregiver and youth each log daily dietary intake using an online dietary tracking survey; dyads in which both members complete diary entries on at least 5 of 7 days are enrolled.
The same set of outcome measures will be collected for children and caregivers at four timepoints: (1) baseline (prior to randomization); (2) post-control (at the end of the assigned 1-, 2-, or 3-month control period); (3) post-treatment (after the 4-month intervention); and (4) at 2-month follow-up. Software usage data will be collected throughout the intervention period, and product evaluations will be collected at post-intervention.
- Conditions
- Childhood Obesity
- Being tested
- FBT 2.0, Delayed-Start Control (AAP educational materials)
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FBT 2.0Behavioural
FBT 2.0 is a translation of Family-Based Behavioral Treatment (FBT) into an e-health intervention product for families with a child/adolescent with obesity. FBT is an evidence-based obesity intervention that takes a family-centered approach to weight management that includes training in behavioral skills for the family, such as self-monitoring, stimulus control, problem solving, pre-planning, and impulse control. Youth with obesity, along with one participating caregiver, will be introduced to the evidence- based Traffic Light Eating Plan and behavioral skill training appropriate for their developmental age, while the caregiver learns positive parenting approaches to help shape and support their child's weight change efforts in addition to their own weight management goals. The final product will consist of eight modules, each aligned with evidence-based FBT skills and competencies.
Delayed-Start Control (AAP educational materials)Behavioural
All caregiver-youth dyads receive the FBT 2.0 intervention. At enrollment, dyads are randomized to one of three delayed-start cohorts that begin treatment after a 1-, 2-, or 3-month control period. During the control period, dyads receive a link to American Academy of Pediatrics educational materials on healthy eating, physical activity, screen time, and sleep, and complete weight measurements; no treatment components are delivered. Prior to enrollment, dyads complete a 1-week run-in during which the caregiver and youth each log daily dietary intake using an online dietary tracking survey; dyads in which both members complete diary entries on at least 5 of 7 days are enrolled.
| Study group | Role | What they receive |
|---|---|---|
| FBT 2.0 | Experimental | Dyads assigned to receive FBT 2.0 will receive all eight modules over the 4-month treatment period, completing approximately one module every two weeks. Dyads will have free access to all completed modules for the duration of the treatment period Each module is expected to take approximately two to three sessions to complete, each session lasting approximately 45 minutes. At least one interventionist-led session (20-30 minutes) will occur per week, with additional sessions or coach support as needed via text exchange and/or videoconferencing supported on the website. Families will be able to engage with the software for as long as desired during the trial. Receives: Behavioral: FBT 2.0 |
| Delayed-Start Control | Other | All caregiver-youth dyads receive the FBT 2.0 intervention. At enrollment, dyads are randomized to one of three delayed-start cohorts that begin treatment after a 1-, 2-, or 3-month control period. During the control period, dyads receive a link to American Academy of Pediatrics educational materials on healthy eating, physical activity, screen time, and sleep, and complete weight measurements; no treatment components are delivered. Prior to enrollment, dyads complete a 1-week run-in during which the caregiver and youth each log daily dietary intake using an online dietary tracking survey; dyads in which both members complete diary entries on at least 5 of 7 days are enrolled. Receives: Behavioral: Delayed-Start Control (AAP educational materials) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative Weight
Youth: The participating caregiver is given the CDC guidelines for "Measuring Children's Height and Weight Accurately at Home." The FBT coach will review these guidelines with the caregiver to assure comprehension. Median body mass index (BMI) for that child's age (in months) and sex is based on norms defined by Kuczmarski and colleagues and available from the CDC. Percent overweight was chosen as the primary outcome measure given its sensitivity to change throughout the BMI range. Caregiver: Exploratory analyses will examine caregiver weight change, defined as percent change from weight at baseline, among caregivers who have obesity (BMI ≥ 30) at baseline.
Measured: Baseline, post-control (1 to 3 months depending on Cohort), post-treatment (4 months), and 2-month follow-up (6 months)
Youth Pediatric Symptom Checklist-17
Youth: The Pediatric Symptom Checklist-17 is a widely used, briefer version of the PSC-35, a caregiver-completed measure of children's psychosocial functioning, where caregivers rate each symptom on a scale of 0-2, where 0 means never, 1 means sometimes, and 2 means often.
Measured: Baseline, post-control (1 to 3 months depending on Cohort), post-treatment (4 months), and 2-month follow-up (6 months)
Youth Center for Epidemiological Studies Depression Scale for Children
Youth: Depression is measured in children using a 20-item Center for Epidemiological Studies Depression Scale for Children. Possible scores range from 0-60 with each item response scored as 0 = Not At All, 1 = A Little, 2 = Some, and 3 = A Lot.
Measured: Baseline, post-control (1 to 3 months depending on Cohort), post-treatment (4 months), and 2-month follow-up (6 months)
Caregiver Adult Patient Health Questionnaire
Caregiver: Adults complete the 2- item Patient Health Questionnaire to measure depression. Each symptom is scored on a scale of 0-3, with 0 = Not At All, 1 = Several Days, 2 = More than half the Days, and 3 = Nearly every day.
Measured: Baseline, post-control (1 to 3 months depending on Cohort), post-treatment (4 months), and 2-month follow-up (6 months)
Family Nutrition and Physical Activity Screening Tool
The Family Nutrition \& Physical Activity Screening Tool is a 20-item parent-report scale designed to assess family environments and practices that have been shown to be associated with children's risk of becoming overweight. Each item is scored on a 1-4 point scale with 4 representing the more favorable practice or policy.
Measured: Baseline, post-control (1 to 3 months depending on Cohort), post-treatment (4 months), and 2-month follow-up (6 months)
Caregiver Generalized Anxiety Disorder-7 (GAD-7)
Caregiver: The GAD-7 is a 7-item measure of anxiety symptoms. Items are scored 0-3; total scores range 0-21, with higher scores indicating greater anxiety severity.
Measured: Baseline, post-control (1 to 3 months depending on Cohort), post-treatment (4 months), and 2-month follow-up (6 months)
Youth Screen for Child Anxiety Related Disorders (SCARED)
Youth: The 5-item SCARED is a brief screening measure for child anxiety disorders. Items are scored 0-2; total scores range 0-10, with higher scores indicating greater anxiety and scores of 3 or higher indicating possible anxiety disorder.
Measured: Baseline, post-control (1 to 3 months depending on Cohort), post-treatment (4 months), and 2-month follow-up (6 months)
Caregiver Brief Eating Disorder Examination Questionnaire (EDE-Q Brief)
Caregiver: The EDE-Q Brief is a brief self-report version of the Eating Disorder Examination Questionnaire assessing eating disorder psychopathology. Higher scores indicate greater eating disorder pathology.
Measured: Baseline, post-control (1 to 3 months depending on Cohort), post-treatment (4 months), and 2-month follow-up (6 months)
Youth Brief Eating Disorder Examination Questionnaire (Youth EDE-Q Brief)
Youth: The Youth EDE-Q Brief (Body U) is a brief youth-report version of the Youth Eating Disorder Examination Questionnaire assessing eating disorder psychopathology. Higher scores indicate greater eating disorder pathology.
Measured: Baseline, post-control (1 to 3 months depending on Cohort), post-treatment (4 months), and 2-month follow-up (6 months)
Experiences of Weight Stigma
Experiences of weight-based stigma will be assessed by self-report for caregivers and youth, with higher scores indicating more frequent experiences of weight stigma.
Measured: Baseline, post-control (1 to 3 months depending on Cohort), post-treatment (4 months), and 2-month follow-up (6 months)
Youth Experiences with Teasing and Bullying
Youth: The Experiences with Teasing and Bullying measure is a 12-item youth-report tool evaluating experiences of teasing and bullying, administered verbally for children under age 8. Higher scores indicate more frequent experiences.
Measured: Baseline, post-control (1 to 3 months depending on Cohort), post-treatment (4 months), and 2-month follow-up (6 months)
Food Insecurity (Hunger Vital Sign)
Caregiver: The Hunger Vital Sign is a validated 2-item food insecurity screener. An affirmative response to either item indicates risk of household food insecurity.
Measured: Baseline, post-control (1 to 3 months depending on Cohort), post-treatment (4 months), and 2-month follow-up (6 months)
Delay Discounting
Youth and Caregiver: The Delay Discounting Task measures the tendency to discount the value of delayed rewards. Steeper discounting rates indicate greater preference for immediate rewards.
Measured: Baseline, post-control (1 to 3 months depending on Cohort), post-treatment (4 months), and 2-month follow-up (6 months)
Relative Reinforcing Efficacy of Food
Youth and Caregiver: The relative reinforcing value of food is measured by questionnaire, with higher scores indicating greater reinforcing value of food relative to alternative activities.
Measured: Baseline, post-control (1 to 3 months depending on Cohort), post-treatment (4 months), and 2-month follow-up (6 months)
Automated Self-Administered 24-hour Dietary Assessment Tool
The Automated Self-Administered 24-hour (ASA24®) Dietary Assessment Tool is a free, web-based tool that enables automatically coded, self-administered 24-hour diet recalls that will be completed by the participating adolescent aged 13 or older, or with the caregiver's assistance (for youth < 13 years of age). The caregiver will also complete a 24-hour dietary recall for their own intake. Outcomes will be average daily kilocalories, fruit and vegetable servings, and percentage intake from fat.
Measured: Baseline, post-control (1 to 3 months depending on Cohort), post-treatment (4 months), and 2-month follow-up (6 months)
Physical activity
Objective physical activity will be assessed for youth and caregivers using accelerometers worn on the wrist during sleep and daily activities for seven days at each assessment time point. Outcomes will be minutes of moderate or vigorous activity (physical activity) and minutes of sedentary activity.
Measured: 7 days at each assessment timepoint
Caregiver PROMIS Global Health
Caregiver: The PROMIS Global Health scale (v1.2) is a 10-item measure of overall physical and mental health-related quality of life. Items are scored on 5-point scales; raw scores are converted to T-scores, with higher scores indicating better health.
Measured: Baseline, post-control (1 to 3 months depending on Cohort), post-treatment (4 months), and 2-month follow-up (6 months)
Youth PROMIS Pediatric Global Health
Youth: The PROMIS Pediatric Global Health 7+2 is a 9-item child-report measure of perceived physical, mental, and social health. Raw scores are converted to T-scores, with higher scores indicating better global health.
Measured: Baseline, post-control (1 to 3 months depending on Cohort), post-treatment (4 months), and 2-month follow-up (6 months)
Intervention Feedback
Caregivers and youth in both conditions will provide feedback regarding their experiences during the trial period. On a 5-point scale (1=Strongly Disagree to 5=Strongly Agree), respondents will rate the degree to which their experience was: (a) useful for increasing knowledge of weight-related behaviors; (b) useful for learning self-management skills; (c) helped with changing unhealthy behaviors; (d) valuable for families and youth with obesity; (e) engaging for families; (f) innovative compared to alternatives; and (g) better than alternatives. Additionally, child and parent satisfaction with FBT will be assessed at the end of treatment using the 8-item Client Satisfaction Questionnaire. Participants will also be asked to provide written comments, listing specific concerns or problems. Follow-up interviews via telephone by trained research assistants will be conducted to clarify responses and gather additional details, as needed.
Measured: At completion of the 4-month intervention
Product Evaluation
In addition, participants will rate (5-point scale from 1=Not at all to 5=Extremely) the quality of FBT 2.0 in the following areas: (a) user friendly; (b) easy to navigate; (c) appealing graphic design; (d) easy to follow directions; (e) jargon free; (f) engaging; (g) high quality content; (h) high value content; (i) relevance to real-life; (j) login functions; (k) search functions; and (l) help functions.
Measured: At completion of the 4-month intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start1 Oct 2026 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- delayed-start: all dyads receive FBT 2.0 after a randomized 1-, 2-, or 3-month control period
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- 3-C Institute for Social Development
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Washington University School of Medicine, University at Buffalo
- Responsible party
- Sponsor
- Investigators
- Melissa DeRosier, PhD, Principal investigator, 3C InstituteDenise Wilfley, PhD, Principal investigator, Washington University School of MedicineLeonard Epstein, PhD, Principal investigator, University at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06728800
- Sponsor's protocol ID
- FBT 2.0 DPII
- Acronym
- FBT 2
- Status last verified
- Sep 2026
- First submitted
- 6 Dec 2024
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data generated by this project will be made available upon request after the publication of the main findings from each aim. Investigators will require parties requesting data access to submit a detailed description of their plans for the data with their personal identification, institutional affiliation, a CV, estimated duration of the proposed research, source of financial support, and a conflict-of-interest statement. The MPIs will decide whether sharing of the data is appropriate or if other information and/or additional safeguards are needed. Once the request is approved, data transfer and use agreements will be developed if necessary, and the requesting investigator must obtain approval from their institution's IRB or request to rely on the IRB of record. Appropriate de- identification techniques required by both HIPAA and the Common Rule will allow for sharing of data that does not compromise participant confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leveraging Interactive Digital Technology to Increase Access to Family-Based Behavioral Treatment for Childhood Obesity
- ClinicalTrials.gov ID
- NCT06728800
- Acronym / sponsor ID
- FBT 2 / FBT 2.0 DPII
- Conditions
- Childhood Obesity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- 3-C Institute for Social DevelopmentIndustry (pharma, biotech, devices)
- Collaborators
- Washington University School of Medicine, University at Buffalo
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 11 Dec 2024 (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.
The primary goal of this SBIR Direct to Phase II is to expand upon the existing training platform to create an "all-in-one" digital product, FBT 2.0, that offers an integrated suite of intervention components, including (a) dynamic, personalized, self-paced program for children and parent/caregivers; (b) e-training and ongoing support for interventionists; and (c) family engagement and monitoring tools for interventionists. Investigators will create a comprehensive, e-learning digital intervention with engaging, interactive, and personalized online tools for youth and their parents/caregivers that are integrated into the broader interventionist platform.
Detailed description
The primary goal of this SBIR Direct to Phase II is to expand upon the existing training platform to create an "all-in-one" digital product, FBT 2.0, that offers an integrated suite of intervention components, including (a) dynamic, personalized, self-paced program for children and parent/caregivers; (b) e-training and ongoing support for interventionists; and (c) family engagement and monitoring tools for interventionists. Investigators will create a comprehensive, e-learning digital intervention with engaging, interactive, and personalized online tools for youth and their parents/caregivers that are integrated into the broader interventionist platform. For the Pilot test , investigators will randomize enrolled caregiver-youth dyads (stratified by age group, i.e., 6 to 12, > 12) to one of three delayed-start cohorts with a 1-, 2-, or 3-month control period, after which all dyads receive FBT 2.0. Dyads assigned to receive FBT 2.0 will receive all eight modules over the 4-month treatment period, completing approximately one module every two weeks. Dyads will have free access to all completed modules for the duration of the treatment period, until the 6-month follow-up. Each module is expected to take approximately two to three sessions to complete, each session lasting approximately 45 minutes. At least one interventionist-led session (20-30 minutes) will occur per week, with additional sessions or coach support as needed via text exchange and/or videoconferencing supported on the website. Families will be able to engage with the software for as long as desired during the trial.
All caregiver-youth dyads receive the FBT 2.0 intervention. At enrollment, dyads are randomized to one of three delayed-start cohorts that begin treatment after a 1-, 2-, or 3-month control period. During the control period, dyads receive a link to American Academy of Pediatrics educational materials on healthy eating, physical activity, screen time, and sleep, and complete weight measurements; no treatment components are delivered. Prior to enrollment, dyads complete a 1-week run-in during which the caregiver and youth each log daily dietary intake using an online dietary tracking survey; dyads in which both members complete diary entries on at least 5 of 7 days are enrolled.
The same set of outcome measures will be collected for children and caregivers at four timepoints: (1) baseline (prior to randomization); (2) post-control (at the end of the assigned 1-, 2-, or 3-month control period); (3) post-treatment (after the 4-month intervention); and (4) at 2-month follow-up. Software usage data will be collected throughout the intervention period, and product evaluations will be collected at post-intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- delayed-start: all dyads receive FBT 2.0 after a randomized 1-, 2-, or 3-month control period
| Arm | Type | Receives |
|---|---|---|
| FBT 2.0 | Experimental | Behavioral: FBT 2.0Dyads assigned to receive FBT 2.0 will receive all eight modules over the 4-month treatment period, completing approximately one module every two weeks. Dyads will have free access to all completed modules for the duration of the treatment period Each module is expected to take approximately two to three sessions to complete, each session lasting approximately 45 minutes. At least one interventionist-led session (20-30 minutes) will occur per week, with additional sessions or coach support as needed via text exchange and/or videoconferencing supported on the website. Families will be able to engage with the software for as long as desired during the trial. |
| Delayed-Start Control | Other | Behavioral: Delayed-Start Control (AAP educational materials)All caregiver-youth dyads receive the FBT 2.0 intervention. At enrollment, dyads are randomized to one of three delayed-start cohorts that begin treatment after a 1-, 2-, or 3-month control period. During the control period, dyads receive a link to American Academy of Pediatrics educational materials on healthy eating, physical activity, screen time, and sleep, and complete weight measurements; no treatment components are delivered. Prior to enrollment, dyads complete a 1-week run-in during which the caregiver and youth each log daily dietary intake using an online dietary tracking survey; dyads in which both members complete diary entries on at least 5 of 7 days are enrolled. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- must be youth between the ages of 6 and 17
- must have a body mass index (BMI) percentile greater than or equal to the 85th BMI percentile for age and sex
- must have one caregiver participate, who is at least 18 years of age and lives with the child at least 50% of the time.
- the participating caregiver must have a body mass index (BMI) of 25 or greater
- youth and caregiver must be English proficient
Key exclusion criteria (3 listed)
- co-morbid disorders that contraindicate weight loss (e.g., eating disorder).
- caregiver has a medical or psychiatric condition in which weight loss is contraindicated (e.g., pregnancy)
- youth is unable to provide assent
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 |
|---|---|---|
| FBT 2.0FBT 2.0 is a translation of Family-Based Behavioral Treatment (FBT) into an e-health intervention product for families with a child/adolescent with obesity. FBT is an evidence-based obesity intervention that takes a family-centered approach to weight management that includes training in behavioral skills for the family, such as self-monitoring, stimulus control, problem solving, pre-planning, and impulse control. Youth with obesity, along with one participating caregiver, will be introduced to the evidence- based Traffic Light Eating Plan and behavioral skill training appropriate for their developmental age, while the caregiver learns positive parenting approaches to help shape and support their child's weight change efforts in addition to their own weight management goals. The final product will consist of eight modules, each aligned with evidence-based FBT skills and competencies. | Behavioural | FBT 2.0 |
| Delayed-Start Control (AAP educational materials)All caregiver-youth dyads receive the FBT 2.0 intervention. At enrollment, dyads are randomized to one of three delayed-start cohorts that begin treatment after a 1-, 2-, or 3-month control period. During the control period, dyads receive a link to American Academy of Pediatrics educational materials on healthy eating, physical activity, screen time, and sleep, and complete weight measurements; no treatment components are delivered. Prior to enrollment, dyads complete a 1-week run-in during which the caregiver and youth each log daily dietary intake using an online dietary tracking survey; dyads in which both members complete diary entries on at least 5 of 7 days are enrolled. | Behavioural | Delayed-Start Control |
Primary outcome
Relative Weight
Time frame: Baseline, post-control (1 to 3 months depending on Cohort), post-treatment (4 months), and 2-month follow-up (6 months)
Youth: The participating caregiver is given the CDC guidelines for "Measuring Children's Height and Weight Accurately at Home." The FBT coach will review these guidelines with the caregiver to assure comprehension. Median body mass index (BMI) for that child's age (in months) and sex is based on norms defined by Kuczmarski and colleagues and available from the CDC. Percent overweight was chosen as the primary outcome measure given its sensitivity to change throughout the BMI range. Caregiver: Exploratory analyses will examine caregiver weight change, defined as percent change from weight at baseline, among caregivers who have obesity (BMI ≥ 30) at baseline.
Youth Pediatric Symptom Checklist-17
Time frame: Baseline, post-control (1 to 3 months depending on Cohort), post-treatment (4 months), and 2-month follow-up (6 months)
Youth: The Pediatric Symptom Checklist-17 is a widely used, briefer version of the PSC-35, a caregiver-completed measure of children's psychosocial functioning, where caregivers rate each symptom on a scale of 0-2, where 0 means never, 1 means sometimes, and 2 means often.
Youth Center for Epidemiological Studies Depression Scale for Children
Time frame: Baseline, post-control (1 to 3 months depending on Cohort), post-treatment (4 months), and 2-month follow-up (6 months)
Youth: Depression is measured in children using a 20-item Center for Epidemiological Studies Depression Scale for Children. Possible scores range from 0-60 with each item response scored as 0 = Not At All, 1 = A Little, 2 = Some, and 3 = A Lot.
Caregiver Adult Patient Health Questionnaire
Time frame: Baseline, post-control (1 to 3 months depending on Cohort), post-treatment (4 months), and 2-month follow-up (6 months)
Caregiver: Adults complete the 2- item Patient Health Questionnaire to measure depression. Each symptom is scored on a scale of 0-3, with 0 = Not At All, 1 = Several Days, 2 = More than half the Days, and 3 = Nearly every day.
Family Nutrition and Physical Activity Screening Tool
Time frame: Baseline, post-control (1 to 3 months depending on Cohort), post-treatment (4 months), and 2-month follow-up (6 months)
The Family Nutrition \& Physical Activity Screening Tool is a 20-item parent-report scale designed to assess family environments and practices that have been shown to be associated with children's risk of becoming overweight. Each item is scored on a 1-4 point scale with 4 representing the more favorable practice or policy.
Caregiver Generalized Anxiety Disorder-7 (GAD-7)
Time frame: Baseline, post-control (1 to 3 months depending on Cohort), post-treatment (4 months), and 2-month follow-up (6 months)
Caregiver: The GAD-7 is a 7-item measure of anxiety symptoms. Items are scored 0-3; total scores range 0-21, with higher scores indicating greater anxiety severity.
Youth Screen for Child Anxiety Related Disorders (SCARED)
Time frame: Baseline, post-control (1 to 3 months depending on Cohort), post-treatment (4 months), and 2-month follow-up (6 months)
Youth: The 5-item SCARED is a brief screening measure for child anxiety disorders. Items are scored 0-2; total scores range 0-10, with higher scores indicating greater anxiety and scores of 3 or higher indicating possible anxiety disorder.
Caregiver Brief Eating Disorder Examination Questionnaire (EDE-Q Brief)
Time frame: Baseline, post-control (1 to 3 months depending on Cohort), post-treatment (4 months), and 2-month follow-up (6 months)
Caregiver: The EDE-Q Brief is a brief self-report version of the Eating Disorder Examination Questionnaire assessing eating disorder psychopathology. Higher scores indicate greater eating disorder pathology.
Youth Brief Eating Disorder Examination Questionnaire (Youth EDE-Q Brief)
Time frame: Baseline, post-control (1 to 3 months depending on Cohort), post-treatment (4 months), and 2-month follow-up (6 months)
Youth: The Youth EDE-Q Brief (Body U) is a brief youth-report version of the Youth Eating Disorder Examination Questionnaire assessing eating disorder psychopathology. Higher scores indicate greater eating disorder pathology.
Experiences of Weight Stigma
Time frame: Baseline, post-control (1 to 3 months depending on Cohort), post-treatment (4 months), and 2-month follow-up (6 months)
Experiences of weight-based stigma will be assessed by self-report for caregivers and youth, with higher scores indicating more frequent experiences of weight stigma.
Youth Experiences with Teasing and Bullying
Time frame: Baseline, post-control (1 to 3 months depending on Cohort), post-treatment (4 months), and 2-month follow-up (6 months)
Youth: The Experiences with Teasing and Bullying measure is a 12-item youth-report tool evaluating experiences of teasing and bullying, administered verbally for children under age 8. Higher scores indicate more frequent experiences.
Food Insecurity (Hunger Vital Sign)
Time frame: Baseline, post-control (1 to 3 months depending on Cohort), post-treatment (4 months), and 2-month follow-up (6 months)
Caregiver: The Hunger Vital Sign is a validated 2-item food insecurity screener. An affirmative response to either item indicates risk of household food insecurity.
Delay Discounting
Time frame: Baseline, post-control (1 to 3 months depending on Cohort), post-treatment (4 months), and 2-month follow-up (6 months)
Youth and Caregiver: The Delay Discounting Task measures the tendency to discount the value of delayed rewards. Steeper discounting rates indicate greater preference for immediate rewards.
Relative Reinforcing Efficacy of Food
Time frame: Baseline, post-control (1 to 3 months depending on Cohort), post-treatment (4 months), and 2-month follow-up (6 months)
Youth and Caregiver: The relative reinforcing value of food is measured by questionnaire, with higher scores indicating greater reinforcing value of food relative to alternative activities.
Automated Self-Administered 24-hour Dietary Assessment Tool
Time frame: Baseline, post-control (1 to 3 months depending on Cohort), post-treatment (4 months), and 2-month follow-up (6 months)
The Automated Self-Administered 24-hour (ASA24®) Dietary Assessment Tool is a free, web-based tool that enables automatically coded, self-administered 24-hour diet recalls that will be completed by the participating adolescent aged 13 or older, or with the caregiver's assistance (for youth < 13 years of age). The caregiver will also complete a 24-hour dietary recall for their own intake. Outcomes will be average daily kilocalories, fruit and vegetable servings, and percentage intake from fat.
Physical activity
Time frame: 7 days at each assessment timepoint
Objective physical activity will be assessed for youth and caregivers using accelerometers worn on the wrist during sleep and daily activities for seven days at each assessment time point. Outcomes will be minutes of moderate or vigorous activity (physical activity) and minutes of sedentary activity.
Caregiver PROMIS Global Health
Time frame: Baseline, post-control (1 to 3 months depending on Cohort), post-treatment (4 months), and 2-month follow-up (6 months)
Caregiver: The PROMIS Global Health scale (v1.2) is a 10-item measure of overall physical and mental health-related quality of life. Items are scored on 5-point scales; raw scores are converted to T-scores, with higher scores indicating better health.
Youth PROMIS Pediatric Global Health
Time frame: Baseline, post-control (1 to 3 months depending on Cohort), post-treatment (4 months), and 2-month follow-up (6 months)
Youth: The PROMIS Pediatric Global Health 7+2 is a 9-item child-report measure of perceived physical, mental, and social health. Raw scores are converted to T-scores, with higher scores indicating better global health.
Intervention Feedback
Time frame: At completion of the 4-month intervention
Caregivers and youth in both conditions will provide feedback regarding their experiences during the trial period. On a 5-point scale (1=Strongly Disagree to 5=Strongly Agree), respondents will rate the degree to which their experience was: (a) useful for increasing knowledge of weight-related behaviors; (b) useful for learning self-management skills; (c) helped with changing unhealthy behaviors; (d) valuable for families and youth with obesity; (e) engaging for families; (f) innovative compared to alternatives; and (g) better than alternatives. Additionally, child and parent satisfaction with FBT will be assessed at the end of treatment using the 8-item Client Satisfaction Questionnaire. Participants will also be asked to provide written comments, listing specific concerns or problems. Follow-up interviews via telephone by trained research assistants will be conducted to clarify responses and gather additional details, as needed.
Product Evaluation
Time frame: At completion of the 4-month intervention
In addition, participants will rate (5-point scale from 1=Not at all to 5=Extremely) the quality of FBT 2.0 in the following areas: (a) user friendly; (b) easy to navigate; (c) appealing graphic design; (d) easy to follow directions; (e) jargon free; (f) engaging; (g) high quality content; (h) high value content; (i) relevance to real-life; (j) login functions; (k) search functions; and (l) help functions.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: Yes. Data generated by this project will be made available upon request after the publication of the main findings from each aim. Investigators will require parties requesting data access to submit a detailed description of their plans for the data with their personal identification, institutional affiliation, a CV, estimated duration of the proposed research, source of financial support, and a conflict-of-interest statement. The MPIs will decide whether sharing of the data is appropriate or if other information and/or additional safeguards are needed. Once the request is approved, data transfer and use agreements will be developed if necessary, and the requesting investigator must obtain approval from their institution's IRB or request to rely on the IRB of record. Appropriate de- identification techniques required by both HIPAA and the Common Rule will allow for sharing of data that does not compromise participant confidentiality.
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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.
Melissa DeRosier, PhD principal investigator
3C Institute
Denise Wilfley, PhD principal investigator
Washington University School of Medicine
Leonard Epstein, PhD principal investigator
University at Buffalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FBT 2.0 in people with Childhood Obesity, run by 3-C Institute for Social Development 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 6 inclusion and 3 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: opening soon, as of the sponsor's last update on 28 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melissa DeRosier, PhD (984-316-0406, derosier@3cisd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative Weight (time frame: Baseline, post-control (1 to 3 months depending on Cohort), post-treatment (4 months), and 2-month follow-up (6 months)). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Sep 2026.