Childhood ObesityNCT03796221
Parenting Intervention for Pediatric Obesity
A study testing Parenting videos and Standard pediatric obesity treatment in people with Childhood Obesity and Parenting, run by Nemours Children's Health System at 1 site in United States.
Trial summary
The purpose of this study is to see if educational videos about how to help children develop healthy behaviors, paired with treatment in a pediatric obesity clinic, can increase caregiver confidence and improve child behaviors and weight. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity, Parenting
- What is being tested?
- Parenting videos and Standard pediatric obesity treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2019to 12 Sep 2021
- 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 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Legal guardian of a new patient to the Nemours pediatric obesity clinic
- Child with body mass index (BMI) greater than the 95th percentile for age and sex
- Child 4-11 years of age
Who cannot join
- Not proficient in English or Spanish
- Not able to access the internet on any type of device
- Child has a genetic syndrome or primary endocrine disorder associated with obesity
- Child is taking a medication known to impact weight
Trial locations and contacts
1 site in 1 country.
United States1 site
Nemours Alfred I. duPont Hospital for Children
Wilmington, Delaware, 19803
About this study
Official title: Integrating Parenting Interventions Into Pediatric Obesity Care
The purpose of this study is to see if educational videos about how to help children develop healthy behaviors, paired with treatment in a pediatric obesity clinic, can increase caregiver confidence and improve child behaviors and weight. Caregivers of children between the ages of 4 and 11 years old who are new patients to a pediatric obesity clinic will be invited to take part in the study. All families will receive the standard treatment provided in the pediatric obesity clinic. Half of the caregivers will be assigned to also watch a few educational videos every month for 3 months in between clinic visits.
- Conditions
- Childhood Obesity, Parenting
- Being tested
- Parenting videos, Standard pediatric obesity treatment
- Keywords
- Childhood obesity, Parenting intervention, Video intervention, Healthcare delivery
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parenting videosBehavioural
Brief online videos, featuring families of children with obesity of diverse backgrounds, to provide education on parenting skills and motivate families to adopt healthy lifestyle behaviors as a family. Videos will be delivered monthly for three months in between pediatric obesity clinic visits.
Standard pediatric obesity treatmentBehavioural
Standard treatment in a hospital-based pediatric obesity clinic with a team of medical providers, dietitians, exercise specialists, and behavioral health specialists. Treatment includes management of obesity-related medical conditions, nutrition education, physical activity counseling, and discussion of behavioral strategies such as goal-setting and self-monitoring, with elements of motivational interviewing used to encourage behavior change and adoption of healthy lifestyle behaviors by the entire family.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Will receive standard pediatric obesity treatment Receives: Behavioral: Standard pediatric obesity treatment |
| Intervention Group | Experimental | Will receive standard pediatric obesity treatment and parenting videos Receives: Behavioral: Parenting videos; Behavioral: Standard pediatric obesity treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in child weight status
Change in child BMI-z score
Measured: 6 months
Change in child weight status
Change in child BMI percentile (referenced to the 95th percentile)
Measured: 6 months
Change in caregiver confidence managing child lifestyle behaviors
Change in Lifestyle Behavior Checklist Confidence score
Measured: 6 months
Change in child lifestyle behaviors
Change in Lifestyle Behavior Checklist Problem score
Measured: 6 months
Secondary outcomes (5)
Discussion of parenting topics during visits to the pediatric obesity clinic
Discussion helpfulness ratings at each visit
Measured: 1 month, 2 months, 3 months, 6 months
Change in child weight status
Change in child BMI-z score
Measured: 3 months
Change in child weight status
Change in child BMI percentile (referenced to the 95th percentile)
Measured: 3 months
Change in caregiver confidence managing child lifestyle behaviors
Change in Lifestyle Behavior Checklist Confidence score
Measured: 3 months
Change in child lifestyle behaviors
Change in Lifestyle Behavior Checklist Problem score
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 posted8 Jan 2019
- Study start11 Mar 2019
- Primary completion19 Feb 2021
- Study completion12 Sep 2021
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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nemours Children's Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Thao-Ly Phan, Nemours Children's Health System
- Investigators
- Thao-Ly T Phan, MD MPH, Principal investigator, Nemours Children's Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03796221
- Sponsor's protocol ID
- K23HD083439
- Other IDs
- K23HD083439
- Status last verified
- Mar 2022
- First submitted
- 4 Jan 2019
- Last updated
- 23 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Parenting Interventions Into Pediatric Obesity Care
- ClinicalTrials.gov ID
- NCT03796221
- Acronym / sponsor ID
- K23HD083439
- Conditions
- Childhood Obesity, Parenting
- Keywords
- Childhood obesity, Parenting intervention, Video intervention, Healthcare delivery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Nemours Children's Health SystemUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 11 Mar 2019 (actual)
- Primary completion
- 19 Feb 2021 (actual)
- Study completion
- 12 Sep 2021 (actual)
- First posted
- 8 Jan 2019 (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 purpose of this study is to see if educational videos about how to help children develop healthy behaviors, paired with treatment in a pediatric obesity clinic, can increase caregiver confidence and improve child behaviors and weight. Caregivers of children between the ages of 4 and 11 years old who are new patients to a pediatric obesity clinic will be invited to take part in the study. All families will receive the standard treatment provided in the pediatric obesity clinic. Half of the caregivers will be assigned to also watch a few educational videos every month for 3 months in between clinic visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Behavioral: Standard pediatric obesity treatmentWill receive standard pediatric obesity treatment |
| Intervention Group | Experimental | Behavioral: Parenting videos, Behavioral: Standard pediatric obesity treatmentWill receive standard pediatric obesity treatment and parenting videos |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Legal guardian of a new patient to the Nemours pediatric obesity clinic
- Child with body mass index (BMI) greater than the 95th percentile for age and sex
- Child 4-11 years of age
Key exclusion criteria (4 listed)
- Not proficient in English or Spanish
- Not able to access the internet on any type of device
- Child has a genetic syndrome or primary endocrine disorder associated with obesity
- Child is taking a medication known to impact weight
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 |
|---|---|---|
| Parenting videosBrief online videos, featuring families of children with obesity of diverse backgrounds, to provide education on parenting skills and motivate families to adopt healthy lifestyle behaviors as a family. Videos will be delivered monthly for three months in between pediatric obesity clinic visits. | Behavioural | Intervention Group |
| Standard pediatric obesity treatmentStandard treatment in a hospital-based pediatric obesity clinic with a team of medical providers, dietitians, exercise specialists, and behavioral health specialists. Treatment includes management of obesity-related medical conditions, nutrition education, physical activity counseling, and discussion of behavioral strategies such as goal-setting and self-monitoring, with elements of motivational interviewing used to encourage behavior change and adoption of healthy lifestyle behaviors by the entire family. | Behavioural | Control Group, Intervention Group |
Primary outcome
Change in child weight status
Time frame: 6 months
Change in child BMI-z score
Change in child weight status
Time frame: 6 months
Change in child BMI percentile (referenced to the 95th percentile)
Change in caregiver confidence managing child lifestyle behaviors
Time frame: 6 months
Change in Lifestyle Behavior Checklist Confidence score
Change in child lifestyle behaviors
Time frame: 6 months
Change in Lifestyle Behavior Checklist Problem score
5 secondary outcomes
Discussion of parenting topics during visits to the pediatric obesity clinic
Time frame: 1 month, 2 months, 3 months, 6 months
Change in child weight status
Time frame: 3 months
Change in child weight status
Time frame: 3 months
Change in caregiver confidence managing child lifestyle behaviors
Time frame: 3 months
Change in child lifestyle behaviors
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 23 Mar 2022.
- Individual participant dataSharing planned: No
Related trials for Childhood Obesity
Not yet recruitingObservational study
Brain and Obesity Longitudinal Development: Neurobiological Mechanisms of Semaglutide Treatment of Adolescent Obesity
Pediatric Obesity, Obesity
RecruitingObservational study
Early Tracking of Childhood Health Determinants (ETCHED) Study
Diabetes Mellitus, Obesity
Enrolling by invitation
Impact of a Playful Family Education Strategy With ICT on Childhood Obesity Prevention
Pediatric Obesity, Childhood Obesity
Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
Binge Eating Disorder, Binge Eating
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
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.
Thao-Ly T Phan, MD MPH principal investigator
Nemours Children's Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parenting videos and Standard pediatric obesity treatment in people with Childhood Obesity and Parenting, run by Nemours Children's Health System 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 3 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 23 Mar 2022. 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?
Change in child weight status (time frame: 6 months). The study lists 4 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 23 Mar 2022.