Pediatric ObesityvHAPPYNCT04634045

Virtual Health Focused Acceptance-Based Program for Parents and Youth

A study testing Web Based Treatment in people with Pediatric Obesity and Executive Function, run by University of Alabama at Birmingham at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 8 to 14 years
Conditions the study is for: Pediatric Obesity, Executive Function
What is being tested?: Web Based Treatment
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 19 participants
Where: 1 siteUnited States
Study dates: 1 Aug 2021to 28 Feb 2022
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 8 to 14 years
All sexes
No healthy volunteers
Child

Who may be able to join

Children who:
have a BMI ≥ 85th percentile;
are 8 and 14 years old at the beginning of treatment;
can read, write, and speak English, along with their caregiver;
plan to stay living in the local area during the study period;
have a consenting caregiver who can commit to all study procedures.

Who cannot join

Children who:
have been diagnosed with a medical condition and/or are taking medication known to affect appetite/weight, physical activity level or executive function;
are currently participating in a formal weight management program beyond usual medical care or have a caregiver participating in a formal weight management program.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Alabama at Birmingham
Birmingham, Alabama, 35209

Other trials in United States

About this study

Official title: Targeting Self-Regulation in Family-Based Behavioral Treatment for Obesity and Cardiovascular Disease Prevention

The main purpose of vHAPPY is to pilot test a new type of virtual family-based healthy lifestyle program for children aged 8-14 with obesity and their caregivers. vHAPPY aims to (1) Transition a previously developed acceptance-based behavioral treatment to web-based platform, utilizing qualitative and quantitative program evaluation data from past participants. (2) Determine the feasibility, acceptability, and preliminary outcomes of the adapted web-based treatment. (3) Evaluate whether the adapted web-based treatment (self-guided treatment + brief coaching) is similar to the traditional treatment (interventionist-guided treatment) in terms of feasibility, acceptability, and preliminary outcomes utilizing a non-randomized sequential arm design.

Read the detailed description

Caregiver and child pairs will complete a 14 week virtual, self-guided healthy lifestyle program including education on health and wellness topics such as food groups, physical activity and stress management. Special skill builders for managing the thoughts, feelings and emotions associated with changing health behaviors will also be included. Pairs will have biweekly 15 minute coaching sessions to check in on progress in the past week, set goals and problem solve. Optional group sessions will be offered for peer support. In order to assess progress, pairs will also complete assessment visits before and after the program. These visits include one virtual assessment via Zoom and one in-person assessment at the University of Alabama at Birmingham. Caregivers and children will complete questionnaires and measures such has height, weight, blood pressure and a finger prick.

Conditions: Pediatric Obesity, Executive Function
Being tested: Web Based Treatment
Keywords: Pediatric Obesity, Executive Function, Behavioral Intervention, Acceptance Based
Medical subject headings: Pediatric Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Web Based TreatmentBehavioural
Also called Acceptance-Based Treatment
The literature regarding the efficacy of web-based platforms for behavioral weight management interventions in pediatric populations continues to grow. Considering the continued increase in technology and internet use among youth, web-based interventions have the potential to serve as a more cost-effective and personalized approach to pediatric behavioral weight management. Extant research supports this consideration. More research that compares web-based vs. traditional delivery of acceptance-based pediatric behavioral weight management interventions is necessary to understand the utility of this platform as well as which aspects are most effective.

Study groups in NCT04634045
Study group	Role	What they receive
Web-Based Treatment	Experimental	A web-based treatment for pediatric overweight or obesity will be piloted with 10 caregiver and child pairs. Assessments will take place pre (0 months), post intervention (3.5 months) and at six months post-intervention (9.5 months) to evaluate patient outcomes, acceptability and feasibility. Receives: Behavioral: Web Based Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

Acceptability - Interviews
Semi-structured group interviews will assess caregiver and child experiences with the program.
Measured: 3.5 months
Acceptability - Surveys
Surveys will assess the utility of intervention content, intervention burden and satisfaction, participation barriers, and suggestions for change.
Measured: 3.5 months
Feasibility - Interviews
Semi-structured group interviews will assess caregiver and child experiences with the program.
Measured: 3.5 months
Feasibility - Surveys
Surveys will assess the utility of intervention content, intervention burden and satisfaction, participation barriers, and suggestions for change.
Measured: 3.5 months

Secondary outcomes (7)

Child Body Mass Index Z-Score
Measure child's height and weight. Enter into the Children's Hospital Of Philadelphia Body Mass Index calculator.
Measured: Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)
Parent Body Mass Index
Measure parent's height and weight. Enter into the Centers for Disease Control adult Body Mass Index calculator.
Measured: Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)
Parent Subjective Executive Function
Behavior Rating Inventory of Executive Function (BRIEF) - Adult. Subjective EF will be measured using the Behavioral Rating Inventory of Executive Function. The Global Severity Index will be used which is interpreted using T-scores. Higher t-scores indicate better function.
Measured: Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)
Child Subjective Executive Function
Behavior Rating Inventory of Executive Function (BRIEF) screener and BRIEF 2 (parent-report). Subjective EF will be measured using the Behavioral Rating Inventory of Executive Function. The Global Severity Index will be used which is interpreted using T-scores. Higher t-scores indicate better function.
Measured: Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)
Parent Behavioral Functioning - Anxiety
Generalized Anxiety Disorder 7. Self-report questionnaire that will be used to measure parent anxiety symptoms over the past 2 weeks. Responses are coded 0-3. 0 = Not at all and 3 = Nearly every day. Total scores range from 0-21 and are ranked from minimal anxiety to severe anxiety.
Measured: Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)
Parent Behavioral Functioning - Depression
Patient Health Questionnaire 8. Self-report questionnaire that will be used to measure parent depressive symptoms over the past 2 weeks. Eight items, each of which is scored 0-3, providing a 0-24 severity score.
Measured: Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)
Child Behavioral Functioning - Overall
Pediatric Symptom Checklist -17. A parent-proxy report screener of child risk for internalizing (depression), externalizing (oppositional defiant disorder), and attention problems (ADHD). Each item is rated as never, sometimes or often present and scored 0,1 and 2 respectively. Total score is calculated by adding together the score for each item. Three subscale scores (attention, externalizing and internalizing) are calculated by adding the score for appropriately categorized items.
Measured: Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 202128 Feb 2022

First posted18 Nov 2020
Study start1 Aug 2021
Primary completion28 Feb 2022
Study completion28 Feb 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Pediatric ObesityStudies of the same condition, open and under way.
More trials run by University of Alabama at BirminghamThe 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: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 19 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04634045
Sponsor's protocol ID: 300005967
Acronym: vHAPPY
Status last verified: Aug 2022
First submitted: 3 Nov 2020
Last updated: 31 Aug 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Due to the small sample size and risk of confidentiality loss, there is no plan to share IPD.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Impact of a Playful Family Education Strategy With ICT on Childhood Obesity Prevention
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Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
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Growing Healthy Children and Families in Rural Arkansas
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Recruiting
Cities for Better Health Childhood Obesity Prevention Initiative in JAPAN
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Weight Gain in Pediatric Leukemia Survivors
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All Pediatric Obesity trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Targeting Self-Regulation in Family-Based Behavioral Treatment for Obesity and Cardiovascular Disease Prevention
ClinicalTrials.gov ID: NCT04634045
Acronym / sponsor ID: vHAPPY / 300005967
Conditions: Pediatric Obesity, Executive Function
Keywords: Pediatric Obesity, Executive Function, Behavioral Intervention, Acceptance Based
Study type: Interventional
Recruitment status: Completed
Enrolment: 19 participants (actual)
Lead sponsor: University of Alabama at BirminghamUniversity, hospital or other
Collaborators: Childrens of Alabama Kaul Pediatric Research Institute
Study start: 1 Aug 2021 (actual)
Primary completion: 28 Feb 2022 (actual)
Study completion: 28 Feb 2022 (actual)
First posted: 18 Nov 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Web-Based Treatment	Experimental	Behavioral: Web Based TreatmentA web-based treatment for pediatric overweight or obesity will be piloted with 10 caregiver and child pairs. Assessments will take place pre (0 months), post intervention (3.5 months) and at six months post-intervention (9.5 months) to evaluate patient outcomes, acceptability and feasibility.

Who may qualify

Ages: 8 to 14 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (6 listed)

have a BMI ≥ 85th percentile;
are 8 and 14 years old at the beginning of treatment;
can read, write, and speak English, along with their caregiver;
plan to stay living in the local area during the study period;
have a consenting caregiver who can commit to all study procedures.

Key exclusion criteria (3 listed)

have been diagnosed with a medical condition and/or are taking medication known to affect appetite/weight, physical activity level or executive function;
are currently participating in a formal weight management program beyond usual medical care or have a caregiver participating in a formal weight management program.

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
Web Based TreatmentAlso: Acceptance-Based TreatmentThe literature regarding the efficacy of web-based platforms for behavioral weight management interventions in pediatric populations continues to grow. Considering the continued increase in technology and internet use among youth, web-based interventions have the potential to serve as a more cost-effective and personalized approach to pediatric behavioral weight management. Extant research supports this consideration. More research that compares web-based vs. traditional delivery of acceptance-based pediatric behavioral weight management interventions is necessary to understand the utility of this platform as well as which aspects are most effective.	Behavioural	Web-Based Treatment

Primary outcome

Acceptability - Interviews
Time frame: 3.5 months
Semi-structured group interviews will assess caregiver and child experiences with the program.
Acceptability - Surveys
Time frame: 3.5 months
Surveys will assess the utility of intervention content, intervention burden and satisfaction, participation barriers, and suggestions for change.
Feasibility - Interviews
Time frame: 3.5 months
Semi-structured group interviews will assess caregiver and child experiences with the program.
Feasibility - Surveys
Time frame: 3.5 months
Surveys will assess the utility of intervention content, intervention burden and satisfaction, participation barriers, and suggestions for change.

7 secondary outcomes

Child Body Mass Index Z-Score
Time frame: Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)
Parent Body Mass Index
Time frame: Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)
Parent Subjective Executive Function
Time frame: Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)
Child Subjective Executive Function
Time frame: Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)
Parent Behavioral Functioning - Anxiety
Time frame: Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)
Parent Behavioral Functioning - Depression
Time frame: Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)
Child Behavioral Functioning - Overall
Time frame: Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)

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 31 Aug 2022.
Individual participant dataSharing planned: No. Due to the small sample size and risk of confidentiality loss, there is no plan to share IPD.

Related trials for Pediatric 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
Active, not recruiting
Growing Healthy Children and Families in Rural Arkansas
Pediatric Obesity, Health Behavior, Risky
Recruiting
Cities for Better Health Childhood Obesity Prevention Initiative in JAPAN
Quality of Life (QOL), Nutrition
Not yet recruiting
Weight Gain in Pediatric Leukemia Survivors
Leukemia, Pediatric Acute Lymphoblastic Leukemia

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.

Marissa A Gowey, PhD principal investigator

University of Alabama at Birmingham

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Web Based Treatment in people with Pediatric Obesity and Executive Function, run by University of Alabama at Birmingham 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: finished, as of the sponsor's last update on 31 Aug 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?

Acceptability - Interviews (time frame: 3.5 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?

On the ClinicalTrials.gov record for NCT04634045.

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 31 Aug 2022.