Pediatric ObesityNCT02677792
Wellness and Weight Family Group Project
A study testing Behavioral Family Intervention (BFI) in people with Pediatric Obesity, run by University of Mississippi Medical Center at 1 site in United States.
Trial summary
The purpose of the current study is examine the feasibility and efficacy of providing a behavioral family intervention in 30 youth 10 to 17 years of age who are obese and attending a multidisciplinary pediatric obesity clinic and their parents. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Pediatric Obesity
- What is being tested?
- Behavioral Family Intervention (BFI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to Dec 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 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- child 10 to 17 years of age attending an outpatient pediatric obesity clinic visit
- child or adolescent is obese (equal to or above the 95th percentile for BMI based on Centers for Disease Control and Prevention (CDC) norms for age and gender)
- child or adolescent is accompanied by a parent or legal guardian
- participating child and parent speak and read English
- family agrees to attend group meetings at a medical clinic over a 3 month period
Who cannot join
- participating child or parent, according to parent report, has dietary restriction or medical condition contraindicating mild energy restriction or moderate physical activity (e.g., musculoskeletal, heart, or respiratory condition, uncontrolled blood pressure or exercise induced asthma)
- child diagnosed according to parent report with pervasive developmental delay (e.g., autistic disorder)
- child or parent, according to parent report, in commercial weight loss program
- child or parent currently prescribed medications to impact appetite or weight loss/gain, according to parent report
- parent and child do not speak and read English
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Mississippi Medical Center
Jackson, Mississippi, 39216
About this study
The purpose of the current study is examine the feasibility and efficacy of providing a behavioral family intervention in 30 youth 10 to 17 years of age who are obese and attending a multidisciplinary pediatric obesity clinic and their parents. Participating families will complete assessments consisting of weight status, dietary intake, physical activity, health-related quality of life, psychological functioning, home-food environment, parenting skills, and self-efficacy at pre-treatment (Baseline), post-treatment (Month 3), and 2 month post-treatment follow-up (Month 5). Family attendance data will be collected during the behavioral family intervention and children and parents will complete a treatment satisfaction questionnaire at the post-treatment assessment. Health outcomes (e.g., A1C, glucose) routinely assessed through standard medical care in the multidisciplinary pediatric obesity clinic will be obtained from child medical charts.
- Conditions
- Pediatric Obesity
- Being tested
- Behavioral Family Intervention (BFI)
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Family Intervention (BFI)Behavioural
Participating families will receive standard medical care through the Wellness and Weight Clinic, as well as the BFI. The BFI is based on family systems (Minuchin et al., 1975) and social-cognitive (Bandura, 1998) theories. Each dyad will participate in simultaneous, but separate, 75-minute parent and child groups over a 3 month period. The groups will start off meeting every week for 8 weeks and then bi-weekly for 1 month. Thus, dyads will attend a total of 10 group meetings over the 3 month period (12.5 hours of total treatment contact).
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Family Intervention (BFI) | Experimental | Not described Receives: Behavioral: Behavioral Family Intervention (BFI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Child Weight Status (BMIz)
BMIz calculated from measured child height and weight
Measured: Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
Secondary outcomes (7)
Change in Total Child Physical Activity kcals from Block Kids Physical Activity Screener
Child-report questionnaire
Measured: Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
Change in Child Dietary Intake Total kcals from 24-hour dietary recall
Child-report 24-hour dietary recall assessed via Automated Self-administered 24-hour recall (ASA24) System; Children will complete the ASA-2014-Kids
Measured: Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
Change in Child A1C Values
From child medical chart - testing completed as part of standard medical care
Measured: Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
Change in Child Glucose Values
From child medical chart - testing completed as part of standard medical care
Measured: Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
Change in Parent Weight
Measured parent weight
Measured: Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
Change in Total Parent Physical Activity kcals from Block Physical Activity Screener Adults
Parent-report questionnaire
Measured: Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
Change in Parent Dietary Intake Total kcals from 24-hour dietary recall
Parent-report 24-hour dietary recall assessed via ASA24-2014
Measured: Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionDec 2020
- Study completionDec 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.
- 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
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Mississippi Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Crystal Stack Lim, University of Mississippi Medical Center
- Investigators
- Crystal S. Lim, Ph.D., Principal investigator, University of Mississippi Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02677792
- Sponsor's protocol ID
- #2015-0155
- Status last verified
- Feb 2023
- First submitted
- 2 Feb 2016
- Last updated
- 23 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wellness and Weight Family Group Project
- ClinicalTrials.gov ID
- NCT02677792
- Acronym / sponsor ID
- #2015-0155
- Conditions
- Pediatric Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of Mississippi Medical CenterUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2022 (actual)
- First posted
- 9 Feb 2016 (estimated)
- 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 the current study is examine the feasibility and efficacy of providing a behavioral family intervention in 30 youth 10 to 17 years of age who are obese and attending a multidisciplinary pediatric obesity clinic and their parents. Participating families will complete assessments consisting of weight status, dietary intake, physical activity, health-related quality of life, psychological functioning, home-food environment, parenting skills, and self-efficacy at pre-treatment (Baseline), post-treatment (Month 3), and 2 month post-treatment follow-up (Month 5). Family attendance data will be collected during the behavioral family intervention and children and parents will complete a treatment satisfaction questionnaire at the post-treatment assessment. Health outcomes (e.g., A1C, glucose) routinely assessed through standard medical care in the multidisciplinary pediatric obesity clinic will be obtained from child medical charts.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Behavioral Family Intervention (BFI) | Experimental | Behavioral: Behavioral Family Intervention (BFI) |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- child 10 to 17 years of age attending an outpatient pediatric obesity clinic visit
- child or adolescent is obese (equal to or above the 95th percentile for BMI based on Centers for Disease Control and Prevention (CDC) norms for age and gender)
- child or adolescent is accompanied by a parent or legal guardian
- participating child and parent speak and read English
- family agrees to attend group meetings at a medical clinic over a 3 month period
Key exclusion criteria (5 listed)
- participating child or parent, according to parent report, has dietary restriction or medical condition contraindicating mild energy restriction or moderate physical activity (e.g., musculoskeletal, heart, or respiratory condition, uncontrolled blood pressure or exercise induced asthma)
- child diagnosed according to parent report with pervasive developmental delay (e.g., autistic disorder)
- child or parent, according to parent report, in commercial weight loss program
- child or parent currently prescribed medications to impact appetite or weight loss/gain, according to parent report
- parent and child do not speak and read English
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 |
|---|---|---|
| Behavioral Family Intervention (BFI)Participating families will receive standard medical care through the Wellness and Weight Clinic, as well as the BFI. The BFI is based on family systems (Minuchin et al., 1975) and social-cognitive (Bandura, 1998) theories. Each dyad will participate in simultaneous, but separate, 75-minute parent and child groups over a 3 month period. The groups will start off meeting every week for 8 weeks and then bi-weekly for 1 month. Thus, dyads will attend a total of 10 group meetings over the 3 month period (12.5 hours of total treatment contact). | Behavioural | Behavioral Family Intervention (BFI) |
Primary outcome
Change in Child Weight Status (BMIz)
Time frame: Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
BMIz calculated from measured child height and weight
7 secondary outcomes
Change in Total Child Physical Activity kcals from Block Kids Physical Activity Screener
Time frame: Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
Change in Child Dietary Intake Total kcals from 24-hour dietary recall
Time frame: Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
Change in Child A1C Values
Time frame: Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
Change in Child Glucose Values
Time frame: Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
Change in Parent Weight
Time frame: Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
Change in Total Parent Physical Activity kcals from Block Physical Activity Screener Adults
Time frame: Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
Change in Parent Dietary Intake Total kcals from 24-hour dietary recall
Time frame: Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
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 Feb 2023.
- 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.
Crystal S. Lim, Ph.D. principal investigator
University of Mississippi Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Family Intervention (BFI) in people with Pediatric Obesity, run by University of Mississippi Medical Center 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 5 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 23 Feb 2023. 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 (BMIz) (time frame: Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)). 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 Feb 2023.