Pediatric ObesityNCT01004341
Role of Parenting Skills and Parenting Style in Pediatric Weight Loss Programs
A study of Pediatric Obesity, run by University of California, San Diego at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the role of different parenting skills and parenting styles in the success of children enrolled in a family-based behavioral weight control program and to compare these skills and styles to those used by families with normal weight children. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Pediatric Obesity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to May 2012
- 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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children between and including the ages of 8-12 years old
- child BMI >= 85th percentile
- parent willing to attend all treatment meetings
- parent and child must be able to speak, read, and understand English
Who cannot join
- a family member who is participating in another weight loss program
- the child has any serious medical problem that would limit his/her participation in the study, for example, gastrointestinal diseases, cardiac disease, immune compromised state, chronic steroid use or other medication that impacts weight, developmental delays.
- child with serious food allergies that would compromise adherence to dietary recommendations
- any family member has a major psychiatric disease or organic brain syndrome
- family is going to move outside the metropolitan area within the time frame of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Diego
La Jolla, California, 92093
About this study
Official title: Role of Parenting Skills, Style and Family Functioning in Pediatric Weight Loss
The purpose of this study is to evaluate the role of different parenting skills and parenting styles in the success of children enrolled in a family-based behavioral weight control program and to compare these skills and styles to those used by families with normal weight children.
Read the detailed description
Pediatric overweight has nearly tripled in the past several decades and while family-based behavioral weight control programs are the mainstay of treatment, there is considerable variability in their outcomes. Parents play an important role in the success of their children, particularly by implementing new behavioral skills. However recent evidence has also suggested that parenting style, or the way a parent interacts with their child and provides emotional support and discipline, may be another key element in pediatric weight control. Our goal is to evaluate the role of specific parenting (behavioral) skills and parenting style in the success of children enrolled in a standard family-based behavioral weight control intervention. Our goal is to examine whether specific parenting (behavioral) skills and parenting style change during the intervention and whether or not this change is related to changes in the child's BMI z-score.
- Conditions
- Pediatric Obesity
- Being tested
- Family-based behavioral weight control intervention
- Keywords
- pediatric obesity, parenting style, feeding style, behavioral skills, parenting skills, family meals
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family-based behavioral weight control interventionBehavioural
Standard behavioral weight control program for children ages 8-12 years old and their parents in a family-based intervention.
| Study group | Role | What they receive |
|---|---|---|
| Family-based weight control | Other | Group-based family therapy for weight loss in children age 8-12 years. Receives: Behavioral: Family-based behavioral weight control intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in parenting skills and parenting style
Measured: 0 and 6 months
Secondary outcomes (1)
Change in child BMI z-score
Measured: 0 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2009 (estimated)
- Study startJun 2009
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pediatric ObesityStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Brown University
- Responsible party
- Principal investigator, Kay Rhee, University of California, San Diego
- Investigators
- Kyung E Rhee, MD, MSc, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01004341
- Sponsor's protocol ID
- K23HD057299
- Status last verified
- Jun 2013
- First submitted
- 20 Oct 2009
- Last updated
- 19 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Rhee KE, Lumeng JC, Appugliese DP, Kaciroti N, Bradley RH. Parenting styles and overweight status in first grade. Pediatrics. 2006 Jun;117(6):2047-54. doi: 10.1542/peds.2005-2259.
PubMed 16740847Rhee KE, Jelalian E, Boutelle K, Dickstein S, Seifer R, Wing R. Warm Parenting Associated with Decreasing or Stable Child BMI during Treatment. Child Obes. 2016 Apr;12(2):94-102. doi: 10.1089/chi.2015.0127. Epub 2016 Feb 19.
PubMed 26895374
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Parenting Skills, Style and Family Functioning in Pediatric Weight Loss
- ClinicalTrials.gov ID
- NCT01004341
- Acronym / sponsor ID
- K23HD057299
- Conditions
- Pediatric Obesity
- Keywords
- pediatric obesity, parenting style, feeding style, behavioral skills, parenting skills, family meals
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Brown University
- Study start
- Jun 2009
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 29 Oct 2009 (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 this study is to evaluate the role of different parenting skills and parenting styles in the success of children enrolled in a family-based behavioral weight control program and to compare these skills and styles to those used by families with normal weight children.
Detailed description
Pediatric overweight has nearly tripled in the past several decades and while family-based behavioral weight control programs are the mainstay of treatment, there is considerable variability in their outcomes. Parents play an important role in the success of their children, particularly by implementing new behavioral skills. However recent evidence has also suggested that parenting style, or the way a parent interacts with their child and provides emotional support and discipline, may be another key element in pediatric weight control. Our goal is to evaluate the role of specific parenting (behavioral) skills and parenting style in the success of children enrolled in a standard family-based behavioral weight control intervention. Our goal is to examine whether specific parenting (behavioral) skills and parenting style change during the intervention and whether or not this change is related to changes in the child's BMI z-score.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Family-based weight control | Other | Behavioral: Family-based behavioral weight control interventionGroup-based family therapy for weight loss in children age 8-12 years. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- children between and including the ages of 8-12 years old
- child BMI >= 85th percentile
- parent willing to attend all treatment meetings
- parent and child must be able to speak, read, and understand English
Key exclusion criteria (5 listed)
- a family member who is participating in another weight loss program
- the child has any serious medical problem that would limit his/her participation in the study, for example, gastrointestinal diseases, cardiac disease, immune compromised state, chronic steroid use or other medication that impacts weight, developmental delays.
- child with serious food allergies that would compromise adherence to dietary recommendations
- any family member has a major psychiatric disease or organic brain syndrome
- family is going to move outside the metropolitan area within the time frame of the study
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 |
|---|---|---|
| Family-based behavioral weight control interventionStandard behavioral weight control program for children ages 8-12 years old and their parents in a family-based intervention. | Behavioural | Family-based weight control |
Primary outcome
Change in parenting skills and parenting style
Time frame: 0 and 6 months
1 secondary outcome
Change in child BMI z-score
Time frame: 0 and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2013.
- Background: PubMed 16740847Rhee KE, Lumeng JC, Appugliese DP, Kaciroti N, Bradley RH. Parenting styles and overweight status in first grade. Pediatrics. 2006 Jun;117(6):2047-54. doi: 10.1542/peds.2005-2259.
- Derived from this study: PubMed 26895374Rhee KE, Jelalian E, Boutelle K, Dickstein S, Seifer R, Wing R. Warm Parenting Associated with Decreasing or Stable Child BMI during Treatment. Child Obes. 2016 Apr;12(2):94-102. doi: 10.1089/chi.2015.0127. Epub 2016 Feb 19.
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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.
Kyung E Rhee, MD, MSc principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Pediatric Obesity, run by University of California, San Diego 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 4 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 19 Jun 2013. 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 parenting skills and parenting style (time frame: 0 and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01004341, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2013.