Childhood ObesityNCT01789944
Parent Partnership Project
A study testing Behavioral: Family-based behavioral intervention in people with Childhood Obesity, run by Seattle Children's Hospital at 1 site in United States.
Trial summary
To evaluate the acceptability and feasibility of peers as interventionists in delivering family-based behavioral pediatric weight control intervention. Read more about this study
- Who is it for?
- Ages 7 to 11 years
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- Behavioral: Family-based behavioral intervention
- 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
- Jan 2013to Aug 2014
- 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 7 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child age: 7-11 years at time of enrollment
- Overweight child: at or above 85th percentile for age- and gender-specific BMI.
- At least one overweight parent (BMI≥ 25.0).
- Parent is willing and able to actively participate in treatment including willingness to serve as a peer interventionist following treatment.
- Must live within 50 miles of the treatment center.
Who cannot join
- Current enrollment in another weight control program for the participating child or parent.
- The participating parent is pregnant.
- Thought disorder, suicidality, or substance abuse disorder in either the participating parent or the participating child.
- Inability of the child to comprehend English at a 1st-grade level or participating parent to comprehend English at an 8th-grade level.
- Physical disability or illness in either the participating parent or the child that precludes moderate intensity physical activity.
- Medication regimen for the child that affects his or her weight.
- Conditions known to promote obesity in the participating child (e.g. Prader-Willi).
- Diagnosed eating disorder (i.e., anorexia nervosa, bulimia nervosa, binge eating disorder) in either parent (participating and nonparticipating) and/or the participating child.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Peer Counseling in Family-Based Pediatric Overweight Treatment
To evaluate the acceptability and feasibility of peers as interventionists in delivering family-based behavioral pediatric weight control intervention.
Read the detailed description
A new model of delivering family-based pediatric overweight treatment that decreases costs but sustains short- and long-term efficacy is needed. One possible opportunity for this is a peer intervention model in which families receiving professionally-led intervention then subsequently providing intervention to other families. In addition, peer interventionists' continued engagement in the behavior change process through providing intervention to others could improve their own long-term efficacy. The project begins with the standard approach of having professional interventionists provide family-based behavioral pediatric overweight treatment to overweight children and their parent (1st generation families; n=30). Subsequently, half of 1st generation families will be randomly assigned to serve as peer interventionists to other overweight parents and children (2nd generation families; n=30). The remaining 1st generation families will neither receive nor provide any additional treatment. This project aims to develop the peer intervention training and delivery and then to examine the feasibility and acceptability of the peer intervention. This project also aims to derive an estimate of the efficacy of peer intervention (receiving and providing) both at the end of receiving treatment and 6 months later, as well as the impact of providing intervention on peer interventionists' weight outcomes.
- Conditions
- Childhood Obesity
- Being tested
- Behavioral: Family-based behavioral intervention
- Keywords
- Childhood Obesity
- 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-based behavioral interventionBehavioural
This behavioral treatment includes behavioral skills training and accountability, including food and activity self-monitoring, goal setting, and home environment change
| Study group | Role | What they receive |
|---|---|---|
| Provide Treatment | Experimental | Peers provide treatment to 2nd generation following receipt of the intervention. Receives: Behavioral: Behavioral: Family-based behavioral intervention |
| Treatment Only | Experimental | Peers receive treatment and return for a 6-month follow-up Receives: Behavioral: Behavioral: Family-based behavioral intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child BMI z-score
Measured: 20 Weeks
Secondary outcomes (1)
Acceptability & Feasibility
Participant ratings based on Likert-type items regarding treatment satisfaction and helpfulness of treatment provision
Measured: 11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2013 (estimated)
- Study startJan 2013
- Primary completionAug 2014
- Study completionAug 2014
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
- Crossover
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Saelens, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01789944
- Sponsor's protocol ID
- 1R21DK095676-01
- Status last verified
- May 2015
- First submitted
- 8 Feb 2013
- Last updated
- 20 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peer Counseling in Family-Based Pediatric Overweight Treatment
- ClinicalTrials.gov ID
- NCT01789944
- Acronym / sponsor ID
- 1R21DK095676-01
- Conditions
- Childhood Obesity
- Keywords
- Childhood Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 12 Feb 2013 (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.
To evaluate the acceptability and feasibility of peers as interventionists in delivering family-based behavioral pediatric weight control intervention.
Detailed description
A new model of delivering family-based pediatric overweight treatment that decreases costs but sustains short- and long-term efficacy is needed. One possible opportunity for this is a peer intervention model in which families receiving professionally-led intervention then subsequently providing intervention to other families. In addition, peer interventionists' continued engagement in the behavior change process through providing intervention to others could improve their own long-term efficacy. The project begins with the standard approach of having professional interventionists provide family-based behavioral pediatric overweight treatment to overweight children and their parent (1st generation families; n=30). Subsequently, half of 1st generation families will be randomly assigned to serve as peer interventionists to other overweight parents and children (2nd generation families; n=30). The remaining 1st generation families will neither receive nor provide any additional treatment. This project aims to develop the peer intervention training and delivery and then to examine the feasibility and acceptability of the peer intervention. This project also aims to derive an estimate of the efficacy of peer intervention (receiving and providing) both at the end of receiving treatment and 6 months later, as well as the impact of providing intervention on peer interventionists' weight outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Provide Treatment | Experimental | Behavioral: Behavioral: Family-based behavioral interventionPeers provide treatment to 2nd generation following receipt of the intervention. |
| Treatment Only | Experimental | Behavioral: Behavioral: Family-based behavioral interventionPeers receive treatment and return for a 6-month follow-up |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Child age: 7-11 years at time of enrollment
- Overweight child: at or above 85th percentile for age- and gender-specific BMI.
- At least one overweight parent (BMI≥ 25.0).
- Parent is willing and able to actively participate in treatment including willingness to serve as a peer interventionist following treatment.
- Must live within 50 miles of the treatment center.
Key exclusion criteria (8 listed)
- Current enrollment in another weight control program for the participating child or parent.
- The participating parent is pregnant.
- Thought disorder, suicidality, or substance abuse disorder in either the participating parent or the participating child.
- Inability of the child to comprehend English at a 1st-grade level or participating parent to comprehend English at an 8th-grade level.
- Physical disability or illness in either the participating parent or the child that precludes moderate intensity physical activity.
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-based behavioral interventionThis behavioral treatment includes behavioral skills training and accountability, including food and activity self-monitoring, goal setting, and home environment change | Behavioural | Provide Treatment, Treatment Only |
Primary outcome
Child BMI z-score
Time frame: 20 Weeks
1 secondary outcome
Acceptability & Feasibility
Time frame: 11 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 20 May 2015.
Related trials for Childhood 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
Active, not recruiting
Growing Healthy Children and Families in Rural Arkansas
Pediatric Obesity, Health Behavior, Risky
RecruitingObservational study
Early Tracking of Childhood Health Determinants (ETCHED) Study
Diabetes Mellitus, Obesity
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.
The record lists no contact. Use the official record to reach the sponsor.
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-based behavioral intervention in people with Childhood Obesity, run by Seattle Children's Hospital 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 8 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 20 May 2015. 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?
Child BMI z-score (time frame: 20 Weeks). 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 20 May 2015.