Childhood ObesitySHIFTNCT02580162
Success in Health: Impacting Families Together
A study testing FBT for Pediatric Weight Management by Professionals, FBT for Pediatric Weight Management by Peers and Peer Interventionists in people with Childhood Obesity, run by Seattle Children's Hospital at 1 site in United States.
Trial summary
This study evaluates and compares the efficacy of professional versus peer-based delivery of family-based treatment for childhood overweight and obesity in elementary school aged children. 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?
- FBT for Pediatric Weight Management by Professionals, FBT for Pediatric Weight Management by Peers and Peer Interventionists
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to 20 Dec 2020
- 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: Parents as Peer Interventionists in Treatment for Pediatric Weight Management
This study evaluates and compares the efficacy of professional versus peer-based delivery of family-based treatment for childhood overweight and obesity in elementary school aged children. Families will be randomized to receive treatment from professionals or to receive treatment from professionally-trained peer interventionists. Some parents will then be invited to serve as peer interventionists for the next group of families.
Read the detailed description
The high prevalence of pediatric overweight and obesity in the U.S. necessitates the development of efficacious, but cost-effective and easily disseminable interventions that improve and sustain better pediatric weight outcomes. Accumulated evidence finds initial and long-term efficacy of moderate-to-high intensity (>25 contact hours) family-based treatment (FBT) for elementary school-aged children, but such treatment is prohibitively expensive because of high personnel costs (delivery by behavioral health professionals) and therefore limited in availability, reach, and impact. Very few overweight/obese children receive evidence-based treatment to improve their weight status or health.
The pilot data suggest a new model, peer-based delivery FBT with FBT-treated parents trained and subsequently delivering FBT to other families, is feasible and demonstrates initial efficacy. This delivery model could dramatically reduce FBT costs and increase FBT availability. Preliminary data also suggest that serving as a peer interventionist may also benefit the peers themselves and their children in better sustaining their own weight outcomes. The present study aims to provide a more definitive test of the short- and long-term efficacy of peer- versus professionally-delivered FBT on child weight outcomes. Embedded in this comparison is an examination of the feasibility of peer-based FBT delivery, investigating the impact of serving as a peer interventionist on the peers' own and their child's long- term weight status, and a more comprehensive examination of differential costs of professional- versus peer- based FBT delivery.
The present study will also test potential dissemination and sustainability by examining the efficacy of peer-delivered FBT among peer interventionists who themselves received FBT from other peers and not from professional interventionists. Moderation of treatment outcome is also examined, focusing on peer interventionist and child characteristics. This multi-phase trial will enroll 304 families with 7-11 year old overweight/obese children in multiple sites throughout the region, and include short-term (post-treatment) and long-term (up through 1 year after treatment cessation) assessments. This investigation of an innovative approach that could significantly reduce FBT delivery costs, while also improving the maintenance of treatment effects, is critical to improving the health of the many already overweight children at risk for chronic disease.
- Conditions
- Childhood Obesity
- Being tested
- FBT for Pediatric Weight Management by Professionals, FBT for Pediatric Weight Management by Peers, Peer Interventionists
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FBT for Pediatric Weight Management by ProfessionalsBehavioural
This behavioral treatment includes behavioral skills training and accountability, including food and activity self-monitoring, goal setting, and home environment change. This 20 week treatment is adapted from our existing evidence-based interventions and is delivered by PROFESSIONAL interventionists.
FBT for Pediatric Weight Management by PeersBehavioural
This behavioral treatment includes behavioral skills training and accountability, including food and activity self-monitoring, goal setting, and home environment change. This 20 week treatment is adapted from our existing evidence-based interventions and is provided by PEER interventionists.
Peer InterventionistsBehavioural
Parents who receive FBT complete 6 weeks of training and then serve as peer interventionists to a new group of families.
| Study group | Role | What they receive |
|---|---|---|
| Pro.Treatment, Not a Peer | Active comparator | Families receive FBT for Pediatric Weight Management by Professionals interventionists and parents are NOT Peer Interventionists Receives: Behavioral: FBT for Pediatric Weight Management by Professionals |
| Pro.Treatment, Peer | Experimental | Families receive FBT for Pediatric Weight Management by Professionals and parents ARE Peer Interventionists Receives: Behavioral: FBT for Pediatric Weight Management by Professionals; Behavioral: Peer Interventionists |
| Peer Treatment, Not a Peer | Experimental | Families receive FBT for Pediatric Weight Management by Peers and parents are NOT Peer Interventionists Receives: Behavioral: FBT for Pediatric Weight Management by Peers |
| Peer Treatment, Peer | Experimental | Families receive FBT for Pediatric Weight Management by Peers and parents ARE Peer Interventionists Receives: Behavioral: FBT for Pediatric Weight Management by Peers; Behavioral: Peer Interventionists |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Child BMI z-score
BMI will be calculated as kg/m2 and children's BMI z-scores will be calculated using CDC growth charts.
Measured: Baseline, 20 Weeks (post treatment), 6 and 12 months post treatment
Secondary outcomes (2)
Costs of Peer Versus Professional Treatment
Direct and indirect costs of associated with intervention using peer or professional interventionists. Direct costs will be estimated using hours spent providing treatment of both peers and professionals who will track their time using an online application. Costs associated with hours spent will be based on professional salaries or stipends provided to peer interventionists.
Measured: 20 weeks
Change in Parent BMI
BMI of parent will be calculated as kg/m2.
Measured: Baseline, 20 Weeks (post treatment), 6 and 12 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2015 (estimated)
- Study startDec 2015
- Primary completion20 Dec 2020
- Study completion20 Dec 2020
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.
- More trials run by Seattle Children's HospitalThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington, San Diego State University
- Responsible party
- Principal investigator, Brian Saelens, Seattle Children's Hospital
- Investigators
- Brian E Saelens, PhD, Principal investigator, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02580162
- Sponsor's protocol ID
- 1R01DK104863-01A1
- Acronym
- SHIFT
- Status last verified
- Mar 2021
- First submitted
- 14 Oct 2015
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parents as Peer Interventionists in Treatment for Pediatric Weight Management
- ClinicalTrials.gov ID
- NCT02580162
- Acronym / sponsor ID
- SHIFT / 1R01DK104863-01A1
- Conditions
- Childhood Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Collaborators
- University of Washington, San Diego State University
- Study start
- Dec 2015 (actual)
- Primary completion
- 20 Dec 2020 (actual)
- Study completion
- 20 Dec 2020 (actual)
- First posted
- 20 Oct 2015 (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.
This study evaluates and compares the efficacy of professional versus peer-based delivery of family-based treatment for childhood overweight and obesity in elementary school aged children. Families will be randomized to receive treatment from professionals or to receive treatment from professionally-trained peer interventionists. Some parents will then be invited to serve as peer interventionists for the next group of families.
Detailed description
The high prevalence of pediatric overweight and obesity in the U.S. necessitates the development of efficacious, but cost-effective and easily disseminable interventions that improve and sustain better pediatric weight outcomes. Accumulated evidence finds initial and long-term efficacy of moderate-to-high intensity (>25 contact hours) family-based treatment (FBT) for elementary school-aged children, but such treatment is prohibitively expensive because of high personnel costs (delivery by behavioral health professionals) and therefore limited in availability, reach, and impact. Very few overweight/obese children receive evidence-based treatment to improve their weight status or health.
The pilot data suggest a new model, peer-based delivery FBT with FBT-treated parents trained and subsequently delivering FBT to other families, is feasible and demonstrates initial efficacy. This delivery model could dramatically reduce FBT costs and increase FBT availability. Preliminary data also suggest that serving as a peer interventionist may also benefit the peers themselves and their children in better sustaining their own weight outcomes. The present study aims to provide a more definitive test of the short- and long-term efficacy of peer- versus professionally-delivered FBT on child weight outcomes. Embedded in this comparison is an examination of the feasibility of peer-based FBT delivery, investigating the impact of serving as a peer interventionist on the peers' own and their child's long- term weight status, and a more comprehensive examination of differential costs of professional- versus peer- based FBT delivery.
The present study will also test potential dissemination and sustainability by examining the efficacy of peer-delivered FBT among peer interventionists who themselves received FBT from other peers and not from professional interventionists. Moderation of treatment outcome is also examined, focusing on peer interventionist and child characteristics. This multi-phase trial will enroll 304 families with 7-11 year old overweight/obese children in multiple sites throughout the region, and include short-term (post-treatment) and long-term (up through 1 year after treatment cessation) assessments. This investigation of an innovative approach that could significantly reduce FBT delivery costs, while also improving the maintenance of treatment effects, is critical to improving the health of the many already overweight children at risk for chronic disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pro.Treatment, Not a Peer | Active comparator | Behavioral: FBT for Pediatric Weight Management by ProfessionalsFamilies receive FBT for Pediatric Weight Management by Professionals interventionists and parents are NOT Peer Interventionists |
| Pro.Treatment, Peer | Experimental | Behavioral: FBT for Pediatric Weight Management by Professionals, Behavioral: Peer InterventionistsFamilies receive FBT for Pediatric Weight Management by Professionals and parents ARE Peer Interventionists |
| Peer Treatment, Not a Peer | Experimental | Behavioral: FBT for Pediatric Weight Management by PeersFamilies receive FBT for Pediatric Weight Management by Peers and parents are NOT Peer Interventionists |
| Peer Treatment, Peer | Experimental | Behavioral: FBT for Pediatric Weight Management by Peers, Behavioral: Peer InterventionistsFamilies receive FBT for Pediatric Weight Management by Peers and parents ARE Peer Interventionists |
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 |
|---|---|---|
| FBT for Pediatric Weight Management by ProfessionalsThis behavioral treatment includes behavioral skills training and accountability, including food and activity self-monitoring, goal setting, and home environment change. This 20 week treatment is adapted from our existing evidence-based interventions and is delivered by PROFESSIONAL interventionists. | Behavioural | Pro.Treatment, Not a Peer, Pro.Treatment, Peer |
| FBT for Pediatric Weight Management by PeersThis behavioral treatment includes behavioral skills training and accountability, including food and activity self-monitoring, goal setting, and home environment change. This 20 week treatment is adapted from our existing evidence-based interventions and is provided by PEER interventionists. | Behavioural | Peer Treatment, Not a Peer, Peer Treatment, Peer |
| Peer InterventionistsParents who receive FBT complete 6 weeks of training and then serve as peer interventionists to a new group of families. | Behavioural | Peer Treatment, Peer, Pro.Treatment, Peer |
Primary outcome
Change in Child BMI z-score
Time frame: Baseline, 20 Weeks (post treatment), 6 and 12 months post treatment
BMI will be calculated as kg/m2 and children's BMI z-scores will be calculated using CDC growth charts.
2 secondary outcomes
Costs of Peer Versus Professional Treatment
Time frame: 20 weeks
Change in Parent BMI
Time frame: Baseline, 20 Weeks (post treatment), 6 and 12 months post treatment
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 1 Apr 2021.
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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.
Brian E Saelens, PhD principal investigator
Seattle Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FBT for Pediatric Weight Management by Professionals, FBT for Pediatric Weight Management by Peers and Peer Interventionists 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 1 Apr 2021. 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 BMI z-score (time frame: Baseline, 20 Weeks (post treatment), 6 and 12 months post treatment). 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 1 Apr 2021.