Childhood ObesityEPICHNCT01789671
Peer Counseling in Family-Based Treatment for Childhood Obesity
A study testing 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?
- 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
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Jun 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
To evaluate the acceptability and feasibility of peers as interventionists in delivering family-based behavioral pediatric weight control intervention.
Read the detailed description
The current study seeks to test the alternative approach of partnering with families, and more specifically parents who have previously received family-based weight control treatment, to serve as peer interventionists to deliver this treatment to other families. Peer-led interventions, common for other health behaviors among adults, has not been previously developed or tested for family-based pediatric weight control intervention. Peer-delivered interventions considerably reduce the high costs of delivering behavioral interventions and could increase the availability of those able to deliver the intervention. In fact, peer interventionists' may be better able to deliver intervention than professionals to families, given these peers have faced similar challenges and barriers to behavior change within their own families. It is also possible that continued engagement in the behavior change process through delivering this intervention to other families could improve peer interventionists' own family's long-term health behaviors and outcomes.
Before utilizing a peer delivery approach more broadly, the novel approach of peer-delivered intervention requires development of training/supervision for peer interventionists and initial evaluation of acceptability/feasibility and efficacy. Therefore, this project has the following aims:
- To develop procedures for training and supervising of parents to be peer interventionists, based on our prior intervention delivery experience and family advisory board input
- To evaluate the acceptability and feasibility of peers as interventionists in delivering family-based behavioral pediatric weight control intervention
- To compare change in weight and health behavior outcomes of overweight/obese children and parents receiving peer- versus professionally-delivered intervention
This study begins to address the high cost and limited availability of the needed, but intense, family-based pediatric weight control intervention required for efficacy. This approach expands the interdisciplinary nature of this work by engaging the resources and assets of previously treated families to contribute to the reduction of the burden of childhood obesity. Led by a project director (Saelens) and intervention coordinator (Scholz) with over 20 years of combined experience in family-based pediatric weight control intervention, this project moves this intervention in a different and important direction.
- Conditions
- Childhood Obesity
- Being tested
- 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.
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 |
|---|---|---|
| Peer Interventionist | Experimental | Families randomized to this family-based behavioral intervention arm will receive 20 weeks of family-based behavioral pediatric overweight intervention delivered by parents who previously received this treatment (PEER). This behavioral treatment includes behavioral skills training and accountability, including food and activity self-monitoring, goal setting, and home environment change. Receives: Behavioral: Family-based behavioral intervention |
| Professional Interventionist | Active comparator | Families randomized to this family-based behavioral intervention arm will receive 20 weeks of family-based behavioral pediatric overweight intervention delivered by behavioral specialists(PROFESSIONAL). This behavioral treatment includes behavioral skills training and accountability, including food and activity self-monitoring, goal setting, and home environment change. Receives: 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
Participant ratings based on Likert-type items regarding treatment satisfaction and helpfulness of treatment provision
Measured: 20 weeks
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 startSep 2012
- Primary completionMar 2014
- Study completionJun 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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 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
- Investigators
- Brian E. Saelens, PhD, Principal investigator, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01789671
- Sponsor's protocol ID
- SafewayFoundationSaelens-01
- Acronym
- EPICH
- Status last verified
- May 2015
- First submitted
- 12 Dec 2012
- 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 Treatment for Childhood Obesity
- ClinicalTrials.gov ID
- NCT01789671
- Acronym / sponsor ID
- EPICH / SafewayFoundationSaelens-01
- Conditions
- Childhood Obesity
- Keywords
- Childhood Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Jun 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
The current study seeks to test the alternative approach of partnering with families, and more specifically parents who have previously received family-based weight control treatment, to serve as peer interventionists to deliver this treatment to other families. Peer-led interventions, common for other health behaviors among adults, has not been previously developed or tested for family-based pediatric weight control intervention. Peer-delivered interventions considerably reduce the high costs of delivering behavioral interventions and could increase the availability of those able to deliver the intervention. In fact, peer interventionists' may be better able to deliver intervention than professionals to families, given these peers have faced similar challenges and barriers to behavior change within their own families. It is also possible that continued engagement in the behavior change process through delivering this intervention to other families could improve peer interventionists' own family's long-term health behaviors and outcomes.
Before utilizing a peer delivery approach more broadly, the novel approach of peer-delivered intervention requires development of training/supervision for peer interventionists and initial evaluation of acceptability/feasibility and efficacy. Therefore, this project has the following aims:
- To develop procedures for training and supervising of parents to be peer interventionists, based on our prior intervention delivery experience and family advisory board input
- To evaluate the acceptability and feasibility of peers as interventionists in delivering family-based behavioral pediatric weight control intervention
- To compare change in weight and health behavior outcomes of overweight/obese children and parents receiving peer- versus professionally-delivered intervention
This study begins to address the high cost and limited availability of the needed, but intense, family-based pediatric weight control intervention required for efficacy. This approach expands the interdisciplinary nature of this work by engaging the resources and assets of previously treated families to contribute to the reduction of the burden of childhood obesity. Led by a project director (Saelens) and intervention coordinator (Scholz) with over 20 years of combined experience in family-based pediatric weight control intervention, this project moves this intervention in a different and important direction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peer Interventionist | Experimental | Behavioral: Family-based behavioral interventionFamilies randomized to this family-based behavioral intervention arm will receive 20 weeks of family-based behavioral pediatric overweight intervention delivered by parents who previously received this treatment (PEER). This behavioral treatment includes behavioral skills training and accountability, including food and activity self-monitoring, goal setting, and home environment change. |
| Professional Interventionist | Active comparator | Behavioral: Family-based behavioral interventionFamilies randomized to this family-based behavioral intervention arm will receive 20 weeks of family-based behavioral pediatric overweight intervention delivered by behavioral specialists(PROFESSIONAL). This behavioral treatment includes behavioral skills training and accountability, including food and activity self-monitoring, goal setting, and home environment change. |
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 |
|---|---|---|
| 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 | Peer Interventionist, Professional Interventionist |
Primary outcome
Child BMI z-score
Time frame: 20 weeks
1 secondary outcome
Acceptability
Time frame: 20 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 20 May 2015.
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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 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.