Overweight and ObesityFOCUSNCT00746629
Familial Overweight: Comparing Use of Strategies
A study testing FOCUS in people with Overweight and Obesity, run by Seattle Children's Hospital at 1 site in United States.
Trial summary
The purpose of this study is to compare the efficacy of two different approaches (prescribed \& self-directed) to the treatment of childhood obesity and their relative impact on child weight status, physical activity, and diet. Read more about this study
- Who is it for?
- Ages 7 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- FOCUS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Dec 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 7 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Child age: 7-11 years.
- English-speaking.
- Parent is willing and able to actively participate in treatment.
- Overweight child: at or above 85th percentile for age- and gender-specific BMI, but not more than 175% above median BMI for age and gender.
- Overweight parent: BMI≥ 25.
- Live within 50 miles of Children's Hospital and Regional Medical Center.
Who cannot join
- Medical condition known to promote obesity (e.g. Prader-Willi syndrome, Cushing's syndrome).
- Already involved with another weight control program.
- Consistently engaging in weight-affecting behaviors (e.g. child: smoking)
- Significant diagnosed obesity-related co-morbidities (e.g. Type 2 diabetes)
- Taking weight-affecting medications (e.g. Ritalin)
- Participating parent or child: an existing thought disorder, suicidality, substance abuse disorder, or other psychological or medical conditions that may preclude full participation.
- Participating parent or child: Disability or illness that would preclude them from engaging in at least moderate intensity physical activity.
- Participating parent or child: Current or prior diagnosed eating disturbance.
Trial locations and contacts
1 site in 1 country.
United States1 site
Seattle Children's Hospital Research Institute
Seattle, Washington, 98101
About this study
Official title: Behavioral Skill Adherence in Pediatric Obesity Treatment
The purpose of this study is to compare the efficacy of two different approaches (prescribed \& self-directed) to the treatment of childhood obesity and their relative impact on child weight status, physical activity, and diet.
Read the detailed description
Pediatric obesity is a highly prevalent problem, requiring both treatment and prevention efforts to reduce cardiovascular disease risk and metabolic consequences among affected children and the child population. The efficacy of family-based behavioral pediatric obesity treatment is likely compromised by non-optimal parent and child behavioral skills use (BSU). In pediatric obesity treatment trials, BSU assessment is infrequent, incomplete, and has unknown reliability. Poor and incomplete BSU measurement precludes improving behavioral interventions for pediatric obesity. Furthermore, different approaches to help families initiate and sustain BSU during and following treatment have not been tested. This study aims to investigate 1) prospective relations between BSU measured during and following treatment and change in child weight status, physical activity, and diet, and 2) differences in BSU trajectory between two different implementation approaches during and following treatment. Eighty-two parent-child (7-11 y.o.) pairs will participate in a 20-week treatment with follow-up at 3 and 6 months. Participants will be randomly assigned to receive either a prescriptive or self-directed implementation approach to family-based behavioral pediatric obesity treatment. BSU (monitoring, contingency management, environmental control) will be reported or assessed at pre-treatment, at the 5th, 10th, and 15th treatment sessions, at post-treatment and at the 3-month and 6-month follow-ups by the parent, interventionist, and supplemental evaluator. Prospective associations between BSU, measured multiple times and by multiple informant/formats, and change in child weight status (z-BMI) and weight-related behaviors (diet, physical activity) over the course of treatment and throughout follow up will be examined. This proposal will provide important information about the type of BSU and its measurement that is most related to short- and long-term treatment efficacy, and provide pilot data on the relative efficacy of different implementation approaches to initiate and sustain BSU in pediatric obesity intervention.
- Conditions
- Overweight and Obesity
- Being tested
- FOCUS
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOCUSBehavioural
Treatment will be delivered over a 20-week period. Participating children and at least one of their parents will attend weekly in-person clinic sessions. Treatment will consist of 20-25 minute meetings between the assigned interventionist and each child/parent pair to individualize treatment, with an emphasis on helping the family change eating and activity behaviors. Family meetings will be followed by separate child and parent group meetings lasting approximately 35-45 minutes. In both approaches, parents serve as primary implementers of the treatment for the child and, if overweight, for themselves. Group sessions provide education in diet and physical activity, parenting, and behavioral skills, although conditions differ in whether skills are "prescribed" or "self-directed". Children and parents will be weighed at each clinic visit.
| Study group | Role | What they receive |
|---|---|---|
| Prescribed Skills | Active comparator | Behavioral skills are all prescribed and considered necessary tools expected to be used consistently, completely, and uniformly by all participants throughout treatment Receives: Behavioral: FOCUS |
| Self-Directed Skills | Experimental | Behavioral skills are considered a tool box from which families are encouraged to select skills that best apply to that family's situation in attempts to help their child make eating and activity change. Receives: Behavioral: FOCUS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child weight status, physical activity, & diet.
Measured: 6 Months
Secondary outcomes (1)
Secondary outcomes will include parents' BMI, and parents' physical activity and eating behaviors and covariates will include child age, gender, and household income.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2008 (estimated)
- Study startMay 2008
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overweight and 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 72 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
- NCT00746629
- Sponsor's protocol ID
- HD54871 (completed)
- Other IDs
- 1R21DK095676
- Acronym
- FOCUS
- Status last verified
- May 2015
- First submitted
- 3 Sep 2008
- Last updated
- 21 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Saelens BE, Lozano P, Scholz K. A randomized clinical trial comparing delivery of behavioral pediatric obesity treatment using standard and enhanced motivational approaches. J Pediatr Psychol. 2013 Oct;38(9):954-64. doi: 10.1093/jpepsy/jst054. Epub 2013 Jul 31.
PubMed 23902797
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Skill Adherence in Pediatric Obesity Treatment
- ClinicalTrials.gov ID
- NCT00746629
- Acronym / sponsor ID
- FOCUS / HD54871 (completed)
- Conditions
- Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- May 2008
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 4 Sep 2008 (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 compare the efficacy of two different approaches (prescribed \& self-directed) to the treatment of childhood obesity and their relative impact on child weight status, physical activity, and diet.
Detailed description
Pediatric obesity is a highly prevalent problem, requiring both treatment and prevention efforts to reduce cardiovascular disease risk and metabolic consequences among affected children and the child population. The efficacy of family-based behavioral pediatric obesity treatment is likely compromised by non-optimal parent and child behavioral skills use (BSU). In pediatric obesity treatment trials, BSU assessment is infrequent, incomplete, and has unknown reliability. Poor and incomplete BSU measurement precludes improving behavioral interventions for pediatric obesity. Furthermore, different approaches to help families initiate and sustain BSU during and following treatment have not been tested. This study aims to investigate 1) prospective relations between BSU measured during and following treatment and change in child weight status, physical activity, and diet, and 2) differences in BSU trajectory between two different implementation approaches during and following treatment. Eighty-two parent-child (7-11 y.o.) pairs will participate in a 20-week treatment with follow-up at 3 and 6 months. Participants will be randomly assigned to receive either a prescriptive or self-directed implementation approach to family-based behavioral pediatric obesity treatment. BSU (monitoring, contingency management, environmental control) will be reported or assessed at pre-treatment, at the 5th, 10th, and 15th treatment sessions, at post-treatment and at the 3-month and 6-month follow-ups by the parent, interventionist, and supplemental evaluator. Prospective associations between BSU, measured multiple times and by multiple informant/formats, and change in child weight status (z-BMI) and weight-related behaviors (diet, physical activity) over the course of treatment and throughout follow up will be examined. This proposal will provide important information about the type of BSU and its measurement that is most related to short- and long-term treatment efficacy, and provide pilot data on the relative efficacy of different implementation approaches to initiate and sustain BSU in pediatric obesity intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prescribed Skills | Active comparator | Behavioral: FOCUSBehavioral skills are all prescribed and considered necessary tools expected to be used consistently, completely, and uniformly by all participants throughout treatment |
| Self-Directed Skills | Experimental | Behavioral: FOCUSBehavioral skills are considered a tool box from which families are encouraged to select skills that best apply to that family's situation in attempts to help their child make eating and activity change. |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Child age: 7-11 years.
- English-speaking.
- Parent is willing and able to actively participate in treatment.
- Overweight child: at or above 85th percentile for age- and gender-specific BMI, but not more than 175% above median BMI for age and gender.
- Overweight parent: BMI≥ 25.
Key exclusion criteria (8 listed)
- Medical condition known to promote obesity (e.g. Prader-Willi syndrome, Cushing's syndrome).
- Already involved with another weight control program.
- Consistently engaging in weight-affecting behaviors (e.g. child: smoking)
- Significant diagnosed obesity-related co-morbidities (e.g. Type 2 diabetes)
- Taking weight-affecting medications (e.g. Ritalin)
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 |
|---|---|---|
| FOCUSTreatment will be delivered over a 20-week period. Participating children and at least one of their parents will attend weekly in-person clinic sessions. Treatment will consist of 20-25 minute meetings between the assigned interventionist and each child/parent pair to individualize treatment, with an emphasis on helping the family change eating and activity behaviors. Family meetings will be followed by separate child and parent group meetings lasting approximately 35-45 minutes. In both approaches, parents serve as primary implementers of the treatment for the child and, if overweight, for themselves. Group sessions provide education in diet and physical activity, parenting, and behavioral skills, although conditions differ in whether skills are "prescribed" or "self-directed". Children and parents will be weighed at each clinic visit. | Behavioural | Prescribed Skills, Self-Directed Skills |
Primary outcome
Child weight status, physical activity, & diet.
Time frame: 6 Months
1 secondary outcome
Secondary outcomes will include parents' BMI, and parents' physical activity and eating behaviors and covariates will include child age, gender, and household income.
Time frame: 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 21 May 2015.
- Results publication: PubMed 23902797Saelens BE, Lozano P, Scholz K. A randomized clinical trial comparing delivery of behavioral pediatric obesity treatment using standard and enhanced motivational approaches. J Pediatr Psychol. 2013 Oct;38(9):954-64. doi: 10.1093/jpepsy/jst054. Epub 2013 Jul 31.
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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 FOCUS in people with Overweight and 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 6 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 21 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 weight status, physical activity, & diet. (time frame: 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 NCT00746629, which also lists 1 linked publication.
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 21 May 2015.