OverweightPhase 1/2PONCT00807560
Parent-Based Treatment for Pediatric Overweight
A Phase 1/2 study testing FBT-PO and NEC in people with Overweight and Obesity, run by Icahn School of Medicine at Mount Sinai at 2 sites in United States.
Trial summary
The purpose of this study is to determine whether a parent/guardian intervention for adolescent overweight/obesity more effective than a nutritional counseling education curriculum for reducing body mass index z-score (BMI Z-score) and related outcomes. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- FBT-PO and NEC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2008to Jun 2013
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Ages 13-17
- Male and female
- Living with at least one parent or guardian who is willing to participate in treatment
- A BMI percentile >85% for gender and age (e.g., overweight or at risk for overweight)
Who cannot join
- Current psychotic illness
- Current alcohol/drug dependence
- Active suicidality
- Eating disorders (e.g., binge eating disorder)
- History of bariatric surgery
- Medication associated with significant weight changes (e.g., antipsychotics)
- Serious medical or physical conditions resulting in significant weight changes (e.g., pregnancy, genetic disorders).
- Complications of obesity that contraindicate moderate physical activity (e.g. orthopedic disorders)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The University of Chicago
Chicago, Illinois, 60637
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
The purpose of this study is to determine whether a parent/guardian intervention for adolescent overweight/obesity more effective than a nutritional counseling education curriculum for reducing body mass index z-score (BMI Z-score) and related outcomes.
Read the detailed description
Rates of pediatric overweight (PO) among Americans are increasing and associated with significant psychological, social, quality of life, and health related outcomes. Because of the broad mental and physical health implications of PO and the difficulty in sustaining weight loss as an adult, it is of interest to find successful methods of weight loss and/or prevention of weight gain for obese children and adolescents. The family unit is a logical and empirically supported point of intervention for PO. Interventions on this level have shown good long term efficacy in young children, but there is very little research on adolescent family intervention. Within the eating disorder literature, there is growing support for the efficacy of family-based interventions (FBI) for adolescents. Given its trans-developmental applicability, focus on family as the unit of intervention, and utility in creating a healthy eating environment, FBI is a logical candidate for adaptation to intervention for PO and intervention for at-risk for overweight youth (FBI-PO). The core of the current project is to test the feasibility and efficacy of an adapted FBI manual for adolescent overweight and at-risk for overweight in an outpatient eating and weight disorders clinic and compare this modality to a minimal nutritional educational control (NEC) condition.
- Conditions
- Overweight, Obesity
- Being tested
- FBT-PO, NEC
- Keywords
- Overweight, Obesity, Adolescents, Family Therapy
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FBT-POBehavioural
Also called Family Based Therapy for Pediatric Overweight
The goal of FBT-PO is to resolve the eating disorder and return the patient to healthy psychosocial and physiological developmental trajectories through active family involvement across three treatment phases.
NECBehavioural
Also called Nutritional Educational Control Condition
Families assigned to NEC will receive a minimal nutrition and physical activity education curriculum across 16 sessions over 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| FBT-PO | Experimental | Family Based Therapy for Pediatric Overweight. Receives: Behavioral: FBT-PO |
| NEC-control | Active comparator | Nutritional Educational Control Condition (NEC). Receives: Behavioral: NEC |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI Z Score
Z-score was calculated using the Baylor College of Medicine Children's Nutrition Research Center's online BMI calculator (https://www.bcm.edu/research/centers/childrens-nutrition-research-center/bodycomp/bmiz2.html).
Measured: baseline
BMI Z Score
Z-score was calculated using the Baylor College of Medicine Children's Nutrition Research Center's online BMI calculator (https://www.bcm.edu/research/centers/childrens-nutrition-research-center/bodycomp/bmiz2.html)
Measured: up to 44 weeks
Secondary outcomes (13)
Percent Completion
Percent of participants who completed the trial to assess feasibility and retention in the trial
Measured: at 44 weeks
Waist Measurement
Waist measurement in inches. This is not a primary outcome variable.
Measured: baseline
Waist Measurement
Waist measurement in inches. This is not a primary outcome variable.
Measured: up to 44 weeks
Hip Measurement
Hip measurement in inches. This is not a primary outcome variable.
Measured: baseline
Hip Measurement
Hip measurement in inches. This is not a primary outcome variable.
Measured: up to 44 weeks
Height
This variable informs the calculation of the outcome variable of BMI Z score.
Measured: Baseline
Height
This variable informs the calculation of the outcome variable of BMI Z score.
Measured: up to 44 weeks
Weight
This variable informs the calculation for the outcome variable of BMI Z score.
Measured: baseline
Weight
This variable informs the calculation of the outcome variable of BMI z score.
Measured: up to 44 weeks
BMI
Body Mass Index: this variable informs the calculation of the outcome variable of BMI z-score.
Measured: baseline
BMI
Body Mass Index: this variable informs the calculation of the primary outcome variable of BMI z-score.
Measured: up to 44 weeks
BMI Percentile
Body Mass Index percentile. This is not a primary outcome variable.
Measured: baseline
BMI Percentile
Body Mass Index percentile. This is not a primary outcome variable.
Measured: up to 44 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2008 (estimated)
- Study startSep 2008
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Katherine L Loeb, PH.D., Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00807560
- Sponsor's protocol ID
- GCO 07-0216
- Other IDs
- 1R21HD057394-01
- Acronym
- PO
- Status last verified
- Dec 2015
- First submitted
- 11 Dec 2008
- Last updated
- 8 Jan 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parent-Based Treatment for Pediatric Overweight
- ClinicalTrials.gov ID
- NCT00807560
- Acronym / sponsor ID
- PO / GCO 07-0216
- Conditions
- Overweight, Obesity
- Keywords
- Overweight, Obesity, Adolescents, Family Therapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Sep 2008
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 12 Dec 2008 (estimated)
- Results
- Posted 8 Jan 2016
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 determine whether a parent/guardian intervention for adolescent overweight/obesity more effective than a nutritional counseling education curriculum for reducing body mass index z-score (BMI Z-score) and related outcomes.
Detailed description
Rates of pediatric overweight (PO) among Americans are increasing and associated with significant psychological, social, quality of life, and health related outcomes. Because of the broad mental and physical health implications of PO and the difficulty in sustaining weight loss as an adult, it is of interest to find successful methods of weight loss and/or prevention of weight gain for obese children and adolescents. The family unit is a logical and empirically supported point of intervention for PO. Interventions on this level have shown good long term efficacy in young children, but there is very little research on adolescent family intervention. Within the eating disorder literature, there is growing support for the efficacy of family-based interventions (FBI) for adolescents. Given its trans-developmental applicability, focus on family as the unit of intervention, and utility in creating a healthy eating environment, FBI is a logical candidate for adaptation to intervention for PO and intervention for at-risk for overweight youth (FBI-PO). The core of the current project is to test the feasibility and efficacy of an adapted FBI manual for adolescent overweight and at-risk for overweight in an outpatient eating and weight disorders clinic and compare this modality to a minimal nutritional educational control (NEC) condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FBT-PO | Experimental | Behavioral: FBT-POFamily Based Therapy for Pediatric Overweight. |
| NEC-control | Active comparator | Behavioral: NECNutritional Educational Control Condition (NEC). |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Ages 13-17
- Male and female
- Living with at least one parent or guardian who is willing to participate in treatment
- A BMI percentile >85% for gender and age (e.g., overweight or at risk for overweight)
Key exclusion criteria (8 listed)
- Current psychotic illness
- Current alcohol/drug dependence
- Active suicidality
- Eating disorders (e.g., binge eating disorder)
- History of bariatric surgery
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-POAlso: Family Based Therapy for Pediatric OverweightThe goal of FBT-PO is to resolve the eating disorder and return the patient to healthy psychosocial and physiological developmental trajectories through active family involvement across three treatment phases. | Behavioural | FBT-PO |
| NECAlso: Nutritional Educational Control ConditionFamilies assigned to NEC will receive a minimal nutrition and physical activity education curriculum across 16 sessions over 24 weeks. | Behavioural | NEC-control |
Primary outcome
BMI Z Score
Time frame: baseline
Z-score was calculated using the Baylor College of Medicine Children's Nutrition Research Center's online BMI calculator (https://www.bcm.edu/research/centers/childrens-nutrition-research-center/bodycomp/bmiz2.html).
BMI Z Score
Time frame: up to 44 weeks
Z-score was calculated using the Baylor College of Medicine Children's Nutrition Research Center's online BMI calculator (https://www.bcm.edu/research/centers/childrens-nutrition-research-center/bodycomp/bmiz2.html)
13 secondary outcomes
Percent Completion
Time frame: at 44 weeks
Waist Measurement
Time frame: baseline
Waist Measurement
Time frame: up to 44 weeks
Hip Measurement
Time frame: baseline
Hip Measurement
Time frame: up to 44 weeks
Height
Time frame: Baseline
Height
Time frame: up to 44 weeks
Weight
Time frame: baseline
Weight
Time frame: up to 44 weeks
BMI
Time frame: baseline
BMI
Time frame: up to 44 weeks
BMI Percentile
Time frame: baseline
BMI Percentile
Time frame: up to 44 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Katherine L Loeb, PH.D. principal investigator
Icahn School of Medicine at Mount Sinai
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing FBT-PO and NEC in people with Overweight and Obesity, run by Icahn School of Medicine at Mount Sinai at 2 sites 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 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 8 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
BMI Z Score (time frame: baseline). The study lists 2 primary outcomes in all. 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 8 Jan 2016.