ObesityTEENSNCT01073215
Primary Care Research Network for the Treatment of Adolescent Obesity
A study testing Family-Based Lifestyle Modification and Family-Based Lifestyle Modification Program in people with Obesity, run by Children's Hospital of Philadelphia.
Trial summary
The "Primary Care Research Network for the Treatment of Adolescent Obesity" will establish infrastructure within the primary care setting to support programmatic research on weight loss for underserved adolescents, primarily urban African Americans, rural Caucasians, and Latinos. Read more about this study
- Who is it for?
- Ages 12 to 16 years
- Conditions the study is for
- Obesity
- What is being tested?
- Family-Based Lifestyle Modification and Family-Based Lifestyle Modification Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 173 participants
- Where
- No sites listed yet
- Study dates
- Jul 2006to May 2010
- 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 12 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female adolescents
- Age 12 to 16 years
- Body Mass Index (BMI) of 28 kg/m2
- Adolescent expresses desire to lose weight
- Parent willing to participate
- Live within 40 minutes from study clinic at CHOP or 60 minutes at Geisinger
Who cannot join
- Uncontrolled hypertension (blood pressure > 140/90 mm HG)
- Diabetes mellitus (fasting glucose > 126 mg/dl)
- Any serious uncontrolled medical disorder that would complicate participation in a weight loss program
- Bipolar disorder or psychosis (depression ok if adolescent is receiving treatment)
- Use of any medication affecting body weight, appetite or metabolism within 30 days prior to the start of treatment
- Positive pregnancy test at medical evaluation
About this study
The "Primary Care Research Network for the Treatment of Adolescent Obesity" will establish infrastructure within the primary care setting to support programmatic research on weight loss for underserved adolescents, primarily urban African Americans, rural Caucasians, and Latinos. Using primary care settings, to which many youths already have entry, may increase access for underserved adolescents to participate in obesity treatment and research. The primary project will be a 12 month randomized controlled study comparing the relative effectiveness of two interventions for weight reduction: Group Condition (a family based lifestyle modification program delivered by health care providers in 23 sessions); Self-Guided Condition (a family based lifestyle modification program that combines a self-guided, home-based approach with 6 sessions delivered by health care providers).
Read the detailed description
The broad objective is to establish a Center of Excellence for Research on Obesity at The Children's Hospital of Philadelphia (CHOP) that will create a statewide, collaborative research network to develop and test effective treatments for reducing adolescent obesity and related medical co-morbidities in underserved populations. Collaborating institutions include Lincoln University (LU), Geisinger Health System (GHS), and the University of Pennsylvania (UPenn). Given the locations of these institutions, we will focus on urban African Americans and Latinos and rural Caucasian adolescents. The novelty of this program will be the use of a family-based, lifestyle modification program within the pediatric primary care setting with interdisciplinary teams trained to treat obese adolescents. Specific aims are to: a) design, implement, and evaluate improved treatments for obese teenagers, b) conduct focus groups and treatment development projects to better understand the needs of these populations and c) train, minority students and faculty to become healthcare research professionals. The primary research project will be a randomized clinical trial occurring at two sites: CHOP and GHS. In a four-year study, 156 adolescents (ages 12-16) will be randomized to either a one-year, 23 session, multi-family, group based Lifestyle Modification Program known as the Group Condition, or to a one-year, six-session Self-Guided Condition. Both Group and Self-Guided will be tested as possible treatment protocols for primary care pediatric practice.
The primary aim is to compare the effectiveness of these two treatments in reducing body mass index (BMI) at 12 months. Secondary aims will compare impact of the treatments on reduction of risk factors related to cardiovascular disease and diabetes, including lipids, glucose and insulin, waist circumference, blood pressure, and measures of appetite. Further, the effectiveness of these two treatments in reducing BMI at 15 and 18 months will also be analyzed. Training aims will be met through collaboration with Lincoln University to set up undergraduate summer internships, graduate assistantships, and faculty development. Other methods for achieving the objectives of the Center include: a) establishing a multidisciplinary advisory board consisting of parents, providers, and researchers; b) providing clinical training in obesity treatment for doctors, nurses, dieticians, and behavioral interventionists at our collaborating institutions (CHOP and GHS); c) making all protocols and materials culturally sensitive to the populations they serve; and d) carrying out treatment development activities to tailor the manuals for Latino youth and their families.
- Conditions
- Obesity
- Being tested
- Family-Based Lifestyle Modification, Family-Based Lifestyle Modification Program
- Keywords
- Adolescents, Obesity, Weight Management, Family-based Lifestyle Modification
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family-Based Lifestyle ModificationBehavioural
Also called TEENS Study
The Self-Guided condition will receive the same manual content and recommendations for eating and physical activity as the Group Condition. Since this approach is primarily home-based, participants in this condition will also receive additional tips and guidelines to assist the family in following the program at home. There will be 6 visits with the health coach at weeks 01, 04, 08, 24, 40, and 52. Participants will receive 2 phone calls from health coach at weeks 16 and 32. Parents and teens will be encouraged to hold weekly meetings at home to discuss program goals and progress.
Family-Based Lifestyle Modification ProgramBehavioural
Also called TEENS Study
The Group condition will consist of a comprehensive family based lifestyle modification program of 23 visits (8 weekly, 8 bi-weekly, 7 monthly).
Intervention visits include a combination of 17 group sessions and 6 individual meetings with health coach. There will be 7 phone calls two weeks after each monthly visit. Adolescents and their parents attend concurrent group meetings. The content of the sessions will include topics related to nutrition, physical activity, and behavior modification for weight management.
| Study group | Role | What they receive |
|---|---|---|
| Group Condition | Active comparator | Not described Receives: Behavioral: Family-Based Lifestyle Modification Program |
| Self-Guided Condition | Experimental | Not described Receives: Behavioral: Family-Based Lifestyle Modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change in initial body mass index (BMI) at 12 months
Measured: 12 months
Secondary outcomes (3)
Compare mean reduction in percentage of initial BMI in the two treatments within each ethnic group/site (CHOP: urban African American adolescents and GHS: rural Caucasian adolescents
Measured: 12 months
Compare the effectiveness of the two treatment approaches on improving risk factors for cardiovascular disease and diabetes (Total, HDL, and LDL cholesterol, triglycerides, glucose, insulin, and blood pressure) and on improving liver function
Measured: 12 months
Compare mean reduction in percentage of initial BMI in each treatment group at month 6
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 posted23 Feb 2010 (estimated)
- Study startJul 2006
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe 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
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- Pennsylvania Department of Health, Geisinger Clinic, University of Pennsylvania
- Responsible party
- Sponsor
- Investigators
- Robert I Berkowitz, MD, Principal investigator, Children's Hospital of Philadelphia and University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01073215
- Sponsor's protocol ID
- 07-005084
- Other IDs
- SAP4100033130
- Acronym
- TEENS
- Status last verified
- Feb 2012
- First submitted
- 19 Feb 2010
- Last updated
- 20 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Care Research Network for the Treatment of Adolescent Obesity
- ClinicalTrials.gov ID
- NCT01073215
- Acronym / sponsor ID
- TEENS / 07-005084
- Conditions
- Obesity
- Keywords
- Adolescents, Obesity, Weight Management, Family-based Lifestyle Modification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- Pennsylvania Department of Health, Geisinger Clinic, University of Pennsylvania
- Study start
- Jul 2006
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 23 Feb 2010 (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 "Primary Care Research Network for the Treatment of Adolescent Obesity" will establish infrastructure within the primary care setting to support programmatic research on weight loss for underserved adolescents, primarily urban African Americans, rural Caucasians, and Latinos. Using primary care settings, to which many youths already have entry, may increase access for underserved adolescents to participate in obesity treatment and research. The primary project will be a 12 month randomized controlled study comparing the relative effectiveness of two interventions for weight reduction: Group Condition (a family based lifestyle modification program delivered by health care providers in 23 sessions); Self-Guided Condition (a family based lifestyle modification program that combines a self-guided, home-based approach with 6 sessions delivered by health care providers).
Detailed description
The broad objective is to establish a Center of Excellence for Research on Obesity at The Children's Hospital of Philadelphia (CHOP) that will create a statewide, collaborative research network to develop and test effective treatments for reducing adolescent obesity and related medical co-morbidities in underserved populations. Collaborating institutions include Lincoln University (LU), Geisinger Health System (GHS), and the University of Pennsylvania (UPenn). Given the locations of these institutions, we will focus on urban African Americans and Latinos and rural Caucasian adolescents. The novelty of this program will be the use of a family-based, lifestyle modification program within the pediatric primary care setting with interdisciplinary teams trained to treat obese adolescents. Specific aims are to: a) design, implement, and evaluate improved treatments for obese teenagers, b) conduct focus groups and treatment development projects to better understand the needs of these populations and c) train, minority students and faculty to become healthcare research professionals. The primary research project will be a randomized clinical trial occurring at two sites: CHOP and GHS. In a four-year study, 156 adolescents (ages 12-16) will be randomized to either a one-year, 23 session, multi-family, group based Lifestyle Modification Program known as the Group Condition, or to a one-year, six-session Self-Guided Condition. Both Group and Self-Guided will be tested as possible treatment protocols for primary care pediatric practice.
The primary aim is to compare the effectiveness of these two treatments in reducing body mass index (BMI) at 12 months. Secondary aims will compare impact of the treatments on reduction of risk factors related to cardiovascular disease and diabetes, including lipids, glucose and insulin, waist circumference, blood pressure, and measures of appetite. Further, the effectiveness of these two treatments in reducing BMI at 15 and 18 months will also be analyzed. Training aims will be met through collaboration with Lincoln University to set up undergraduate summer internships, graduate assistantships, and faculty development. Other methods for achieving the objectives of the Center include: a) establishing a multidisciplinary advisory board consisting of parents, providers, and researchers; b) providing clinical training in obesity treatment for doctors, nurses, dieticians, and behavioral interventionists at our collaborating institutions (CHOP and GHS); c) making all protocols and materials culturally sensitive to the populations they serve; and d) carrying out treatment development activities to tailor the manuals for Latino youth and their families.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Condition | Active comparator | Behavioral: Family-Based Lifestyle Modification Program |
| Self-Guided Condition | Experimental | Behavioral: Family-Based Lifestyle Modification |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Male or female adolescents
- Age 12 to 16 years
- Body Mass Index (BMI) of 28 kg/m2
- Adolescent expresses desire to lose weight
- Parent willing to participate
Key exclusion criteria (6 listed)
- Uncontrolled hypertension (blood pressure > 140/90 mm HG)
- Diabetes mellitus (fasting glucose > 126 mg/dl)
- Any serious uncontrolled medical disorder that would complicate participation in a weight loss program
- Bipolar disorder or psychosis (depression ok if adolescent is receiving treatment)
- Use of any medication affecting body weight, appetite or metabolism within 30 days prior to the start of treatment
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 Lifestyle ModificationAlso: TEENS StudyThe Self-Guided condition will receive the same manual content and recommendations for eating and physical activity as the Group Condition. Since this approach is primarily home-based, participants in this condition will also receive additional tips and guidelines to assist the family in following the program at home. There will be 6 visits with the health coach at weeks 01, 04, 08, 24, 40, and 52. Participants will receive 2 phone calls from health coach at weeks 16 and 32. Parents and teens will be encouraged to hold weekly meetings at home to discuss program goals and progress. | Behavioural | Self-Guided Condition |
| Family-Based Lifestyle Modification ProgramAlso: TEENS StudyThe Group condition will consist of a comprehensive family based lifestyle modification program of 23 visits (8 weekly, 8 bi-weekly, 7 monthly). Intervention visits include a combination of 17 group sessions and 6 individual meetings with health coach. There will be 7 phone calls two weeks after each monthly visit. Adolescents and their parents attend concurrent group meetings. The content of the sessions will include topics related to nutrition, physical activity, and behavior modification for weight management. | Behavioural | Group Condition |
Primary outcome
Percentage change in initial body mass index (BMI) at 12 months
Time frame: 12 months
3 secondary outcomes
Compare mean reduction in percentage of initial BMI in the two treatments within each ethnic group/site (CHOP: urban African American adolescents and GHS: rural Caucasian adolescents
Time frame: 12 months
Compare the effectiveness of the two treatment approaches on improving risk factors for cardiovascular disease and diabetes (Total, HDL, and LDL cholesterol, triglycerides, glucose, insulin, and blood pressure) and on improving liver function
Time frame: 12 months
Compare mean reduction in percentage of initial BMI in each treatment group at month 6
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 20 Feb 2012.
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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.
Robert I Berkowitz, MD principal investigator
Children's Hospital of Philadelphia and University of Pennsylvania
Questions about this trial
What is this clinical trial studying?
A study testing Family-Based Lifestyle Modification and Family-Based Lifestyle Modification Program in people with Obesity, run by Children's Hospital of Philadelphia.
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 6 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 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
Percentage change in initial body mass index (BMI) at 12 months (time frame: 12 months). 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 Feb 2012.