ObesityPhase 3NCT00284557
A Primary Care Behavioral Approach for Addressing Childhood Overweight
A Phase 3 study testing Group-based behavioral intervention in people with Obesity, run by Emory University.
Trial summary
The purpose of this study is to determine whether participation in a group-based health education curriculum is superior to receipt of standardized health educational materials for children who are overweight or at risk for overweight with regard to achievement of a healthier body weight and improvement of key eating… Read more about this study
- Who is it for?
- Ages 7 to 11 years
- Conditions the study is for
- Obesity
- What is being tested?
- Group-based behavioral intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- Jan 2006to Jul 2010
- Phase
- Phase 3
- 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 7 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Obese (BMI ≥ 95th percentile for age and gender) or at-risk for obesity (85th ≥ BMI > 95th percentile for age and gender);
- African-American by parent report;
- 7-11 years of age;
- Without any medical or psychological condition that would make weight loss or physical activity dangerous, or psychological disorders that would make adoption of health behaviors difficult;
- Without any complications of obesity that indicate prompt referral to a pediatric obesity treatment center for more aggressive weight loss therapy;
- Together with the parent/caregiver indicate that they are ready to make changes in their eating and physical activity behaviors;
- Have a parent/caregiver willing to participate.
Who cannot join
- As noted above, to participate in this study the child must not have a medical or psychological condition that would make weight loss or physical activity dangerous, psychological disorders that would make adoption of health behaviors difficult, or complications of obesity that necessitate prompt referral to a pediatric obesity treatment center for more aggressive weight loss therapy. Examples of medical or psychological conditions that would render the child ineligible for this study include uncontrolled or poorly-controlled asthma or hypertension, bulimia, mental retardation or severe learning disability, as well as pseudotumor cerebri, sleep apnea, obesity hypoventilation syndrome, and slipped capital femoral epiphysis.
About this study
Official title: Evaluation of a Primary Care-Based Behavioral Intervention for Improving Physical Activity and Nutrition Behaviors Among High-Risk African-American Youth
The purpose of this study is to determine whether participation in a group-based health education curriculum is superior to receipt of standardized health educational materials for children who are overweight or at risk for overweight with regard to achievement of a healthier body weight and improvement of key eating and physical activity behaviors.
Read the detailed description
In the United States, childhood obesity has tripled since 1970 such that 15% of those 6 to 19 years of age are obese, with higher observed prevalences for African-American and Hispanic children. Childhood obesity has significant short- and long-term health consequences. To avoid future morbidity, children who are obese or at risk for obesity must be identified and treated at an early stage. The primary care setting, where most children receive health care and where BMI should be tracked, may represent an early opportunity for identifying and treating childhood obesity. However, translational research is needed to test whether existing strategies for childhood obesity can be adapted for delivery via the primary care setting
The ultimate purpose of this work is to help overweight children, particularly those who are African-American, optimize their lifespan and quality of health through achievement of a healthier body mass index (BMI). Specific aims are to perform outcome and process evaluations to determine whether the intervention results in improvement in BMI percentile or habitual healthy eating and physical activity behaviors, and whether the intervention is feasible. The outcome evaluation component involves a randomized controlled trial, in which overweight children (BMI for age percentile >=95th) and children at risk for overweight (BMI for age percentile 85-94th)together with a parent/caregiver receive the primary care-based intervention or health education materials only. The intervention will focus on four main behavioral changes: decreasing consumption of key calorie-dense foods, increasing consumption of fruits and vegetables to ≥ 5 a day, reducing targeted sedentary behaviors to < 15 hrs per week, and increasing moderate and vigorous physical activity to 60 minutes or more daily. We will assess change in BMI percentile, number of servings of calorie-dense foods daily, and percent of time spent in sedentary and physical activities at 6-, 12-, and 18-months using mixed-model ANCOVA for repeated measures.
- Conditions
- Obesity
- Being tested
- Group-based behavioral intervention
- Keywords
- Behavioral/Social, Obesity, Pediatrics, Preventive Medicine
- Medical subject headings
- Obesity, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group-based behavioral interventionBehavioural
The group-based behavioral intervention targets eating behaviors, physical activity, and "screen time", and is delivered to participating children and their parent/caregiver over the course of 4 weeks. Maintenance sessions occur every 3 months thereafter.
| Study group | Role | What they receive |
|---|---|---|
| Group-based behavioral intervention | Experimental | The group-based behavioral intervention targets eating behaviors, physical activity, and "screen time", and is delivered to participating children and their parent/caregiver over the course of 4 weeks. Maintenance sessions occur every 3 months thereafter. Receives: Behavioral: Group-based behavioral intervention |
| Health education materials only | Active comparator | Those allocated to Group 2 were provided with a standardized packet of health education materials addressing the recommended items from the expert committee guidelines (e.g., dietary recommendations using the Food Guide Pyramid and the Traffic Light Diet, a general prescription to increase physical activity to 60 minutes daily). They were also given a community resource list that provides contact and program information for community-based obesity treatment activities in their area. Receives: Behavioral: Group-based behavioral intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI Z-score(for Gender and Age)at 6-months
The body mass index (BMI) for a given age (in years and monthys) and gender (male or female) converted to an exact z-score.
Measured: 6-months post-intervention
BMI Z-score(for Gender and Age)at 12-months
The body mass index (BMI) for a given age (in years and monthys) and gender (male or female) converted to an exact z-score.
Measured: 12-months post-intervention
Secondary outcomes (1)
Change in Eating Behaviors (Consumption of WHOA Foods), Physical Activity, and "Screen Time"
Measured: 6- and 12-months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2006 (estimated)
- Study startJan 2006
- Primary completionMar 2010
- Study completionJul 2010
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 ObesityStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Anne Lang Dunlop, MD, MPH, Emory University
- Investigators
- Anne L Dunlop, MD, MPH, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00284557
- Sponsor's protocol ID
- 416-2005
- Status last verified
- Jun 2012
- First submitted
- 30 Jan 2006
- Last updated
- 11 Jul 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Primary Care-Based Behavioral Intervention for Improving Physical Activity and Nutrition Behaviors Among High-Risk African-American Youth
- ClinicalTrials.gov ID
- NCT00284557
- Acronym / sponsor ID
- 416-2005
- Conditions
- Obesity
- Keywords
- Behavioral/Social, Obesity, Pediatrics, Preventive Medicine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- Jan 2006
- Primary completion
- Mar 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 1 Feb 2006 (estimated)
- Results
- Posted 28 Jun 2012
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 participation in a group-based health education curriculum is superior to receipt of standardized health educational materials for children who are overweight or at risk for overweight with regard to achievement of a healthier body weight and improvement of key eating and physical activity behaviors.
Detailed description
In the United States, childhood obesity has tripled since 1970 such that 15% of those 6 to 19 years of age are obese, with higher observed prevalences for African-American and Hispanic children. Childhood obesity has significant short- and long-term health consequences. To avoid future morbidity, children who are obese or at risk for obesity must be identified and treated at an early stage. The primary care setting, where most children receive health care and where BMI should be tracked, may represent an early opportunity for identifying and treating childhood obesity. However, translational research is needed to test whether existing strategies for childhood obesity can be adapted for delivery via the primary care setting
The ultimate purpose of this work is to help overweight children, particularly those who are African-American, optimize their lifespan and quality of health through achievement of a healthier body mass index (BMI). Specific aims are to perform outcome and process evaluations to determine whether the intervention results in improvement in BMI percentile or habitual healthy eating and physical activity behaviors, and whether the intervention is feasible. The outcome evaluation component involves a randomized controlled trial, in which overweight children (BMI for age percentile >=95th) and children at risk for overweight (BMI for age percentile 85-94th)together with a parent/caregiver receive the primary care-based intervention or health education materials only. The intervention will focus on four main behavioral changes: decreasing consumption of key calorie-dense foods, increasing consumption of fruits and vegetables to ≥ 5 a day, reducing targeted sedentary behaviors to < 15 hrs per week, and increasing moderate and vigorous physical activity to 60 minutes or more daily. We will assess change in BMI percentile, number of servings of calorie-dense foods daily, and percent of time spent in sedentary and physical activities at 6-, 12-, and 18-months using mixed-model ANCOVA for repeated measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group-based behavioral intervention | Experimental | Behavioral: Group-based behavioral interventionThe group-based behavioral intervention targets eating behaviors, physical activity, and "screen time", and is delivered to participating children and their parent/caregiver over the course of 4 weeks. Maintenance sessions occur every 3 months thereafter. |
| Health education materials only | Active comparator | Behavioral: Group-based behavioral interventionThose allocated to Group 2 were provided with a standardized packet of health education materials addressing the recommended items from the expert committee guidelines (e.g., dietary recommendations using the Food Guide Pyramid and the Traffic Light Diet, a general prescription to increase physical activity to 60 minutes daily). They were also given a community resource list that provides contact and program information for community-based obesity treatment activities in their area. |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Obese (BMI ≥ 95th percentile for age and gender) or at-risk for obesity (85th ≥ BMI > 95th percentile for age and gender);
- African-American by parent report;
- 7-11 years of age;
- Without any medical or psychological condition that would make weight loss or physical activity dangerous, or psychological disorders that would make adoption of health behaviors difficult;
- Without any complications of obesity that indicate prompt referral to a pediatric obesity treatment center for more aggressive weight loss therapy;
Key exclusion criteria (1 listed)
- As noted above, to participate in this study the child must not have a medical or psychological condition that would make weight loss or physical activity dangerous, psychological disorders that would make adoption of health behaviors difficult, or complications of obesity that necessitate prompt referral to a pediatric obesity treatment center for more aggressive weight loss therapy. Examples of medical or psychological conditions that would render the child ineligible for this study include uncontrolled or poorly-controlled asthma or hypertension, bulimia, mental retardation or severe learning disability, as well as pseudotumor cerebri, sleep apnea, obesity hypoventilation syndrome, and slipped capital femoral epiphysis.
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 |
|---|---|---|
| Group-based behavioral interventionThe group-based behavioral intervention targets eating behaviors, physical activity, and "screen time", and is delivered to participating children and their parent/caregiver over the course of 4 weeks. Maintenance sessions occur every 3 months thereafter. | Behavioural | Group-based behavioral intervention, Health education materials only |
Primary outcome
BMI Z-score(for Gender and Age)at 6-months
Time frame: 6-months post-intervention
The body mass index (BMI) for a given age (in years and monthys) and gender (male or female) converted to an exact z-score.
BMI Z-score(for Gender and Age)at 12-months
Time frame: 12-months post-intervention
The body mass index (BMI) for a given age (in years and monthys) and gender (male or female) converted to an exact z-score.
1 secondary outcome
Change in Eating Behaviors (Consumption of WHOA Foods), Physical Activity, and "Screen Time"
Time frame: 6- and 12-months post-intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2012.
- 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.
Anne L Dunlop, MD, MPH principal investigator
Emory University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Group-based behavioral intervention in people with Obesity, run by Emory University.
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 7 inclusion and 1 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 11 Jul 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 28 Jun 2012). 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(for Gender and Age)at 6-months (time frame: 6-months post-intervention). 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 11 Jul 2012.