ObesityNCT00132132
Study of Impact of Behavioral Intervention- Exercise, Nutrition, Education- on Body Mass Index (BMI)
A study testing Behavioral education program in people with Obesity, run by Steward St. Elizabeth's Medical Center of Boston, Inc. at 1 site in United States.
Trial summary
This study will evaluate the impact a behavioral intervention can have on BMI. The researchers anticipate the intervention group will experience a decrease in BMI of approximately five points. The intervention group will be compared to a control group. This is a long term, randomized, controlled study. Read more about this study
- Who is it for?
- Ages 10 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Behavioral education program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to Feb 2008
- Phase
- Interventional
- 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 10 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Ages 10-20 years
- BMI>85%
Who cannot join
- Endocrine disorder
- On psychotropic medications
Trial locations and contacts
1 site in 1 country.
United States1 site
Caritas St. Elizabeth's Medical Center
Boston, Massachusetts, 02135
About this study
Official title: Type 2 Diabetes and Obesity Pediatric Prevention Project
This study will evaluate the impact a behavioral intervention can have on BMI. The researchers anticipate the intervention group will experience a decrease in BMI of approximately five points. The intervention group will be compared to a control group. This is a long term, randomized, controlled study. The behavioral intervention is conducted during a four hour monthly session. The behavioral intervention includes: exercise, education on medical aspects and nutrition, and empowerment.
Read the detailed description
This is a long term randomized controlled trial, looking at the impact of a behavioral intervention on BMI,in participants ages 10-20 with a BMI > 85%.
The intervention group will:
- have baseline and follow up blood work (fasting insulin, glucose, lipid panel)
- have baseline and follow up BMI, blood pressure measurements
- see a dietician-minimum of three visits during study
- attend monthly, four hour sessions. These sessions include:
- registration-monitoring of choices of liquid intake using standardized models, monitoring of sedentary behaviors-hours watching television, computer, video games, monitoring of heart rate at baseline and after exercise, monitoring of METs (metabolic equivalents), motivational interviewing, monitoring of exercise abilities (endurance, agility, curl ups, balance, power)
- one hour of exercise (including strength training)
- educational lectures on nutrition and the medical aspects of obesity and Type 2 diabetes epidemic
- projects/games
- empowerment tools such as leading exercises and presenting food labels for discussion
The control group will have:
- baseline and follow up blood work (fasting insulin, glucose, lipid panel)
- baseline and follow up BMI and blood pressure measurements
- visits to dietician (minimum of three visits during study)
- standard education on nutrition and exercise given during office visit with primary care doctor
- Conditions
- Obesity
- Being tested
- Behavioral education program
- Keywords
- BMI, obesity, behavioral intervention, longterm randomized controlled trial, exercise, empowerment, nutrition
- Medical subject headings
- Obesity, Motor Activity, Empowerment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral education programBehavioural
Monthly 4 hr session which incorporates: exercise, empowerment, education, and incentives
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | This is a long term randomized controlled study looking at the effect of a Behavioral program on BMI in a population 10-20years old with a BMI greater than or equal to 85%. The intervention is a Behavioral education program which meets monthly for 4 hour session and includes exercise, education, empowerment and incentives. Both groups are referred to a dietician. The primary outcome is change in BMI and the secondary outcome is improvement in fasting metabolic parameters (lipid panel, insulin, glucose). Receives: Behavioral: Behavioral education program |
| Standard of Care/Control | No intervention | Education on physical activity and nutrition in a primary care office setting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in BMI (Body Mass Index)
Measured: Baseline, 12-15 months
Percentage of Participants With BMI Reduction
Measured: Baseline, 12-15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2005 (estimated)
- Study startAug 2005
- Primary completionFeb 2008
- Study completionFeb 2008
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.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Steward St. Elizabeth's Medical Center of Boston, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shirley Gonzalez, MD, Principal investigator, Steward St. Elizabeth's Medical Center of Boston, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00132132
- Sponsor's protocol ID
- 00203 (number assigned by IRB)
- Status last verified
- May 2015
- First submitted
- 17 Aug 2005
- Last updated
- 21 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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
- Type 2 Diabetes and Obesity Pediatric Prevention Project
- ClinicalTrials.gov ID
- NCT00132132
- Acronym / sponsor ID
- 00203 (number assigned by IRB)
- Conditions
- Obesity
- Keywords
- BMI, obesity, behavioral intervention, longterm randomized controlled trial, exercise, empowerment, nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Steward St. Elizabeth's Medical Center of Boston, Inc.University, hospital or other
- Study start
- Aug 2005
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 19 Aug 2005 (estimated)
- Results
- Posted 27 Jun 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the impact a behavioral intervention can have on BMI. The researchers anticipate the intervention group will experience a decrease in BMI of approximately five points. The intervention group will be compared to a control group. This is a long term, randomized, controlled study. The behavioral intervention is conducted during a four hour monthly session. The behavioral intervention includes: exercise, education on medical aspects and nutrition, and empowerment.
Detailed description
This is a long term randomized controlled trial, looking at the impact of a behavioral intervention on BMI,in participants ages 10-20 with a BMI > 85%.
The intervention group will:
- have baseline and follow up blood work (fasting insulin, glucose, lipid panel)
- have baseline and follow up BMI, blood pressure measurements
- see a dietician-minimum of three visits during study
- attend monthly, four hour sessions. These sessions include:
- registration-monitoring of choices of liquid intake using standardized models, monitoring of sedentary behaviors-hours watching television, computer, video games, monitoring of heart rate at baseline and after exercise, monitoring of METs (metabolic equivalents), motivational interviewing, monitoring of exercise abilities (endurance, agility, curl ups, balance, power)
- one hour of exercise (including strength training)
- educational lectures on nutrition and the medical aspects of obesity and Type 2 diabetes epidemic
- projects/games
- empowerment tools such as leading exercises and presenting food labels for discussion
The control group will have:
- baseline and follow up blood work (fasting insulin, glucose, lipid panel)
- baseline and follow up BMI and blood pressure measurements
- visits to dietician (minimum of three visits during study)
- standard education on nutrition and exercise given during office visit with primary care doctor
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Behavioral education programThis is a long term randomized controlled study looking at the effect of a Behavioral program on BMI in a population 10-20years old with a BMI greater than or equal to 85%. The intervention is a Behavioral education program which meets monthly for 4 hour session and includes exercise, education, empowerment and incentives. Both groups are referred to a dietician. The primary outcome is change in BMI and the secondary outcome is improvement in fasting metabolic parameters (lipid panel, insulin, glucose). |
| Standard of Care/Control | No intervention | –Education on physical activity and nutrition in a primary care office setting |
Who may qualify
- Ages
- 10 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Ages 10-20 years
- BMI>85%
Key exclusion criteria (2 listed)
- Endocrine disorder
- On psychotropic medications
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 |
|---|---|---|
| Behavioral education programMonthly 4 hr session which incorporates: exercise, empowerment, education, and incentives | Behavioural | Intervention |
Primary outcome
Change in BMI (Body Mass Index)
Time frame: Baseline, 12-15 months
Percentage of Participants With BMI Reduction
Time frame: Baseline, 12-15 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2015.
- 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.
Shirley Gonzalez, MD principal investigator
Steward St. Elizabeth's Medical Center of Boston, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral education program in people with Obesity, run by Steward St. Elizabeth's Medical Center of Boston, Inc. 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 2 inclusion and 2 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?
Yes. Results are posted in the registry (first posted 27 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?
Change in BMI (Body Mass Index) (time frame: Baseline, 12-15 months). 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 21 May 2015.