OverweightNCT00373230
Treating Obesity in Underserved Overweight Populations
A study testing telemedicine in people with Overweight, run by Temple University at 2 sites in United States.
Trial summary
Obesity has reached epidemic proportions with nearly two-thirds of the US population either overweight or obese. Thus, novel strategies that both improve weight loss maintenance and are accessible to those most in need are the focus of this application, which will determine if a telemedicine system can help… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight
- What is being tested?
- telemedicine
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2007to Feb 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 27<BMI<45
- Able to walk
Who cannot join
- Diabetes on medications
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Geisinger Medical Center
Danville, Pennsylvania, 17822
Timothy McConnell, PhD, 570-271-8067, tmcconnell@geisinger.edu
- Recruiting
Temple University
Philadelphia, Pennsylvania, 19140
Linda Zamora, RN, BSN, 215-707-9733, zamoralc@temple.edu
Maggie Kerper, RN, BSN, 215 707-9731, kerpermm@tuhs.temple.edu
About this study
Official title: Treating Obesity and Its Consequences in Underserved Overweight Populations
Obesity has reached epidemic proportions with nearly two-thirds of the US population either overweight or obese. Thus, novel strategies that both improve weight loss maintenance and are accessible to those most in need are the focus of this application, which will determine if a telemedicine system can help participants, who have undergone a weight loss program based in church and community centers, maintain their weight loss over a 1 year period. Telemedicine will provide support through self-monitoring, education, supervised chat room, bulletin board, and e-mail.
Read the detailed description
Obesity has reached epidemic proportions with nearly two-thirds of the US population either overweight or obese. Ethnic minorities are disproportionately affected with 37% of African-American adults being obese. Obesity is also inversely related to socioeconomic status. In Pennsylvania, the prevalence of obesity increased from 14.7% in 1991 to 24.0% in 2002, and annual medical expenditures attributable to obesity are estimated at $4.2 billion; making Pennsylvania the 4th highest state in the country in terms of obesity-related costs. The prevalence of obesity is matched by it serious medical consequences including type 2 diabetes, hypertension, dyslipidemia, and atherosclerotic disease. The core pathogenetic factor underlying these conditions appears to be insulin resistance. Weight loss through diet and physical activity is the most desirable way to reduce insulin resistance (IR). Weight losses of 8-10% are associated with significant improvements in IR. While clinic-based weight loss programs at tertiary medical centers can produce clinically significant losses, the cost and location of these programs make them inaccessible to underserved populations (e.g., inner city African Americans and rural poor) who are most in need. Moreover, the most common outcome for weight loss treatments is weight regain. Thus, novel strategies that both improve weight loss maintenance and are accessible to those most in need are a priority for research and the focus of this application.
Based on our expertise in behavioral weight management and telemedicine, this study will determine if a telemedicine system can help participants, who have undergone a weight loss program based in church and community centers, maintain their weight loss over a 1 year period. Overweight and obese men and women (n = 400) will participate in a 16-week behavioral weight loss program in local churches and community centers. After 16 weeks, participants will be randomized to either an "In-person" follow-up group or to a "telemedicine" group for 1-year. The latter will provide support through self-monitoring, education, supervised chat room, bulletin board, and e-mail. Assessments of body weight, body composition and insulin sensitivity will be conducted at baseline, 16 and 68 weeks. Based on recent data, we predict greater maintenance of weight loss (and lower body weights) at 68 weeks in the Telemedicine group as compared to the "In person group".
- Conditions
- Overweight
- Being tested
- telemedicine
- Keywords
- weight loss, telemedicine, african-american, rural
- Medical subject headings
- Overweight, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telemedicineBehavioural
One year behavioral modification weight control program comparing in-person consultations (monthly) to a computer based telemedicine system (available 24/7).
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Internet based telemedicine weight maintenance program Receives: Behavioral: telemedicine |
| 2 | Active comparator | In person weight maintenance monthly consultations Receives: Behavioral: telemedicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
subject's weight
Measured: 3 and 15 months
Secondary outcomes (7)
Use of telemedicine system
Measured: over 12 months
blood lipids
Measured: 3 and 15 months
blood glucose
Measured: 3 and 15 months
A1c
Measured: 3 and 15 months
Insulin
Measured: 3 and 15 months
blood pressure
Measured: 3 and 15 months
Oral Glucose Tolerance
Measured: 3 and 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2006 (estimated)
- Study startOct 2007
- Primary completionFeb 2010 (estimated)
- Study completionFeb 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Collaborators
- Geisinger Clinic, University of Pennsylvania, Insight Telehealth Systems
- Investigators
- Guenther Boden, MD, Principal investigator, Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00373230
- Sponsor's protocol ID
- 2005NFGrantTemple
- Status last verified
- Oct 2008
- First submitted
- 5 Sep 2006
- Last updated
- 23 Oct 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Obesity and Its Consequences in Underserved Overweight Populations
- ClinicalTrials.gov ID
- NCT00373230
- Acronym / sponsor ID
- 2005NFGrantTemple
- Conditions
- Overweight
- Keywords
- weight loss, telemedicine, african-american, rural
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Collaborators
- Geisinger Clinic, University of Pennsylvania, Insight Telehealth Systems
- Study start
- Oct 2007
- Primary completion
- Feb 2010 (estimated)
- Study completion
- Feb 2010 (estimated)
- First posted
- 7 Sep 2006 (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.
Obesity has reached epidemic proportions with nearly two-thirds of the US population either overweight or obese. Thus, novel strategies that both improve weight loss maintenance and are accessible to those most in need are the focus of this application, which will determine if a telemedicine system can help participants, who have undergone a weight loss program based in church and community centers, maintain their weight loss over a 1 year period. Telemedicine will provide support through self-monitoring, education, supervised chat room, bulletin board, and e-mail.
Detailed description
Obesity has reached epidemic proportions with nearly two-thirds of the US population either overweight or obese. Ethnic minorities are disproportionately affected with 37% of African-American adults being obese. Obesity is also inversely related to socioeconomic status. In Pennsylvania, the prevalence of obesity increased from 14.7% in 1991 to 24.0% in 2002, and annual medical expenditures attributable to obesity are estimated at $4.2 billion; making Pennsylvania the 4th highest state in the country in terms of obesity-related costs. The prevalence of obesity is matched by it serious medical consequences including type 2 diabetes, hypertension, dyslipidemia, and atherosclerotic disease. The core pathogenetic factor underlying these conditions appears to be insulin resistance. Weight loss through diet and physical activity is the most desirable way to reduce insulin resistance (IR). Weight losses of 8-10% are associated with significant improvements in IR. While clinic-based weight loss programs at tertiary medical centers can produce clinically significant losses, the cost and location of these programs make them inaccessible to underserved populations (e.g., inner city African Americans and rural poor) who are most in need. Moreover, the most common outcome for weight loss treatments is weight regain. Thus, novel strategies that both improve weight loss maintenance and are accessible to those most in need are a priority for research and the focus of this application.
Based on our expertise in behavioral weight management and telemedicine, this study will determine if a telemedicine system can help participants, who have undergone a weight loss program based in church and community centers, maintain their weight loss over a 1 year period. Overweight and obese men and women (n = 400) will participate in a 16-week behavioral weight loss program in local churches and community centers. After 16 weeks, participants will be randomized to either an "In-person" follow-up group or to a "telemedicine" group for 1-year. The latter will provide support through self-monitoring, education, supervised chat room, bulletin board, and e-mail. Assessments of body weight, body composition and insulin sensitivity will be conducted at baseline, 16 and 68 weeks. Based on recent data, we predict greater maintenance of weight loss (and lower body weights) at 68 weeks in the Telemedicine group as compared to the "In person group".
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: telemedicineInternet based telemedicine weight maintenance program |
| 2 | Active comparator | Behavioral: telemedicineIn person weight maintenance monthly consultations |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 27<BMI<45
- Able to walk
Key exclusion criteria (1 listed)
- Diabetes on 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 |
|---|---|---|
| telemedicineOne year behavioral modification weight control program comparing in-person consultations (monthly) to a computer based telemedicine system (available 24/7). | Behavioural | 1, 2 |
Primary outcome
subject's weight
Time frame: 3 and 15 months
7 secondary outcomes
Use of telemedicine system
Time frame: over 12 months
blood lipids
Time frame: 3 and 15 months
blood glucose
Time frame: 3 and 15 months
A1c
Time frame: 3 and 15 months
Insulin
Time frame: 3 and 15 months
blood pressure
Time frame: 3 and 15 months
Oral Glucose Tolerance
Time frame: 3 and 15 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2008.
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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.
Guenther Boden, MD principal investigator
Temple University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing telemedicine in people with Overweight, run by Temple University 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 2 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: status not confirmed, as of the sponsor's last update on 23 Oct 2008. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carol Homko, PhD (215-707-3784, carol.homko@temple.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
subject's weight (time frame: 3 and 15 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 23 Oct 2008.