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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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.

Carol Homko, PhD contact

215-707-3784

carol.homko@temple.edu

William P Santamore, PhD contact

215-707-4239

Williamsantamore@hotmail.com

United States2 sites, 2 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

    Recruiting

Other trials in United States

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 groups in NCT00373230
Study groupRoleWhat they receive
1ExperimentalInternet based telemedicine weight maintenance program
Receives: Behavioral: telemedicine
2Active comparatorIn 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.

  1. subject's weight

    Measured: 3 and 15 months

Secondary outcomes (7)
  1. Use of telemedicine system

    Measured: over 12 months

  2. blood lipids

    Measured: 3 and 15 months

  3. blood glucose

    Measured: 3 and 15 months

  4. A1c

    Measured: 3 and 15 months

  5. Insulin

    Measured: 3 and 15 months

  6. blood pressure

    Measured: 3 and 15 months

  7. 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.

  1. First posted7 Sep 2006 (estimated)
  2. Study startOct 2007
  3. Primary completionFeb 2010 (estimated)
  4. Study completionFeb 2010 (estimated)

Resources

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)
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

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.

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