NCT00373230

Brief 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 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
320

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2007

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 7, 2006

Completed
1.1 years until next milestone

Study Start

First participant enrolled

October 1, 2007

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

October 23, 2008

Status Verified

October 1, 2008

Enrollment Period

2.3 years

First QC Date

September 5, 2006

Last Update Submit

October 22, 2008

Conditions

Keywords

weight losstelemedicineafrican-americanrural

Outcome Measures

Primary Outcomes (1)

  • subject's weight

    3 and 15 months

Secondary Outcomes (7)

  • Use of telemedicine system

    over 12 months

  • blood lipids

    3 and 15 months

  • blood glucose

    3 and 15 months

  • A1c

    3 and 15 months

  • Insulin

    3 and 15 months

  • +2 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

Internet based telemedicine weight maintenance program

Behavioral: telemedicine

2

ACTIVE COMPARATOR

In person weight maintenance monthly consultations

Behavioral: telemedicine

Interventions

telemedicineBEHAVIORAL

One year behavioral modification weight control program comparing in-person consultations (monthly) to a computer based telemedicine system (available 24/7).

12

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \<BMI\<45
  • Able to walk

You may not qualify if:

  • Diabetes on medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

RECRUITING

Temple University

Philadelphia, Pennsylvania, 19140, United States

RECRUITING

MeSH Terms

Conditions

OverweightWeight Loss

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Intervention Hierarchy (Ancestors)

Delivery of Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Guenther Boden, MD

    Temple University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Carol Homko, PhD

CONTACT

William P Santamore, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 5, 2006

First Posted

September 7, 2006

Study Start

October 1, 2007

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

October 23, 2008

Record last verified: 2008-10

Locations