NCT00277277

Brief Summary

The majority of patients with Type 2 Diabetes are obese and weight loss is known to improve diabetes outcomes and reduce the need for anti-diabetic medical. This 8-week Telehealth study will compare the effects of standard weight loss advice given in a clinic setting to weight loss advice delivered in the home using an interactive cable television technology called Healthium.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Aug 2004

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 16, 2006

Completed
Last Updated

October 31, 2007

Status Verified

October 1, 2007

First QC Date

January 12, 2006

Last Update Submit

October 29, 2007

Conditions

Diabetes Mellitus, Type 2

Keywords

TelemedicineBiobehavioral weight loss programBody Mass IndexBlood GlucoseDiabetes Management

Outcome Measures

Primary Outcomes (1)

  • Body weight at 8 weeks; Body Mass Index at 8 weeks; Diabetes outcomes at 8 weeks

Secondary Outcomes (1)

  • Hip/waist circumference at 8 weeks; Energy and nutrient intake at 8 weeks; Physical activity at 8 weeks

Interventions

HealthiumBEHAVIORAL

Eligibility Criteria

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bastyr Center for Natural Health

Seattle, Washington, 98028, United States

Location

Related Publications (15)

  • Ahring KK, Ahring JP, Joyce C, Farid NR. Telephone modem access improves diabetes control in those with insulin-requiring diabetes. Diabetes Care. 1992 Aug;15(8):971-5. doi: 10.2337/diacare.15.8.971.

    PMID: 1505329BACKGROUND

  • Barnard RJ, Jung T, Inkeles SB. Diet and exercise in the treatment of NIDDM. The need for early emphasis. Diabetes Care. 1994 Dec;17(12):1469-72. doi: 10.2337/diacare.17.12.1469.

    PMID: 7882819BACKGROUND

  • Currell R, Urquhart C, Wainwright P, Lewis R. Telemedicine versus face to face patient care: effects on professional practice and health care outcomes. Nurs Times. 2001 Aug 30-Sep 5;97(35):35. No abstract available.

    PMID: 11957594BACKGROUND

  • Flegal KM, Carroll MD, Ogden CL, Johnson CL. Prevalence and trends in obesity among US adults, 1999-2000. JAMA. 2002 Oct 9;288(14):1723-7. doi: 10.1001/jama.288.14.1723.

    PMID: 12365955BACKGROUND

  • Friedman RH, Kazis LE, Jette A, Smith MB, Stollerman J, Torgerson J, Carey K. A telecommunications system for monitoring and counseling patients with hypertension. Impact on medication adherence and blood pressure control. Am J Hypertens. 1996 Apr;9(4 Pt 1):285-92. doi: 10.1016/0895-7061(95)00353-3.

    PMID: 8722429BACKGROUND

  • Harvey-Berino J, Pintauro S, Buzzell P, DiGiulio M, Casey Gold B, Moldovan C, Ramirez E. Does using the Internet facilitate the maintenance of weight loss? Int J Obes Relat Metab Disord. 2002 Sep;26(9):1254-60. doi: 10.1038/sj.ijo.0802051.

    PMID: 12187404BACKGROUND

  • Hersh WR, Wallace JA, Patterson PK, Shapiro SE, Kraemer DF, Eilers GM, Chan BK, Greenlick MR, Helfand M. Telemedicine for the Medicare population: pediatric, obstetric, and clinician-indirect home interventions. Evid Rep Technol Assess (Summ). 2001 Aug;(24 Suppl):1-32.

    PMID: 11569328BACKGROUND

  • Meyers AW, Graves TJ, Whelan JP, Barclay DR. An evaluation of a television-delivered behavioral weight loss program: are the ratings acceptable? J Consult Clin Psychol. 1996 Feb;64(1):172-8. doi: 10.1037//0022-006x.64.1.172.

    PMID: 8907097BACKGROUND

  • Mokdad AH, Ford ES, Bowman BA, Nelson DE, Engelgau MM, Vinicor F, Marks JS. Diabetes trends in the U.S.: 1990-1998. Diabetes Care. 2000 Sep;23(9):1278-83. doi: 10.2337/diacare.23.9.1278.

    PMID: 10977060BACKGROUND

  • Starren J, Hripcsak G, Sengupta S, Abbruscato CR, Knudson PE, Weinstock RS, Shea S. Columbia University's Informatics for Diabetes Education and Telemedicine (IDEATel) project: technical implementation. J Am Med Inform Assoc. 2002 Jan-Feb;9(1):25-36. doi: 10.1136/jamia.2002.0090025.

    PMID: 11751801BACKGROUND

  • Shea S, Starren J, Weinstock RS, Knudson PE, Teresi J, Holmes D, Palmas W, Field L, Goland R, Tuck C, Hripcsak G, Capps L, Liss D. Columbia University's Informatics for Diabetes Education and Telemedicine (IDEATel) Project: rationale and design. J Am Med Inform Assoc. 2002 Jan-Feb;9(1):49-62. doi: 10.1136/jamia.2002.0090049.

    PMID: 11751803BACKGROUND

  • Tate DF, Wing RR, Winett RA. Using Internet technology to deliver a behavioral weight loss program. JAMA. 2001 Mar 7;285(9):1172-7. doi: 10.1001/jama.285.9.1172.

    PMID: 11231746BACKGROUND

  • Watts NB, Spanheimer RG, DiGirolamo M, Gebhart SS, Musey VC, Siddiq YK, Phillips LS. Prediction of glucose response to weight loss in patients with non-insulin-dependent diabetes mellitus. Arch Intern Med. 1990 Apr;150(4):803-6.

    PMID: 2327840BACKGROUND

  • Wing RR, Shoemaker M, Marcus MD, McDermott M, Gooding W. Variables associated with weight loss and improvements in glycemic control in type II diabetic patients in behavioral weight control programs. Int J Obes. 1990 Jun;14(6):495-503.

    PMID: 2401586BACKGROUND

  • Yamanouchi K, Shinozaki T, Chikada K, Nishikawa T, Ito K, Shimizu S, Ozawa N, Suzuki Y, Maeno H, Kato K, et al. Daily walking combined with diet therapy is a useful means for obese NIDDM patients not only to reduce body weight but also to improve insulin sensitivity. Diabetes Care. 1995 Jun;18(6):775-8. doi: 10.2337/diacare.18.6.775.

    PMID: 7555502BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Jennifer Lovejoy, PhD

    Bastyr University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 12, 2006

First Posted

January 16, 2006

Study Start

August 1, 2004

Study Completion

September 1, 2005

Last Updated

October 31, 2007

Record last verified: 2007-10

Locations

US(1)