NCT01325376

Brief Summary

This is a six month lifestyle management study to compare the effects of iWell; a dynamic online interactive technology to a self-directed program in overweight or obese individuals. The primary aim is to test the hypothesis that dynamic online interactive technology intervention is more effective than self-directed program in obtaining and maintaining weight loss and other biometric improvements.

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
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

October 1, 2010

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

October 22, 2010

Completed
5 months until next milestone

First Posted

Study publicly available on registry

March 29, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

April 19, 2011

Status Verified

April 1, 2011

Enrollment Period

1 year

First QC Date

October 22, 2010

Last Update Submit

April 17, 2011

Conditions

OverweightObesity

Keywords

overweightobesity

Outcome Measures

Primary Outcomes (1)

  • Weight loss from baseline

    at 6 months

Secondary Outcomes (8)

  • Blood pressure change from baseline

    at 3 months

  • Triglyceride level change from baseline

    at 3 months

  • High density lipoprotein level change from baseline

    at 3 months

  • Physical activity adjustment from baseline

    at 3 months

  • Blood pressure change from baseline

    at 6 months

  • +3 more secondary outcomes

Study Arms (2)

Self directed

NO INTERVENTION
Behavioral: Self directed

Technology assisted health behavior

ACTIVE COMPARATOR

The intervention arm will have access to a dynamic online environment with social networking and device data uploads that include activity data, weight data and laboratory data at frequent intervals to nudge optimal health behavior.

Behavioral: Technology assisted health behavior

Interventions

Technology assisted health behaviorBEHAVIORAL

Web-based interactive program using an hpod sensor that tracks physical activity as well as biometric parameters into the iWell server and is transmitted to the internet site via the users PC. Also serves as a social networking site.

Also known as: DOIT Dynamic online interactive technology
Technology assisted health behavior
Self directedBEHAVIORAL

Receives support and encouragement with minimal contact. Receives printed lifestyle guidelines with diet and physical activity recommendations.

Also known as: Standard care
Self directed

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 18-70 years old
  • overweight or obese men and women with BMI between 24 and 38, inclusive
  • concerned about weight/health (and motivated in losing weight)
  • stable medications for past 3 months
  • willing/able to use Web-based services
  • willingness not to use weight loss medications for the duration of the trial
  • able and willing to give informed consent and participate in the interventions
  • willing to come to three sessions and visits
  • willingness to be randomized to intervention or control group

You may not qualify if:

  • contraindication to weight loss (e.g., malignancy or other serious illness)
  • Type 1 DM and Type 2 DM with other end organ compromise (renal, retinal or other)
  • Recent (within 6 months) cardiovascular event (MI or stroke)
  • current symptoms of angina
  • heart, renal, or liver disease (excluding kidney stone)
  • cancer or active neoplasm (excluding skin cancers)
  • hyperthyroidism
  • mental conditions that would preclude full participation
  • prior weight-loss (bariatric) surgery or plan for these procedures
  • liposuction surgery in past 12 months or plan for these procedures
  • recent weight loss in the past 3 months (\>20 lbs)
  • use of prescription weight loss medication in 3 months prior to screening
  • current use of medications for treatment of psychosis or manic-depressive illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PeaceHealth Laboratories

Springfield, Oregon, 97477, United States

Location

MeSH Terms

Conditions

OverweightObesity

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Brigitte Piniewski, MD

    PeaceHealth Laboratories

    PRINCIPAL INVESTIGATOR

  • David Kil

    SKTelecom Americas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 22, 2010

First Posted

March 29, 2011

Study Start

October 1, 2010

Primary Completion

October 1, 2011

Study Completion

October 1, 2012

Last Updated

April 19, 2011

Record last verified: 2011-04

Locations

US(1)