NCT00284167

Brief Summary

The primary objective of this study is to assess the benefit of using online, tailored behavioral weight management materials (Balance), in combination with nutritional materials (Balance and Nourish), in conjunction with a goal setting tool (Balance and Achieve), or a combination of all three (Balance, Nourish and Achieve). This objective will be evaluated by measuring weight loss rates as reported by study participants at 3, 12, and 18 months post-enrollment. The hypothesis is that adding additional materials will increase the effect of the intervention over just using Balance alone.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,848

participants targeted

Target at P75+ for phase_2 obesity

Timeline
Completed

Started Sep 2003

Typical duration for phase_2 obesity

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

January 24, 2006

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 31, 2006

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

July 27, 2011

Status Verified

July 1, 2011

First QC Date

January 24, 2006

Last Update Submit

July 25, 2011

Conditions

Keywords

tailoredweb-basedweight managementobesityefficacy

Outcome Measures

Primary Outcomes (1)

  • The primary objective of this study is to assess weight reduction at 3, 12, and 18 months post intervention.

Secondary Outcomes (12)

  • • To assess psychosocial outcomes including motivation and self-efficacy.

  • • To assess the degree to which participants perceive their support materials have been tailored for them.

  • • To assess lifestyle changes including physical activity and nutrition

  • • To examine relative effectiveness of web-based programs given age, gender, preferred language, ethnicity, and utilization patterns.

  • • To examine percent of weight loss goal attainment.

  • +7 more secondary outcomes

Interventions

Eligibility Criteria

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

You may qualify if:

  • years of age
  • Current KP or GHC member
  • BMI greater than or equal to 30 or BMI greater than or equal to 25 and have one of the following chronic illnesses: diabetes, coronary artery disease, depression, or asthma, or arthritis.
  • Agree to be contacted via computerized questionnaire at 3, 12 and 18 months post-enrollment
  • Regular access to the Internet and a functioning e-mail address

You may not qualify if:

  • Current use of pharmacologic, behavioral or surgical treatment for weight loss
  • Currently pregnant or planning pregnancy
  • Inability to read English.
  • Presence of Congestive Heart Failure
  • KP Ohio region members who participated in the original THeME study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaiser Permanente Care Management Institute

Walnut Creek, California, 94596, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Kevin J Wildenhaus, Ph.D.

    HealthMedia, Inc.

    PRINCIPAL INVESTIGATOR
  • Russ Glasgow, Ph.D.

    Kaiser Permanente

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 24, 2006

First Posted

January 31, 2006

Study Start

September 1, 2003

Study Completion

July 1, 2006

Last Updated

July 27, 2011

Record last verified: 2011-07

Locations