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An Evaluation of a Culturally- and Linguistically-Appropriate Online Diet Program for U.S Hispanics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00372606
Recruitment Status : Completed
First Posted : September 7, 2006
Last Update Posted : October 7, 2009
Sponsor:
Information provided by:
Robert Wood Johnson Foundation

Tracking Information
First Submitted Date  ICMJE September 6, 2006
First Posted Date  ICMJE September 7, 2006
Last Update Posted Date October 7, 2009
Study Start Date  ICMJE September 2004
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 6, 2006)
Weight loss
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00372606 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 6, 2006)
  • Dietary behaviors
  • Fitness activities
  • Program acceptability by users
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Evaluation of a Culturally- and Linguistically-Appropriate Online Diet Program for U.S Hispanics
Official Title  ICMJE An Evaluation of a Culturally- and Linguistically-Appropriate eHealth Portal to Facilitate Improved Diets, Increased Fitness-Levels, and Weight-Loss Among U.S. Hispanics
Brief Summary The purpose of this study is to conduct a randomized trial to rigorously test the efficacy of the MiDieta eHealth portal for weight loss among overweight, though otherwise healthy, members of the Hispanic community, many of whom may be members of collaborating managed care organizations.
Detailed Description

Obesity is a major and growing problem among U.S. Hispanics with serious implications for diabetes and other chronic disease risks. Current trends among youth suggest that disparities in obesity between minorities and non-Hispanic whites will amplify. Reducing such health disparities is a priority for federal, state and local governmental bodies and communities. Attaining these objectives will require interventions that are culturally- and linguistically appropriate. U.S. healthcare providers, however, have few culturally-appropriate tools and inadequate numbers of bilingual, trained healthcare professionals to address these challenges.

A culturally-appropriate weight-management portal, supported by bilingual Latina dietitians available for remote email counseling, offers an attractive mechanism for efficiently serving the underserved. MiDieta/MyDiet is the leading online diet, fitness and weight management portal for U.S. Hispanic/Latinos. MiDieta is bilingual (Spanish/English), based on Latino foods & habits and already available through dozens of media, hospital, and health plan websites. Thousands of Hispanics access MiDieta each week. Tommy Thompson recently selected MiDieta as one of the "20 most innovative health promotion and disease prevention applications" in the U.S.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Prevention
Condition  ICMJE Obesity
Intervention  ICMJE Behavioral: Online MiDieta Diet and Weight Management Program for Hispanics
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: September 6, 2006)
1000
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2009
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Women and men of Hispanic/Latino origin born in Mexico, Central or South America, the Caribbean, Spain or the United States
  • Between 18 and 75 years of age
  • BMI >/= 24.85
  • Otherwise "healthy" individuals (lack of major medical/psychiatric/ or chronic problems/disease - with the exception of Type 2 diabetes and controlled hypertension)
  • Not participating in other weight loss treatment programs and not planning on it for at least 12-16 more months
  • Internet access at least once per week
  • The participant has the ability to engage in at least light activity (walking, etc)

Exclusion Criteria:

  • The participant has a continuous history of major medical or psychiatric problems (requiring continuous medication and/or close physician supervision)
  • Diagnosis with Type 1 diabetes
  • The participant is pregnant or planning a pregnancy within the next 16 months
  • The participant is unable to participate in any exercise regimen
  • The participant is currently participating in MiDieta
  • The participant is currently participating in other weight loss programs or plans to in the next 12-16 months
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00372606
Other Study ID Numbers  ICMJE 51759
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dirk Schroeder, DrTango
Study Sponsor  ICMJE Robert Wood Johnson Foundation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dirk G Schroeder, ScD, MPH DrTango, Inc.
Study Director: Jessica L Malmad, MPH DrTango, Inc.
PRS Account Robert Wood Johnson Foundation
Verification Date October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP