ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: Online MiDieta Diet and Weight Management Program for Hispanics Phase 2

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Prevention
Official Title: An Evaluation of a Culturally- and Linguistically-Appropriate eHealth Portal to Facilitate Improved Diets, Increased Fitness-Levels, and Weight-Loss Among U.S. Hispanics
Study Start Date : September 2004
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Weight loss

Secondary Outcome Measures :
  1. Dietary behaviors
  2. Fitness activities
  3. Program acceptability by users


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00372606


Locations
United States, Georgia
DrTango, Inc.
Roswell, Georgia, United States, 30076
Sponsors and Collaborators
Robert Wood Johnson Foundation
Investigators
Principal Investigator: Dirk G Schroeder, ScD, MPH DrTango, Inc.
Study Director: Jessica L Malmad, MPH DrTango, Inc.

Responsible Party: Dirk Schroeder, DrTango
ClinicalTrials.gov Identifier: NCT00372606     History of Changes
Other Study ID Numbers: 51759
First Posted: September 7, 2006    Key Record Dates
Last Update Posted: October 7, 2009
Last Verified: October 2009

Keywords provided by Robert Wood Johnson Foundation:
Obesity
Overweight
Hispanics
Online
Weight Loss