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

• ClinicalTrials.gov Identifier: NCT00372606
• Recruitment Status: Completed
• First Posted: September 7, 2006
• Last Update Posted: October 7, 2009
• Sponsor: Robert Wood Johnson Foundation
• Information provided by: Robert Wood Johnson Foundation

Tracking Information

• First Submitted Date: September 6, 2006
• First Posted Date: September 7, 2006
• Last Update Posted Date: October 7, 2009
• Study Start Date: September 2004
• Actual Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: September 6, 2006): Weight loss
• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT00372606 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: September 6, 2006)

• Dietary behaviors
• Fitness activities
• Program acceptability by users

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: An Evaluation of a Culturally- and Linguistically-Appropriate Online Diet Program for U.S Hispanics
• 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
• 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single; Primary Purpose: Prevention
• Condition: Obesity
• Intervention: Behavioral: Online MiDieta Diet and Weight Management Program for Hispanics
• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: September 6, 2006): 1000
• Original Enrollment: Same as current
• Actual Study Completion Date: February 2009
• Actual Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00372606
• Other Study ID Numbers: 51759
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Dirk Schroeder, DrTango
• Study Sponsor: Robert Wood Johnson Foundation
• Collaborators: Not Provided

Investigators

• 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