ObesityPhase 2NCT00372606
An Evaluation of a Culturally- and Linguistically-Appropriate Online Diet Program for U.S Hispanics
A Phase 2 study testing Online MiDieta Diet and Weight Management Program for Hispanics in people with Obesity, run by Robert Wood Johnson Foundation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Online MiDieta Diet and Weight Management Program for Hispanics
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Feb 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Online MiDieta Diet and Weight Management Program for Hispanics
- Keywords
- Obesity, Overweight, Hispanics, Online, Weight Loss
- Medical subject headings
- Obesity, Overweight, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online MiDieta Diet and Weight Management Program for HispanicsBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
Secondary outcomes (3)
Dietary behaviors
Fitness activities
Program acceptability by users
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2006 (estimated)
- Study startSep 2004
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Robert Wood Johnson Foundation
- Sponsor type
- University, hospital or other
- Investigators
- Dirk G Schroeder, ScD, MPH, Principal investigator, DrTango, Inc.Jessica L Malmad, MPH, Study director, DrTango, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00372606
- Sponsor's protocol ID
- 51759
- Status last verified
- Oct 2009
- First submitted
- 6 Sep 2006
- Last updated
- 7 Oct 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00372606
- Acronym / sponsor ID
- 51759
- Conditions
- Obesity
- Keywords
- Obesity, Overweight, Hispanics, Online, Weight Loss
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Robert Wood Johnson FoundationUniversity, hospital or other
- Study start
- Sep 2004
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 7 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online MiDieta Diet and Weight Management Program for Hispanics | Behavioural | – |
Primary outcome
Weight loss
3 secondary outcomes
Dietary behaviors
Fitness activities
Program acceptability by users
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dirk G Schroeder, ScD, MPH principal investigator
DrTango, Inc.
Jessica L Malmad, MPH study director
DrTango, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Online MiDieta Diet and Weight Management Program for Hispanics in people with Obesity, run by Robert Wood Johnson Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight loss. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2009.