NCT00372606

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for phase_2 obesity

Timeline
Completed

Started Sep 2004

Longer than P75 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, 2004

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 6, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 7, 2006

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

October 7, 2009

Status Verified

October 1, 2009

Enrollment Period

4.4 years

First QC Date

September 6, 2006

Last Update Submit

October 6, 2009

Conditions

Obesity

Keywords

ObesityOverweightHispanicsOnlineWeight Loss

Outcome Measures

Primary Outcomes (1)

  • Weight loss

Secondary Outcomes (3)

  • Dietary behaviors

  • Fitness activities

  • Program acceptability by users

Interventions

Online MiDieta Diet and Weight Management Program for HispanicsBEHAVIORAL

Eligibility Criteria

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

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

DrTango, Inc.

Roswell, Georgia, 30076, United States

Location

MeSH Terms

Conditions

ObesityOverweightWeight Loss

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • Dirk G Schroeder, ScD, MPH

    DrTango, Inc.

    PRINCIPAL INVESTIGATOR

  • Jessica L Malmad, MPH

    DrTango, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 6, 2006

First Posted

September 7, 2006

Study Start

September 1, 2004

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

October 7, 2009

Record last verified: 2009-10

Locations

US(1)