NCT00233259

Brief Summary

The Viva Bien! trial will comprehensively evaluate a multiple risk factor intervention (diet, physical activity, stress management, social support, and smoking cessation) in a randomized effectiveness trial, which will be offered in English and Spanish to diabetic Latinas.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
273

participants targeted

Target at P50-P75 for not_applicable cardiovascular-diseases

Timeline
Completed

Started Mar 2006

Longer than P75 for not_applicable cardiovascular-diseases

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 3, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 5, 2005

Completed
5 months until next milestone

Study Start

First participant enrolled

March 1, 2006

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

October 25, 2011

Status Verified

October 1, 2011

Enrollment Period

4.4 years

First QC Date

October 3, 2005

Last Update Submit

October 24, 2011

Conditions

Cardiovascular DiseasesHeart DiseasesDiabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

  • Adherence to the Mediterranean Diet, physical activity, stress management, and smoking cessation protocols

    Measured at baseline, 6, 12, and 24 months

  • Hemoglobin A1c

    Measured at baseline, 6, 12, and 24 months

Secondary Outcomes (1)

  • Social support

    Measured at baseline, 6, 12, and 24 months

Study Arms (2)

1

ACTIVE COMPARATOR

Multiple risk factor intervention, that will include diet, physical activity, stress management, social support, and smoking cessation components

Behavioral: Mediterranean DietBehavioral: Physical ActivityBehavioral: Stress ManagementBehavioral: Social SupportBehavioral: Smoking Cessation

2

PLACEBO COMPARATOR

Control group

Other: Control group

Interventions

Mediterranean DietBEHAVIORAL

Mediterranean dietary program

1
Physical ActivityBEHAVIORAL

Physical activity program

1
Stress ManagementBEHAVIORAL

Stress management program

1
Social SupportBEHAVIORAL

Social support

1
Smoking CessationBEHAVIORAL

Smoking cessation program

1
Control groupOTHER

Usual Diabetes Care Control group

2

Eligibility Criteria

Age30 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes
  • Postmenopausal
  • Latina

You may not qualify if:

  • Cognitive impairment or inability to comprehend program
  • Has other life-threatening illnesses
  • Planning to move from the area during the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Health Research

Denver, Colorado, 80237, United States

Location

Related Publications (3)

  • Toobert DJ, Strycker LA, King DK, Barrera M Jr, Osuna D, Glasgow RE. Long-term outcomes from a multiple-risk-factor diabetes trial for Latinas: inverted exclamation markViva Bien! Transl Behav Med. 2011 Sep;1(3):416-426. doi: 10.1007/s13142-010-0011-1.

    PMID: 22022345DERIVED

  • Toobert DJ, Strycker LA, Glasgow RE, Osuna D, Doty AT, Barrera M, Geno CR, Ritzwoller DP. Viva bien!: Overcoming recruitment challenges in a multiple-risk-factor diabetes trial. Am J Health Behav. 2010 Jul-Aug;34(4):432-41. doi: 10.5993/ajhb.34.4.5.

    PMID: 20218755DERIVED

  • Osuna D, Barrera M Jr, Strycker LA, Toobert DJ, Glasgow RE, Geno CR, Almeida F, Perdomo M, King D, Doty AT. Methods for the cultural adaptation of a diabetes lifestyle intervention for Latinas: an illustrative project. Health Promot Pract. 2011 May;12(3):341-8. doi: 10.1177/1524839909343279. Epub 2009 Oct 20.

    PMID: 19843703DERIVED

MeSH Terms

Conditions

Cardiovascular DiseasesHeart DiseasesDiabetes Mellitus, Type 2

Interventions

Diet, MediterraneanExerciseControl Groups

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Diet, Plant-BasedDiet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Deborah J. Toobert, PhD

    Oregon Research Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2005

First Posted

October 5, 2005

Study Start

March 1, 2006

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

October 25, 2011

Record last verified: 2011-10

Locations

US(1)