NCT01333241

Brief Summary

The overall goal of this randomized controlled trial is to evaluate the effects of a community-based lifestyle behavior intervention (LSBI) that is designed to improve dietary habits and physical activity (PA), and reduce weight of Latino women who are predominantly Spanish-speaking immigrants. It is hypothesized that middle-aged overweight/obese Latinas participating in a LSBI conducted by lay health advisors will demonstrate improved dietary habits, increased physical activity and a decrease in BMI compared to those in a control condition, Women in the LSBI also are expected to demonstrate improvements in selected physiologic outcomes (waist circumference, blood pressure \[BP\], measures of cholesterol and blood sugar).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
223

participants targeted

Target at P50-P75 for not_applicable cardiovascular-diseases

Timeline
Completed

Started Aug 2009

Typical duration 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

Study Start

First participant enrolled

August 1, 2009

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

April 6, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 11, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

November 7, 2019

Status Verified

November 1, 2019

Enrollment Period

2.9 years

First QC Date

April 6, 2011

Last Update Submit

November 5, 2019

Conditions

Cardiovascular Diseases

Keywords

Hispanic/Latina AmericansCardiovascular diseasesObesityIntervention

Outcome Measures

Primary Outcomes (1)

  • Change in Body mass index (BMI)

    Baseline, 6 and 9 month follow-up.

Secondary Outcomes (3)

  • Change in Physical Activity

    Baseline, 6 and 9 month follow-up

  • Change in Physiologic measures

    Baseline, 6 and 9 month follow-up.

  • Change in Lifestyle behaviors

    Baseline, 6 and 9 month follow-up.

Study Arms (2)

Lifestyle behavior intervention group

EXPERIMENTAL

The 6-month lifestyle behavior intervention includes group education and individual teaching and coaching.

Behavioral: Lifestyle behavior interventon grop

Control group

SHAM COMPARATOR

Disaster Preparedness/Home Safety group education and teaching

Other: Placebo Comparator: Control group

Interventions

Lifestyle behavior interventon gropBEHAVIORAL
Lifestyle behavior intervention group
Placebo Comparator: Control groupOTHER
Also known as: Disaster Preparedness/Home Safety
Control group

Eligibility Criteria

Age35 Years - 64 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Latina
  • to 64 years of age
  • body mass index (BMI) \>25
  • fluent in either Spanish or English.

You may not qualify if:

  • pregnant or planning to get pregnant in next year
  • history of myocardial infarction or stroke
  • currently under treatment for cancer
  • orthopedic or joint problems that would prohibit participation in physical activity
  • insulin-dependent diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA School of Nursing

Los Angeles, California, 90095, United States

Location

Related Publications (3)

  • Koniak-Griffin, D., Brecht, M. L., Takayanagi, S., Villegas, J., Melendrez, M., & Balcázar, H. (2014). A community health worker-led lifestyle behavior intervention for Latina (Hispanic) women: Feasibility and outcomes of a randomized controlled trial. International journal of nursing studies. Koniak-Griffin, D., & Brecht, M.-L. (2014, July 30). Awareness of Cardiovascular Disease and Preventive Behaviors Among Overweight Immigrant Latinas. Journal of Cardiovascular Nursing [Epub ahead of print] Koniak-Griffin, D., Brecht, M. L., Takayanagi, S., Villegas, J., & Melendrez, M. (2013). Physical Activity and Cardiometabolic Characteristics in Overweight Latina Women. Journal of Immigrant and Minority Health, 1-9.

    BACKGROUND

  • Koniak-Griffin D, Brecht ML, Takayanagi S, Villegas J, Melendrez M, Balcazar H. A community health worker-led lifestyle behavior intervention for Latina (Hispanic) women: feasibility and outcomes of a randomized controlled trial. Int J Nurs Stud. 2015 Jan;52(1):75-87. doi: 10.1016/j.ijnurstu.2014.09.005. Epub 2014 Sep 22.

    PMID: 25307195DERIVED

  • Koniak-Griffin D, Brecht ML, Takayanagi S, Villegas J, Melendrez M. Physical activity and cardiometabolic characteristics in overweight Latina women. J Immigr Minor Health. 2014 Oct;16(5):856-64. doi: 10.1007/s10903-013-9782-z.

    PMID: 23355122DERIVED

MeSH Terms

Conditions

Cardiovascular DiseasesObesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Deborah Koniak-Griffin, RNC, EdD

    UCLA School of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 6, 2011

First Posted

April 11, 2011

Study Start

August 1, 2009

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

November 7, 2019

Record last verified: 2019-11

Locations

US(1)