NCT03028935

Brief Summary

This pilot clinical trial studies how well an evidence-based exercise and nutrition program adapted for Latinas works in improving physical activity and dietary behavior in non-active, overweight, or obese rural Latinas. An exercise and nutrition program may reduce the risk for developing certain cancers, obesity, and chronic health conditions in Latinas who are non-active, overweight, or obese.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Jul 2016

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

July 5, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2016

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 23, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2017

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 19, 2018

Completed
Last Updated

June 26, 2018

Status Verified

June 1, 2018

Enrollment Period

12 months

First QC Date

September 22, 2016

Last Update Submit

June 22, 2018

Conditions

ObesityOverweight

Outcome Measures

Primary Outcomes (1)

  • Change in weight

    Mean and standard deviation will be calculated.

    Baseline up to post intervention, up to 7 months

Secondary Outcomes (1)

  • Change in fitness level as assessed by the 6 minute walk test

    Baseline up to post intervention, up to 7 months

Study Arms (1)

Prevention (exercise, nutrition education program)

EXPERIMENTAL

Exercise Intervention \& Nutritional Intervention. Participants undergo instructor-led exercise and nutrition education classes for 60 minutes twice a week for 12 weeks.

Behavioral: Exercise InterventionBehavioral: Nutritional Intervention

Interventions

Exercise InterventionBEHAVIORAL

Undergo instructor-led exercise program

Prevention (exercise, nutrition education program)
Nutritional InterventionBEHAVIORAL

Undergo instructor-led nutritional education program

Prevention (exercise, nutrition education program)

Eligibility Criteria

Age40 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Phase I:
  • Bilingual Latina
  • Live in the community
  • Phase II:
  • Latina
  • Currently non-active (exercise two days or less per week)
  • Overweight or obese (body mass index \[BMI\] of 24 or greater)

You may not qualify if:

  • A medical condition that precludes moderate-vigorous physical activity as determined by health care provider
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

ObesityOverweight

Condition Hierarchy (Ancestors)

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

Study Officials

  • Cynthia Perry

    OHSU Knight Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 22, 2016

First Posted

January 23, 2017

Study Start

July 5, 2016

Primary Completion

June 30, 2017

Study Completion

March 19, 2018

Last Updated

June 26, 2018

Record last verified: 2018-06

Locations

US(1)