Exercise and Nutrition Program in Improving Physical Activity and Dietary Behavior in Non-Active, Overweight, or Obese Latinas

NCT ID: NCT03028935

Last Updated: 2018-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-05

Study Completion Date

2018-03-19

Brief Summary

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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.

Detailed Description

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PRIMARY OBJECTIVES:

I. Adapt an effective evidence-based exercise and nutrition program to meet the needs of rural Latinas.

II. Implement the adapted program in a rural Latina population. III. Evaluate feasibility and potential to improve physical activity and dietary behavior of the adapted program in a rural Latina population.

OUTLINE:

Phase I: Create a community advisory board to adapt Strong Women Healthy Hearts Program (SWHHP) using feedback on the existing SWHHP from Latinas residing in the community.

Phase II: Conduct a small pilot study to assess effectiveness of the adapted program (one group pre-post design, with data collected at three time points).

INTERVENTION GROUP: Participants undergo instructor-led exercise and nutrition education classes for 60 minutes each twice a week for 12 weeks.

Conditions

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Obesity Overweight

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Prevention (exercise, nutrition education program)

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

Group Type EXPERIMENTAL

Exercise Intervention

Intervention Type BEHAVIORAL

Undergo instructor-led exercise program

Nutritional Intervention

Intervention Type BEHAVIORAL

Undergo instructor-led nutritional education program

Interventions

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Exercise Intervention

Undergo instructor-led exercise program

Intervention Type BEHAVIORAL

Nutritional Intervention

Undergo instructor-led nutritional education program

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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)

Exclusion Criteria

* A medical condition that precludes moderate-vigorous physical activity as determined by health care provider
* Pregnancy
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

OHSU Knight Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Cynthia Perry

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cynthia Perry

Role: PRINCIPAL_INVESTIGATOR

OHSU Knight Cancer Institute

Locations

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OHSU Knight Cancer Institute

Portland, Oregon, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2016-01321

Identifier Type: REGISTRY

Identifier Source: secondary_id

IRB00011637

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA069533

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R03CA197657

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00011637

Identifier Type: -

Identifier Source: org_study_id

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