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CompletedNCT03028935Updated Jun 26, 2018

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

An interventional study of Exercise Intervention and Nutritional Intervention in Obesity and Overweight, sponsored by OHSU Knight Cancer Institute. Completed at 1 site in United States. Open to female participants aged 40 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-06-26.

Sponsored by OHSU Knight Cancer Institute · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
40 Years to 70 Years
Sex
Female
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Study 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.

Read the detailed description

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.

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Conditions studied

  • Obesity
  • Overweight

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03

In context

Overweight

3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.

This study's enrollment of 15 is below the median of 73 across 3,175 interventional studies indexed under Overweight.

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Lead sponsor

OHSU Knight Cancer Institute is the lead sponsor of 242 studies on the registry; 45 are open to participants now.

Of its 27 completed or terminated interventional studies of FDA-regulated products, 15 (56%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • A medical condition that precludes moderate-vigorous physical activity as determined by health care provider
  • Pregnancy
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • Experimental
    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.

    Behavioral: Exercise Intervention · Behavioral: Nutritional Intervention

Interventions

  • BehavioralExercise Intervention

    Undergo instructor-led exercise program

  • BehavioralNutritional Intervention

    Undergo instructor-led nutritional education program

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What researchers measure

Primary outcomes

  1. Change in weight

    Mean and standard deviation will be calculated.

    Time frame: Baseline up to post intervention, up to 7 months

Secondary outcomes

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

    The distance walked in 6 minutes will be recorded. Mean and standard deviation will be calculated.

    Time frame: Baseline up to post intervention, up to 7 months

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Study locations

1 site
  • OHSU Knight Cancer Institute
    Portland, Oregon 97239, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 26, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03028935
Lead sponsor
OHSU Knight Cancer Institute
Collaborators
National Cancer Institute (NCI)
Responsible party
Cynthia Perry (Principal Investigator, OHSU Knight Cancer Institute) — Principal investigator
First posted
Jan 23, 2017
Start date
Jul 5, 2016
Primary completion
Jun 30, 2017
Completion
Mar 19, 2018
Last update
Jun 26, 2018

Study contacts

Cynthia Perry
principal investigator · OHSU Knight Cancer Institute
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.

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