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Completed

NCT Number: NCT03028935

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

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

40 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise Intervention

Behavioral

Undergo instructor-led exercise program

Nutritional Intervention

Behavioral

Undergo instructor-led nutritional education program

Primary outcomes

  1. Change in weight

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

    Mean and standard deviation will be calculated.

Secondary outcomes

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

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

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

Sponsors and collaborators

Lead sponsor

OHSU Knight Cancer Institute

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Jan 23, 2017
Registry last updated
Jun 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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