Back to resultsExercise and Nutrition Program in Improving Physical Activity and Dietary Behavior in Non-Active, Overweight, or Obese Latinas
Primary Purpose
Obesity, Overweight
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise Intervention
Nutritional Intervention
Sponsored by
About this trial
This is an interventional prevention trial for Obesity
Eligibility Criteria
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
Sites / Locations
- OHSU Knight Cancer Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Prevention (exercise, nutrition education program)
Arm Description
Exercise Intervention & Nutritional Intervention. Participants undergo instructor-led exercise and nutrition education classes for 60 minutes twice a week for 12 weeks.
Outcomes
Primary Outcome Measures
Change in weight
Mean and standard deviation will be calculated.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT03028935
First Posted
September 22, 2016
Last Updated
June 22, 2018
Sponsor
OHSU Knight Cancer Institute
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT03028935
Brief Title
Exercise and Nutrition Program in Improving Physical Activity and Dietary Behavior in Non-Active, Overweight, or Obese Latinas
Official Title
Fuerte y Sanas: Exercise and Nutrition Program in Improving Physical Activity and Dietary Behavior in Non-Active, Overweight, or Obese Latinas
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
July 5, 2016 (Actual)
Primary Completion Date
June 30, 2017 (Actual)
Study Completion Date
March 19, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
OHSU Knight Cancer Institute
Collaborators
National Cancer Institute (NCI)
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prevention (exercise, nutrition education program)
Arm Type
Experimental
Arm Description
Exercise Intervention & Nutritional Intervention. Participants undergo instructor-led exercise and nutrition education classes for 60 minutes twice a week for 12 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Exercise Intervention
Intervention Description
Undergo instructor-led exercise program
Intervention Type
Behavioral
Intervention Name(s)
Nutritional Intervention
Intervention Description
Undergo instructor-led nutritional education program
Primary Outcome Measure Information:
Title
Change in weight
Description
Mean and standard deviation will be calculated.
Time Frame
Baseline up to post intervention, up to 7 months
Secondary Outcome Measure Information:
Title
Change in fitness level as assessed by the 6 minute walk test
Description
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cynthia Perry
Organizational Affiliation
OHSU Knight Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
OHSU Knight Cancer Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Exercise and Nutrition Program in Improving Physical Activity and Dietary Behavior in Non-Active, Overweight, or Obese Latinas
We'll reach out to this number within 24 hrs