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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03028935
• Other study ID #: IRB00011637
• Secondary ID: NCI-2016-01321IR
• Status: Completed
• Phase: N/A
• Start date: July 5, 2016
• Est. completion date: March 19, 2018

Study information

• Verified date: June 2018
• Source: OHSU Knight Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: March 19, 2018
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Behavioral:
• Exercise Intervention
Undergo instructor-led exercise program
• Nutritional Intervention
Undergo instructor-led nutritional education program

Locations

Country	Name	City	State
United States	OHSU Knight Cancer Institute	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
OHSU Knight Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in weight	Mean and standard deviation will be calculated.	Baseline up to post intervention, up to 7 months
Secondary	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.	Baseline up to post intervention, up to 7 months