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

Not Applicable

Completed

• Conditions: Obesity; Overweight
• Interventions: Behavioral: Exercise Intervention; Behavioral: Nutritional Intervention

• Registration Number: NCT03028935
• Lead Sponsor: OHSU Knight Cancer Institute

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.

Study Timeline

• Study Start: 2016-07-05
• Study First Submitted: 2016-09-22
• Study First Submitted QC: 2017-01-19
• Study First Posted: 2017-01-23
• Primary Completion: 2017-06-30
• Study Completion: 2018-03-19
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-22
• Last Update Posted: 2018-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prevention (exercise, nutrition education program)	Exercise Intervention	Exercise Intervention \& Nutritional Intervention. Participants undergo instructor-led exercise and nutrition education classes for 60 minutes twice a week for 12 weeks.
Prevention (exercise, nutrition education program)	Nutritional Intervention	Exercise Intervention \& Nutritional Intervention. Participants undergo instructor-led exercise and nutrition education classes for 60 minutes twice a week for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Change in weight	Baseline up to post intervention, up to 7 months	Mean and standard deviation will be calculated.

Secondary Outcome Measures

Name	Time	Method
Change in fitness level as assessed by the 6 minute walk test	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.

Trial Locations

Locations (1)

OHSU Knight Cancer Institute; 🇺🇸 Portland, Oregon, United States