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

Study Overview
=================
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.

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

Conditions
-----------------
Obesity, Overweight

Intervention / Treatment
-----------------
* Behavioral: Exercise Intervention
* Behavioral: Nutritional Intervention


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prevention (exercise, nutrition education program)<br>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<br>* Undergo instructor-led exercise program<br>Behavioral: Nutritional Intervention<br>* Undergo instructor-led nutritional education program<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in weight | Mean and standard deviation will be calculated. | Baseline up to post intervention, up to 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |