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

OHSU Knight Cancer Institute

Status: Completed

Conditions: Overweight; Obesity

Treatments: Behavioral: Exercise Intervention; Behavioral: Nutritional Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03028935

NCI-2016-01321 (Registry Identifier)

R03CA197657 (U.S. NIH Grant/Contract)

IRB00011637 (Other Identifier)

P30CA069533 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: Female

Ages: 40 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Prevention (exercise, nutrition education program)

Experimental group

Description:

Exercise Intervention \& Nutritional Intervention. Participants undergo instructor-led exercise and nutrition education classes for 60 minutes twice a week for 12 weeks.

Treatment:

Behavioral: Nutritional Intervention

Behavioral: Exercise Intervention