Physical Activity and Education Program for Somali Women

Sedentary Lifestyle Clinical Trial

Official title:

Physical Activity and Education to Reduce Cancer Risk Among Somali Women (Ladnaan Project)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02254902
• Other study ID #: ACS-MRSG-13-069
• Status: Terminated
• Phase: N/A
• First received: September 29, 2014
• Last updated: May 11, 2016
• Start date: September 2014
• Est. completion date: December 2015

Study information

• Verified date: May 2016
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

There is a significant need for culturally adapted and effective health education programs to address rising rates of obesity and chronic disease concerns for refugee communities. Physical activity has been identified as an important prevention tool to prevent numerous chronic health conditions. This research tests the feasibility and acceptability of a culturally adapted physical activity intervention for sedentary adult Somali women. Study participants will be randomized to a 3-month physical activity program or a wait-list control group. The primary outcome is increases in physical activity between baseline and the end of the program as measured by pedometer.

Description:

Participants in the physical activity program will participate in 12 weekly 1.5-hour sessions focused on increasing physical activity. The group sessions will include participating in physical activity as well as group discussions on the barriers and opportunities for increasing physical activity in their daily life. The 12-week program covers educational topics related to physical activity (e.g. overcoming barriers to activity, exercising safely, relapse prevention strategies) and the program gradually increases the amount of physical activity completed during the group sessions over the course of the 12 weeks. Over a 3-month wait period, individuals in the wait-list control group will be offered monthly sessions on health and wellness topics before being offered the physical activity program. Measurement visits will occur at baseline, at the end of the12-week program, and approximately 12-weeks after the end of the intervention. During the measurement sessions participants will complete assessments related to their physical activity and other health behaviors.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 27
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Sedentary (less than 90 minutes per week of moderate or vigorous physical activity)

• Self-identify as Somali

• Planning on living in the area for the next 6 months

• Ability to attend 12-weeks of in-person group sessions at a designated community site

Exclusion Criteria:

• Currently pregnant or within 3 months of delivery

• BMI greater than or equal to 40

• Medical conditions or physical problems that interfere with physical activity or require medical supervision to exercise

• Have another member of the household participating in the study

• Employment by one of the collaborating organizations

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sedentary Lifestyle

Intervention

Behavioral:
• Physical Activity intervention
The Physical Activity intervention is a 3-month group-based program based on an efficacious physical activity intervention that has been culturally adapted for use with adult Somali women. The program targets increased physical activity through educational and experiential opportunities.

Locations

Country	Name	City	State
United States	University of California San Diego	La Jolla	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	American Cancer Society, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in physical activity as measured by pedometer from baseline to 3 months		Baseline and 3 months	No