Clinical trial NCT02254902: Physical Activity and Education Program for Somali Women
Official title: Physical Activity and Education to Reduce Cancer Risk Among Somali Women (Ladnaan Project)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Sedentary Lifestyle
Keywords: sedentary lifestyle
physical activity
Somali women
prevention
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2014-10-02
Enrollment: 27
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in physical activity as measured by pedometer from baseline to 3 months
timeFrame: Baseline and 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California San Diego
state: California
Study officials:
affiliation: University of California, San Diego
name: Kate E Murray, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: