NCT02254902

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

September 29, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 2, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

May 13, 2016

Status Verified

May 1, 2016

Enrollment Period

1.2 years

First QC Date

September 29, 2014

Last Update Submit

May 11, 2016

Conditions

Keywords

sedentary lifestylephysical activitySomali womenprevention

Outcome Measures

Primary Outcomes (1)

  • Change in physical activity as measured by pedometer from baseline to 3 months

    Baseline and 3 months

Study Arms (2)

Physical Activity

EXPERIMENTAL

Participants in the Physical Activity intervention arm of the study receive culturally-modified, materials through participation in 12 weekly 1-.5-hour sessions focused on increasing daily step counts and bouts of moderate intensity physical activity. The group sessions include participation in different forms of physical activity as well as group discussions on the barriers and opportunities for increasing physical activity in daily life.

Behavioral: Physical Activity intervention

Wait List Control

NO INTERVENTION

Participants in the Wait List Control will be offered the program after a 3-month wait period. While waiting for the program, participants are offered to attend monthly sessions on various wellness and prevention topics.

Interventions

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.

Physical Activity

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California San Diego

La Jolla, California, 92093-0725, United States

Location

MeSH Terms

Conditions

Sedentary BehaviorMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Kate E Murray, PhD, MPH

    University of California, San Diego

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 29, 2014

First Posted

October 2, 2014

Study Start

September 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

May 13, 2016

Record last verified: 2016-05

Locations