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SHE Tribe: An Intervention to Improve Health Behavior Among Women in Underserved Communities

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ClinicalTrials.gov Identifier: NCT03463213
Recruitment Status : Recruiting
First Posted : March 13, 2018
Last Update Posted : June 5, 2018
Sponsor:
Collaborators:
YMCA of Metropolitan Fort Worth
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
Emily Spence-Almaguer, University of North Texas Health Science Center

Brief Summary:
While healthy lifestyle behaviors have been identified as instrumental to preventing chronic disease, programs to successfully promote healthy behavior adoption in underserved communities have had limited sustainable success. SHE Tribe is a culturally tailored, social network intervention created through CBPR to overcome previously identified barriers and improve health behavior among women in underserved communities.

Condition or disease Intervention/treatment Phase
Health Promotion Behavioral: SHE Tribe Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Intervention Model: Single Group Assignment
Intervention Model Description: This is a feasibility study with a single group pre/post outcome design.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: She's Healthy and Empowered (SHE Tribe): A Social Networked-based Peer-facilitated Intervention to Improve Health Behavior Among Women in Underserved Communities
Actual Study Start Date : May 16, 2018
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adoption

Arm Intervention/treatment
Experimental: SHE Tribe
SHE Tribe is a social network-based peer-facilitated intervention to promote adoption of health behaviors
Behavioral: SHE Tribe
Social network-based peer-facilitated intervention to promote adoption of health behavior




Primary Outcome Measures :
  1. Change in Healthy Habits Tracking [ Time Frame: Baseline and 8 weeks. ]
    This tool includes 42 items representing tracking and monitoring behaviors, such as weighing oneself, keeping a food diary, etc... Each is answered with a yes/no (0/1) response. Scores range from 0 to 42. The questionnaire is administered at baseline and again at 8 weeks. The desired outcome is an increase in the total score between baseline and 8 weeks.


Secondary Outcome Measures :
  1. Social Support for Diet and Physical Activity [ Time Frame: Baseline and 8 weeks. ]
    These 11 items are adapted from the Patient Assessment and Counseling for Exercise (PACE+ Women: Measurement Questionnaire). Scores range from 11 to 44, with higher scores indicating a greater social support for healthy lifestyle choices associated with diet and exercise.

  2. Coping with stress [ Time Frame: Baseline and 8 weeks. ]
    These 10 questions include 5 subscales from the Brief COPE tool which measure use of emotional support, use of instrumental support, positive reframing, planning and religion. Each sub-scale score ranges from 0 to 4 with higher values reflecting better coping strategies.

  3. Body Appreciation Scale (BAS-2) [ Time Frame: Baseline and 8 weeks. ]
    This is a 10 item scale measuring body positivity. Scores are based on mean values of all items.

  4. Healthy Lifestyle Activation [ Time Frame: Baseline and 8 weeks. ]
    This tool includes 7 items that measure health-related efficacy, agency, and self-management. Each item is ranked on a scale of 1 to 10 with overall scores ranging from 7 to 70.

  5. Fruit and vegetable consumption [ Time Frame: Baseline and 8 weeks. ]
    This item is from the Patient Assessment and Counseling for Exercise (PACE+ Women: Measurement Questionnaire) and measures self-reported days of purposeful physical activity (30 minutes or more) during a typical week. Scores range from 0 to 7 with higher values reflecting more frequent physical activity.

  6. Physical activity days [ Time Frame: Baseline and 8 weeks. ]
    This item is from the Patient Assessment and Counseling for Exercise (PACE+ Women: Measurement Questionnaire) and measures self-reported daily consumption of fruit and vegetables servings.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Must self-represent as a female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female
  • representative of underserved community (determined by race, ethnicity, socioeconomic status, and/or neighborhood)
  • 18 and older

Exclusion Criteria:

  • Males
  • Children

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03463213


Contacts
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Contact: Emily E Spence-Almaguer, PhD 817-735-2323 emily.spence-almaguer@unthsc.edu
Contact: Shlesma Chhetri, MPH 817-735-2378 shlesma.chhetri@unthsc.edu

Locations
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United States, Texas
University of North Texas Health Science Center Recruiting
Fort Worth, Texas, United States, 76107
Contact: Shlesma Chhetri, MPH    817-735-2378    shlesma.chhetri@unthsc.edu   
Sponsors and Collaborators
University of North Texas Health Science Center
YMCA of Metropolitan Fort Worth
National Institute on Minority Health and Health Disparities (NIMHD)
Investigators
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Principal Investigator: Emily Spence-Almaguer, PhD UNT Health Science Center

Additional Information:
Publications:

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Responsible Party: Emily Spence-Almaguer, Associate Dean; Associate Professor, University of North Texas Health Science Center
ClinicalTrials.gov Identifier: NCT03463213     History of Changes
Other Study ID Numbers: 2017-148
U54MD006882-06 ( U.S. NIH Grant/Contract )
First Posted: March 13, 2018    Key Record Dates
Last Update Posted: June 5, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Emily Spence-Almaguer, University of North Texas Health Science Center:
health behavior
chronic disease prevention
healthy lifestyle