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

• ClinicalTrials.gov Identifier: NCT03463213
• Recruitment Status: Unknown
• First Posted: March 13, 2018
• Last Update Posted: June 6, 2018
• Sponsor: University of North Texas Health Science Center
• 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

Study Description

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

Detailed Description:

The leading causes of death for women in the United States are heart disease, cancer, and stroke. Chronic diseases disproportionately affect underserved communities where race, poverty, education-level, healthcare access, and other social and environmental determinants intersect. African-American (AA) and Hispanic women are at particularly high risk for diabetes-related mortality 1 and are more likely than white women to be functionally impacted by chronic disease . Factors associated with increased disease risk include physical inactivity, poor nutrition, obesity, underutilization of health screenings, and high stress/allostatic load . 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, due in part to perceived relevance of program outcomes, lack of cultural tailoring, access to care, and lack of social support for health behavior change.

The Texas Center for Health Disparities received National Institute of Minority Health and Health Disparities funding to address women's chronic health conditions through community outreach and research strategies from 2012-2017. A workgroup of community members, former research and program participants, and University of North Texas Health Science Center faculty and staff utilized a Community-Based Participatory Research (CBPR) process to design SHE Tribe (She's Healthy and Empowered), a social-network based initiative to support healthy behavior adoption among women in underserved communities. This effort was based on earlier findings that women in underserved neighborhoods were often resistant to participating in a "disease-labeled" intervention (e.g., obesity prevention) and expressed a desire to practice wellness-oriented behaviors that have been adapted for their social and cultural groups. These findings were consistent with the growing body of literature indicating that being "healthy and strong" is perceived as more desirable than engaging in a program where the explicit expectation is to lose weight. As part of the development process, the workgroup sought to develop a sustainable, evidence-based approach that would appeal to underserved communities that are disproportionately impacted by chronic disease.

Components of SHE Tribe include evidence-based characteristics associated with the adoption and maintenance of health behaviors: a) incorporating social network to promote healthy activities, b) setting goals that are specific to the needs and interests of the individual , c) self-monitoring of desired behaviors, d) motivational interviewing-based dialogue that promotes intrinsic motivation to change, e) choosing small units of change for the purpose of habit formation, and f) combining practice and reflection to promote integration with existing life patterns and beliefs. The advantage of SHE Tribe over previous models is its explicit use of social networks and reliance on a broader set of activities that are consistent with a healthy lifestyle rather than disease. SHE Tribe was initially pilot-tested with a small cohort of 5 peer facilitators. Based on their feedback, it was then enhanced to include telephone or tablet-based assessment and tailored feedback at the beginning (baseline) and end of each 5-session cycle. The current version is being pilot-tested as a community-initiated project, and as such includes only a basic set of assessment tools that are necessary to make the intervention work. The purpose of this 2-year exploratory submission is to examine the effects of SHE Tribe on key health outcomes such as health self-management, coping, diet, activity, and social network health norms.

AIM 1. Determine whether SHE Tribe can be feasibly implemented with groups of women from communities at high risk for chronic health conditions. The research team will examine the characteristics of women recruited to SHE Tribe to determine whether the network-based recruitment is an effective method for reaching the underserved communities. This will include a review of audio-recorded sessions, session summary reports, and semi-structured interviews with participants and facilitators to understand the perceived value and adoption of different intervention components.

AIM 2. Examine how health behaviors are adopted by individuals and diffused through social networks. At the individual level: Using validated measures, the research team determine which goals are selected and the relationship between goal selection, key health outcomes, and activation of health behavior self-management. At the interpersonal level: Using a social network analysis instrument which measures participants' perceptions of identified individuals in their networks, the research team will examine the diffusion of healthy lifestyle norms.

The impact of this study will be the refinement of an intervention that supports sustainability and reach in underserved communities that are at high-risk for chronic diseases. The emphasis on a constellation of healthy behaviors and the use of peer facilitators will appeal to the cultural identities of women residing in underserved and/or high poverty communities.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 240 participants
• Allocation: N/A
• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Contacts

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

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

• Principal Investigator: Emily Spence-Almaguer, PhD; UNT Health Science Center

More Information

Additional Information:

Diabetes Prevention Programs: Effectiveness and Value 

The rise of fitness tribes 

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• Responsible Party: Emily Spence-Almaguer, Associate Dean; Associate Professor, University of North Texas Health Science Center
• ClinicalTrials.gov Identifier: NCT03463213
• Other Study ID Numbers: 2017-148; U54MD006882-06 ( U.S. NIH Grant/Contract )
• First Posted: March 13, 2018
• Last Update Posted: June 6, 2018
• Last Verified: June 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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