Clinical trial NCT03463213: SHE Tribe: An Intervention to Improve Health Behavior Among Women in Underserved Communities
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Health Promotion
Keywords: health behavior
chronic disease prevention
healthy lifestyle
Lead sponsor: University of North Texas Health Science Center
Sponsor class: OTHER
Collaborators: name: YMCA of Metropolitan Fort Worth
name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2018-03-13
Enrollment: 240
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a feasibility study with a single group pre/post outcome design.
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Males
* Children

Primary outcomes:
measure: Change in Healthy Habits Tracking
timeFrame: Baseline and 8 weeks.
Secondary outcomes:
measure: Social Support for Diet and Physical Activity
timeFrame: Baseline and 8 weeks.
measure: Coping with stress
timeFrame: Baseline and 8 weeks.
measure: Body Appreciation Scale (BAS-2)
timeFrame: Baseline and 8 weeks.
measure: Healthy Lifestyle Activation
timeFrame: Baseline and 8 weeks.
measure: Fruit and vegetable consumption
timeFrame: Baseline and 8 weeks.
measure: Physical activity days
timeFrame: Baseline and 8 weeks.
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: University of North Texas Health Science Center
state: Texas
Study officials:
affiliation: UNT Health Science Center
name: Emily Spence-Almaguer, PhD
role: PRINCIPAL_INVESTIGATOR
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