An interventional study of SHE Tribe in Health Promotion, sponsored by University of North Texas Health Science Center. Status unknown at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-06-06.
Sponsored by University of North Texas Health Science Center · Not applicable, Interventional, and Prevention
Among 421 studies in Health Behavior with a site in United States — 66 open to participants now, 86 under way, 1 of them phase 3. Health Behavior · United States.
Among the 421 studies in Health Behavior with a site in United States, this one is the 152nd largest by planned enrollment of the 385 interventional ones that give a count, is one of 25 that started in 2018, is one of 363 with no phase, and was the 153rd registered.
968 studies on the registry are indexed under Health Behavior; 166 are open to participants now.
Browse Health Behavior studies →66 of the 421 studies in Health Behavior with a site in United States are open now. Recruiting first, the newest first:
University of Alabama at Birmingham · Sites in United States
Ages 25–65
University of South Florida · Sites in United States
Ages 18–70
St. Jude Children's Research Hospital · Sites in United States
Ages 26+
William Brandenburg, MD · Sites in United States
Ages 18+ · Healthy volunteers
University of North Carolina, Chapel Hill · Sites in United States
Ages 21+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 93 Health Behavior studies recruiting now, 39 (42%) set no upper age limit and 37 (40%) stop at 75 or younger; 25 take children under 18; 58 take healthy volunteers.
This study: 18 Years and older · female · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
421 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 7 · Phase 2 10 · Phase 3 6 · Phase 4 1
First in 1999; this study’s year is marked. 25 started in 2018.
This study's planned enrollment of 240 is above the median of 150 across 825 interventional studies indexed under Health Behavior.
Median enrollment 130 across the 385 interventional studies, 108 across the 36 observational. Of the 319 that completed or were terminated, 88 (28%) have results posted.
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18 of 421 have an industry lead sponsor. The 10 most frequent:
University of North Texas Health Science Center is the lead sponsor of 31 studies on the registry; 3 are open to participants now.
University of North Texas Health Science Center has 1 study filed under Health Behavior — fewer than ten, so there is no comparison to draw.
26 of the studies in Health Behavior with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05397951University of North Carolina, Chapel HillThe Validation Study of Bioelectronics | 2026-11 |
| NCT05760573Rutgers, The State University of New JerseyThe Ready and Healthy for Kindergarten Study | 2026-11-30 |
| NCT07055165University of OklahomaConnect2Care: Prostate Cancer Education and Screenings for African American Men | 2026-12 |
| NCT06684483National Institutes of Health Clinical Center (CC)The Impact of Heavy Alcohol Use on Saliva and Oral Health | 2026-12-01 |
| NCT05619705Johns Hopkins UniversityHealthy for Two-Home Visiting (H42-HV): Health Coaching for Pregnant Women | 2026-12-15 |
Add all 26 to your calendar (.ics) → With an account.
Among the 421 studies in Health Behavior with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
Change in Healthy Habits Tracking
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.
Time frame: Baseline and 8 weeks.
Social Support for Diet and Physical Activity
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.
Time frame: Baseline and 8 weeks.
Coping with stress
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.
Time frame: Baseline and 8 weeks.
Body Appreciation Scale (BAS-2)
This is a 10 item scale measuring body positivity. Scores are based on mean values of all items.
Time frame: Baseline and 8 weeks.
Healthy Lifestyle Activation
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.
Time frame: Baseline and 8 weeks.
Fruit and vegetable consumption
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.
Time frame: Baseline and 8 weeks.
Physical activity days
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.
Time frame: Baseline and 8 weeks.
Plan to share: No
Started May 2018 (actual). Primary completion is estimated for Jun 2020, 25 months after the start.
Of 568 non-industry interventional studies with no phase under Health Behavior, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 33. This study's planned 25 months is above that.
Counting every sponsor, half of 586 studies reached it within 15 months; a quarter within 5 and three quarters within 32.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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University of North Texas Health Science Center