Health PromotionNCT03463213
SHE Tribe: An Intervention to Improve Health Behavior Among Women in Underserved Communities
A study testing SHE Tribe in people with Health Promotion, run by University of North Texas Health Science Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Health Promotion
- What is being tested?
- SHE Tribe
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 16 May 2018to Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female
- representative of underserved community (determined by race, ethnicity, socioeconomic status, and/or neighborhood)
- 18 and older
Who cannot join
- Males
- Children
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of North Texas Health Science Center
Fort Worth, Texas, 76107
Shlesma Chhetri, MPH, 817-735-2378, shlesma.chhetri@unthsc.edu
About this study
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
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.
Read the 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.
- Conditions
- Health Promotion
- Being tested
- SHE Tribe
- Keywords
- health behavior, chronic disease prevention, healthy lifestyle
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHE TribeBehavioural
Social network-based peer-facilitated intervention to promote adoption of health behavior
| Study group | Role | What they receive |
|---|---|---|
| SHE Tribe | Experimental | SHE Tribe is a social network-based peer-facilitated intervention to promote adoption of health behaviors Receives: Behavioral: SHE Tribe |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 8 weeks.
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2018
- Study start16 May 2018
- Primary completionJun 2020 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (37)Papers the sponsor has linked to this study.
- Other trials for Health PromotionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a feasibility study with a single group pre/post outcome design.
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Texas Health Science Center
- Sponsor type
- University, hospital or other
- Collaborators
- YMCA of Metropolitan Fort Worth, National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Emily Spence-Almaguer, University of North Texas Health Science Center
- Investigators
- Emily Spence-Almaguer, PhD, Principal investigator, UNT Health Science Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03463213
- Sponsor's protocol ID
- 2017-148
- Other IDs
- U54MD006882-06
- Status last verified
- Jun 2018
- First submitted
- 10 Feb 2018
- Last updated
- 6 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sudano JJ, Baker DW. Explaining US racial/ethnic disparities in health declines and mortality in late middle age: the roles of socioeconomic status, health behaviors, and health insurance. Soc Sci Med. 2006 Feb;62(4):909-22. doi: 10.1016/j.socscimed.2005.06.041. Epub 2005 Aug 2.
PubMed 16055252Lantz PM, House JS, Lepkowski JM, Williams DR, Mero RP, Chen J. Socioeconomic factors, health behaviors, and mortality: results from a nationally representative prospective study of US adults. JAMA. 1998 Jun 3;279(21):1703-8. doi: 10.1001/jama.279.21.1703.
PubMed 9624022Kington RS, Smith JP. Socioeconomic status and racial and ethnic differences in functional status associated with chronic diseases. Am J Public Health. 1997 May;87(5):805-10. doi: 10.2105/ajph.87.5.805.
PubMed 9184510Mosca L. Guidelines for prevention of cardiovascular disease in women: a summary of recommendations. Prev Cardiol. 2007 Fall;10 Suppl 4:19-25. doi: 10.1111/j.1520-037x.2007.07255.x.
PubMed 17917527Geronimus AT, Hicken M, Keene D, Bound J. "Weathering" and age patterns of allostatic load scores among blacks and whites in the United States. Am J Public Health. 2006 May;96(5):826-33. doi: 10.2105/AJPH.2004.060749. Epub 2005 Dec 27.
PubMed 16380565Bauer UE, Briss PA, Goodman RA, Bowman BA. Prevention of chronic disease in the 21st century: elimination of the leading preventable causes of premature death and disability in the USA. Lancet. 2014 Jul 5;384(9937):45-52. doi: 10.1016/S0140-6736(14)60648-6. Epub 2014 Jul 1.
PubMed 24996589Nelson D, Harris A, Horner-Ibler B, Harris KS, Burns E. Hearing the Community: Evolution of a Nutrition and Physical Activity Program for African American Women to Improve Weight. J Health Care Poor Underserved. 2016;27(2):560-7. doi: 10.1353/hpu.2016.0088.
PubMed 27180695Bacon L, Aphramor L. Weight science: evaluating the evidence for a paradigm shift. Nutr J. 2011 Jan 24;10:9. doi: 10.1186/1475-2891-10-9.
PubMed 21261939Bacon L, Keim NL, Van Loan MD, Derricote M, Gale B, Kazaks A, Stern JS. Evaluating a 'non-diet' wellness intervention for improvement of metabolic fitness, psychological well-being and eating and activity behaviors. Int J Obes Relat Metab Disord. 2002 Jun;26(6):854-65. doi: 10.1038/sj.ijo.0802012.
PubMed 12037657Kumanyika SK, Wadden TA, Shults J, Fassbender JE, Brown SD, Bowman MA, Brake V, West W, Frazier J, Whitt-Glover MC, Kallan MJ, Desnouee E, Wu X. Trial of family and friend support for weight loss in African American adults. Arch Intern Med. 2009 Oct 26;169(19):1795-804. doi: 10.1001/archinternmed.2009.337.
PubMed 19858438Anderson JW, Konz EC, Frederich RC, Wood CL. Long-term weight-loss maintenance: a meta-analysis of US studies. Am J Clin Nutr. 2001 Nov;74(5):579-84. doi: 10.1093/ajcn/74.5.579.
PubMed 11684524Fitzgibbon ML, Tussing-Humphreys LM, Porter JS, Martin IK, Odoms-Young A, Sharp LK. Weight loss and African-American women: a systematic review of the behavioural weight loss intervention literature. Obes Rev. 2012 Mar;13(3):193-213. doi: 10.1111/j.1467-789X.2011.00945.x. Epub 2011 Nov 10.
PubMed 22074195Warsi A, Wang PS, LaValley MP, Avorn J, Solomon DH. Self-management education programs in chronic disease: a systematic review and methodological critique of the literature. Arch Intern Med. 2004 Aug 9-23;164(15):1641-9. doi: 10.1001/archinte.164.15.1641.
PubMed 15302634Samuel-Hodge CD, Johnson CM, Braxton DF, Lackey M. Effectiveness of Diabetes Prevention Program translations among African Americans. Obes Rev. 2014 Oct;15 Suppl 4:107-24. doi: 10.1111/obr.12211.
PubMed 25196409Brady TJ, Murphy L, O'Colmain BJ, Beauchesne D, Daniels B, Greenberg M, House M, Chervin D. A meta-analysis of health status, health behaviors, and health care utilization outcomes of the Chronic Disease Self-Management Program. Prev Chronic Dis. 2013;10:120112. doi: 10.5888/pcd10.120112.
PubMed 23327828
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03463213
- Acronym / sponsor ID
- 2017-148
- Conditions
- Health Promotion
- Keywords
- health behavior, chronic disease prevention, healthy lifestyle
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University of North Texas Health Science CenterUniversity, hospital or other
- Collaborators
- YMCA of Metropolitan Fort Worth, National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 16 May 2018 (actual)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 13 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a feasibility study with a single group pre/post outcome design.
| Arm | Type | Receives |
|---|---|---|
| SHE Tribe | Experimental | Behavioral: SHE TribeSHE Tribe is a social network-based peer-facilitated intervention to promote adoption of health behaviors |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female
- representative of underserved community (determined by race, ethnicity, socioeconomic status, and/or neighborhood)
- 18 and older
Key exclusion criteria (2 listed)
- Males
- Children
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHE TribeSocial network-based peer-facilitated intervention to promote adoption of health behavior | Behavioural | SHE Tribe |
Primary outcome
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.
6 secondary outcomes
Social Support for Diet and Physical Activity
Time frame: Baseline and 8 weeks.
Coping with stress
Time frame: Baseline and 8 weeks.
Body Appreciation Scale (BAS-2)
Time frame: Baseline and 8 weeks.
Healthy Lifestyle Activation
Time frame: Baseline and 8 weeks.
Fruit and vegetable consumption
Time frame: Baseline and 8 weeks.
Physical activity days
Time frame: Baseline and 8 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2018.
- Background: PubMed 16055252Sudano JJ, Baker DW. Explaining US racial/ethnic disparities in health declines and mortality in late middle age: the roles of socioeconomic status, health behaviors, and health insurance. Soc Sci Med. 2006 Feb;62(4):909-22. doi: 10.1016/j.socscimed.2005.06.041. Epub 2005 Aug 2.
- Background: PubMed 9624022Lantz PM, House JS, Lepkowski JM, Williams DR, Mero RP, Chen J. Socioeconomic factors, health behaviors, and mortality: results from a nationally representative prospective study of US adults. JAMA. 1998 Jun 3;279(21):1703-8. doi: 10.1001/jama.279.21.1703.
- Background: PubMed 9184510Kington RS, Smith JP. Socioeconomic status and racial and ethnic differences in functional status associated with chronic diseases. Am J Public Health. 1997 May;87(5):805-10. doi: 10.2105/ajph.87.5.805.
- Background: PubMed 17917527Mosca L. Guidelines for prevention of cardiovascular disease in women: a summary of recommendations. Prev Cardiol. 2007 Fall;10 Suppl 4:19-25. doi: 10.1111/j.1520-037x.2007.07255.x.
- Background: PubMed 16380565Geronimus AT, Hicken M, Keene D, Bound J. "Weathering" and age patterns of allostatic load scores among blacks and whites in the United States. Am J Public Health. 2006 May;96(5):826-33. doi: 10.2105/AJPH.2004.060749. Epub 2005 Dec 27.
- Background: PubMed 24996589Bauer UE, Briss PA, Goodman RA, Bowman BA. Prevention of chronic disease in the 21st century: elimination of the leading preventable causes of premature death and disability in the USA. Lancet. 2014 Jul 5;384(9937):45-52. doi: 10.1016/S0140-6736(14)60648-6. Epub 2014 Jul 1.
- Background: PubMed 27180695Nelson D, Harris A, Horner-Ibler B, Harris KS, Burns E. Hearing the Community: Evolution of a Nutrition and Physical Activity Program for African American Women to Improve Weight. J Health Care Poor Underserved. 2016;27(2):560-7. doi: 10.1353/hpu.2016.0088.
- Background: PubMed 21261939Bacon L, Aphramor L. Weight science: evaluating the evidence for a paradigm shift. Nutr J. 2011 Jan 24;10:9. doi: 10.1186/1475-2891-10-9.
- Background: PubMed 12037657Bacon L, Keim NL, Van Loan MD, Derricote M, Gale B, Kazaks A, Stern JS. Evaluating a 'non-diet' wellness intervention for improvement of metabolic fitness, psychological well-being and eating and activity behaviors. Int J Obes Relat Metab Disord. 2002 Jun;26(6):854-65. doi: 10.1038/sj.ijo.0802012.
- Background: PubMed 19858438Kumanyika SK, Wadden TA, Shults J, Fassbender JE, Brown SD, Bowman MA, Brake V, West W, Frazier J, Whitt-Glover MC, Kallan MJ, Desnouee E, Wu X. Trial of family and friend support for weight loss in African American adults. Arch Intern Med. 2009 Oct 26;169(19):1795-804. doi: 10.1001/archinternmed.2009.337.
- Background: PubMed 11684524Anderson JW, Konz EC, Frederich RC, Wood CL. Long-term weight-loss maintenance: a meta-analysis of US studies. Am J Clin Nutr. 2001 Nov;74(5):579-84. doi: 10.1093/ajcn/74.5.579.
- Background: PubMed 22074195Fitzgibbon ML, Tussing-Humphreys LM, Porter JS, Martin IK, Odoms-Young A, Sharp LK. Weight loss and African-American women: a systematic review of the behavioural weight loss intervention literature. Obes Rev. 2012 Mar;13(3):193-213. doi: 10.1111/j.1467-789X.2011.00945.x. Epub 2011 Nov 10.
- Diabetes Prevention Programs: Effectiveness and ValueLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily Spence-Almaguer, PhD principal investigator
UNT Health Science Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SHE Tribe in people with Health Promotion, run by University of North Texas Health Science Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emily E Spence-Almaguer, PhD (817-735-2323, emily.spence-almaguer@unthsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Healthy Habits Tracking (time frame: Baseline and 8 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03463213, which also lists 37 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2018.