NCT03463213

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 13, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

May 16, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

June 6, 2018

Status Verified

June 1, 2018

Enrollment Period

2 years

First QC Date

February 10, 2018

Last Update Submit

June 1, 2018

Conditions

Keywords

health behaviorchronic disease preventionhealthy lifestyle

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline and 8 weeks.

Secondary Outcomes (6)

  • Social Support for Diet and Physical Activity

    Baseline and 8 weeks.

  • Coping with stress

    Baseline and 8 weeks.

  • Body Appreciation Scale (BAS-2)

    Baseline and 8 weeks.

  • Healthy Lifestyle Activation

    Baseline and 8 weeks.

  • Fruit and vegetable consumption

    Baseline and 8 weeks.

  • +1 more secondary outcomes

Study Arms (1)

SHE Tribe

EXPERIMENTAL

SHE Tribe is a social network-based peer-facilitated intervention to promote adoption of health behaviors

Behavioral: SHE Tribe

Interventions

SHE TribeBEHAVIORAL

Social network-based peer-facilitated intervention to promote adoption of health behavior

SHE Tribe

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsMust self-represent as a female
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Males
  • Children

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Texas Health Science Center

Fort Worth, Texas, 76107, United States

RECRUITING

Related Publications (37)

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Related Links

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Emily Spence-Almaguer, PhD

    UNT Health Science Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Emily E Spence-Almaguer, PhD

CONTACT

Shlesma Chhetri, MPH

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: This is a feasibility study with a single group pre/post outcome design.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Dean; Associate Professor

Study Record Dates

First Submitted

February 10, 2018

First Posted

March 13, 2018

Study Start

May 16, 2018

Primary Completion

June 1, 2020

Study Completion

August 1, 2020

Last Updated

June 6, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations