SHE Tribe: An Intervention to Improve Health Behavior Among Women in Underserved Communities
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|ClinicalTrials.gov Identifier: NCT03463213|
Recruitment Status : Recruiting
First Posted : March 13, 2018
Last Update Posted : June 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Health Promotion||Behavioral: SHE Tribe||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||240 participants|
|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)|
|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|
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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03463213
|Contact: Emily E Spence-Almaguer, PhDfirstname.lastname@example.org|
|Contact: Shlesma Chhetri, MPHemail@example.com|
|United States, Texas|
|University of North Texas Health Science Center||Recruiting|
|Fort Worth, Texas, United States, 76107|
|Contact: Shlesma Chhetri, MPH 817-735-2378 firstname.lastname@example.org|
|Principal Investigator:||Emily Spence-Almaguer, PhD||UNT Health Science Center|