Stress-reduction Wellness Program for Midlife Black Women (B-SWELL)
Condition: Cardiovascular Risk Factor; Stress; Self Efficacy; Depressive Symptoms; Health Behavior
MeSH terms: Depression
Study type: Interventional

Summary: 
      This research study examines the unique cultural and gender-based factors that influence how
      midlife Black women experience stress and incorporate healthy lifestyle behaviors into daily
      life. The B-SWELL intervention uses stress reduction and goal setting to increase self
      efficacy in adopting healthy lifestyle behaviors. The B-SWELL intervention will be compared
      to an inattention control wellness group in a randomized control trial. The long-term outcome
      is to decrease cardiovascular disease risk in this high-risk population, midlife Black women.
    

Detailed description: 
      Cardiovascular disease (CVD) is the primary cause of death in all women, and as women
      transition through midlife, the prevalence of CVD exceeds that of men.1 Midlife Black women,
      defined as ages 40-64,unduly shoulder the burden of CVD (49%), hypertension (40%), and heart
      failure (50% greater risk). Midlife Black women also report higher levels of chronic stress
      and greater numbers of stressful life events in comparison to midlife White women, putting
      them at greater risk for CVD. In addition to the physical impact, coping with chronic stress
      takes time and energy away from self-care, functioning as a barrier to the adoption of
      healthy lifestyle behaviors. Existent interventions do not fully address the unique factors
      contributing to the experience of stress, lifestyle behaviors, and CVD risk in midlife Black
      women.

      The purpose of this research proposal is to develop a midlife Black women's Stress-reduction
      WELLness intervention, B-SWELL, to promote healthy lifestyle behaviors based on the stressors
      and themes identified in preliminary research. Community-based participatory research (CBPR)
      methods will be used to engage the community and include midlife Black women in the
      development of the B-SWELL. We propose that the skills and knowledge gained through
      participation in the B-SWELL program will increase receptivity to the healthy lifestyle
      behaviors outlined in the American Heart Association's Life Simple 7 Success Plan (LS7). The
      LS7 targets seven risk factors known to increase cardiovascular related health risk:
      cholesterol, fasting glucose, blood pressure, body mass index, physical activity, diet, and
      smoking.

      Our hypothesis proposes that low stress scores and greater self efficacy will be associated
      with the adoption of AHA's healthy lifestyle behaviors. Low stress and self efficacy will be
      facilitated through peer support and culturally relevant content, materials, and themes.
      B-SWELL participants will show improved self-efficacy in managing life stress and adopting
      the LS7 behaviors, compared to a control group receiving traditional wellness education (WE
      group).

      Aim 1: Develop the B-SWELL intervention for midlife Black women through the innovative
      leveraging of CBPR methodology and LS7 modifiable healthy lifestyle behaviors.

        1. To develop components of the B-SWELL intervention prototype for midlife Black women.

        2. Obtain ratings of the new components of the B-SWELL from our community advisory board
           for degree of accuracy, relevance, and feasibility to inform further refinements.

      Aim 2: Determine the feasibility of the B-SWELL intervention with a trial of 50 midlife Black
      women randomized to the B-SWELL intervention (25) or to a wellness education (WE) control
      group (25):

        1. Obtain recruitment, retention, treatment fidelity ratings, and satisfaction ratings for
           the intervention procedures for both groups;

        2. Compare mediator measures (stress, self-efficacy) for participants in the B-SWELL
           intervention group with those in the WE group at 8 and 12 weeks.

        3. Compare outcome measures (LS7 summary scores, unhealthy days, general health, depressive
           symptoms) for participants in the B-SWELL intervention group with those in the WE
           attention control group at 8 and 12 weeks.
    

Intervention name(s): B-SWELL: Midlife Black Women's Stress Reduction Wellness Program; WE: Wellness program for Midlife Black Women
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Stress reduction and culturally tailored information on healthy lifestyle behaviors will be used to increase healthy lifestyle behaviors according to the AHA's Life's Simple 7. Focus of intervention on per support, goal setting, stress reduction, and culturally relevant information.; Culturally tailored information will be provided about healthy lifestyle behaviors will be used to increase healthy lifestyle behaviors according to the AHA's Life's Simple 7. Focus of intervention on peer support and culturally relevant content.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized control trial comparing intervention group (B-SWELL) with an attention control group (WE) to assess the following outcomes: healthy lifestyle scores, perceived stress scores, self efficacy, unhealthy days, and depressive symptoms.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Black women; Stress; Heart disease; Health behaviors; Midlife; Community-based research