Stress-reduction Wellness Program for Midlife Black Women (B-SWELL)

NCT04404478 | Completed Results DMC

• 2 other identifiers: B-SWELL2019K01HL141676
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiovascular Risk Factor; Stress; Self Efficacy; Depressive Symptoms; Health Behavior

Keywords

Black women; Stress; Heart disease; Health behaviors; Midlife; Community-based research

Outcome Measures

Primary Outcomes (1)

• American Heart Association's Life's Simple Seven (LS7) Score

  Life's Simple 7 score measures cardiovascular health. Minimum score is 0. Maximum score is 14. Each of the 7 metrics (weight loss, diet, exercise, cholesterol management, glucose management, smoking, and blood pressure management) is rated 0 (poor), 1 (average), or 2 (best). Higher scores indicate greater cardiovascular health. Lower scores indicate greater risk for heart disease.

  Baseline to 12 weeks

Secondary Outcomes (3)

• Unhealthy Days

  baseline to 12 weeks

• Perceived General Health

  Baseline to 12 weeks

• Patient Health Questionnaire (PHQ9)

  Baseline to 12 weeks

Other Outcomes (3)

• Cohen's Perceived Stress Scale (PSS-10)

  Baseline to 12 weeks

• General Self-Efficacy Scale (GSE)

  baseline to 12 weeks.

• Satisfaction (Adapted From Satisfaction Questionnaire).

  8 weeks

Study Arms (2)

B-SWELL

EXPERIMENTAL

Participants in the B-SWELL intervention will receive information about stress and goal setting in addition to healthy lifestyle behaviors. The intervention will take place weekly for eight weeks in groups of 11 to 13 midlife Black women for peer support. Outcome measures will include perceived general health, depressive symptoms, life's simple 7 (LS7) score, and number of unhealthy days. Data collections will occur at baseline, 8 weeks, and 12 weeks.

Behavioral: B-SWELL: Midlife Black Women's Stress Reduction Wellness Program

WE

ACTIVE COMPARATOR

The attention control group (WE), will include education about healthy lifestyle behaviors and peer support. The attention control groups will also have weekly sessions for eight weeks in groups of 11 to 13 midlife Black women. Outcome measures will include perceived general health, depressive symptoms, life's simple 7 (LS7) score, and number of unhealthy days. Data collections will occur at baseline, 8 weeks, and 12 weeks.

Behavioral: WE: Wellness program for Midlife Black Women

Interventions

B-SWELL: Midlife Black Women's Stress Reduction Wellness Program BEHAVIORAL

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.

B-SWELL

WE: Wellness program for Midlife Black Women BEHAVIORAL

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.

WE

Eligibility Criteria

• Age: 40 Years - 64 Years
• Gender Eligibility Details: Midlife Black/African-American women between the ages of 40 and 64,
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• fluent in the English language,
• ability to hear and talk well enough to engage in everyday conversation,
• access to a telephone with messaging,
• access to WIFI,
• willingness to participate for duration of the study.

You may not qualify if:

• recent immigration to the U.S.,
• prisoner or on house arrest,
• pregnant,
• terminal illness (i.e., late stage cancer, end-of-life condition, renal failure requiring dialysis),
• history of Alzheimer's, dementia, or severe mental illness (i.e., suicidal tendencies, schizophrenia, or severe untreated depression),
• any other major health conditions or disabilities prohibiting safe participation in the program.

Sponsors & Collaborators

• University of Cincinnati: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Cincinnati, College of Nursing

Cincinnati, Ohio, 45219, United States

Location

Related Publications (7)

• Jones HJ, Norwood CR, Bankston K. Leveraging Community Engagement to Develop Culturally Tailored Stress Management Interventions in Midlife Black Women. J Psychosoc Nurs Ment Health Serv. 2019 Mar 1;57(3):32-38. doi: 10.3928/02793695-20180925-01. Epub 2018 Oct 1.

  PMID: 30272812 BACKGROUND

• Jones HJ, Norwood CR, Bankston K, Bakas T. Stress Reduction Strategies Used by Midlife Black Women to Target Cardiovascular Risk. J Cardiovasc Nurs. 2019 Nov/Dec;34(6):483-490. doi: 10.1097/JCN.0000000000000615.

  PMID: 31609281 BACKGROUND

• Jones HJ, Sternberg RM, Janson SL, Lee KA. A Qualitative Understanding of Midlife Sources of Stress and Support in African-American Women. J Natl Black Nurses Assoc. 2016 Jul;27(1):24-30.

  PMID: 29932540 BACKGROUND

• Jones HJ, Bakas T, Nared S, Humphries J, Wijesooriya J, Butsch Kovacic M. Co-Designing a Program to Lower Cardiovascular Disease Risk in Midlife Black Women. Int J Environ Res Public Health. 2022 Jan 26;19(3):1356. doi: 10.3390/ijerph19031356.

  PMID: 35162379 BACKGROUND

• Jones HJ, Kovacic MB, Bakas T. Establishing Validity of the Midlife Black Women's Stress-Reduction Wellness Program Materials Using a Mixed Methods Approach. J Cardiovasc Nurs. 2022 Sep-Oct 01;37(5):446-455. doi: 10.1097/JCN.0000000000000876. Epub 2021 Dec 22.

  PMID: 34935740 BACKGROUND

• Jones HJ, Kovacic MB, Bacchus P, Almallah W, Bakas T. Participant Satisfaction in a Cardiovascular Disease Prevention Intervention for Midlife Black Women. West J Nurs Res. 2024 Jan;46(1):3-9. doi: 10.1177/01939459231208420. Epub 2023 Oct 31.

  PMID: 37905540 DERIVED

• Jones HJ, Butsch Kovacic M, Lambert J, Almallah WR, Becker R, de las Fuentes L, Bakas T. A randomized feasibility trial of the Midlife Black Women's Stress and Wellness intervention (B-SWELL); a community participatory intervention to increase adoption of Life's Simple 7 healthy lifestyle behaviors. Transl Behav Med. 2022 Nov 21;12(11):1084-1095. doi: 10.1093/tbm/ibac075.

  PMID: 36208220 DERIVED

MeSH Terms

Conditions

Depression; Health Behavior; Heart Diseases

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Cardiovascular Diseases

Limitations and Caveats

Limitations include: * The comparison group included culturally tailored materials and was not a true control. * The effects of peer support and group interactions may have been underestimated in the WE group. * The threat of group contamination could not be eliminated. * The small sample in this feasibility study prohibits our ability to make inferences.

Results Point of Contact

• Title: Dr. Holly Jones
• Organization: Ohio State University

jones.7935@osu.edu

760-415-6147

Study Officials

• Holly J Jones, PhD,RN,NP

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The participants will be randomized into groups. Group sessions held online on different dates and times. Participants are asked not to share details about the study. Data collectors are blinded to participant grouping. Facilitators are blinded to the groups they are not facilitating.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: May 18, 2020
• First Posted: May 27, 2020
• Study Start: February 13, 2021
• Primary Completion: June 12, 2021
• Study Completion: June 12, 2021
• Last Updated: February 3, 2023
• Results First Posted: February 3, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will become available upon completion of the study and remain available for 1 year.
• Access Criteria: To be determined.

Locations

US (1)