Trial Outcomes & Findings for Stress-reduction Wellness Program for Midlife Black Women (B-SWELL) (NCT NCT04404478)
NCT ID: NCT04404478
Last Updated: 2023-02-03
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
52 participants
Primary outcome timeframe
Baseline to 12 weeks
Results posted on
2023-02-03
Participant Flow
Women were recruited from the community using fliers, social media, email list serves, and word of mouth. The recruitment efforts were led by community partners. Recruitment was completed within 7 weeks.
Of the 52 persons randomized and enrolled in the study, 3 persons withdrew prior to the start of the study (week 1) and 1 person was withdrawn prior to week 2 for lack of participation.
Participant milestones
| Measure |
B-SWELL Intervention Group (B-SWELL)
Black women's stress and wellness intervention
|
Wellness (WE)
Comparison group
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
26
|
|
Overall Study
COMPLETED
|
25
|
23
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
| Measure |
B-SWELL Intervention Group (B-SWELL)
Black women's stress and wellness intervention
|
Wellness (WE)
Comparison group
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
Baseline Characteristics
Stress-reduction Wellness Program for Midlife Black Women (B-SWELL)
Baseline characteristics by cohort
| Measure |
B-SWELL Group
n=25 Participants
The Midlife Black women's Stress and Wellness group (B-SWELL) is the intervention group.
|
WE Group
n=23 Participants
The Wellness (WE) group is the comparison group.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age between 40 and 64
|
25 participants
n=5 Participants
|
23 participants
n=7 Participants
|
48 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
25 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 12 weeksPopulation: These measures were used to calculate the differences between timepoints for the two groups.
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.
Outcome measures
| Measure |
B-SWELL
n=25 Participants
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.
B-SWELL: Midlife Black Women's Stress Reduction Wellness Program: 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.
|
WE (Wellness Comparison Group)
n=23 Participants
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.
WE: Wellness program for Midlife Black Women: 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.
|
|---|---|---|
|
American Heart Association's Life's Simple Seven (LS7) Score
|
8.76 units on a scale
Standard Deviation 2.11
|
8.21 units on a scale
Standard Deviation 2.50
|
SECONDARY outcome
Timeframe: baseline to 12 weeksPopulation: The number of unhealthy days measured within 2 weeks.
'Unhealthy Days' is measures by the number of unhealthy days reported by the participant. This question asks the participant how many days in past month that their physical/mental health was not good. This is a continuous numeric response. Higher numbers indicate poorer health during the reported timeframe.
Outcome measures
| Measure |
B-SWELL
n=25 Participants
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.
B-SWELL: Midlife Black Women's Stress Reduction Wellness Program: 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.
|
WE (Wellness Comparison Group)
n=23 Participants
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.
WE: Wellness program for Midlife Black Women: 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.
|
|---|---|---|
|
Unhealthy Days
|
2.52 days
Standard Deviation 6.26
|
3.09 days
Standard Deviation 4.86
|
SECONDARY outcome
Timeframe: Baseline to 12 weeksThe Perceived General Health question is one item from the Short Form Health Survey. The participants will rate their health as 'excellent', 'very good', 'good', 'fair' and 'poor'. Responses are categorical. The reported outcome reflects the number of participants who rate their health as 'good'.
Outcome measures
| Measure |
B-SWELL
n=25 Participants
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.
B-SWELL: Midlife Black Women's Stress Reduction Wellness Program: 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.
|
WE (Wellness Comparison Group)
n=23 Participants
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.
WE: Wellness program for Midlife Black Women: 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.
|
|---|---|---|
|
Perceived General Health
|
17 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Baseline to 12 weeksThe PHQ9 measures depressive symptoms. Participants rate their depressive symptoms from '0' (not at all) to '3' (every day). Scores range from 0 to 27. Higher scores indicate greater risk of clinical depression. Lower scores indicate less risk for depression.
Outcome measures
| Measure |
B-SWELL
n=25 Participants
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.
B-SWELL: Midlife Black Women's Stress Reduction Wellness Program: 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.
|
WE (Wellness Comparison Group)
n=23 Participants
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.
WE: Wellness program for Midlife Black Women: 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.
|
|---|---|---|
|
Patient Health Questionnaire (PHQ9)
|
4.80 units on a scale
Standard Deviation 5.17
|
5.39 units on a scale
Standard Deviation 3.20
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to 12 weeksThe Perceived stress scale (PSS-10) measures a person's perception of general stress. Items are rated on a scale of 0 to 4 with a maximum score of 40. Higher levels of stress correspond with higher scores. Low scores indicate less stress.
Outcome measures
| Measure |
B-SWELL
n=25 Participants
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.
B-SWELL: Midlife Black Women's Stress Reduction Wellness Program: 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.
|
WE (Wellness Comparison Group)
n=23 Participants
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.
WE: Wellness program for Midlife Black Women: 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.
|
|---|---|---|
|
Cohen's Perceived Stress Scale (PSS-10)
|
16.68 units on a scale
Standard Deviation 6.32
|
15.39 units on a scale
Standard Deviation 5.48
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline to 12 weeks.The GSE is a 10-item psychometric scale that assesses optimistic self-beliefs to cope with life demands. The total score is calculated by finding the sum of the all items. Scores range from 1 (not at all true) to 4 (exactly true). Total scores range between 10 and 40. A higher score indicates greater self-efficacy in achieving a particular outcome. Lower scores indicate the participant has less self-efficacy in achieving the outcome.
Outcome measures
| Measure |
B-SWELL
n=25 Participants
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.
B-SWELL: Midlife Black Women's Stress Reduction Wellness Program: 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.
|
WE (Wellness Comparison Group)
n=23 Participants
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.
WE: Wellness program for Midlife Black Women: 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.
|
|---|---|---|
|
General Self-Efficacy Scale (GSE)
|
33.44 units on a scale
Standard Deviation 3.36
|
32.91 units on a scale
Standard Deviation 2.70
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 8 weeksSatisfaction. Participants rate their satisfaction of the overall B-SWELL program using a Likert type scale ranging from 1=strongly disagree to 5=strongly agree. The questionnaire includes items for usefulness, ease of use, and acceptability of the intervention. Ratings are averaged across participants. The results reported here refer to the question: 'The weekly program materials addressed the problems I was having as a midlife Black woman.'
Outcome measures
| Measure |
B-SWELL
n=25 Participants
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.
B-SWELL: Midlife Black Women's Stress Reduction Wellness Program: 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.
|
WE (Wellness Comparison Group)
n=23 Participants
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.
WE: Wellness program for Midlife Black Women: 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.
|
|---|---|---|
|
Satisfaction (Adapted From Satisfaction Questionnaire).
|
4.52 units on a scale
Standard Deviation 0.92
|
4.30 units on a scale
Standard Deviation 0.70
|
Adverse Events
B-SWELL
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
WE - Wellness Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place