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This is a two arm, pilot randomized control trial (RCT) in which 60 African American women (AAW), 40-64 years of age, with HbA1c ≥8% and multi-caregiving responsibilities will be recruited from communities in Milwaukee, Wisconsin and randomized to either: 1) an individual-based, social support, health educator-facilitated intervention to address multi-caregiving responsibilities (n=30), or 2) individual-based, health educator-facilitated diabetes education and skills training and general health education (n=30). All sessions will be delivered via telephone (i.e., landline, mobile device, smart device, etc.) by a health educator (i.e., nurse, social worker, Master's trained health educator) and is comprised of 12 weekly sessions and 3 booster sessions. Each session will last up to 60min. All study assessments will be administered by a Program Assistant at baseline, 3-months, and 6-months.
The investigators propose to test the feasibility and preliminary efficacy of this multi-caregiving intervention on improving outcomes among AAW, ages 40-64 years with type 2 diabetes (T2DM) and multi-caregiving responsibilities using a pilot randomized design compared to diabetes enhanced usual care. The goals of the study will be assessed under the following specific aims:
Aim 1: To determine the feasibility of the multi-caregiving intervention as measured by recruitment, session attendance, retention, and treatment adherence in AAW with T2DM
Aim 2: To test the preliminary efficacy of the multi-caregiving intervention on glycemic and blood pressure control in AAW with T2DM compared to individual-delivered, health-educator led diabetes enhanced usual care at 6 months Hypothesis 1: AAW who receive the multi-caregiving intervention will have significant reductions in hemoglobin A1c at 6 months compared to AAW who receive diabetes enhanced usual care Hypothesis 2: AAW who receive the multi-caregiving intervention will have significant reductions in blood pressure at 6 months compared to AAW who receive diabetes enhanced usual care
Aim 3: To test the preliminary efficacy of the multi-caregiving intervention on self-care behaviors and quality of life in AAW with T2DM compared to individual-delivered, health educator led diabetes enhanced usual care at 6 months Hypothesis 1: AAW who receive the multi-caregiving intervention will have significant improvements in self-care behaviors (diet, physical activity, medication adherence, and blood glucose monitoring) at 6 months compared to AAW who receive diabetes enhanced usual care Hypothesis 2: AAW who receive the multi-caregiving intervention will have significant improvements in quality of life (SF-12 scores) at 6 months compared to AAW who receive diabetes enhanced usual care
In the final 6-month assessment, study participants will be asked to participate in 30 to 40-minute, semi-structured interviews by telephone. Findings will help refine the intervention and emphasize elements that enhance participant uptake and motivation for sustained behavior change for the future R01.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multi-Caregiving Intervention | Experimental | The multi-caregiving intervention consists of individual-based, social support, and health-educator facilitation and includes: a. Storytelling/sharing of experiences (5 minutes); social support and problem solving (15 minutes); Coping strategies (15minutes); and Structured Diabetes Education and Skills Training (15 minutes). The final 5min will be used for debriefing/reviewing goals. |
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| Diabetes Enhanced Usual Care Intervention | Active Comparator | This is composed of individual-based, health educator-facilitated diabetes education and skills training and general health education and will receive structured diabetes education and skills training as described above (30 minutes) and an additional discussion on general health topics (i.e., back pain, dyspepsia, etc.) (30 minutes). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multi-Caregiving Intervention | Behavioral | The multi-caregiving intervention consists of individual-based, social support, and health educator facilitation and includes: a. Storytelling/sharing of experiences (5 minutes); social support and problem solving (15 minutes); Coping strategies (15 minutes); and Structured Diabetes Education and Skills Training (15 minutes). The last 5 minutes will be used to debrief and review goals. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in HbA1c% From Baseline to 6 Months | Trained personnel collected 100cc of blood via venipuncture to measure hemoglobin A1c (HbA1c). All collections were performed in the community at a location convenient for the study participant. At the screening visit, the HbA1c had to be 8% or greater to be eligible for participation. | Baseline, 6-months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Physical Activity From Baseline to 6 Months | Physical activity was measured using the 7-item International Physical Activity Questionnaire (IPAQ) that asks about physical activities over the last 7 days. The minimum and maximum values can vary; however, IPAQ provides ranges for physical activity in MET-minutes per week (MET-min/wk). MET-min/wk: The primary unit, calculated by multiplying minutes per week by the MET value (e.g., walking=3.3, moderate=4.0, vigorous=8.0). Low: No activity or not meeting moderate/high criteria. Moderate: Meeting criteria like 3+ days vigorous activity (≥20 min/day) OR 5+ days moderate/walking (≥30 min/day) OR 5+ days combined (≥600 MET-min/wk). High: Meeting criteria like 3+ days vigorous activity (≥1500 MET-min/wk) OR 7+ days combined (≥3000 MET-min/wk). |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joni Williams, MD, MPH | Medical College of Wisconsin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
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Recruitment occurred through community outreach and engagement in collaboration with community partners. Study information, eligibility criteria, and contact information for study personnel were detailed in correspondence materials of community partners and their affiliated networks. The recruitment flyer was displayed prominently in locations throughout the community. Self-referral/word-of-mouth was encouraged in response to recruitment flyers, the snowball method, and study advertisements.
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| ID | Title | Description |
|---|---|---|
| FG000 | Multi-caregiving Intervention | The multi-caregiving intervention consisted of individual-based, social support, and health-educator facilitation and includes: a. storytelling/sharing of experiences (5 minutes); social support and problem solving (15 minutes); coping strategies (15minutes); and structured diabetes education and skills training (15 minutes). The final 5min were used for debriefing/reviewing goals. |
| FG001 | Enhanced Usual Care | This comparator group was composed of individual-based, health educator-facilitated diabetes education and skills training (30 minutes) and an additional discussion on general health topics (i.e., back pain, dyspepsia, etc.) (30 minutes). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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A total of 60 Black women between the ages of 40-64, in the sandwich and club-sandwich generations, with multi-caregiving responsibilities, defined as the provision of informal care (emotional, physical/tangible, financial, spiritual support) to parents/grandparents, children/grandchildren, significant others, or others in their social networks within the larger community, were enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Multi-Caregiving Intervention | The multi-caregiving intervention consists of individual-based, social support, and health-educator facilitation and includes: storytelling/sharing of experiences (5 minutes); social support and problem solving (15 minutes); coping strategies (15minutes); and structured diabetes education and skills training (15 minutes). The final 5min will be used for debriefing/reviewing goals. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age was self-reported and confirmed via medical records. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Change in HbA1c% From Baseline to 6 Months | Trained personnel collected 100cc of blood via venipuncture to measure hemoglobin A1c (HbA1c). All collections were performed in the community at a location convenient for the study participant. At the screening visit, the HbA1c had to be 8% or greater to be eligible for participation. | Posted | Mean | 95% Confidence Interval | Mean Change in HbA1c% | Baseline, 6-months |
|
From enrollment until end of follow-up, up to 6 months
The clinicaltrials.gov definition for adverse event and/or serious adverse event was used to collect adverse event information.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Multi-Caregiving Intervention | The multi-caregiving intervention consists of individual-based, social support, and health-educator facilitation and includes: a. Storytelling/sharing of experiences (5 minutes); social support and problem solving (15 minutes); Coping strategies (15minutes); and Structured Diabetes Education and Skills Training (15 minutes). The final 5min will be used for debriefing/reviewing goals. |
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There are no limitations or caveats to report.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joni S. Williams | Medical College of Wisconsin | 414.955.8827 | jswilliams@mcw.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 22, 2025 | Jul 22, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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|
| Diabetes Enhanced Usual Care Intervention | Behavioral | This is composed of individual-based, health educator-facilitated diabetes education and skills training and general health education and will receive structured diabetes education and skills training as described above (30 minutes) and an additional discussion on general health topics (i.e., back pain, dyspepsia, etc.) (30 minutes). |
|
| Screening/Baseline, 3-months, 6-months |
| Change in Blood Pressure Control From Baseline to 6 Months | Blood pressure measurements were obtained by the nurse/health educator using an automated BP monitor with participants seated comfortably for 5 minutes prior to the measurements. | Screening/Baseline, 3-months, 6-months |
| Change in Blood Glucose Monitoring From Baseline to 6 Months | Blood glucose monitoring was assessed with the previously validated Summary of Diabetes Self-Care Activities (SDSCA) scale, where scores are calculated for each of the five areas assessed by the SDSCA over the past 7 days: diet, exercise, blood glucose monitoring, foot care, and smoking status. Higher scores mean more engagement in self-care behaviors. | Screening/Baseline, 3-months, 6-months |
| Change in Medication Adherence From Baseline to 6 Months | Medication adherence was measured with the 6-item validated self-report Brooks Medication Adherence Scale. Each question asks yes-no questions about adherence, where a "no" response indicates better adherence. | Screening/Baseline, 3-months, 6-months |
| Change in Health Related Quality of Life From Baseline to 6 Months | The SF-12 is a valid and reliable instrument that was used to measure functional status and yielded summary physical (PCS-12) and mental health (MCS-12) outcome scores. Summary scores range from 0 to 100 where higher scores mean better quality of life. | Screening/Baseline, 3-months, 6-months |
| BG001 | Diabetes Enhanced Usual Care Intervention | This arm included individual-based, health educator-facilitated diabetes education and skills training (30 minutes) and an additional discussion on general health topics (i.e., back pain, dyspepsia, etc.) (30 minutes). |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Full Range |
| years |
|
| Sex: Female, Male | Sex was self-reported. | A total of 60 Black women between the ages of 40-64, in the sandwich and club-sandwich generations, with multi-caregiving responsibilities, defined as the provision of informal care (emotional, physical/tangible, financial, spiritual support) to parents/grandparents, children/grandchildren, significant others, or others in their social networks within the larger community, were enrolled in the study. | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Race was self-reported. | A total of 60 Black women were enrolled in the study. | Count of Participants | Participants |
|
| Glycemic Control (Measured by HbA1c) | Trained personnel collected 100cc of blood via venipuncture to measure hemoglobin A1c (HbA1c). All collections were performed in the community at a location convenient for the study participant. At the screening visit, the HbA1c had to be 8% or greater to be eligible for participation. | Mean | Full Range | % |
|
| Diabetes Enhanced Usual Care Intervention |
This arm included individual-based, health educator-facilitated diabetes education and skills training as described in the multi-caregiving intervention (30 minutes) and an additional discussion on general health topics (i.e., back pain, dyspepsia, etc.) (30 minutes). |
|
|
| Secondary | Change in Physical Activity From Baseline to 6 Months | Physical activity was measured using the 7-item International Physical Activity Questionnaire (IPAQ) that asks about physical activities over the last 7 days. The minimum and maximum values can vary; however, IPAQ provides ranges for physical activity in MET-minutes per week (MET-min/wk). MET-min/wk: The primary unit, calculated by multiplying minutes per week by the MET value (e.g., walking=3.3, moderate=4.0, vigorous=8.0). Low: No activity or not meeting moderate/high criteria. Moderate: Meeting criteria like 3+ days vigorous activity (≥20 min/day) OR 5+ days moderate/walking (≥30 min/day) OR 5+ days combined (≥600 MET-min/wk). High: Meeting criteria like 3+ days vigorous activity (≥1500 MET-min/wk) OR 7+ days combined (≥3000 MET-min/wk). | Not Posted | Dec 2026 | Screening/Baseline, 3-months, 6-months | Participants |
| Secondary | Change in Blood Pressure Control From Baseline to 6 Months | Blood pressure measurements were obtained by the nurse/health educator using an automated BP monitor with participants seated comfortably for 5 minutes prior to the measurements. | Not Posted | Dec 2026 | Screening/Baseline, 3-months, 6-months | Participants |
| Secondary | Change in Blood Glucose Monitoring From Baseline to 6 Months | Blood glucose monitoring was assessed with the previously validated Summary of Diabetes Self-Care Activities (SDSCA) scale, where scores are calculated for each of the five areas assessed by the SDSCA over the past 7 days: diet, exercise, blood glucose monitoring, foot care, and smoking status. Higher scores mean more engagement in self-care behaviors. | Not Posted | Dec 2026 | Screening/Baseline, 3-months, 6-months | Participants |
| Secondary | Change in Medication Adherence From Baseline to 6 Months | Medication adherence was measured with the 6-item validated self-report Brooks Medication Adherence Scale. Each question asks yes-no questions about adherence, where a "no" response indicates better adherence. | Not Posted | Dec 2026 | Screening/Baseline, 3-months, 6-months | Participants |
| Secondary | Change in Health Related Quality of Life From Baseline to 6 Months | The SF-12 is a valid and reliable instrument that was used to measure functional status and yielded summary physical (PCS-12) and mental health (MCS-12) outcome scores. Summary scores range from 0 to 100 where higher scores mean better quality of life. | Not Posted | Dec 2026 | Screening/Baseline, 3-months, 6-months | Participants |
| 0 |
| 29 |
| 0 |
| 29 |
| 0 |
| 29 |
| EG001 | Diabetes Enhanced Usual Care | This is composed of individual-based, health educator-facilitated diabetes education and skills training and general health education and will receive structured diabetes education and skills training as described above (30 minutes) and an additional discussion on general health topics (i.e., back pain, dyspepsia, etc.) (30 minutes). | 0 | 31 | 0 | 31 | 0 | 31 |
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| D004700 | Endocrine System Diseases |