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| ID | Type | Description | Link |
|---|---|---|---|
| K23HL156758 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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This clinical trial will assess the acceptability and feasibility of a peer-supported behavioral physical activity intervention for women living with HIV and Hypertension.
An individually randomized pilot trial (N=50) of an adapted behavioral physical activity (PA) intervention will be used to assess the feasibility and acceptability of providing exercise prescription, peer support, and home blood pressure monitoring to women ages 40+ living with HIV and Hypertension. Secondary outcomes to be assessed include systolic and diastolic blood pressure, PA time and intensity, PA self-efficacy, perceived social support, and health-related quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peer support arm | Experimental | Women in the peer support arm will receive weekly peer contacts via phone or text message to assess progress towards study-assigned physical activity goal/prescription and to provide motivational counseling and support. |
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| Control arm | Active Comparator | Women in the control arm will receive physical activity prescription and home blood pressure monitoring, but will not receive peer support calls. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peer support | Behavioral | Peer support counseling will include phone or text communication to assess goal progress, provide motivational counseling as needed, and to provide social support. |
| Measure | Description | Time Frame |
|---|---|---|
| Participant attrition | Measure of participants who withdraw from the behavioral trial in the intervention and the control groups to determine feasibility of enrolling and retaining individuals in the trial. Approximately 15% attrition is expected in a behavioral clinical trial. Higher levels of attrition relate to lower feasibility. | From enrollment to end of 12 week intervention |
| Intervention acceptability: Satisfaction | Participant satisfaction with the intervention: Treatment Satisfaction Questionnaire adapted for behavioral treatment. The measure includes 11 items asked on a Likert-type scale from 1=Extremely Dissatisfied to 7=Extremely Satisfied, with 3 items asked on a 1-5 scale. 1 item will be removed that asks about medication side effects. Scores can range from 10 to 64. Higher scores mean higher satisfaction with the treatment/intervention. | Mid-point (6-week) assessment and end of intervention assessment (12-week) |
| Intervention Acceptability: Treatment burden | The Brief Patient Experiences with Treatment and Self Management will be used. The scale includes 32 items total. Most items use a 5-point Likert-type scale from 1=very easy to 5=very difficult. Some items use a 5-point Likert scale (agreement). And some use a Likert-type frequency/intensity measure from 1=not at all to 5=very much. Does not apply=0. Total scores range from 0 to 150. Higher scores mean higher treatment burden. | At 6-week (mid-point intervention) and 12-weeks (end of intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| Systolic and diastolic blood pressure | Home blood pressure readings taken x3 and averaged. | Measured at baseline, 6-weeks (mid-point) and 12-weeks (end of intervention) |
| Daily physical activity: Accelerometer measured |
| Measure | Description | Time Frame |
|---|---|---|
| General Social Support | Medical outcomes study social support scale will be used to assess global social support. The scale includes 19 items and the overall support index is calculated by taking the mean of all of the items resulting in a range from 1-5. Scores can be transformed to a 0-100 score by the following equation: 100*((observed score-minimum possible score)/(maximum possible score-minimum possible score)). Higher scores mean greater social support. |
Inclusion Criteria:
Exclusion Criteria:
Women are eligible to participate
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| Name | Affiliation | Role |
|---|---|---|
| Kaylee B Crockett, PhD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Family & Community Medicine; University of Alabama at Birmingham | Birmingham | Alabama | 35205 | United States |
Pilot trial; Certificate of confidentiality
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001519 | Behavior |
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| Exercise Prescription | Behavioral | Women will be provided with an exercise prescription (Frequency, Intensity, Time, Type) which may be adjusted weekly for 6 weeks to goal of 150min/week of moderate to vigorous physical activity. |
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| Blood pressure self monitoring | Behavioral | Women will receive a home blood pressure monitor and encourage to record their readings in a log. |
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7-day accelerometer observation of daily physical activity
| Collected at baseline pre-randomization, and at 12-weeks (end of intervention) |
| Self reported physical activity | Time and intensity of physical activity via the International Physical Activity Questionnaire - Short Form (IPAQ-SF) which are then computed to a continuous score of MET (metabolic equivalents)-minutes per week. Computed as follows: Total PA METmin/week=[(3.3*walking minutes*walking days)+(4.0*moderate activity minutes*moderate activity days)+(8.0*vigorous activity minutes*vigorous activity days)]. Higher scores mean greater physical activity. | Collected at baseline, 6 weeks (mid-point), and 12-weeks (post-intervention) |
| Physical Activity Self Efficacy | Confidence to engage in regular physical activity will be measured using the Exercise Self Efficacy Scale. A total of 9 items are asked using a scale from 0=not at all confident to 10=completely confident. Scores range from 0-90. Higher scores mean higher self efficacy. | Collected at baseline, 6-weeks (mid-point) and 12-weeks (post-intervention) |
| Physical activity enjoyment | Physical activity enjoyment scale will be used. The scale has 18 items and each item is asked on a 1 to 7 scale. Scores may range from 18-126. Higher scores mean higher enjoyment and perceived positive outcomes from exercise/physical activity. | Collected at baseline, 6-weeks (mid-point), and 12-weeks (post-intervention) |
| Social support for physical activity | Social support for exercise behaviors scale will be used that includes 10 items asked on a scale from 1=none to 5=very often, there is also an option for does not apply. Scores range from 10-50. Higher scores mean more social support for physical activity. | Collected at baseline, 6-weeks (mid-point), and 12-weeks (post-intervention) |
| Collected at baseline, 6-weeks (mid-point), and 12-weeks (post-intervention) |
| Health related quality of life | The Short Form Health Survey-12 (SF-12) will be used to assess Health related quality of life (HRQoL) which asks about physical and emotional health in the past 4 weeks using 12 items. In scoring, all items are coded to yield a total score between 0 and 100 such that higher scores mean better HRQoL. | Collected at baseline, 6-weeks (mid-point), and 12-weeks (post-intervention) |