Capri G. Foy

The design and rationale of a multicenter clinical trial comparing two strategies for control of systolic blood pressure: The Systolic Blood Pressure Intervention Trial (SPRINT)

Background: High blood pressure is an important public health concern because it is highly prevalent and a risk factor for adverse health outcomes, including coronary heart disease, stroke, decompensated heart failure, chronic kidney disease, and decline in cognitive function. Observational studies show a progressive increase in risk associated with blood pressure above 115/75 mm Hg. Prior research has shown that reducing elevated systolic blood pressure lowers the risk of subsequent clinical complications from cardiovascular disease. However, the optimal systolic blood pressure to reduce blood pressure–related adverse outcomes is unclear, and the benefit of treating to a level of systolic blood pressure well below 140 mm Hg has not been proven in a large, definitive clinical trial. Purpose: To describe the design considerations of the Systolic Blood Pressure Intervention Trial (SPRINT) and the baseline characteristics of trial participants. Methods: The Systolic Blood Pressure Intervention Trial is a multicenter, randomized, controlled trial that compares two strategies for treating systolic blood pressure: one targets the standard target of <140 mm Hg, and the other targets a more intensive target of <120 mm Hg. Enrollment focused on volunteers of age ≥50 years (no upper limit) with an average baseline systolic blood pressure ≥130 mm Hg and evidence of cardiovascular disease, chronic kidney disease, 10-year Framingham cardiovascular disease risk score ≥15%, or age ≥75 years. The Systolic Blood Pressure Intervention Trial recruitment also targeted three pre-specified subgroups: participants with chronic kidney disease (estimated glomerular filtration rate <60 mL/min/1.73 m2), participants with a history of cardiovascular disease, and participants 75 years of age or older. The primary outcome is first the occurrence of a myocardial infarction (MI), acute coronary syndrome, stroke, heart failure, or cardiovascular disease death. Secondary outcomes include all-cause mortality, decline in kidney function or development of end-stage renal disease, incident dementia, decline in cognitive function, and small-vessel cerebral ischemic disease. Results: Between 8 November 2010 and 15 March 2013, Systolic Blood Pressure Intervention Trial recruited and randomized 9361 people at 102 clinics, including 3331 women, 2648 with chronic kidney disease, 1877 with a history of cardiovascular disease, 3962 minorities, and 2636 ≥75 years of age. Limitations: Although the overall recruitment target was met, the numbers recruited in the high-risk subgroups were lower than planned. Conclusions: The Systolic Blood Pressure Intervention Trial will provide important information on the risks and benefits of intensive blood pressure treatment targets in a diverse sample of high-risk participants, including those with prior cardiovascular disease, chronic kidney disease, and those aged ≥75 years.

Older adults with chronic disease: benefits of group-mediated counseling in the promotion of physically active lifestyles.

In this 12-month trial standard exercise training was compared with a group-mediated cognitive-behavioral (GMCB) intervention with respect to effects on long-term adherence and change in physical function of older adults who were either at risk for or had cardiovascular disease. Participants (147 older men and women) were randomized to the 2 treatments. Outcomes included self-reportedphysical activity, fitness, and self-efficacy. The GMCB treatment produced greater improvements on all outcomes than did standard exercise therapy. Regardless of treatment assignment, men had more favorable change on the study outcomes than did women. Analysis of a self-regulatory process measure in the GMCB group revealed that change in barriers efficacy was related to change in physical activity and fitness. Results suggest that teaching older adults to integrate physical activity into their lives via GMCB leads to better long-term outcomes than standardized exercise therapy.

Exercise Adherence among Older Adults: Challenges and Strategies

This paper explores physical activity adherence among older adults in clinical research. We address the unique challenges associated with promoting physical activity, including the amount of time and effort, perceived benefits, and recommendations from professionals. We explore useful strategies to enhance adherence in the realm of physical activity interventions, including the development of theory-based physical activity interventions that acknowledge participant needs and expectations, promote self-regulatory skills, view exercise as an ongoing process subject to relapse, and utilize phone contacts for home-based activity programs. We conclude with directions for future clinical trials to enhance exercise adherence that include the need for a precise definition and operationalization of adherence, linkages between physical activity interventions and theory, and the study of exercise in both structured and home-based settings. Control Clin Trials 2000;21:212S-217S

Intensive Lifestyle Intervention Improves Physical Function Among Obese Adults With Knee Pain: Findings From the Look AHEAD Trial

Lifestyle interventions have resulted in weight loss or improved physical fitness among individuals with obesity, which may lead to improved physical function. This prospective investigation involved participants in the Action for Health in Diabetes (Look AHEAD) trial who reported knee pain at baseline (n = 2,203). The purposes of this investigation were to determine whether an Intensive Lifestyle Intervention (ILI) condition resulted in improvement in self‐reported physical function from baseline to 12 months vs. a Diabetes Support and Education (DSE) condition, and whether changes in weight or fitness mediated the effect of the ILI. Outcome measures included the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain, stiffness, and physical function subscales, and WOMAC summary score. ILI participants exhibited greater adjusted mean weight loss (s.e.) vs. DSE participants (−9.02 kg (0.48) vs. −0.78 kg (0.49); P < 0.001)). ILI participants also demonstrated more favorable change in WOMAC summary scores vs. DSE participants (β (s.e.) = −1.81 (0.63); P = 0.004). Multiple regression mediation analyses revealed that weight loss was a mediator of the effect of the ILI intervention on change in WOMAC pain, function, and summary scores (P < 0.001). In separate analyses, increased fitness also mediated the effect of the ILI intervention upon WOMAC summary score (P < 0.001). The ILI condition resulted in significant improvement in physical function among overweight and obese adults with diabetes and knee pain. The ILI condition also resulted in significant weight loss and improved fitness, which are possible mechanisms through which the ILI condition improved physical function.

A Multilevel Assessment of Barriers to Adoption of Dietary Approaches to Stop Hypertension (DASH) among African Americans of Low Socioeconomic Status

Background. We examined perceptions of Dietary Approaches to Stop Hypertension (DASH) and the food environment among African Americans (AA) with high blood pressure living in two low-income communities and objectively assessed local food outlets. Methods. Focus groups were conducted with 30 AAs; participants discussed DASH and the availability of healthy foods in their community. Sessions were transcribed and themes identified. Fifty-four stores and 114 restaurants were assessed using the Nutrition Environment Measures Survey (NEMS). Results. Common themes included poor availability, quality, and cost of healthy foods; tension between following DASH and feeding other family members; and lack of congruity between their preferred foods and DASH. Food outlets in majority AA census tracts had lower NEMS scores (stores: -11.7, p=.01, restaurants: -8.3, p=.001) compared with majority White areas. Conclusions. Interventions promoting DASH among lower income AAs should reflect the food customs, economic concerns, and food available in communities.

A lifestyle activity intervention in patients with chronic obstructive pulmonary disease

BACKGROUND Chronic obstructive pulmonary disease (COPD) patients have lower levels of physical activity compared to age-matched controls, and they limit physical activities requiring normal exertion. Our purpose was to compare the effectiveness of a traditional exercise therapy (TET) program with a behavioral lifestyle activity program (LAP) in promoting physical activity. METHODS Moderate physical activity (kcal/week) was assessed in 176 COPD patients using the Community Health Activities Model for Seniors questionnaire. Patients were randomized to either a three month TET program that meet thrice weekly or a LAP. The LAP was designed to teach behavioral skills that encouraged the daily accumulation of self-selected physical activities of at least moderate intensity. Interventionist contact was similar (36 h) between the two groups. Patients were assessed at baseline and 3, 6 and 12 months. RESULTS Compared to baseline values, self-reported moderate physical activity increased three months post-randomization with no significant difference (p = 0.99) found between the TET (2501 +/- 197 kcal/week) and the LAP (2498 +/- 211 kcal/week). At 6 and 12 months post-randomization, there were no significant differences (p = 0.37 and 0.69, respectively) in self-reported levels of moderate physical activity between the TET (2210 +/- 187 and 2213 +/- 218 kcal/week, respectively) and the LAP (2456 +/- 198 and 2342 +/- 232 kcal/week, respectively). CONCLUSION Although there was no difference between treatment groups, the TET and the LAP were both effective at in increasing moderate levels of physical activity at 3 months and maintaining moderate physical activity levels 12 months post-randomization. This clinical trial is registered with ClinicalTrials.gov. Its identifier is NCT00328484.

Visceral Fat and Prevalence of Hypertension Among African Americans and Hispanic Americans: Findings From the IRAS Family Study

BACKGROUND We examined the relationship between visceral adipose tissue (VAT), independent of overall adiposity, and prevalent hypertension among adults enrolled in the Insulin Resistance Atherosclerosis (IRAS) Family Study. We also examined the role of insulin sensitivity (S(I)) upon hypertension. This was a cross-sectional epidemiological study in which African-American and Hispanic-American families were recruited from three clinical sites. The main outcome measure was prevalent hypertension, as defined by standardized protocol. METHODS The relationship between VAT and prevalent hypertension was examined in adjusted marginal models among 1,582 participants. All continuous variables were standardized. RESULTS A significant VAT by gender interaction prompted separate analyses for VAT according to gender. Further adjustment for S(I) was performed to determine its potential roles in the VAT-hypertension relationship. The mean age (s.d.) of the sample was 41.3 (13.8) years, with a mean body mass index (BMI) (s.d.) of 28.7 (6.0) kg/m2. Women comprised 58.5% of the sample (N = 925), and Hispanic Americans comprised 69.2% of the sample (N = 1,095). One in five participants (21.2%) had prevalent hypertension. In women, VAT was significantly associated with hypertension, independent of BMI (odds ratio (OR) = 1.49, P = 0.006). African-American women demonstrated increased odds of prevalent hypertension compared to Hispanic-American women (OR = 3.08, P < 0.001). Among men, VAT was not associated with hypertension independent of BMI, and BMI explained a significant amount of the variation in hypertension. CONCLUSIONS A significant relationship may exist between VAT and hypertension among women, but not among men. The relationship between VAT and hypertension in women was not associated with insulin resistance.

Effect of Intensive Blood-Pressure Treatment on Patient-Reported Outcomes

BACKGROUND The previously published results of the Systolic Blood Pressure Intervention Trial showed that among participants with hypertension and an increased cardiovascular risk, but without diabetes, the rates of cardiovascular events were lower among those who were assigned to a target systolic blood pressure of less than 120 mm Hg (intensive treatment) than among those who were assigned to a target of less than 140 mm Hg (standard treatment). Whether such intensive treatment affected patient‐reported outcomes was uncertain; those results from the trial are reported here. METHODS We randomly assigned 9361 participants with hypertension to a systolic blood‐pressure target of less than 120 mm Hg or a target of less than 140 mm Hg. Patient‐reported outcome measures included the scores on the Physical Component Summary (PCS) and Mental Component Summary (MCS) of the Veterans RAND 12‐Item Health Survey, the Patient Health Questionnaire 9‐item depression scale (PHQ‐9), patient‐reported satisfaction with their blood‐pressure care and blood‐pressure medications, and adherence to blood‐pressure medications. We compared the scores in the intensive‐treatment group with those in the standard‐treatment group among all participants and among participants stratified according to physical and cognitive function. RESULTS Participants who received intensive treatment received an average of one additional antihypertensive medication, and the systolic blood pressure was 14.8 mm Hg (95% confidence interval, 14.3 to 15.4) lower in the group that received intensive treatment than in the group that received standard treatment. Mean PCS, MCS, and PHQ‐9 scores were relatively stable over a median of 3 years of follow‐up, with no significant differences between the two treatment groups. No significant differences between the treatment groups were noted when participants were stratified according to baseline measures of physical or cognitive function. Satisfaction with blood‐pressure care was high in both treatment groups, and we found no significant difference in adherence to blood‐pressure medications. CONCLUSIONS Patient‐reported outcomes among participants who received intensive treatment, which targeted a systolic blood pressure of less than 120 mm Hg, were similar to those among participants who received standard treatment, including among participants with decreased physical or cognitive function. (Funded by the National Institutes of Health; SPRINT ClinicalTrials.gov number, NCT01206062.)

Five-Year Change in Visceral Adipose Tissue Quantity in a Minority Cohort: The Insulin Resistance Atherosclerosis Study (IRAS) Family Study

OBJECTIVE To describe the 5-year change in visceral adipose tissue (VAT) and subcutaneous adipose tissue (SAT) areas. RESEARCH DESIGN AND METHODS Absolute change in VAT and SAT measured by abdominal computed tomography scans has been obtained at a 5-year interval from African Americans (n = 389) and Hispanic Americans (n = 844), aged 20–69 years, in 10-year age-groups. RESULTS Mean 5-year increases in VAT areas in women were 18, 7, 4, 0.4, and −3 cm2 for African Americans and 13, 7, 3, 1, and −15 cm2 for Hispanics, across the 5 age decades (trend not significant). Mean 5-year increases in SAT areas in women were 88, 46, 19, 17, and 14 cm2 for African Americans and 53, 20, 17, 12, and 1 cm2 for Hispanics, across the 5 age decades (P < 0.05 for both). Similar trends have been observed in men. CONCLUSIONS Accumulation of abdominal fat is greatest in young adulthood. These data may be useful in identifying subgroups at risk of type 2 diabetes.

Long-Term Exercise Therapy Resolves Ethnic Differences in Baseline Health Status in Older Adults with Knee Osteoarthritis

Objectives: To determine whether ethnicity was associated with baseline and 18‐month health status within a merged sample of older adults with knee osteoarthritis (OA) from the Fitness Arthritis in Seniors Trial and the Arthritis, Diet, and Activity Promotion Trial.