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Inflammation moderates the effects of lifestyle modification on neurocognition among individuals with resistant hypertension.
Avorgbedor, F, Blumenthal, JA, Hinderliter, A, Ingle, K, Lin, PH, Craighead, L, Tyson, C, Kraus, W, Sherwood, A, Smith, PJ
Journal of clinical hypertension (Greenwich, Conn.). 2023;25(1):106-110
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Hypertension is one of the primary causes of cardiovascular disease, stroke, Alzheimer’s Disease, and Alzheimer’s Disease and related dementias (AD/ADRD). Among individuals with hypertension, those with resistant hypertension (RH) appear to have the greatest risk of cerebrovascular disease and associated cognitive impairment. The aim of this study was to investigate the potential influence of individual differences in pre-treatment inflammatory profiles on changes in cognition following lifestyle modification among RH participants in the TRIUMPH clinical trial. This study is a report based on the TRIUMPH study which was a randomised clinical trial. One hundred forty patients with RH were randomised with 2:1 allocation to either a 4-month Centre-based Lifestyle intervention or Standardized Education and Physician Advice. Results show that basal levels of elevated peripheral inflammation may represent an intermediate phenotype of risk for cognitive decline. In fact, individuals with higher levels of c-reactive protein at baseline demonstrated greater improvements in Executive Function/Learning following participation in an intensive lifestyle intervention. Authors conclude that their findings may help inform targeted treatments to reduce ADRD among middle-aged and older adults with cardiovascular disease risk factors.
Abstract
Individuals with resistant hypertension (RH) have the greatest risk of cerebrovascular disease and cognitive impairment among individuals with hypertension. Elevated levels of pro-inflammatory cytokines may represent a critical yet unexamined factor influencing the impact of healthy lifestyle changes on cognitive function. We explored the influence of inflammation on changes in cognition following lifestyle modification among individuals with RH participating in the TRIUMPH clinical trial. One hundred forty participants with RH completed a battery of neurocognitive tests along with the inflammatory marker C-reactive protein (hsCRP) and were subsequently randomized to an intensive 4-month lifestyle modification intervention or to education and physician advice control. Results indicated that the effects of lifestyle modification on Executive Function and Learning were moderated by pre-intervention hsCRP levels (P = .049), with treatment efficacy increasing across levels of baseline inflammation levels (low: d = 0.12; mild: d = 0.43; moderate: d = 0.81). We conclude that inflammatory profiles may help identify individuals more likely to improve executive functioning resulting from lifestyle modification.
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Lifestyle modification and cognitive function among individuals with resistant hypertension: cognitive outcomes from the TRIUMPH trial.
Smith, PJ, Sherwood, A, Hinderliter, AL, Mabe, S, Watkins, LL, Craighead, L, Ingle, K, Tyson, C, Avorgbedor, F, Lin, PH, et al
Journal of hypertension. 2022;(7):1359-1368
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BACKGROUND Resistant hypertension is associated with increased risk of cognitive decline, stroke, and dementia. Lifestyle modification has been suggested to improve cognitive function through its salutary effects on vascular function. METHODS Participants included 140 patients with resistant hypertension participating in the TRIUMPH trial. Participants were randomized to a cardiac rehabilitation-based lifestyle program (C-LIFE) or a standardized education and physician advice condition (SEPA). Participants completed a 45-min cognitive test battery consisting of tests of Executive Functioning and Learning, Memory, and Processing Speed. Biomarkers of vascular [flow mediated dilation of the brachial artery (FMD)], microvascular, and cerebrovascular function were also collected, in addition to weight, fitness, and ambulatory blood pressure. RESULTS Participants averaged 63 years of age, 48% women, 59% black, and obese [mean BMI = 36 kg/m 2 (SD = 4)]. Cognitive performance improved across the entire cohort during the 4-month trial [ t -scores pretreatment = 48.9 (48, 50) vs. posttreatment = 50.0 (49, 51), P < 0.001]. Postintervention Executive Function/Learning composite performance was higher for participants in C-LIFE compared to SEPA ( d = 0.37, P = 0.039). C-LIFE intervention effects on Memory and Processing Speed were moderated by sex and baseline stroke risk, respectively ( P = 0.026 and P = 0.043 for interactions), such that males and participants with greater stroke risk showed the greatest cognitive changes. FMD [C-LIFE: +0.3% (-0.3, 1.0) vs. SEPA -1.4% (-2.5, -0.3), P = 0.022], and microvascular function [C-LIFE: 97 (65, 130) vs. SEPA 025 (-75, 23), P < 0.001] were improved in C-LIFE compared with SEPA, whereas cerebrovascular reactivity was not [C-LIFE: -0.2 (-0.4, 0) vs. SEPA 0.1 (-0.2, 0.4), P = 0.197). Mediation analyses suggested that increased executive function/learning was associated with reduced ambulatory SBP levels secondary to weight loss [indirect effect: B = 0.25 (0.03, 0.71)]. CONCLUSION Lifestyle modification individuals with resistant hypertension improves cognition, which appeared to be associated with reduced ambulatory SBP changes through weight loss. Cognitive improvements were accompanied by parallel improvements in endothelial and microvascular function.
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Effects of Lifestyle Modification on Patients With Resistant Hypertension: Results of the TRIUMPH Randomized Clinical Trial.
Blumenthal, JA, Hinderliter, AL, Smith, PJ, Mabe, S, Watkins, LL, Craighead, L, Ingle, K, Tyson, C, Lin, PH, Kraus, WE, et al
Circulation. 2021;(15):1212-1226
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BACKGROUND Although lifestyle modifications generally are effective in lowering blood pressure (BP) among patients with unmedicated hypertension and in those treated with 1 or 2 antihypertensive agents, the value of exercise and diet for lowering BP in patients with resistant hypertension is unknown. METHODS One hundred forty patients with resistant hypertension (mean age, 63 years; 48% female; 59% Black; 31% with diabetes; 21% with chronic kidney disease) were randomly assigned to a 4-month program of lifestyle modification (C-LIFE [Center-Based Lifestyle Intervention]) including dietary counseling, behavioral weight management, and exercise, or a single counseling session providing SEPA (Standardized Education and Physician Advice). The primary end point was clinic systolic BP; secondary end points included 24-hour ambulatory BP and select cardiovascular disease biomarkers including baroreflex sensitivity to quantify the influence of the baroreflex on heart rate, high-frequency heart rate variability to assess vagally mediated modulation of heart rate, flow-mediated dilation to evaluate endothelial function, pulse wave velocity to assess arterial stiffness, and left ventricular mass to characterize left ventricular structure. RESULTS Between-group comparisons revealed that the reduction in clinic systolic BP was greater in C-LIFE (-12.5 [95% CI, -14.9 to -10.2] mm Hg) compared with SEPA(-7.1 [-95% CI, 10.4 to -3.7] mm Hg) (P=0.005); 24-hour ambulatory systolic BP also was reduced in C-LIFE (-7.0 [95% CI, -8.5 to -4.0] mm Hg), with no change in SEPA (-0.3 [95% CI, -4.0 to 3.4] mm Hg) (P=0.001). Compared with SEPA, C-LIFE resulted in greater improvements in resting baroreflex sensitivity (2.3 ms/mm Hg [95% CI, 1.3 to 3.3] versus -1.1 ms/mm Hg [95% CI, -2.5 to 0.3]; P<0.001), high-frequency heart rate variability (0.4 ln ms2 [95% CI, 0.2 to 0.6] versus -0.2 ln ms2 [95% CI, -0.5 to 0.1]; P<0.001), and flow-mediated dilation (0.3% [95% CI, -0.3 to 1.0] versus -1.4% [95% CI, -2.5 to -0.3]; P=0.022). There were no between-group differences in pulse wave velocity (P=0.958) or left ventricular mass (P=0.596). CONCLUSIONS Diet and exercise can lower BP in patients with resistant hypertension. A 4-month structured program of diet and exercise as adjunctive therapy delivered in a cardiac rehabilitation setting results in significant reductions in clinic and ambulatory BP and improvement in selected cardiovascular disease biomarkers. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02342808.
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The Association Between Engagement and Weight Loss Through Personal Coaching and Cell Phone Interventions in Young Adults: Randomized Controlled Trial.
Lin, PH, Grambow, S, Intille, S, Gallis, JA, Lazenka, T, Bosworth, H, Voils, CL, Bennett, GG, Batch, B, Allen, J, et al
JMIR mHealth and uHealth. 2018;(10):e10471
Abstract
BACKGROUND Understanding how engagement in mobile health (mHealth) weight loss interventions relates to weight change may help develop effective intervention strategies. OBJECTIVE This study aims to examine the (1) patterns of participant engagement overall and with key intervention components within each intervention arm in the Cell Phone Intervention For You (CITY) trial; (2) associations of engagement with weight change; and (3) participant characteristics related to engagement. METHODS The CITY trial tested two 24-month weight loss interventions. One was delivered with a smartphone app (cell phone) containing 24 components (weight tracking, etc) and included prompting by the app in predetermined frequency and forms. The other was delivered by a coach via monthly calls (personal coaching) supplemented with limited app components (18 overall) and without any prompting by the app. Engagement was assessed by calculating the percentage of days each app component was used and the frequency of use. Engagement was also examined across 4 weight change categories: gained (≥2%), stable (±2%), mild loss (≥2% to <5%), and greater loss (≥5%). RESULTS Data from 122 cell phone and 120 personal coaching participants were analyzed. Use of the app was the highest during month 1 for both arms; thereafter, use dropped substantially and continuously until the study end. During the first 6 months, the mean percentage of days that any app component was used was higher for the cell phone arm (74.2%, SD 20.1) than for the personal coaching arm (48.9%, SD 22.4). The cell phone arm used the apps an average of 5.3 times/day (SD 3.1), whereas the personal coaching participants used them 1.7 times/day (SD 1.2). Similarly, the former self-weighed more than the latter (57.1% days, SD 23.7 vs 32.9% days, SD 23.3). Furthermore, the percentage of days any app component was used, number of app uses per day, and percentage of days self-weighed all showed significant differences across the 4 weight categories for both arms. Pearson correlation showed a negative association between weight change and the percentage of days any app component was used (cell phone: r=-.213; personal coaching: r=-.319), number of apps use per day (cell phone: r=-.264; personal coaching: r=-.308), and percentage of days self-weighed (cell phone: r=-.297; personal coaching: r=-.354). None of the characteristics examined, including age, gender, race, education, income, energy expenditure, diet quality, and hypertension status, appeared to be related to engagement. CONCLUSIONS Engagement in CITY intervention was associated with weight loss during the first 6 months. Nevertheless, engagement dropped substantially early on for most intervention components. Prompting may be helpful initially. More flexible and less intrusive prompting strategies may be needed during different stages of an intervention to increase or sustain engagement. Future studies should explore the motivations for engagement and nonengagement to determine meaningful levels of engagement required for effective intervention. TRIAL REGISTRATION ClinicalTrials.gov NCT01092364; https://clinicaltrials.gov/ct2/show/NCT01092364 (Archived by WebCite at http://www.webcitation.org/72V8A4e5X).
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The impact of continued intervention on weight: Five-year results from the weight loss maintenance trial.
Coughlin, JW, Brantley, PJ, Champagne, CM, Vollmer, WM, Stevens, VJ, Funk, K, Dalcin, AT, Jerome, GJ, Myers, VH, Tyson, C, et al
Obesity (Silver Spring, Md.). 2016;(5):1046-53
Abstract
OBJECTIVE In the Weight Loss Maintenance (WLM) Trial, a personal contact (PC) intervention sustained greater weight loss relative to a self-directed (SD) group over 30 months. This study investigated the effects of continued intervention over an additional 30 months and overall weight change across the entire WLM Trial. METHODS WLM had 3 phases. Phase 1 was a 6-month weight loss program. In Phase 2, those who lost ≥4 kg were randomized to a 30-month maintenance trial. In Phase 3, PC participants (n = 196, three sites) were re-randomized to no further intervention (PC-Control) or continued intervention (PC-Active) for 30 more months; 218 SD participants were also followed. RESULTS During Phase 3, weight increased 1.0 kg in PC-Active and 0.5 kg in PC-Control (mean difference 0.6 kg; 95% CI:-1.4 to 2.7; P = 0.54). Mean weight change over the entire study was -3.2 kg in those originally assigned to PC (PC-Combined) and -1.6 kg in SD (mean difference -1.6 kg; 95% CI:-3.0 to -0.1; P = 0.04). CONCLUSIONS After 30 months of the PC maintenance intervention, continuation for another 30 months provided no additional benefit. However, across the entire study, weight loss was slightly greater in those originally assigned to PC.
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Application of Latent Class Analysis to Identify Behavioral Patterns of Response to Behavioral Lifestyle Interventions in Overweight and Obese Adults.
Fitzpatrick, SL, Coughlin, JW, Appel, LJ, Tyson, C, Stevens, VJ, Jerome, GJ, Dalcin, A, Brantley, PJ, Hill-Briggs, F
International journal of behavioral medicine. 2015;(4):471-80
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BACKGROUND Examining responders and non-responders to behavioral lifestyle interventions among overweight/obese adults with additional comorbidities may aid in refining and tailoring obesity treatment. PURPOSE The purpose of this study is to demonstrate the use of latent class analysis to identify patterns of response to behavioral lifestyle interventions based on adherence to diet and exercise recommendations. METHOD Repeated measures latent class analysis was applied to two clinical trial datasets, combination of two active interventions in the PREMIER Trial (n = 501) and phase 1 of the Weight Loss Maintenance Trial (WLM; n = 1685), to identify patterns of response to behavioral lifestyle interventions. Treatment response was based on adherence to daily recommendations for fruit/vegetable, fat, saturated fat, sodium, and exercise at baseline and 6 months. RESULTS In PREMIER, three distinct latent classes emerged: responders (45.9%), non-responders (23.6%), and early adherers (30.5%). Responders and Early Adherers had greater weight loss at 6 and 18 months and were more likely to meet behavioral recommendations at 18 months than Non-responders. For WLM, there were four latent classes: partial responders (16%), non-responders (40%), early adherers (2%), and fruit/veggie only responders (41%). Non-responders in WLM had significantly less weight loss at 6 months compared to that of the other three latent classes. CONCLUSION Latent class analysis is a useful method to apply to clinical trial data to identify distinct patterns of response to behavioral interventions. Overweight/ obese participants who respond to behavioral lifestyle treatment (i.e., meet behavioral recommendations) have significantly greater weight loss than that of participants who do not make behavioral changes.
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Adaptive intervention design in mobile health: Intervention design and development in the Cell Phone Intervention for You trial.
Lin, PH, Intille, S, Bennett, G, Bosworth, HB, Corsino, L, Voils, C, Grambow, S, Lazenka, T, Batch, BC, Tyson, C, et al
Clinical trials (London, England). 2015;(6):634-45
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BACKGROUND/AIMS: The obesity epidemic has spread to young adults, and obesity is a significant risk factor for cardiovascular disease. The prominence and increasing functionality of mobile phones may provide an opportunity to deliver longitudinal and scalable weight management interventions in young adults. The aim of this article is to describe the design and development of the intervention tested in the Cell Phone Intervention for You study and to highlight the importance of adaptive intervention design that made it possible. The Cell Phone Intervention for You study was a National Heart, Lung, and Blood Institute-sponsored, controlled, 24-month randomized clinical trial comparing two active interventions to a usual-care control group. Participants were 365 overweight or obese (body mass index≥25 kg/m2) young adults. METHODS Both active interventions were designed based on social cognitive theory and incorporated techniques for behavioral self-management and motivational enhancement. Initial intervention development occurred during a 1-year formative phase utilizing focus groups and iterative, participatory design. During the intervention testing, adaptive intervention design, where an intervention is updated or extended throughout a trial while assuring the delivery of exactly the same intervention to each cohort, was employed. The adaptive intervention design strategy distributed technical work and allowed introduction of novel components in phases intended to help promote and sustain participant engagement. Adaptive intervention design was made possible by exploiting the mobile phone's remote data capabilities so that adoption of particular application components could be continuously monitored and components subsequently added or updated remotely. RESULTS The cell phone intervention was delivered almost entirely via cell phone and was always-present, proactive, and interactive-providing passive and active reminders, frequent opportunities for knowledge dissemination, and multiple tools for self-tracking and receiving tailored feedback. The intervention changed over 2 years to promote and sustain engagement. The personal coaching intervention, alternatively, was primarily personal coaching with trained coaches based on a proven intervention, enhanced with a mobile application, but where all interactions with the technology were participant-initiated. CONCLUSION The complexity and length of the technology-based randomized clinical trial created challenges in engagement and technology adaptation, which were generally discovered using novel remote monitoring technology and addressed using the adaptive intervention design. Investigators should plan to develop tools and procedures that explicitly support continuous remote monitoring of interventions to support adaptive intervention design in long-term, technology-based studies, as well as developing the interventions themselves.
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Lifestyle modification for resistant hypertension: The TRIUMPH randomized clinical trial.
Blumenthal, JA, Sherwood, A, Smith, PJ, Mabe, S, Watkins, L, Lin, PH, Craighead, LW, Babyak, M, Tyson, C, Young, K, et al
American heart journal. 2015;(5):986-994.e5
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BACKGROUND Resistant hypertension (RH) is a growing health burden in this country affecting as many as 1 in 5 adults being treated for hypertension. Resistant hypertension is associated with increased risk of adverse cardiovascular disease (CVD) events and all-cause mortality. Strategies to reduce blood pressure (BP) in this high-risk population are a national priority. METHODS TRIUMPH is a single-site, prospective, randomized clinical trial to evaluate the efficacy of a center-based lifestyle intervention consisting of exercise training, reduced sodium and calorie Dietary Approaches to Stop Hypertension eating plan, and weight management compared to standardized education and physician advice in treating patients with RH. Patients (n = 150) will be randomized in a 2:1 ratio to receive either a 4-month supervised lifestyle intervention delivered in the setting of a cardiac rehabilitation center or to a standardized behavioral counseling session to simulate real-world medical practice. The primary end point is clinic BP; secondary end points include ambulatory BP and an array of CVD biomarkers including left ventricular hypertrophy, arterial stiffness, baroreceptor reflex sensitivity, insulin resistance, lipids, sympathetic nervous system activity, and inflammatory markers. Lifestyle habits, BP, and CVD risk factors also will be measured at 1-year follow-up. CONCLUSIONS The TRIUMPH randomized clinical trial (ClinicalTrials.gov NCT02342808) is designed to test the efficacy of an intensive, center-based lifestyle intervention compared to a standardized education and physician advice counseling session on BP and CVD biomarkers in patients with RH after 4 months of treatment and will determine whether lifestyle changes can be maintained for a year.
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Weight loss intervention for young adults using mobile technology: design and rationale of a randomized controlled trial - Cell Phone Intervention for You (CITY).
Batch, BC, Tyson, C, Bagwell, J, Corsino, L, Intille, S, Lin, PH, Lazenka, T, Bennett, G, Bosworth, HB, Voils, C, et al
Contemporary clinical trials. 2014;(2):333-41
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BACKGROUND The obesity epidemic has spread to young adults, leading to significant public health implications later in adulthood. Intervention in early adulthood may be an effective public health strategy for reducing the long-term health impact of the epidemic. Few weight loss trials have been conducted in young adults. It is unclear what weight loss strategies are beneficial in this population. PURPOSE To describe the design and rationale of the NHLBI-sponsored Cell Phone Intervention for You (CITY) study, which is a single center, randomized three-arm trial that compares the impact on weight loss of 1) a behavioral intervention that is delivered almost entirely via cell phone technology (Cell Phone group); and 2) a behavioral intervention delivered mainly through monthly personal coaching calls enhanced by self-monitoring via cell phone (Personal Coaching group), each compared to 3) a usual care, advice-only control condition. METHODS A total of 365 community-dwelling overweight/obese adults aged 18-35 years were randomized to receive one of these three interventions for 24 months in parallel group design. Study personnel assessing outcomes were blinded to group assignment. The primary outcome is weight change at 24 [corrected] months. We hypothesize that each active intervention will cause more weight loss than the usual care condition. Study completion is anticipated in 2014. CONCLUSIONS If effective, implementation of the CITY interventions could mitigate the alarming rates of obesity in young adults through promotion of weight loss. ClinicalTrial.gov: NCT01092364.
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Recruiting young adults into a weight loss trial: report of protocol development and recruitment results.
Corsino, L, Lin, PH, Batch, BC, Intille, S, Grambow, SC, Bosworth, HB, Bennett, GG, Tyson, C, Svetkey, LP, Voils, CI
Contemporary clinical trials. 2013;(2):1-7
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Obesity has spread to all segments of the U.S. population. Young adults, aged 18-35 years, are rarely represented in clinical weight loss trials. We conducted a qualitative study to identify factors that may facilitate recruitment of young adults into a weight loss intervention trial. Participants were 33 adults aged 18-35 years with BMI ≥25 kg/m(2). Six group discussions were conducted using the nominal group technique. Health, social image, and "self" factors such as emotions, self-esteem, and confidence were reported as reasons to pursue weight loss. Physical activity, dietary intake, social support, medical intervention, and taking control (e.g. being motivated) were perceived as the best weight loss strategies. Incentives, positive outcomes, education, convenience, and social support were endorsed as reasons young adults would consider participating in a weight loss study. Incentives, advertisement, emphasizing benefits, and convenience were endorsed as ways to recruit young adults. These results informed the Cellphone Intervention for You (CITY) marketing and advertising, including message framing and advertising avenues. Implications for recruitment methods are discussed.