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Delahanty, Linda

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Delahanty

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Linda

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Delahanty, Linda
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    Impact of Canagliflozin Treatment on Health-Related Quality of Life among People with Type 2 Diabetes Mellitus: A Pooled Analysis of Patient-Reported Outcomes from Randomized Controlled Trials
    (Springer International Publishing, 2018) Cai, Jennifer; Delahanty, Linda; Akapame, Sydney; Slee, April; Traina, Shana
    Background: Evidence from patient-reported outcomes in clinical trials may explain health-related behaviors observed in the real world. Objective: The purpose of this analysis was to evaluate the effect of treatment with canagliflozin, a sodium glucose co-transporter 2 inhibitor, compared with placebo or sitagliptin on health-related quality-of-life outcomes in participants with type 2 diabetes mellitus from the clinical development program. Methods: Patient-reported outcomes data from four randomized controlled trials of canagliflozin (n = 2536) were pooled and analyzed to evaluate participants’ interest in continuing study medication; satisfaction with weight; and physical, mental, and emotional health after 26–52 weeks of treatment with canagliflozin vs. placebo or sitagliptin. Results: Upon trial completion, participants treated with canagliflozin were more likely to express interest in continuing study medication than participants treated with placebo or sitagliptin [odds ratio (95% confidence interval) of 1.54 (1.19–1.99); p = 0.001]. Those treated with canagliflozin were also more likely to be satisfied with their weight and report favorable outcomes (score improvement or maintenance of good scores) related to physical and emotional health. Conclusions: The results of this pooled analysis suggest that people with type 2 diabetes mellitus treated with canagliflozin generally had positive experiences with treatment and improvements in health-related quality of life. Future research is needed to determine if these improvements result in improved type 2 diabetes mellitus management and treatment adherence. ClinicalTrials.gov identifiers NCT01106625, NCT01106677, NCT01137812, NCT02025907. Electronic supplementary material The online version of this article (10.1007/s40271-017-0290-4) contains supplementary material, which is available to authorized users.
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    Short and long-term lifestyle coaching approaches used to address diverse participant barriers to weight loss and physical activity adherence
    (BioMed Central, 2014) Venditti, Elizabeth M; Wylie-Rosett, Judith; Delahanty, Linda; Mele, Lisa; Hoskin, Mary A; Edelstein, Sharon L
    Background: Individual barriers to weight loss and physical activity goals in the Diabetes Prevention Program, a randomized trial with 3.2 years average treatment duration, have not been previously reported. Evaluating barriers and the lifestyle coaching approaches used to improve adherence in a large, diverse participant cohort can inform dissemination efforts. Methods: Lifestyle coaches documented barriers and approaches after each session (mean session attendance = 50.3 ± 21.8). Subjects were 1076 intensive lifestyle participants (mean age = 50.6 years; mean BMI = 33.9 kg/m2; 68% female, 48% non-Caucasian). Barriers and approaches used to improve adherence were ranked by the percentage of the cohort for whom they applied. Barrier groupings were also analyzed in relation to baseline demographic characteristics. Results: Top weight loss barriers reported were problems with self-monitoring (58%); social cues (58%); holidays (54%); low activity (48%); and internal cues (thought/mood) (44%). Top activity barriers were holidays (51%); time management (50%); internal cues (30%); illness (29%), and motivation (26%). The percentage of the cohort having any type of barrier increased over the long-term intervention period. A majority of the weight loss barriers were significantly associated with younger age, greater obesity, and non-Caucasian race/ethnicity (p-values vary). Physical activity barriers, particularly thought and mood cues, social cues and time management, physical injury or illness and access/weather, were most significantly associated with being female and obese (p < 0.001 for all). Lifestyle coaches used problem-solving with most participants (≥75% short-term; > 90% long term) and regularly reviewed self-monitoring skills. More costly approaches were used infrequently during the first 16 sessions (≤10%) but increased over 3.2 years. Conclusion: Behavioral problem solving approaches have short and long term dissemination potential for many kinds of participant barriers. Given minimal resources, increased attention to training lifestyle coaches in the consistent use of these approaches appears warranted.
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    Variation at the Melanocortin 4 Receptor gene and response to weight-loss interventions in the Diabetes Prevention Program
    (2013) Pan, Qing; Delahanty, Linda; Jablonski, Kathleen A.; Knowler, William C.; Kahn, Steven E.; Florez, Jose; Franks, Paul W.
    Objective: To assess associations and genotype × treatment interactions for melanocortin 4 receptor (MC4R) locus variants and obesity-related traits. Design and Methods Diabetes Prevention Program (DPP) participants (N=3,819, of whom 3,356 were genotyped for baseline and 3,234 for longitudinal analyses) were randomized into intensive lifestyle modification (diet, exercise, weight loss), metformin or placebo control. Adiposity was assessed in a subgroup (n=909) using computed tomography. All analyses were adjusted for age, sex, ethnicity and treatment. Results: The rs1943218 minor allele was nominally associated with short-term (6 month; P=0.032) and long-term (2 year; P=0.038) weight change. Eight SNPs modified response to treatment on short-term (rs17066856, rs9966412, rs17066859, rs8091237, rs17066866, rs7240064) or long-term (rs12970134, rs17066866) reduction in body weight, or diabetes incidence (rs17066829) (all Pinteraction <0.05). Conclusion: This is the first study to comprehensively assess the role of MC4R variants and weight regulation in a weight loss intervention trial. One MC4R variant was directly associated with obesity-related traits or diabetes; numerous other variants appear to influence body weight and diabetes risk by modifying the protective effects of the DPP interventions.
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    Pretreatment, Psychological, and Behavioral Predictors of Weight Outcomes Among Lifestyle Intervention Participants in the Diabetes Prevention Program (DPP)
    (American Diabetes Association, 2013) Delahanty, Linda; Peyrot, Mark; Shrader, Peter J.; Williamson, Donald A.; Meigs, James; Nathan, David
    OBJECTIVE To identify the most important pretreatment characteristics and changes in psychological and behavioral factors that predict weight outcomes in the Diabetes Prevention Program (DPP). RESEARCH DESIGN AND METHODS Approximately 25% of DPP lifestyle intervention participants (n = 274) completed questionnaires to assess weight history and psychological and behavioral factors at baseline and 6 months after completion of the 16-session core curriculum. The change in variables from baseline to 6 months was assessed with t tests. Multivariate models using hierarchical logistic regression assessed the association of weight outcomes at end of study with each demographic, weight loss history, psychological, and behavioral factor. RESULTS At end of study, 40.5% had achieved the DPP 7% weight loss goal. Several baseline measures (older age, race, older age when first overweight, fewer self-implemented weight loss attempts, greater exercise self-efficacy, greater dietary restraint, fewer fat-related dietary behaviors, more sedentary activity level) were independent predictors of successful end-of-study weight loss with the DPP lifestyle program. The DPP core curriculum resulted in significant improvements in many psychological and behavioral targets. Changes in low-fat diet self-efficacy and dietary restraint skills predicted better long-term weight loss, and the association of low-fat diet self-efficacy with weight outcomes was explained by dietary behaviors. CONCLUSIONS Health care providers who translate the DPP lifestyle intervention should be aware of pretreatment characteristics that may hamper or enhance weight loss, consider prioritizing strategies to improve low-fat diet self-efficacy and dietary restraint skills, and examine whether taking these actions improves weight loss outcomes.
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    Validity of Medication Adherence Self-Reports in Adults With Type 2 Diabetes
    (American Diabetes Association, 2013) Gonzalez, Jeffrey S.; Schneider, Havah E.; Wexler, Deborah; Psaros, Christina; Delahanty, Linda; Cagliero, Enrico; Safren, Steven A.
    OBJECTIVE To assess the validity of self-report measures of diabetes medication adherence and evaluate the effect of depression on the validity of these reports. RESEARCH DESIGN AND METHODS Adults with type 2 diabetes, treated with oral medications, completed a set of medication adherence self-reports that varied response scales and time frames, were administered structured clinical interviews for depression, and provided blood samples for HbA1c as part of a screening for an intervention study. A subsample of participants with HbA1c ≥7.0% and clinically significant depression received Medication Event Monitoring System (MEMS) bottle caps to record adherence. Analyses examined relationships between adherence measures and HbA1c and, in the subsample, MEMS. Moderated linear regression evaluated whether depression severity modified relationships with HbA1c. RESULTS Participant (n = 170, 57% men, 81% white, mean HbA1c 8.3% [SD, 1.7]) adherence self-reports were significantly (r = −0.18 to −0.28; P < 0.03) associated with lower HbA1c. In the subsample (n = 88), all self-reports were significantly (r = 0.35 to 0.55; P ≤ 0.001) associated with MEMS-measured adherence. Depression significantly moderated the relationship between three of six self-reports and HbA1c; at high levels of depression, associations with HbA1c became nonsignificant. CONCLUSIONS Results support the validity of easily administered self-reports for diabetes medication adherence. One-month, percentage-based ratings of adherence had the strongest associations with MEMS and HbA1c; those requiring the report of missed doses had weaker associations. One-week self-ratings and measures that require respondents to record the number of missed doses appear to be vulnerable to bias from depression severity.
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    Personalized Genetic Risk Counseling to Motivate Diabetes Prevention: A randomized trial
    (American Diabetes Association, 2013) Grant, Richard W.; O’Brien, Kelsey E.; Waxler, Jessica L.; Vassy, Jason; Delahanty, Linda; Bissett, Laurie G.; Green, Robert; Stember, Katherine G.; Guiducci, Candace; Park, Elyse; Florez, Jose; Meigs, James
    OBJECTIVE To examine whether diabetes genetic risk testing and counseling can improve diabetes prevention behaviors. RESEARCH DESIGN AND METHODS We conducted a randomized trial of diabetes genetic risk counseling among overweight patients at increased phenotypic risk for type 2 diabetes. Participants were randomly allocated to genetic testing versus no testing. Genetic risk was calculated by summing 36 single nucleotide polymorphisms associated with type 2 diabetes. Participants in the top and bottom score quartiles received individual genetic counseling before being enrolled with untested control participants in a 12-week, validated, diabetes prevention program. Middle-risk quartile participants were not studied further. We examined the effect of this genetic counseling intervention on patient self-reported attitudes, program attendance, and weight loss, separately comparing higher-risk and lower-risk result recipients with control participants. RESULTS The 108 participants enrolled in the diabetes prevention program included 42 participants at higher diabetes genetic risk, 32 at lower diabetes genetic risk, and 34 untested control subjects. Mean age was 57.9 ± 10.6 years, 61% were men, and average BMI was 34.8 kg/m2, with no differences among randomization groups. Participants attended 6.8 ± 4.3 group sessions and lost 8.5 ± 10.1 pounds, with 33 of 108 (30.6%) losing ≥5% body weight. There were few statistically significant differences in self-reported motivation, program attendance, or mean weight loss when higher-risk recipients and lower-risk recipients were compared with control subjects (P > 0.05 for all but one comparison). CONCLUSIONS Diabetes genetic risk counseling with currently available variants does not significantly alter self-reported motivation or prevention program adherence for overweight individuals at risk for diabetes.
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    A Randomized Controlled Trial of Cognitive Behavioral Therapy for Adherence and Depression (CBT-AD) in Patients With Uncontrolled Type 2 Diabetes
    (American Diabetes Association, 2014) Safren, Steven A.; Gonzalez, Jeffrey S.; Wexler, Deborah; Psaros, Christina; Delahanty, Linda; Blashill, Aaron J.; Margolina, Aleksandra I.; Cagliero, Enrico
    OBJECTIVE To test cognitive behavioral therapy for adherence and depression (CBT-AD) in type 2 diabetes. We hypothesized that CBT-AD would improve adherence; depression; and, secondarily, hemoglobin A1c (A1C). RESEARCH DESIGN AND METHODS Eighty-seven adults with unipolar depression and uncontrolled type 2 diabetes received enhanced treatment as usual (ETAU), including medication adherence, self-monitoring of blood glucose (SMBG), and lifestyle counseling; a provider letter documented psychiatric diagnoses. Those randomized to the intervention arm also received 9–11 sessions of CBT-AD. RESULTS Immediately after acute treatment (4 months), adjusting for baseline, CBT-AD had 20.7 percentage points greater oral medication adherence on electronic pill cap (95% CI −31.14 to −10.22, P = 0.000); 30.2 percentage points greater SMBG adherence through glucometer downloads (95% CI −42.95 to −17.37, P = 0.000); 6.44 points lower depression scores on the Montgomery-Asberg Depression Rating Scale (95% CI 2.33–10.56, P = 0.002); 0.74 points lower on the Clinical Global Impression (95% CI 0.16–1.32, P = 0.01); and 0.72 units lower A1C (95% CI 0.29–1.15, P = 0.001) relative to ETAU. Analyses of 4-, 8-, and 12-month follow-up time points indicated that CBT-AD maintained 24.3 percentage points higher medication adherence (95% CI −38.2 to −10.3, P = 0.001); 16.9 percentage points greater SMBG adherence (95% CI −33.3 to −0.5, P = 0.043); and 0.63 units lower A1C (95% CI 0.06–1.2, P = 0.03) after acute treatment ended. For depression, there was some evidence of continued improvement posttreatment, but no between-group differences. CONCLUSIONS CBT-AD is an effective intervention for adherence, depression, and glycemic control, with enduring and clinically meaningful benefits for diabetes self-management and glycemic control in adults with type 2 diabetes and depression.
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    Depression, Stress and Weight Loss in Individuals with Metabolic Syndrome in SHINE, a DPP Translation Study
    (2014) Trief, Paula M.; Cibula, Donald; Delahanty, Linda; Weinstock, Ruth S.
    OBJECTIVE To examine the relationships between elevated depression symptoms (EDS) or stress and weight loss in SHINE, a telephonic, primary-care based, translation of the Diabetes Prevention Program. DESIGN AND METHODS N=257 adults with metabolic syndrome were randomized to individual (IC) or group (CC) phone participation. We assessed weight, depression, anti-depressant use (ADMs), and stress (baseline, 6 months, 1 and 2 years). Univariate analyses used linear and logistic regression, t-tests for continuous variables and exact tests for categorical variables. Stratified analyses assessed modifiers of effects of depression/stress on weight loss. RESULTS Approximately 35% reported EDS, with no change over time. Approximately 28% of all participants used ADMs. Participants with EDS had lower mean % weight loss and a smaller % who achieved ≥ 5% weight loss. Participants with EDS were less likely to be “completers” (40.1 % vs. 61.5%, p=.002), coached (48.0% vs. 60.7%, p=.049), or log diet/activity (19.4% vs. 42.7%, p<.001), behaviors related to weight loss. Results were similar for high stress. ADM use had no independent effect on weight loss. CONCLUSIONS Individuals with metabolic syndrome and EDS and/or high stress were less likely to lose significant weight. Pre-intervention depression and stress screening to intervene may improve weight loss.
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    Perceived Impact of Diabetes Genetic Risk Testing Among Patients at High Phenotypic Risk for Type 2 Diabetes
    (American Diabetes Association, 2011) Markowitz, Sarah M.; Park, Elyse; Delahanty, Linda; O’Brien, Kelsey E.; Grant, Richard W.
    Objective: Rapid advances in diabetes genetic epidemiology may lead to a new era of “personalized medicine” based on individual genetic risk assessment. There is minimal experience to guide how best to clinically implement such testing so that results (e.g., “higher” or “lower” relative genetic risk) improve rather than reduce patient motivation for behavior change. Research Design and Methods: Between November 2009 and May 2010, we conducted in-depth interviews with 22 overweight participants at high phenotypic risk for type 2 diabetes to explore perceptions of diabetes genetic risk testing compared with currently available prediction using nongenetic risk factors (e.g., family history, abnormal fasting glucose, obesity). We used hypothetical scenarios to specifically investigate the impact of both “higher” and “lower” relative genetic risk results on participants’ views about diabetes prevention. Results: Many participants conferred a unique value on personal genetic risk information relative to nongenetic risk based on the perceived scientific certainty and durability of genetic results. In contrast, other participants considered their genetic risk within the overall context of their other measured risk factors. Reactions to diabetes genetic test results differed by current motivation levels. Whereas most subjects reported that “higher” risk results would motivate behavior change, subjects with lower current motivation often reported that “lower” genetic risk results would further reduce their motivation to engage in diabetes prevention behaviors. Conclusions: To be effective, future clinical implementation of type 2 diabetes genetic risk testing should be individualized based on each patient’s risk perception and current level of motivation to prevent diabetes.
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    Genetic Predictors of Weight Loss and Weight Regain After Intensive Lifestyle Modification, Metformin Treatment, or Standard Care in the Diabetes Prevention Program
    (American Diabetes Association, 2012) Delahanty, Linda; Pan, Qing; Jablonski, Kathleen A.; Watson, Karol E.; McCaffery, Jeanne M.; Shuldiner, Alan; Kahn, Steven E.; Knowler, William C.; Florez, Jose; Franks, Paul W.
    OBJECTIVE: We tested genetic associations with weight loss and weight regain in the Diabetes Prevention Program, a randomized controlled trial of weight loss–inducing interventions (lifestyle and metformin) versus placebo. RESEARCH DESIGN AND METHODS: Sixteen obesity-predisposing single nucleotide polymorphisms (SNPs) were tested for association with short-term (baseline to 6 months) and long-term (baseline to 2 years) weight loss and weight regain (6 months to study end). RESULTS: Irrespective of treatment, the Ala12 allele at PPARG associated with short- and long-term weight loss (−0.63 and −0.93 kg/allele, P ≤ 0.005, respectively). Gene–treatment interactions were observed for short-term (LYPLAL1 rs2605100, P\(_{lifestyle*SNP}\) = 0.032; GNPDA2 rs10938397, P\(_{lifestyle*SNP}\) = 0.016; MTCH2 rs10838738, P\(_{lifestyle*SNP}\) = 0.022) and long-term (NEGR1 rs2815752, P\(_{metformin*SNP}\) = 0.028; FTO rs9939609, P\(_{lifestyle*SNP}\) = 0.044) weight loss. Three of 16 SNPs were associated with weight regain (NEGR1 rs2815752, BDNF rs6265, PPARG rs1801282), irrespective of treatment. TMEM18 rs6548238 and KTCD15 rs29941 showed treatment-specific effects (P\(_{lifestyle*SNP}\) < 0.05). CONCLUSIONS: Genetic information may help identify people who require additional support to maintain reduced weight after clinical intervention.