-
1.
Personalized Web-Based Weight Loss Behavior Change Program With and Without Dietitian Online Coaching for Adults With Overweight and Obesity: Randomized Controlled Trial.
Beleigoli, A, Andrade, AQ, Diniz, MF, Ribeiro, AL
Journal of medical Internet research. 2020;(11):e17494
Abstract
BACKGROUND The effect of computer- or human-delivered personalized feedback on the effectivess of web-based behavior change platforms for weight loss is unclear. OBJECTIVE We aimed to compare the effectiveness of a web-based behavior change intervention personalized through either computerized or human-delivered feedback with a nonpersonalized intervention in promoting weight loss in community-based adults with overweight or obesity. METHODS This pragmatic, 3-group, parallel-arm, randomized trial recruited students and staff in a Brazilian public university who were aged 18 to 60 years, had a BMI of ≥25 kg/m2, and were not pregnant. Participants were allocated to one of 3 groups: platform only (24-week behavior change program delivered using a web platform with personalized computer-delivered feedback), platform plus coaching (same 24-week web-based behavior change program plus 12 weeks of personalized feedback delivered online by a dietitian), or waiting list (nonpersonalized dietary and physical activity recommendations delivered through an e-booklet and videos). Self-reported weight at 24 weeks was the primary outcome. Changes in dietary and physical activity habits within 24 weeks were secondary outcomes. RESULTS Among the 1298 participants, 375 (28.89%) were lost to follow-up. In the intention-to-treat analysis, the platform-only and platform plus coaching groups had greater mean weight loss than the waiting-list group at 24 weeks (-1.08 kg, 95% CI -1.41 to -0.75 vs -1.57 kg, 95% CI -1.92 to -1.22 vs -0.66 kg, 95% CI -0.98 to -0.34, respectively). The platform-only and platform plus coaching groups, compared with the waiting list group, had a greater increase in the consumption of vegetables (3%, 95% CI 1% to 6% vs 5%, 95% CI 2% to 8% vs -3%, 95% CI -5% to 0%) and fruits (9%, 95% CI 6% to 12% vs 6%, 95% CI 2% to 9% vs 2%, 95% CI 0% to 6%) and a larger reduction in ultraprocessed food intake (-18%, 95% CI -23% to -13% vs -25%, 95% CI -30% to -20% vs -12%, 95% CI -16% to -8%). Changes in physical activity did not differ across the groups. Engagement was higher in the platform plus coaching group than in the platform-only group (7.6 vs 5.2 completed sessions; P=.007). Longer usage of the platform was associated with clinically meaningful (≥5%) weight loss (odds ratio 1.02, 95% CI 1.01 to 1.04). CONCLUSIONS The web-based behavior change programs with computer- and human-delivered personalized feedback led to greater, albeit small-magnitude, weight loss within 24 weeks. Improvement in multiple dietary habits, but not physical activity, were also greater in the personalized programs compared with the nonpersonalized one. The human-delivered personalized feedback by the online dietitian coach increased user engagement with the program and was associated with a significantly higher chance of clinically meaningful weight loss. TRIAL REGISTRATION ClinicalTrials.gov NCT03435445; https://clinicaltrials.gov/ct2/show/NCT03435445. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/10.1186/s12889-018-5882-y.
-
2.
Study design of Dal-GenE, a pharmacogenetic trial targeting reduction of cardiovascular events with dalcetrapib.
Tardif, JC, Dubé, MP, Pfeffer, MA, Waters, DD, Koenig, W, Maggioni, AP, McMurray, JJV, Mooser, V, White, HD, Heinonen, T, et al
American heart journal. 2020;:157-165
-
-
Free full text
-
Abstract
The objectives of precision medicine are to better match patient characteristics with the therapeutic intervention to optimize the chances of beneficial actions while reducing the exposure to unneeded adverse drug experiences. In a retrospective genome-wide association study of the overall neutral placebo-controlled dal-Outcomes trial, the effect of the cholesteryl ester transfer protein (CETP) modulator dalcetrapib on the composite of cardiovascular death, myocardial infarction or stroke was found to be influenced by a polymorphism in the adenylate cyclase type 9 (ADCY9) gene. Whereas patients with the AA genotype at position rs1967309 experienced fewer cardiovascular events with dalcetrapib, those with the GG genotype had an increased rate and the heterozygous AG genotype exhibited no difference from placebo. Measurements of cholesterol efflux and C-reactive protein (CRP) offered directionally supportive genotype-specific findings. In a separate, smaller, placebo-controlled trial, regression of ultrasonography-determined carotid intimal-medial thickness was only observed in dalcetrapib-treated patients with the AA genotype. Collectively, these observations led to the hypothesis that the cardiovascular effects of dalcetrapib may be pharmacogenetically determined, with a favorable benefit-risk ratio only for patients with this specific genotype. We describe below the design of dal-GenE, a precision medicine, placebo-controlled clinical outcome trial of dalcetrapib in patients with a recent acute myocardial infarction with the unique feature of selecting only those with the AA genotype at rs1967309 in the ADCY9 gene.
-
3.
Brief Acceptance and Commitment Therapy for Fibromyalgia: Feasibility and Effectiveness of a Replicated Single-Case Design.
Gómez-Pérez, MC, García-Palacios, A, Castilla, D, Zaragozá, I, Suso-Ribera, C
Pain research & management. 2020;:7897268
Abstract
OBJECTIVE Overall, the literature on the effectiveness of psychological treatments in general and those for fibromyalgia in particular has been dominated by research designs that focus on large groups and explore changes on average, so the treatment impact at the individual level remains unclear. In this quasi-experimental, replicated single-case design, we will test the feasibility and effectiveness of a brief acceptance and committed therapy intervention using ecological momentary assessment supported by technology. METHODS The sample comprised 7 patients (3 in the individual condition and 4 in the group condition) who received a brief, 5-week psychological treatment. Patient evolution was assessed one week prior to treatment onset and during the whole study with a smartphone app. Because ecological momentary assessment and the use of an app are not frequent practices in routine care, we also evaluated the feasibility of this assessment methodology (i.e., compliance with the app). Change was investigated with a nonoverlap of all pairs index. Outcomes were pain interference with sleep and social activities, fatigue, sadness, and pain intensity. RESULTS Patient change was not uniform across outcomes. Four patients (two in each condition) showed relatively moderate levels of change (approximately 60% nonoverlap in several outcomes). The remaining patients showed more modest improvements which affected a reduced number of outcomes. Based on nonoverlapping indices, there was no clear evidence in favor of any treatment format. CONCLUSIONS An alternative design to large-scale trials, one that focuses on the individual change, exists and it can be implemented in pain research. The use of technology (e.g., smartphones) simplifies such designs by facilitating ecological momentary assessment. Based on our findings showing that changes were not homogeneous across patients or outcomes, more single-case designs and patient-centered analyses (e.g., responder and moderation analyses) are required.
-
4.
Characteristics of participants who benefit most from personalised nutrition: findings from the pan-European Food4Me randomised controlled trial.
Livingstone, KM, Celis-Morales, C, Navas-Carretero, S, San-Cristobal, R, Forster, H, Woolhead, C, O'Donovan, CB, Moschonis, G, Manios, Y, Traczyk, I, et al
The British journal of nutrition. 2020;(12):1396-1405
Abstract
Little is known about who would benefit from Internet-based personalised nutrition (PN) interventions. This study aimed to evaluate the characteristics of participants who achieved greatest improvements (i.e. benefit) in diet, adiposity and biomarkers following an Internet-based PN intervention. Adults (n 1607) from seven European countries were recruited into a 6-month, randomised controlled trial (Food4Me) and randomised to receive conventional dietary advice (control) or PN advice. Information on dietary intake, adiposity, physical activity (PA), blood biomarkers and participant characteristics was collected at baseline and month 6. Benefit from the intervention was defined as ≥5 % change in the primary outcome (Healthy Eating Index) and secondary outcomes (waist circumference and BMI, PA, sedentary time and plasma concentrations of cholesterol, carotenoids and omega-3 index) at month 6. For our primary outcome, benefit from the intervention was greater in older participants, women and participants with lower HEI scores at baseline. Benefit was greater for individuals reporting greater self-efficacy for 'sticking to healthful foods' and who 'felt weird if [they] didn't eat healthily'. Participants benefited more if they reported wanting to improve their health and well-being. The characteristics of individuals benefiting did not differ by other demographic, health-related, anthropometric or genotypic characteristics. Findings were similar for secondary outcomes. These findings have implications for the design of more effective future PN intervention studies and for tailored nutritional advice in public health and clinical settings.
-
5.
Cardiovascular phenotyping for personalized lifestyle treatments of chronic abdominal pain in Irritable Bowel Syndrome: A randomized pilot study.
Davydov, DM, Shahabi, L, Naliboff, B
Neurogastroenterology and motility. 2019;(12):e13710
-
-
Free full text
-
Abstract
BACKGROUND Different physical exercise interventions for pain and other related symptoms largely follow non-personalized guidelines and show a high degree of variability in outcome. These interventions are considered to have different pathways toward improvement in autonomic regulation of energy metabolism. The current pilot study was conducted to assess the predictive value of individual cardiovascular (CV) activity markers at rest to predict clinical outcomes for two popular exercise-based interventions (walking and yoga) in patients with Irritable Bowel Syndrome (IBS). METHODS Twenty-seven adult participants with IBS were randomly assigned to a 16-biweekly Iyengar yoga or walking program. They completed pre- and post-treatment assessments on IBS symptom severity, affective and somatic complaints, and various measures of resting autonomic function including blood pressure (BP), heart rate and its variability, baroreceptor sensitivity (BRS) to activations and inhibitions with gains of brady- and tachycardiac baro-responses, and BP start points for these spontaneous baroreflexes. RESULTS Pretreatment BRS was differentially related to clinical response for the treatment groups. Specifically, a significant decrease in pain severity was found in response to yoga for those participants who had lower resting BRS to activations, but decreased pain severity was associated with higher resting BRS for those in the walking group. The effect was not related to affective symptom relief. Other CV measures showed similar associations with clinical outcomes for both groups. CONCLUSIONS The data suggest therefore that CV based phenotypes may be useful in personalizing clinical interventions for IBS. They may also point to autonomic mechanisms that are targets for such interventions.
-
6.
Weight loss at your fingertips: personalized nutrition with fasting glucose and insulin using a novel statistical approach.
Ritz, C, Astrup, A, Larsen, TM, Hjorth, MF
European journal of clinical nutrition. 2019;(11):1529-1535
Abstract
BACKGROUND/OBJECTIVES Precision medicine is changing the way people are diagnosed and treated into a more personalized approach. Using a novel statistical approach, we demonstrate how two diets cause differential weight loss depending on pre-treatment fasting plasma glucose (FPG) and fasting insulin (FI) levels. SUBJECTS/METHODS One hundred and eighty-one overweight people with increased waist circumference were randomly assigned to receive an ad libitum New Nordic Diet (NND) high in dietary fiber and whole grain or an Average Danish (Western) Diet (ADD) for 26 weeks. All foods were provided free of charge. Body weight was measured throughout the study and blood was drawn before randomization from where FPG and FI were analyzed. Weight was described by linear mixed models including biomarker (FPG or FI) diet group interactions. Individualized predictions were estimated as contrasts of intercepts and slopes of pre-treatment biomarkers. RESULTS Every mmol/L increase in baseline FPG predicted a between-diet difference of 3.00 (1.18;4.83, n = 181, P = 0.001) kg larger weight loss from choosing NND over ADD. For instance, a baseline FPG level of 4.7 mmol/L would lead to an average of 1.42 kg larger weight loss on NND vs. ADD (above 0.41 kg with 95% certainty), whereas the average effect size would be 8.33 kg (above 5.50 kg with 95% certainty) among subjects with FPG level of 7.0 mmol/L. Among individuals with FPG <5.6 mmol/L, each pmol/L lower baseline FI predicted a 0.039 (95% CI 0.017;0.061, n = 143, P < 0.001) kg larger weight loss from choosing NND over ADD. CONCLUSIONS Use of pre-treatment FPG and FI led to truly individualized predictions of treatment effect of introducing more fiber and whole grain in the diet on weight loss, ranging from almost no effect to losing >8 kg. These findings suggest that this novel statistical approach has great potential when re-evaluating data from existing randomized controlled trials.
-
7.
Effectiveness of Individual Nutrition Education Compared to Group Education, in Improving Anthropometric and Biochemical Indices among Hypertensive Adults with Excessive Body Weight: A Randomized Controlled Trial.
Gajewska, D, Kucharska, A, Kozak, M, Wunderlich, S, Niegowska, J
Nutrients. 2019;(12)
Abstract
OBJECTIVE The study aims to compare the effectiveness of individual and group nutrition education methods in improving key anthropometric and biochemical markers in drug-treated, overweight-obese hypertensive adults. METHODS The randomized trial included 170 patients with pharmacologically well-controlled primary hypertension and body mass index (BMI) ≥ 25 kg/m2. For six months, the patients received six sessions, either one-to-one individual nutrition education (IE, n = 89) or group education (GE, n = 81), developed by dietitians. Anthropometric measurements, body composition, and fasting measures of biochemical parameters were obtained at baseline and after six months of intervention. RESULTS 150 patients completed the nutrition education program. The IE group significantly improved in many parameters compared to the GE group, including weight (p < 0.001), waist circumference (p < 0.001), BMI (p < 0.001), systolic and diastolic blood pressure (BP) (p < 0.001), fasting plasma glucose (p = 0.011), oral glucose tolerance test (OGGT) (p = 0.030), and insulin resistance (homeostatic model assessment of insulin resistance, HOMA-IR) (p < 0.001). The groups did not differ in terms of total cholesterol, high-density lipoprotein cholesterol (HDL-C) and low-density lipoprotein cholesterol (LDL-C) concentrations. CONCLUSION Individual nutrition education is more effective than group education in terms of improving anthropometric and biochemical indices in overweight-obese hypertensive adults.
-
8.
A Tailored Letter Based on Electronic Health Record Data Improves Gestational Weight Gain Among Women With Gestational Diabetes Mellitus: The Gestational Diabetes' Effects on Moms (GEM) Cluster-Randomized Controlled Trial.
Hedderson, MM, Brown, SD, Ehrlich, SF, Tsai, AL, Zhu, Y, Quesenberry, CP, Crites, Y, Ferrara, A
Diabetes care. 2018;(7):1370-1377
-
-
Free full text
-
Abstract
OBJECTIVE Evaluate whether a tailored letter improved gestational weight gain (GWG) and whether GWG mediated a multicomponent intervention's effect on postpartum weight retention among women with gestational diabetes mellitus (GDM). RESEARCH DESIGN AND METHODS A cluster-randomized controlled trial of 44 medical facilities (n = 2,014 women) randomized to usual care or a multicomponent lifestyle intervention delivered during pregnancy (tailored letter) and postpartum (13 telephone sessions) to reduce postpartum weight retention. The tailored letter, using electronic health record (EHR) data, recommended an end-of-pregnancy weight goal tailored to prepregnancy BMI and GWG trajectory at GDM diagnosis: total GWG at the lower limit of the IOM range if BMI ≥18.5 kg/m2 or the midpoint if <18.5 kg/m2 and weight maintenance if women had exceeded this. The outcomes for this study were the proportion of women meeting the Institute of Medicine (IOM) guidelines for weekly rate of GWG from GDM diagnosis to delivery and meeting the end-of-pregnancy weight goal. RESULTS The tailored letter significantly increased the proportion of women meeting the IOM guidelines (72.6% vs. 67.1%; relative risk 1.08 [95% CI 1.01-1.17]); results were similar among women with BMI <25.0 kg/m2 (1.07 [1.00-1.15]) and ≥25.0 kg/m2 (1.08 [0.98-1.18]). Thirty-six percent in the intervention vs. 33.0% in usual care met the end-of-pregnancy weight goal (1.08 [0.99-1.18]); the difference was statistically significant among women with BMI <25.0 kg/m2 (1.28 [1.05-1.57]) but not ≥25.0 kg/m2 (0.99 [0.87-1.13]). Meeting the IOM guidelines mediated the effect of the multicomponent intervention in reducing postpartum weight retention by 24.6% (11.3-37.8%). CONCLUSIONS A tailored EHR-based letter improved GWG, which mediated the effect of a multicomponent intervention in reducing postpartum weight retention.
-
9.
Personalized diet and exercise recommendations in early rheumatoid arthritis: A feasibility trial.
Garner, S, Fenton, T, Martin, L, Creaser, C, Johns, C, Barnabe, C
Musculoskeletal care. 2018;(1):167-172
Abstract
BACKGROUND Physical activity and diet have a positive influence on disease activity and cardiovascular risk in patients with rheumatoid arthritis (RA). OBJECTIVE We tested the feasibility and effect of a brief individualized counselling intervention on physical activity levels and fitness, and dietary intake, compared with standard of care. METHODS Thirty patients with inflammatory arthritis (<1 year duration) were assigned to standard of care or the intervention, which consisted of individualized visits with a dietetic intern and physiotherapist at two time points, to review age-specific strategies on diet and exercise. Primary outcomes included anthropometric measurements (height, weight, waist and hip circumference), nutritional intake, physical activity (pedometer steps) and physical fitness. Disease activity measures and biochemical testing (blood pressure measurement, inflammatory markers, cholesterol profile and random glucose) were collected. The changes in these outcomes from baseline to 6 months were assessed using paired t-tests between groups. RESULTS Thirteen patients in the intervention group and 10 in the control group completed the study. There were non-significant trends in improvements in physical activity, low-density lipoprotein cholesterol level and nutritional intake (vitamin C, iron, fibre, vitamin A and folate) in the intervention group. CONCLUSIONS Poor enrolment and high dropout rates in this short-term study highlighted the difficulty of behavioural change. Those continuing in the study and who received the intervention demonstrated a non-significantly improved activity level and nutritional intake that may benefit long-term outcomes.
-
10.
Targeting the underlying causes of undernutrition. Cost-effectiveness of a multifactorial personalized intervention in community-dwelling older adults: A randomized controlled trial.
van der Pols-Vijlbrief, R, Wijnhoven, HAH, Bosmans, JE, Twisk, JWR, Visser, M
Clinical nutrition (Edinburgh, Scotland). 2017;(6):1498-1508
Abstract
BACKGROUND & AIMS Undernutrition in old age is associated with increased morbidity, mortality and health care costs. Treatment by caloric supplementation results in weight gain, but compliance is poor in the long run. Few studies targeted underlying causes of undernutrition in community-dwelling older adults. This study aimed to evaluate the cost-effectiveness of a multifactorial personalized intervention focused on eliminating or managing the underlying causes of undernutrition to prevent and reduce undernutrition in comparison with usual care. METHODS A randomized controlled trial was performed among 155 community-dwelling older adults receiving home care with or at risk of undernutrition. The intervention included a personalized action plan and 6 months support. The control group received usual care. Body weight, and secondary outcomes were measured in both groups at baseline and 6 months follow-up. Multiple imputation, linear regression and generalized estimating equation analyses were used to analyze intervention effects. In the cost-effectiveness analyses regression models were bootstrapped to estimate statistical uncertainty. RESULTS This intervention showed no statistically significant effects on body weight, mid-upper arm circumference, grip strength, gait speed and 12-Item Short-Form Health Survey physical component scale as compared to usual care, but there was an effect on the 12-Item Short-Form Health Survey mental component scale (0-100) (β = 8.940, p=0.001). Borderline significant intervention effects were found for both objective and subjective physical function measures, Short Physical Performance Battery (0-12) (β = 0.56, p=0.08) and ADL-Barthel score (0-20) (β = 0.69, p=0.09). Societal costs in the intervention group were statistically non-significantly lower than in the control group (mean difference -274; 95% CI -1111; 782). Cost-effectiveness acceptability curves showed that the probability of cost-effectiveness was 0.72 at a willingness-to-pay of 1000 €/kg weight gain and 0.80 at a willingness-to-pay of 20,000 €/quality-adjusted life year gained. CONCLUSIONS This multifactorial personalized intervention showed a statistically non-significant effect and was not cost-effective on body-weight compared to usual care. We observed consistently beneficial treatment effects in the intervention group on all outcomes measures. CLINICAL TRIAL REGISTRY NUMBER AND WEBSITE NTR5184 (www.trialregister.nl).