-
1.
Goal directed fluid removal with furosemide versus placebo in intensive care patients with fluid overload: A trial protocol for a randomised, blinded trial (GODIF trial).
Wichmann, S, Itenov, TS, Berthelsen, RE, Lange, T, Perner, A, Gluud, C, Lawson-Smith, P, Nebrich, L, Wiis, J, Brøchner, AC, et al
Acta anaesthesiologica Scandinavica. 2022;(9):1138-1145
-
-
Free full text
-
Abstract
BACKGROUND Fluid overload is a risk factor for mortality in intensive care unit (ICU) patients. Administration of loop diuretics is the predominant treatment of fluid overload, but evidence for its benefit is very uncertain when assessed in a systematic review of randomised clinical trials. The GODIF trial will assess the benefits and harms of goal directed fluid removal with furosemide versus placebo in ICU patients with fluid overload. METHODS An investigator-initiated, international, randomised, stratified, blinded, parallel-group trial allocating 1000 adult ICU patients with fluid overload to infusion of furosemide versus placebo. The goal is to achieve a neutral fluid balance. The primary outcome is days alive and out of hospital 90 days after randomisation. Secondary outcomes are all-cause mortality at day 90 and 1-year after randomisation; days alive at day 90 without life support; number of participants with one or more serious adverse events or reactions; health-related quality of life and cognitive function at 1-year follow-up. A sample size of 1000 participants is required to detect an improvement of 8% in days alive and out of hospital 90 days after randomisation with a power of 90% and a risk of type 1 error of 5%. The conclusion of the trial will be based on the point estimate and 95% confidence interval; dichotomisation will not be used. CLINICALTRIALS gov identifier: NCT04180397. PERSPECTIVE The GODIF trial will provide important evidence of possible benefits and harms of fluid removal with furosemide in adult ICU patients with fluid overload.
-
2.
A 2.5-Year Weight Management Program Using Noom Health: Protocol for a Randomized Controlled Trial.
Sysko, R, Bibeau, J, Boyar, A, Costello, K, Michaelides, A, Mitchell, ES, Susanin, A, Hildebrandt, T
JMIR research protocols. 2022;(8):e37541
Abstract
BACKGROUND Overweight and obesity are serious public health concerns. As the prevalence of excess weight among individuals continues to increase, there is a parallel need for inexpensive, highly accessible, and evidence-based weight loss programs. OBJECTIVE This weight loss trial will aim to examine the efficacy of the Noom weight loss program in comparison to a digital control after a 6-month intervention phase and a 24-month maintenance phase, with assessments continuing for 2 years beyond the intervention (to 30 months-after the baseline). The secondary outcomes include quality of life, psychosocial functioning, sleep quality, physical activity, diet, and health status. This trial will also examine the severity of obesity-related functional impairment, weight loss history, and demographic moderators, along with adherence and self-efficacy as mediators of the outcome. METHODS A total of 600 participants were randomized in a parallel-group, controlled trial to either Noom Healthy Weight Program (intervention) or Noom Healthy Weight Control (control) for a 6-month intervention. Both intervention and control groups include diet and exercise recommendations, educational content, daily logging capabilities, and daily weigh-in entries. The Noom Healthy Weight Program also includes a coach support for weight loss. Remote follow-up assessments of eating, physical activity, psychosocial factors, app use data, and weight will be conducted at 1, 4, 6, 12, 18, 24, and 30 months after baseline. Weight is measured at each follow-up point during a Zoom call using the participants' scales. RESULTS Enrollment began in March 2021 and the 6-month intervention phase ended in March 2022. Data collection for the final assessment will be completed in March 2024. CONCLUSIONS This study tests commercially available digital lifestyle interventions for individuals with overweight and obesity seeking weight loss support. Data obtained from the study will evaluate whether the Noom Healthy Weight Control Program can help individuals overcome weight loss, achieve long-term maintenance, adhere to lifestyle changes, and feature use barriers that are present in other traditional weight loss treatments. TRIAL REGISTRATION ClinicalTrials.gov NCT04797169; https://clinicaltrials.gov/ct2/show/NCT04797169. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/37541.
-
3.
An Initial Test of the Efficacy of a Digital Health Intervention for Bariatric Surgery Candidates.
Sysko, R, Michaelides, A, Costello, K, Herron, DM, Hildebrandt, T
Obesity surgery. 2022;(11):3641-3649
-
-
Free full text
-
Abstract
BACKGROUND Rigorous research on smartphone apps for individuals pursuing bariatric surgery is limited. A digital health intervention was recently developed using standard behavioral weight loss programs with specific modifications for bariatric surgery. The current study evaluated this intervention for improving diet, exercise, and psychosocial health over 8 weeks prior to surgery in an academic medical center. METHODS Fifty patients were randomized to receive either the digital intervention or treatment as usual prior to a surgical procedure. Measures of anxiety, depression, stress, quality of life, physical activity, and diet were administered at baseline and at 8-week follow-up. Statistical power of 80% estimated for N = 50 to detect ES = 0.68 with alpha = 0.05. RESULTS Results of intent-to-treat (N = 50 baseline, N = 36 follow-up) analyses indicated significant moderate differences in stress and anxiety (ES = - 0.58 to - 0.62) favoring the digital intervention. Effects of the program on total daily calories consumed, body mass index, quality of life, and eating disorder symptoms were small (ES = - 0.24 to 0.33) and not significant. Given small effects for these domains, the sample size of the study likely affected the ability to detect significant differences. CONCLUSIONS The digital health intervention appears to significantly impact several measures of physical activity and emotional functioning in candidates for bariatric surgery, which could augment surgical outcomes.
-
4.
Randomized Controlled Trial Comparing Health Coach-Delivered Smartphone-Guided Self-Help With Standard Care for Adults With Binge Eating.
Hildebrandt, T, Michaeledes, A, Mayhew, M, Greif, R, Sysko, R, Toro-Ramos, T, DeBar, L
The American journal of psychiatry. 2020;(2):134-142
Abstract
OBJECTIVE Cognitive-behavioral therapy (CBT) has shown efficacy in the treatment of eating disorders. The authors conducted a randomized controlled telemedicine trial of CBT-guided self-help (CBT-GSH) assisted with a smartphone app, Noom Monitor, for binge eating with or without purging. They hypothesized that coach-delivered CBT-GSH telemedicine sessions plus Noom Monitor would yield greater reductions in symptoms of binge eating, purging, and eating disorders compared with standard care. METHODS Fifty-two-week outcomes for CBT-GSH plus Noom Monitor (N=114) were compared with outcomes for standard care (N=111) among members of an integrated health care system in the Pacific Northwest. Patients in the health system who met inclusion criteria were ≥18 years old, had a body mass index ≥18.5, met criteria for DSM-5 binge eating disorder or bulimia nervosa, had 12 months of continuous health care enrollment in Kaiser Permanente Northwest, and had a personal smartphone. Participants received eight CBT-GSH telemedicine sessions over 12 weeks administered by health coaches, and outcomes were assessed at baseline and at weeks 4, 8, 12, 26, and 52. The use of available treatment offered within the Kaiser Permanente health care system was permitted for participants assigned to standard care. RESULTS Participants who received CBT-GSH plus Noom Monitor reported significant reductions in objective binge-eating days (β=-0.66, 95% CI=-1.06, -0.25; Cohen's d=-1.46, 95% CI=-4.63, -1.09) and achieved higher rates of remission (56.7% compared with 30%; number needed to treat=3.74) at 52 weeks compared with participants in standard care, none of whom received any eating disorder treatment during the intervention period (baseline and weeks 1-12). Similar patterns emerged for compensatory behaviors (vomiting, use of laxatives, and excessive exercise; 76.3% compared with 56.8%; number needed to treat=5.11), eating disorder symptoms (body shape, weight, eating concerns, and dietary restraint), and clinical impairment (Cohen's d=-10.07, -2.15). CONCLUSIONS These results suggest that CBT-GSH plus Noom Monitor delivered via telemedicine by routine-practice health coaches in a nonacademic health care system yields reductions in symptoms and impairment over 52 weeks compared with standard care.
-
5.
The Female Athlete Body project study: 18-month outcomes in eating disorder symptoms and risk factors.
Stewart, TM, Pollard, T, Hildebrandt, T, Wesley, NY, Kilpela, LS, Becker, CB
The International journal of eating disorders. 2019;(11):1291-1300
-
-
Free full text
-
Abstract
OBJECTIVE To evaluate the efficacy of the Female Athlete Body project (FAB) in reducing eating disorder (ED) symptoms and risk factors. METHOD This study was a community participatory three-site, two-arm, cluster randomized controlled trial (RCT). Female collegiate athletes (N = 481) were randomly assigned by team to the FAB intervention, a behavioral ED risk factor reduction program, or a waitlist control condition. Primary analyses examined 18-month effects for ED pathology. Secondary analyses examined risk factors and correlates (e.g., thin-ideal internalization, negative mood, Female Athlete Triad knowledge, and body mass index [BMI]). RESULTS Linear mixed effects models with team as a cluster level variable and study condition as a between-subjects variable revealed significantly reduced dietary restraint in FAB teams relative to control teams. FAB teams also reported significantly fewer objective and subjective binge episodes than control teams. Finally, FAB teams showed significantly lower thin-ideal internalization and increased BMI at 18-months. No other significant differences were found. DISCUSSION This RCT examined the effects of a short intervention on ED pathology and risk factors in female collegiate athletes through 18-month follow-up. This trial is one of only three trials with female athletes that have shown long-term reductions in any ED symptoms or produced positive effects on ED risk factors. The present study is the first to find such effects with athletes using a brief (i.e., 4 hr) intervention at 18-month follow-up. Although small effects were found, the current trial provides valuable lessons about future design and implementation of similar trials with athletes. TRIAL REGISTRATION Clinical trials NCT01735994.
-
6.
Adapting family-based treatment for paediatric obesity: A randomized controlled pilot trial.
Loeb, KL, Le Grange, D, Celio Doyle, A, Crosby, RD, Glunz, C, Laraque-Arena, D, Hildebrandt, T, Bacow, T, Vangeepuram, N, Gault, A
European eating disorders review : the journal of the Eating Disorders Association. 2019;(5):521-530
-
-
Free full text
-
Abstract
OBJECTIVE This pilot study aimed to refine and test an adaption of family-based treatment (FBT) for eating disorders that addressed the distinct clinical needs of adolescents with overweight or obesity in the absence of eating disorder pathology. Our hypothesis was that FBT for paediatric obesity (FBT-PO) would be feasible to implement and superior to a nutrition education counselling (NEC) condition delivered to both parents and patients, thereby controlling for key information dissemination across groups while manipulating active therapeutic content and strategy. METHOD Seventy-seven adolescents were randomized to FBT-PO or NEC across two sites. RESULTS Results supported our core prediction, in that weight status among adolescent study participants receiving FBT-PO remained stable while increasing among participants randomized to NEC. Attrition was high in both conditions. CONCLUSIONS FBT-PO, while not seeming to yield a marked decrease in body mass index z-score, may arrest an otherwise-occurring weight-gain trajectory for these adolescents. This efficacy finding is consistent with the overall PO literature supporting parental involvement in the treatment of PO. Future research efforts should address retention in FBT-PO.
-
7.
Randomized controlled trial comparing smartphone assisted versus traditional guided self-help for adults with binge eating.
Hildebrandt, T, Michaelides, A, Mackinnon, D, Greif, R, DeBar, L, Sysko, R
The International journal of eating disorders. 2017;50(11):1313-1322
-
-
-
Free full text
-
Plain language summary
Mobile technology offers the potential for greater accessibility to patients, and a reduced treatment burden, which could increase adherence to self-help treatments. The aim of this randomised controlled study was to test the efficacy of a smartphone app – Noom Monitor - compared to traditional cognitive behaviour therapy in the management of binge eating episodes. The study recruited 66 adults who were randomized into two groups: cognitive-behaviour therapy through self-guided help or cognitive-behaviour therapy through self-guided help using Noom Monitor. Results show that patients receiving cognitive-behaviour therapy through self-guided help using Noom Monitor experienced a greater reduction in objective bulimic episodes and purging, and an increase in weekly meal and snack adherence. Authors conclude that smartphone apps can improve initial outcomes of cognitive-behaviour therapy through self-guided help and may offer a useful way to improve participant adherence among those who stay engaged in the treatment.
Abstract
OBJECTIVE Guided self-help treatments based on cognitive-behavior therapy (CBT-GSH) are efficacious for binge eating. With limited availability of CBT-GSH in the community, mobile technology offers a means to increase use of these interventions. The purpose of this study was to test the initial efficacy of Noom Monitor, a smartphone application designed to facilitate CBT-GSH (CBT-GSH + Noom), on study retention, adherence, and eating disorder symptoms compared to traditional CBT-GSH. METHOD Sixty-six men and women with DSM-5 binge-eating disorder (BED) or bulimia nervosa (BN) were randomized to receive eight sessions of CBT-GSH + Noom (n = 33) or CBT-GSH (n = 33) over 12 weeks. Primary symptom outcomes were eating disorder examination objective bulimic episodes (OBEs), subjective bulimic episodes (SBEs), and compensatory behaviors. Assessments were collected at 0, 4, 8, 12, 24, and 36 weeks. Behavioral outcomes were modeled using zero-inflated negative-binomial latent growth curve models with intent-to-treat. RESULTS There was a significant effect of treatment on change in OBEs (β = -0.84, 95% CI = -1.49, -0.19) favoring CBT-GSH + Noom. Remission rates were not statistically different between treatments for OBEs (βlogit = -0.73, 95% CI = -1.86, 3.27; CBT-GSH-Noom = 17/27, 63.0% vs. CBT-GSH 11/27, 40.7%, NNT = 4.5), but CBT-GSH-Noom participants reported greater meal and snack adherence and regular meal adherence mediated treatment effects on OBEs. The treatments did not differ at the 6-month follow-up. DISCUSSION Smartphone applications for the treatment binge eating appear to have advantages for adherence, a critical component of treatment dissemination.
-
8.
The mitochondrial complexome of Arabidopsis thaliana.
Senkler, J, Senkler, M, Eubel, H, Hildebrandt, T, Lengwenus, C, Schertl, P, Schwarzländer, M, Wagner, S, Wittig, I, Braun, HP
The Plant journal : for cell and molecular biology. 2017;(6):1079-1092
-
-
Free full text
-
Abstract
Mitochondria are central to cellular metabolism and energy conversion. In plants they also enable photosynthesis through additional components and functional flexibility. A majority of those processes relies on the assembly of individual proteins to larger protein complexes, some of which operate as large molecular machines. There has been a strong interest in the makeup and function of mitochondrial protein complexes and protein-protein interactions in plants, but the experimental approaches used typically suffer from selectivity or bias. Here, we present a complexome profiling analysis for leaf mitochondria of the model plant Arabidopsis thaliana for the systematic characterization of protein assemblies. Purified organelle extracts were separated by 1D Blue native (BN) PAGE, a resulting gel lane was dissected into 70 slices (complexome fractions) and proteins in each slice were identified by label free quantitative shot-gun proteomics. Overall, 1359 unique proteins were identified, which were, on average, present in 17 complexome fractions each. Quantitative profiles of proteins along the BN gel lane were aligned by similarity, allowing us to visualize protein assemblies. The data allow re-annotating the subunit compositions of OXPHOS complexes, identifying assembly intermediates of OXPHOS complexes and assemblies of alternative respiratory oxidoreductases. Several protein complexes were discovered that have not yet been reported in plants, such as a 530 kDa Tat complex, 460 and 1000 kDa SAM complexes, a calcium ion uniporter complex (150 kDa) and several PPR protein complexes. We have set up a tailored online resource (https://complexomemap.de/at_mito_leaves) to deposit the data and to allow straightforward access and custom data analyses.
-
9.
Reducing eating disorder risk factors: a controlled investigation of a blended task-shifting/train-the-trainer approach to dissemination and implementation.
Kilpela, LS, Hill, K, Kelly, MC, Elmquist, J, Ottoson, P, Keith, D, Hildebrandt, T, Becker, CB
Behaviour research and therapy. 2014;:70-82
-
-
Free full text
-
Abstract
Recent advances in psychological intervention research have led to an increase in evidence-based interventions (EBIs), yet there remains a lag in dissemination and implementation of EBIs. Task-shifting and the train-the-trainer (TTT) model offer two potential strategies for enhancing reach of EBIs. The Body Project, an EBI found to prevent onset of eating disorders, served as the vehicle for this dissemination/implementation study. The primary aim of this study was to determine if training of peer-leaders for the Body Project could be task-shifted to undergraduate students using a hybrid task-shifting/TTT model. Our secondary aim was to determine if subgroups of participants evidenced different trajectories of change through 14-month follow-up. Regarding the first aim, we found almost no evidence to suggest that a presence of a doctoral-level trainer yielded superior participant outcomes compared to training by undergraduates alone. Regarding Aim 2, almost all classes for all variables evidenced improvement or a benign response. Additionally, for three key risk factors (thin-ideal internalization, body dissatisfaction, and ED symptoms) virtually all trajectories showed improvement. This study provides initial support for the use of a blended task-shifting/TTT approach to dissemination and implementation within prevention generally, and further support for broad dissemination of the Body Project specifically.
-
10.
Stress and addiction.
Hildebrandt, T, Greif, R
Psychoneuroendocrinology. 2013;(9):1923-7
-
-
Free full text
-
Abstract
Appetitive behaviors such as substance use and eating are under significant regulatory control by the hypothalamic-pituitary adrenal (HPA) and hypothalamic pituitary gonadal (HPG) axes. Recent research has begun to examine how these systems interact to cause and maintain poor regulation of these appetitive behaviors. A range of potential molecular, neuroendocrine, and hormonal mechanisms are involved in these interactions and may explain individual differences in both risk and resilience to a range of addictions. This manuscript provides a commentary on research presented during the International Society of Psychoneuroendocrinology's mini-conference on sex differences in eating and addiction with an emphasis on how HPG and HPA axis interactions affect appetitive behaviors in classic addictions and may be used to help inform the ongoing debate about the validity of food addiction.