-
1.
Using a Revised Protein-Sparing Modified Fast (rPSMF) for Children and Adolescents with Severe Obesity: A Pilot Study.
Eneli, I, Xu, J, Tindall, A, Watowicz, R, Worthington, J, Tanner, K, Pratt, K, Walston, M
International journal of environmental research and public health. 2019;(17)
Abstract
Treatment options are limited for children and adolescents with severe obesity. One alternative treatment is the protein-sparing modified fast (PSMF), a low-carbohydrate, high-protein diet that can result in substantial weight loss. The aim of the study is to evaluate the adherence and efficacy of a revised PSMF (rPSMF) for severe obesity in a pediatric tertiary care weight-management program. The rPSMF with 1200-1800 calories, 40-60 g of carbohydrate/day and 1.2-1.5 g protein/kg of ideal bodyweight was implemented over 12 months. Twenty-one participants enrolled in the study. Mean age 16.2 ± 1.4 years, females (76.2%) and mean weight at baseline was 119 ± 19.9 kg. Regardless of adherence to the rPSMF, the mean weight change at 1 month was -3.7 ± 3.5 kg, (range -13.5 kg to 0.9 kg); at 3 months was -5.5 ± 5.1 kg, (range -19.3 kg to 1.8 kg) and at 6 months was -4.7 ± 6.6 kg, (range -18.3 kg to 8.6 kg). At 12 months, the mean weight change was -1.3 ± 10.6 kg (range -17.7 kg to 14.8 kg). Parent and child-reported physical and psychosocial quality of life (HRQOL) improved. Despite limited adherence, the rPSMF diet resulted in clinically significant weight loss and improved HRQOL for children and adolescents with severe obesity.
-
2.
Adherence to dietary guidelines for the Spanish population and risk of overweight/obesity in the SUN cohort.
Gómez-Donoso, C, Martínez-González, MÁ, Martínez, JA, Sayón-Orea, C, de la Fuente-Arrillaga, C, Bes-Rastrollo, M
PloS one. 2019;(12):e0226565
Abstract
Dietary guidelines play a key role in setting standards for nutrition policies and promoting healthy eating. Like other public health guidelines, they are often influenced by political and economic factors that could place other concerns ahead of the population's health. In order to determine their effectiveness on obesity prevention, we prospectively examined the association between adherence to the latest available national dietary guidelines and the incidence of overweight/obesity in a Spanish cohort study. A sample of 11,554 participants of the "Seguimiento Universidad de Navarra" (SUN) cohort, initially free of overweight or obesity, was included in the study. The Spanish Society of Community Nutrition (SENC) food pyramid (FP) score was computed based on the ratio of consumed to recommended daily servings of grains, fruits, vegetables, dairy, protein-rich foods, olive oil, red and processed meat, sweets, salty snacks and spreadable fats, fermented alcoholic beverages and water. The same approach was followed to calculate the SENC hydration pyramid (HP) score, considering the intake of water and different kind of beverages. Adherence was calculated at baseline and after 10 years of follow-up. Cox proportional hazards models were used to assess the incidence of overweight/obesity (BMI ≥25 kg/m2). During a median follow-up of 10.3 years, 2320 incident cases were identified. The highest level of adherence to the SENC FP score was modestly associated with a reduced risk of overweight/obesity (multivariable-adjusted HR for the fifth quintile vs. the first quintile = 0.78; 95% CI: 0.67-0.91; p-trend: 0.007). No consistent trends were found for the SENC HP. In a large prospective cohort of Spanish university graduates, we found an inverse linear association between adherence to the SENC FP and overweight/obesity risk, whereas this was not the case for the HP.
-
3.
Feasibility of Patient Reporting of Symptomatic Adverse Events via the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) in a Chemoradiotherapy Cooperative Group Multicenter Clinical Trial.
Basch, E, Pugh, SL, Dueck, AC, Mitchell, SA, Berk, L, Fogh, S, Rogak, LJ, Gatewood, M, Reeve, BB, Mendoza, TR, et al
International journal of radiation oncology, biology, physics. 2017;(2):409-418
-
-
Free full text
-
Abstract
PURPOSE To assess the feasibility of measuring symptomatic adverse events (AEs) in a multicenter clinical trial using the National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). METHODS AND MATERIALS Patients enrolled in NRG Oncology's RTOG 1012 (Prophylactic Manuka Honey for Reduction of Chemoradiation Induced Esophagitis-Related Pain during Treatment of Lung Cancer) were asked to self-report 53 PRO-CTCAE items representing 30 symptomatic AEs at 6 time points (baseline; weekly ×4 during treatment; 12 weeks after treatment). Reporting was conducted via wireless tablet computers in clinic waiting areas. Compliance was defined as the proportion of visits when an expected PRO-CTCAE assessment was completed. RESULTS Among 226 study sites participating in RTOG 1012, 100% completed 35-minute PRO-CTCAE training for clinical research associates (CRAs); 80 sites enrolled patients, of which 34 (43%) required tablet computers to be provided. All 152 patients in RTOG 1012 agreed to self-report using the PRO-CTCAE (median age 66 years; 47% female; 84% white). Median time for CRAs to learn the system was 60 minutes (range, 30-240 minutes), and median time for CRAs to teach a patient to self-report was 10 minutes (range, 2-60 minutes). Compliance was high, particularly during active treatment, when patients self-reported at 86% of expected time points, although compliance was lower after treatment (72%). Common reasons for noncompliance were institutional errors, such as forgetting to provide computers to participants; patients missing clinic visits; Internet connectivity; and patients feeling "too sick." CONCLUSIONS Most patients enrolled in a multicenter chemoradiotherapy trial were willing and able to self-report symptomatic AEs at visits using tablet computers. Minimal effort was required by local site staff to support this system. The observed causes of missing data may be obviated by allowing patients to self-report electronically between visits, and by using central compliance monitoring. These approaches are being incorporated into ongoing studies.
-
4.
Reasons for participation and non-participation in a diabetes prevention trial among women with prior gestational diabetes mellitus (GDM).
Infanti, JJ, O'Dea, A, Gibson, I, McGuire, BE, Newell, J, Glynn, LG, O'Neill, C, Connolly, SB, Dunne, FP
BMC medical research methodology. 2014;:13
Abstract
BACKGROUND Gestational diabetes mellitus (GDM) is a risk factor for the development of type 2 diabetes. Lifestyle intervention can prevent progression to type 2 diabetes in high risk populations. We designed a randomised controlled trial (RCT) to evaluate the effectiveness of an established lifestyle intervention compared to standard care for delaying diabetes onset in European women with recent GDM. Recruitment into the RCT was more challenging than anticipated with only 89 of 410 (22%) women agreeing to participate. This paper identifies factors that could enhance participation of the target population in future interventions. METHODS We hypothesised that women who agreed to participate would have higher diabetes risk profiles than those who declined, and secondly that it would be possible to predict participation on the bases of those risk factors. To test our hypothesis, we identified the subset of women for whom we had comprehensive data on diabetes risks factors 3-5 years following GDM, reducing the sample to 43 participants and 73 decliners. We considered established diabetes risk factors: smoking, daily fruit and vegetable intake, participation in exercise, family history of diabetes, glucose values and BMI scores on post-partum re-screens, use of insulin during pregnancy, and age at delivery. We also analysed narrative data from 156 decliners to further understand barriers to and facilitators of participation. RESULTS Two factors differentiated participants and decliners: age at delivery (with women older than 34 years being more likely to participate) and insulin use during pregnancy (with women requiring the use of insulin in pregnancy less likely to participate). Binary logistic regression confirmed that insulin use negatively affected the odds of participation. The most significant barriers to participation included the accessibility, affordability and practicality of the intervention. CONCLUSIONS Women with recent GDM face multiple barriers to lifestyle change. Intervention designers should consider: (i) the practicalities of participation for this population, (ii) research designs that capitalise on motivational differences between participants, (iii) alleviating concerns about long-term diabetes management. We hope this work will support future researchers in developing interventions that are more relevant, effective and successful in recruiting the desired population. TRIAL REGISTRATION Current Controlled Trials ISRCTN41202110.
-
5.
Predictors of long-term weight loss in adults with modest initial weight loss, by sex and race.
Svetkey, LP, Ard, JD, Stevens, VJ, Loria, CM, Young, DY, Hollis, JF, Appel, LJ, Brantley, PJ, Kennedy, BM, Kumanyika, SK, et al
Obesity (Silver Spring, Md.). 2012;(9):1820-8
Abstract
Effective weight management interventions could reduce race-sex disparities in cardiovascular disease (CVD), yet little is known about factors associated with successful weight loss maintenance in race-sex subgroups. In the Weight Loss Maintenance trial (WLM), overweight/obese (BMI 25-45 kg/m(2)) adults who lost ≥4 kg in a 6-month behavioral weight loss intervention (phase I) were randomized into one of three 30-month maintenance interventions (phase II). To investigate predictors in subgroups, randomized groups were combined for this analysis. Of 1,685 phase I participants, 1,032 (61%) entered phase II, including 12% black men (BM), 26% black women (BW), 25% white men (WM), and 37% white women (WW). Weight change over the 36-month study ranged from -2.3% (95% confidence interval = -3.1 to -1.5%) in BW to -4.5% (95% confidence interval = -5.7 to -4.0%) in WM, the result of differential weight loss during phase I. Within race, men lost significantly more weight than women, but within sex group, weight loss did not differ significantly between races. Although participants regained weight during phase II, regain did not differ by race-sex group, and mean weight at the end of the study was significantly lower than phase I entry weight for each subgroup. In regression models, phase I weight loss predicted overall 36-month weight loss in all race-sex groups. Healthy dietary pattern at entry, improvement in dietary pattern, or both were predictive in three of four race-sex groups. Few other variables other than initial weight loss and dietary pattern were predictive. Future research should identify additional modifiable influences on long-term maintenance after a modest weight loss.
-
6.
Predictors of adherence to a Mediterranean-type diet in the PREDIMED trial.
Zazpe, I, Estruch, R, Toledo, E, Sánchez-Taínta, A, Corella, D, Bulló, M, Fiol, M, Iglesias, P, Gómez-Gracia, E, Arós, F, et al
European journal of nutrition. 2010;(2):91-9
-
-
Free full text
-
Abstract
BACKGROUND Determinants of dietary changes obtained with a nutritional intervention promoting the Mediterranean diet have been rarely evaluated. AIM: To identify predictors of higher success of an intervention aimed to increase adherence to a Mediterranean diet (MeDiet) in individuals at high cardiovascular risk participating in a trial for primary prevention of cardiovascular disease: the PREDIMED (PREvención con DIeta MEDiterránea) trial. Candidate predictors included demographic and socioeconomic characteristics, cardiovascular risk factors, and baseline dietary habits. METHODS A total of 1,048 asymptomatic subjects aged 55-80 years allocated to the active intervention groups (subjects in the control group were excluded). Participants' characteristics were assessed at baseline among subjects. Dietary changes were evaluated after 12 months. Main outcome measures were: attained changes in five dietary goals: increases in (1) fruit consumption, (2) vegetable consumption, (3) monounsaturated fatty acid (MUFA)/saturated fatty acid (SFA) ratio, and decreases in (4) sweets and pastries consumption, (5) and meat consumption. Univariate and multivariate logistic regression analyses were used to examine associations between the candidate predictors and likelihood of attaining optimum dietary change (improved adherence to a MeDiet). RESULTS Among men, positive changes toward better compliance with the MeDiet were more frequent among non-diabetics, and among those with worse dietary habits at baseline (higher consumption of meat, higher SFA intake, lower consumption of fruit and vegetables). Among women, marital status (married) and worse baseline dietary habits (high in meats, low in fruits and vegetables) were the strongest predictors of success in improving adherence to the MeDiet. CONCLUSIONS Some participant characteristics (marital status and baseline dietary habits) could contribute to predicting the likelihood of achieving dietary goals in interventions aimed to improve adherence to a MeDiet, and may be useful for promoting individualized long-term dietary changes and improving the effectiveness of dietary counseling.
-
7.
Overload: impact of incident stressful events on antiretroviral medication adherence and virologic failure in a longitudinal, multisite human immunodeficiency virus cohort study.
Mugavero, MJ, Raper, JL, Reif, S, Whetten, K, Leserman, J, Thielman, NM, Pence, BW
Psychosomatic medicine. 2009;(9):920-6
-
-
Free full text
-
Abstract
OBJECTIVE To examine the influence of incident stressful experiences on antiretroviral medication adherence and treatment outcomes. Past trauma history predicts poorer medication adherence and health outcomes. Human immunodeficiency virus (HIV)-infected individuals experience frequently traumatic and stressful events, such as sexual and physical assault, housing instability, and major financial, employment, and legal difficulties. METHODS We measured prospectively incident stressful and traumatic events, medication adherence, and viral load over 27 months in an eight-site, five-state study. Using multivariable logistic and generalized estimating equation modeling, we assessed the impact of incident stressful events on 27-month changes in self-reported medication adherence and virologic failure (viral load = >or=400 c/mL). RESULTS Of 474 participants on antiretroviral therapy at baseline, 289 persons were interviewed and still received treatment at 27 months. Participants experiencing the median number of incident stressful events (n = 9) had over twice the predicted odds (odds ratio = 2.32) of antiretroviral medication nonadherence at follow-up compared with those with no events. Stressful events also predicted increased odds of virologic failure during follow-up (odds ratio = 1.09 per event). CONCLUSIONS Incident stressful events are exceedingly common in the lives of HIV-infected individuals and negatively affect antiretroviral medication adherence and treatment outcomes. Interventions to address stress and trauma are needed to improve HIV outcomes.
-
8.
Weight bias and weight loss treatment outcomes in treatment-seeking adults.
Carels, RA, Young, KM, Wott, CB, Harper, J, Gumble, A, Oehlof, MW, Clayton, AM
Annals of behavioral medicine : a publication of the Society of Behavioral Medicine. 2009;(3):350-5
-
-
Free full text
-
Abstract
BACKGROUND Few studies have explored the relationship between weight bias and weight loss treatment outcomes. PURPOSE This investigation examined the relationship between implicit and explicit weight bias and (a) program attrition, (b) weight loss, (c) self-monitoring adherence, (d) daily exercise levels and overall caloric expenditure, (e) daily caloric intake, and (f) daily caloric deficit among overweight/obese treatment-seeking adults. METHODS Forty-six overweight/obese adults (body mass index > or = 27 kg/m(2)) participating in an 18-week, stepped-care, behavioral weight loss program completed implicit and explicit measures of weight bias. Participants were instructed to self-monitor and electronically report daily energy intake, exercise, and energy expenditure. RESULTS Greater weight bias was associated with inconsistent self-monitoring, greater caloric intake, lower energy expenditure and exercise, creation of a smaller caloric deficit, higher program attrition, as well as less weight loss during the self-help phase of the stepped-care treatment. CONCLUSIONS Weight bias may interfere with overweight/obese treatment-seeking adults' ability to achieve optimal health.
-
9.
Weight loss during the intensive intervention phase of the weight-loss maintenance trial.
Hollis, JF, Gullion, CM, Stevens, VJ, Brantley, PJ, Appel, LJ, Ard, JD, Champagne, CM, Dalcin, A, Erlinger, TP, Funk, K, et al
American journal of preventive medicine. 2008;(2):118-26
-
-
Free full text
-
Abstract
BACKGROUND To improve methods for long-term weight management, the Weight Loss Maintenance (WLM) trial, a four-center randomized trial, was conducted to compare alternative strategies for maintaining weight loss over a 30-month period. This paper describes methods and results for the initial 6-month weight-loss program (Phase I). METHODS Eligible adults were aged > or =25, overweight or obese (BMI=25-45 kg/m2), and on medications for hypertension and/or dyslipidemia. Anthropomorphic, demographic, and psychosocial measures were collected at baseline and 6 months. Participants (n=1685) attended 20 weekly group sessions to encourage calorie restriction, moderate-intensity physical activity, and the DASH (dietary approaches to stop hypertension) dietary pattern. Weight-loss predictors with missing data were replaced by multiple imputation. RESULTS Participants were 44% African American and 67% women; 79% were obese (BMI> or =30), 87% were taking anti-hypertensive medications, and 38% were taking antidyslipidemia medications. Participants attended an average of 72% of 20 group sessions. They self-reported 117 minutes of moderate-intensity physical activity per week, kept 3.7 daily food records per week, and consumed 2.9 servings of fruits and vegetables per day. The Phase-I follow-up rate was 92%. Mean (SD) weight change was -5.8 kg (4.4), and 69% lost at least 4 kg. All race-gender subgroups lost substantial weight: African-American men (-5.4 kg +/- 7.7); African-American women (-4.1 kg +/- 2.9); non-African-American men (-8.5 kg +/- 12.9); and non-African-American women (-5.8 kg +/- 6.1). Behavioral measures (e.g., diet records and physical activity) accounted for most of the weight-loss variation, although the association between behavioral measures and weight loss differed by race and gender groups. CONCLUSIONS The WLM behavioral intervention successfully achieved clinically significant short-term weight loss in a diverse population of high-risk patients.