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Participant experiences in the Diabetes REmission Clinical Trial (DiRECT).
Rehackova, L, Rodrigues, AM, Thom, G, Brosnahan, N, Barnes, AC, McCombie, L, Leslie, WS, Zhyzhneuskaya, S, Peters, C, Adamson, AJ, et al
Diabetic medicine : a journal of the British Diabetic Association. 2022;(1):e14689
Abstract
INTRODUCTION The Diabetes REmission Clinical Trial (DiRECT) has shown that sustained remission of type 2 diabetes in primary care is achievable through weight loss using total diet replacement (TDR) with continued behavioural support. Understanding participants' experiences can help optimise the intervention, support implementation into healthcare, and understand the process of behaviour change. METHODS Thirty-four DiRECT participants were recruited into this embedded qualitative evaluation study. In-person and telephone interviews were conducted before the TDR; at week 6-8 of the TDR; 2 weeks into food reintroduction (FR); and at 1 year, to learn about participant experiences with the programme. Transcribed narratives were analysed thematically, and we used interpretation to develop overarching themes. RESULTS Initiation of the TDR and transition to FR were challenging and required increased behavioural support. In general, adhering to TDR proved easier than the participants had anticipated. Some participants chose the optional extension of TDR. Rapid weight loss and changes in diabetes markers provided ongoing motivation. Further weight loss, behavioural support and occasional use of TDR facilitated weight loss maintenance (WLM). A process of behaviour adaptation to change following regime disruption was identified in three stages: (1) expectations of the new, (2) overcoming difficulties with adherence, and (3) acceptance of continuous effort and establishment of routines. CONCLUSIONS The DiRECT intervention was acceptable and regularity, continuity, and tailoring of behavioural support was instrumental in its implementation in primary care. The adaptation process accounts for some of the individual variability of experiences with the intervention and highlights the need for programme flexibility.
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Associations of quantity and quality of carbohydrate sources with subjective appetite sensations during 3-year weight-loss maintenance: Results from the PREVIEW intervention study.
Zhu, R, Larsen, TM, Poppitt, SD, Silvestre, MP, Fogelholm, M, Jalo, E, Hätönen, KA, Huttunen-Lenz, M, Taylor, MA, Simpson, L, et al
Clinical nutrition (Edinburgh, Scotland). 2022;(1):219-230
Abstract
BACKGROUND & AIMS The association of quantity and quality of carbohydrate sources with appetite during long-term weight-loss maintenance (WLM) after intentional weight loss (WL) is unclear. We aimed to investigate longitudinal associations of quantity and quality of carbohydrate sources with changes in subjective appetite sensations during WLM. METHODS This secondary analysis evaluated longitudinal data from the 3-year WLM phase of the PREVIEW study, a 2 × 2 factorial (diet-physical activity arms), multi-center, randomized trial. 1279 individuals with overweight or obesity and prediabetes (25-70 years; BMI≥25 kg m-2) were included. Individuals were merged into 1 group to assess longitudinal associations of yearly changes in appetite sensations. Quantity and quality of carbohydrate sources including total carbohydrate, glycemic index (GI), glycemic load (GL), and total dietary fiber were assessed via 4-day food diaries at 4 timepoints (26, 52, 104, and 156 weeks) during WLM. Visual analog scales were used to assess appetite sensations in the previous week. RESULTS During WLM, participants consumed on average 160.6 (25th, 75th percentiles 131.1, 195.8) g·day-1 of total carbohydrate, with GI 53.8 (48.7, 58.8) and GL 85.3 (67.2, 108.9) g day-1, and 22.3 (17.6, 27.3) g·day-1 of dietary fiber. In the available-case analysis, multivariable-adjusted linear mixed models with repeated measures showed that each 30-g increment in total carbohydrate was associated with increases in hunger (1.36 mm year-1, 95% CI 0.77, 1.95, P < 0.001), desire to eat (1.10 mm year-1, 0.59, 1.60, P < 0.001), desire to eat something sweet (0.99 mm year-1, 0.30, 1.68, P = 0.005), and weight regain (0.20%·year-1, 0.03, 0.36, P = 0.022). Increasing GI was associated with weight regain, but not associated with increases in appetite sensations. Each 20-unit increment in GL was associated with increases in hunger (0.92 mm year-1, 0.33, 1.51, P = 0.002), desire to eat (1.12 mm year-1, 0.62, 1.62, P < 0.001), desire to eat something sweet (1.13 mm year-1, 0.44, 1.81, P < 0.001), and weight regain (0.35%·year-1, 0.18, 0.52, P < 0.001). Surprisingly, dietary fiber was also associated with increases in desire to eat, after adjustment for carbohydrate or GL. CONCLUSIONS In participants with moderate carbohydrate and dietary fiber intake, and low to moderate GI, we found that higher total carbohydrate, GL, and total fiber, but not GI, were associated with increases in subjective desire to eat or hunger over 3 years. This study was registered as ClinicalTrials.gov, NCT01777893.
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Rationale and Design for a Higher (Dairy) Protein Weight Loss Intervention That Promotes Muscle Quality and Bone Health in Older Adults with Obesity: A Randomized, Controlled Pilot Study.
Miller, MG, Porter Starr, KN, Rincker, J, Orenduff, MC, McDonald, SR, Pieper, CF, Fruik, AR, Lyles, KW, Bales, CW
Journal of nutrition in gerontology and geriatrics. 2021;(2-3):150-170
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Abstract
In contrast to recommendations for young and middle-aged adults, intentional weight loss among older adults remains controversial and is inconsistently advised. Recent research suggests that a higher protein diet can mitigate loss of lean mass during periods of intentional weight loss among older adults with obesity; however, the effects of intentional weight loss on skeletal muscle and bone are not fully understood. The Dairy in the Diet Yields New Approaches for Muscle Optimization (DDYNAMO) trial is a 6-month, randomized, controlled pilot study assessing the effects of combining regular, generous intakes of high quality protein (30 g/meal; primarily from dairy) with caloric restriction (-500kcal/d) and low-intensity resistance exercise (30 min/3 times per week) on muscle quality, muscle composition, bone mineral density in men and women aged ≥60 years with obesity and mild to moderate functional impairment (Short Physical Performance Battery [SPPB] score ≥4 to ≤10). Participants will be re-assessed at 18 months to evaluate weight maintenance, bone mineral density, physical function, and other secondary measures. ClinicalTrials.gov Identifier: NCT02437643.
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Protein intake, weight loss, dietary intervention, and worsening of quality of life in older patients during chemotherapy for cancer.
Regueme, SC, Echeverria, I, Monéger, N, Durrieu, J, Becerro-Hallard, M, Duc, S, Lafargue, A, Mertens, C, Laksir, H, Ceccaldi, J, et al
Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer. 2021;(2):687-696
Abstract
Decreased health-related quality of life (HRQoL) is common in patients with cancer. We investigated the effects of dietary intervention and baseline nutritional status on worsening of HRQoL in older patients during chemotherapy. In this randomized control trial assessing the effect on mortality of dietary advice to increase dietary intake during chemotherapy, this post hoc analysis included 155 patients with cancer at risk of malnutrition. The effects of dietary intervention, baseline Mini Nutritional Assessment item scores, weight loss, and protein and energy intake before treatment on the worsening of HRQoL (physical functioning, fatigue) and secondary outcomes (Timed Up and Go test, one-leg stance time, depressive symptoms, basic (ADL), or instrumental (IADL) activities of daily living) were analyzed by multinomial regressions. Dietary intervention increased total energy and protein intake but had no effect on any examined outcomes. Worsening of fatigue and ADL was predicted by very low protein intake (< 0.8 g kg-1 day-1) before chemotherapy (OR 3.02, 95% CI 1.22-7.46, p = 0.018 and OR 5.21, 95% CI 1.18-22.73, p = 0.029 respectively). Increase in depressive symptomatology was predicted by 5.0-9.9% weight loss before chemotherapy (OR 2.68, 95% CI 1.10-6.80, p = 0.038). Nutritional intervention to prevent HRQoL decline during chemotherapy should focus on patients with very low protein intake along with those with weight loss.
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Assessing the utility of cardiorespiratory fitness, visceral fat, and liver fat in predicting changes in insulin sensitivity beyond simple changes in body weight after exercise training in adolescents.
Kuk, JL, Lee, S
Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme. 2021;(1):55-62
Abstract
To examine the utility of changes in cardiorespiratory fitness (CRF) and body composition in response to exercise training in adolescents with obesity beyond simple measures of body weight change. This is a secondary analysis of our previously published randomized trials of aerobic, resistance, and combined training. We included 104 adolescents (body mass index (BMI) ≥85th percentile) who had complete baseline and post-intervention data for CRF, regional body fat, insulin sensitivity, and oral glucose tolerance. Associations between changes in body composition and CRF with cardiometabolic variables were examined adjusted for age, sex, Tanner stage, race, exercise group, and weight loss. At baseline, CRF, visceral fat and liver fat were correlated with insulin sensitivity with and without adjustment for BMI percentile. Training-associated changes in CRF, visceral fat, and liver fat were also correlated with insulin sensitivity changes, but not independent of body weight change. After accounting for body weight change, none of the body composition or CRF were associated with changes in insulin sensitivity, glucose tolerance, systolic blood pressure, or high-density lipoprotein cholesterol. Although CRF and body composition were strong independent correlates of insulin sensitivity at baseline, changes in CRF and visceral fat were not associated with changes in insulin sensitivity after accounting for body weight change. Clinicaltrials.gov registration nos.: NCT00739180, NCT01323088, NCT01938950. Novelty With exercise training, changes in body weight, CRF, visceral fat, and liver fat were correlated with changes in insulin sensitivity. Changes in body composition or CRF generally did not remain significant correlates of changes in insulin sensitivity after adjusting for body weight changes.
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Liraglutide after diet-induced weight loss for pain and weight control in knee osteoarthritis: a randomized controlled trial.
Gudbergsen, H, Overgaard, A, Henriksen, M, Wæhrens, EE, Bliddal, H, Christensen, R, Nielsen, SM, Boesen, M, Knop, FK, Astrup, A, et al
The American journal of clinical nutrition. 2021;(2):314-323
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BACKGROUND Weight loss is critical for preventing and managing obesity-related diseases. There is a notable lack of valid and reliable means to manage patients with overweight/obesity and knee osteoarthritis (KOA). OBJECTIVE To determine the efficacy and safety of liraglutide in a 30 mg/d dosing in patients with overweight/obesity and KOA. METHODS The trial was designed as a randomized controlled trial including patients between the age of 18 and 74 y with KOA and a BMI ≥27 (measured in kg/m2).Patients underwent a pre-random assignment diet intervention (week -8 to 0). At week 0, patients having lost >5% of their body weight were randomly assigned to liraglutide 3 mg/d or placebo for 52 wk. The coprimary outcomes were changes in body weight and the Knee injury and Osteoarthritis Outcome Score (KOOS) pain subscale from week 0 to 52. RESULTS In total, 168 patients enrolled and 156 were randomly assigned to receive liraglutide or placebo. Patients experienced a significant reduction in body weight and KOOS pain during the pre-random assignment dietary intervention period (week -8 to 0). From week 0 to 52 there was a significant difference in body weight between the liraglutide and placebo group (mean changes: -2.8 and +1.2 kg, respectively; group difference, 3.9 kg; 95% CI: -6.9, -1.0; P = 0.008). There was, however, no group difference in KOOS pain (mean changes: 0.4 and -0.6 points, respectively; group difference, 0.9 points; 95% CI: -3.9, 5.7; P = 0.71). Treatment-emergent adverse events related to the gastrointestinal system were experienced by 50.2% and 39.2% of patients in the liraglutide and placebo groups, respectively. CONCLUSIONS In patients with KOA and overweight/obesity liraglutide added after an 8-wk pre-random assignment diet induced a significant weight loss at >52 wk but did not reduce knee pain compared to placebo. This trial was registered at clinicaltrials.gov as NCT02905864.
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Effects of sodium-glucose cotransporter-2 inhibitors on appetite markers in patients with type 2 diabetes mellitus.
McMillin, SM, Pham, ML, Sherrill, CH
Nutrition, metabolism, and cardiovascular diseases : NMCD. 2021;(8):2507-2511
Abstract
BACKGROUND AND AIMS Glycosuria induced by sodium-glucose cotransporter 2 (SGLT2) inhibitors leads to weight loss and improved diabetes control, but a significant disparity exists between observed and expected weight loss with these medications, hindering clinical effects. This study investigated whether this discrepancy could be explained by compensatory increases in appetite and associated alterations in appetite-regulating hormones. METHODS AND RESULTS This was a prospective single-center observational pilot study. Adults 18-70 years old newly prescribed an SGLT2 inhibitor through usual care were invited to participate. Fasting and postprandial appetite was assessed immediately before, 1 week after, and 12 weeks after SGLT2 inhibitor initiation. Serum samples were collected at corresponding time points to measure ghrelin, leptin, and peptide tyrosine-tyrosine (PYY). Seven patients were included. At 1 and 12 weeks after SGLT2 inhibitor initiation, self-reported appetite did not change significantly and trended toward a decrease in appetite. There were no significant differences in fasting or postprandial ghrelin, leptin, or PYY. CONCLUSION Results suggest the discrepancy between expected and observed weight loss with SGLT2 inhibitors cannot be explained by increases in appetite or changes in appetite-regulating hormones. Further studies are needed to investigate alternative metabolic compensatory mechanisms to optimize weight loss with SGLT2 inhibitor use.
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Examining differences between overweight women and men in 12-month weight loss study comparing healthy low-carbohydrate vs. low-fat diets.
Aronica, L, Rigdon, J, Offringa, LC, Stefanick, ML, Gardner, CD
International journal of obesity (2005). 2021;(1):225-234
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BACKGROUND/OBJECTIVES Biological sex factors and sociocultural gender norms affect the physiology and behavior of weight loss. However, most diet intervention studies do not report outcomes by sex, thereby impeding reproducibility. The objectives of this study were to compare 12-month changes in body weight and composition in groups defined by diet and sex, and adherence to a healthy low carbohydrate (HLC) vs. healthy low fat (HLF) diet. PARTICIPANTS/METHODS This was a secondary analysis of the DIETFITS trial, in which 609 overweight/obese nondiabetic participants (age, 18-50 years) were randomized to a 12-month HLC (n = 304) or HLF (n = 305) diet. Our first aim concerned comparisons in 12-month changes in weight, fat mass, and lean mass by group with appropriate adjustment for potential confounders. The second aim was to assess whether or not adherence differed by diet-sex group (HLC women n = 179, HLC men n = 125, HLF women n = 167, HLF men n = 138). RESULTS 12-month changes in weight (p < 0.001) were different by group. HLC produced significantly greater weight loss, as well as greater loss of both fat mass and lean mass, than HLF among men [-2.98 kg (-4.47, -1.50); P < 0.001], but not among women. Men were more adherent to HLC than women (p = 0.02). Weight loss estimates within group remained similar after adjusting for adherence, suggesting adherence was not a mediator. CONCLUSIONS By reporting outcomes by sex significant weight loss differences were identified between HLC and HLF, which were not recognized in the original primary analysis. These findings highlight the need to consider sex in the design, analysis, and reporting of diet trials.
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Sitting Time, Type, and Context Among Long-Term Weight-Loss Maintainers.
Roake, J, Phelan, S, Alarcon, N, Keadle, SK, Rethorst, CD, Foster, GD
Obesity (Silver Spring, Md.). 2021;(6):1067-1073
Abstract
OBJECTIVE This study aimed to investigate sitting time, the home sedentary environment, and physical activity among weight-loss maintainers in WW (formerly Weight Watchers). METHODS Participants were 4,305 weight-loss maintainers who had maintained ≥9.1 kg of weight loss (24.7 kg on average) for 3.3 years and had an average current BMI of 27.6 kg/m2 . A control group of weight-stable individuals with obesity (n = 619) had an average BMI of 38.9 kg/m2 . The Multicontext Sitting Time Questionnaire and Paffenbarger physical activity questionnaire were administered. RESULTS Weight-loss maintainers versus controls spent 3 hours less per day sitting during the week (10.9 vs. 13.9; ηp2 = 0.039; P = 0.0001) and weekends (9.7 vs. 12.6; ηp2 = 0.038). Weight-loss maintainers versus controls spent 1 hour less per day in non-work-related sitting using a computer or video games during the week (1.4 vs. 2.3; ηp2 = 0.03; P = 0.0001) and weekends (1.5 vs. 2.5; ηp2 = 0.03; P = 0.0001). Weight-loss maintainers versus controls had similar numbers of sedentary-promoting devices (15.8 vs. 14.8) and expended significantly more calories per week in physical activity (1,835 vs. 785; ηp2 = 0.036; P = 0.0001). CONCLUSIONS Weight-loss maintainers reported less time sitting than weight-stable individuals with obesity. Future research should test the efficacy of targeting sitting time to help promote long-term weight-loss maintenance.
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Banting Memorial Lecture 2021-Banting, banting, banter and bravado: Convictions meet evidence in the scientific process: Diabetes UK Professional Conference, 27 April 2021.
Lean, MEJ
Diabetic medicine : a journal of the British Diabetic Association. 2021;(11):e14643
Abstract
This personal account presents some glimpses into the clinical research processes which have made radical changes to our understanding of disease and treatment, and some characteristics of researchers, drawn from history and personal experiences around obesity and type 2 diabetes. Some summary messages emerge: The history of clinical diabetes research has shown how, perhaps through skilful leadership, combining very different personalities, skills and motivation can solve great challenges: Type 2 diabetes is a primary nutritional disease, secondary to the disease-process of obesity, not a primary endocrine disease. Type 2 diabetes is a manifestation of the disease-process of obesity, revealed by weight gain in people with underlying metabolic syndrome genetics/diathesis, mediated in large part at least by reversible ectopic fat accumulation impairing function of organs (liver, pancreas, brown adipose tissue). Treat overweight/obesity more seriously (defined as a disease-process with multiple organ-specific complications-not as a disease-state or BMI cut-off). Discuss the complications and risks of T2D openly: remission is as important as for cancers. Offer and support an optimal dietary weight management program as soon as possible from diagnosis, specifically aiming for remission: (a) Warn against non-evidence-based programs that look similar or claim to have similar potential: we have fully evidence-based programs; (b) Target sustained loss of >15 kg for Europeans (possibly less, e.g. >10 kg for Asians?). Increase future research support to enhance long-term weight loss maintenance. Several approaches need consideration: (a) Personalise diet compositions (recognising there is no intrinsic advantage from different carbohydrate/fat content). (b) Novel diet strategies (e.g. 5:2, time-restricted, flexible diet compositions). (c) New pharmaceutical agents as adjuncts to diet if necessary. (d) Novel food supplements to increase endogenous GLP-1 secretion.