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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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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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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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Hypocaloric diet with lower meal frequency did not affect weight loss, body composition and insulin responsiveness, but improved lipid profile: a randomized clinical trial.
Grangeiro, ÉD, Trigueiro, MS, Siais, LO, Paiva, HM, Sola-Penna, M, Alves, MR, Rosado, EL
Food & function. 2021;(24):12594-12605
Abstract
Dietary approaches are essential to control obesity, but the effectiveness of changes in meal frequency (MF) as a strategy for body weight loss or maintenance remain unclear. This study aimed to evaluate the influence of MF of a hypocaloric diet on weight loss, body composition, active ghrelin levels and metabolic indicators of obese women. This is a randomized, parallel clinical trial, including 40 women divided into two groups that received a hypocaloric diet with different MFs: MF6: six meals per day, and MF3: three meals per day. Dietary, laboratory, anthropometric and body composition indicators were assessed, as well as energy expenditure (EE), before and after the 90 days of the intervention. Dietary consumption did not differ between groups, before or after intervention. The two groups reduced their energy intake after intervention, but there were no differences between the groups. Waist circumference (WC) was reduced and resting metabolic rate had increased in the MF3 group at the end compared to baseline. Moreover, there was a significant difference in the triglyceride levels between groups after intervention, with an important reduction in the MF3 group, although changes in body composition, blood glucose, plasma ghrelin levels and EE variables did not differ between the groups at the end. It is concluded that, the hypocaloric diet with different MF each day did not change weight loss, body composition or insulin responsiveness, but there was an improvement of triglyceridemia in the MF3 group. The present study suggests that eating snacks between meals is not an important factor for weight loss and improvement of metabolic health in women with obesity.
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Effect of Aerobic Exercise-induced Weight Loss on the Components of Daily Energy Expenditure.
Broskey, NT, Martin, CK, Burton, JH, Church, TS, Ravussin, E, Redman, LM
Medicine and science in sports and exercise. 2021;(10):2164-2172
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INTRODUCTION Exercise usually results in less weight loss than expected. This suggests increased energy intake and/or deceased expenditure counteract the energy deficit induced by exercise. The aim of this study was to evaluate changes in components of daily energy expenditure (doubly labeled water and room calorimetry) after 24 wk of exercise training with two doses of aerobic exercise. METHODS This was an ancillary study in 42 (29 women, 13 men) sedentary, middle-age (47.8 ± 12.5 yr) individuals with obesity (35 ± 3.7 kg·m-2) enrolled in the Examination of Mechanisms of Exercise-induced Weight Compensation study. Subjects were randomized to three groups: healthy living control group (n = 13), aerobic exercise that expended 8 kcal·kg-1 of body weight per week (8 KKW, n = 14), or aerobic exercise that expended 20 kcal per kilogram of weight per week (20 KKW, n = 15). Total daily energy expenditure (TDEE) was measured in free-living condition by doubly labeled water and in sedentary conditions in a metabolic chamber over 24 h (24EE). Energy intake was calculated over 14 d from TDEE before and after the intervention using the intake-balance method. RESULTS Significant weight loss occurred with 20 KKW (-2.1 ± 0.7 kg, P = 0.04) but was only half of expected. In the 20 KKW group free-living TDEE increased by ~4% (P = 0.03), which is attributed to the increased exercise energy expenditure (P = 0.001), while 24EE in the chamber decreased by ~4% (P = 0.04). Aerobic exercise at 8 KKW did not induce weight change, and there was no significant change in any component of EE. There was no significant change in energy intake for any group (P = 0.53). CONCLUSIONS Structured aerobic exercise at a dose of 20 KKW produced less weight loss than expected possibly due to behavioral adaptations leading to reduced 24EE in a metabolic chamber without any change in energy intake.
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Changes in Dietary Inflammatory Index Patterns with Weight Loss in Women: A Randomized Controlled Trial.
Duggan, C, Tapsoba, JD, Shivappa, N, Harris, HR, Hébert, JR, Wang, CY, McTiernan, A
Cancer prevention research (Philadelphia, Pa.). 2021;(1):85-94
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Dietary composition can influence systemic inflammation; higher levels of circulating inflammatory biomarkers are associated with increased risk of breast and other cancers. A total of 438 overweight/obese, healthy, postmenopausal women were randomized to a caloric-restriction diet (goal: 10% weight-loss), aerobic-exercise (225 min/week moderate-to-vigorous activity), combined diet+exercise, or control. Dietary inflammatory index (DII) and energy-adjusted (E-DII) scores were derived from food frequency questionnaires (FFQ) and could be calculated for 365 participants with complete FFQs at baseline and 12 months. Changes from baseline to 12 months in E-DII scores in the intervention arms versus controls were analyzed using generalized estimating equations, adjusted for confounders. We examined associations between changes in previously measured biomarkers and E-DII at 12 months. Participants randomized to diet and diet+exercise arms had greater reductions in E-DII (-104.4% and -84.4%), versus controls (-34.8%, both P < 0.001). Weight change had a more marked effect than E-DII change on biomarkers at 12-months; associations between E-DII and biomarker changes were reduced after adjustment by weight change. Changes in E-DII at 12 months, adjusted for weight change, were negatively associated with changes in ghrelin [r = -0.19; P = 0.05 (diet), r = -0.29; P = 0.02 (diet+exercise)], and positively with VEGF [r = 0.22; P = 0.03 (diet+exercise)], and red blood cell counts [r = 0.30; P = 0.004 (exercise)]. C-reactive protein (CRP) and IL6 levels were not associated with E-DII changes at 12 months. In conclusion, a behavior change of low-calorie, low-fat diet significantly reduces dietary inflammatory potential, modulating biomarkers that are associated with tumorigenesis, such as VEGF, but not CRP or IL6. PREVENTION RELEVANCE Diets high in saturated fats and low in fruit and vegetable intake are associated with increased inflammation, which increases cancer risk. This study showed that changes in diet quality had effects on factors associated with cancer; however, the majority of beneficial effects were associated with weight loss rather than diet quality.