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1.
Comparing Glycaemic Benefits of Active Versus Passive Lifestyle Intervention in Kidney Allograft Recipients: A Randomized Controlled Trial.
Kuningas, K, Driscoll, J, Mair, R, Smith, H, Dutton, M, Day, E, Sharif, AA
Transplantation. 2020;(7):1491-1499
Abstract
BACKGROUND New-onset diabetes is common after kidney transplantation, but the benefit of lifestyle intervention to improve glucose metabolism posttransplantation is unproven. METHODS We conducted a single-center, randomized controlled trial involving 130 nondiabetic kidney transplant recipients with stable function between 3 and 24 months post-transplantation. Participants were randomly assigned in a 1:1 ratio to receive active intervention (lifestyle advice delivered by renal dietitians using behavior change techniques) versus passive intervention (leaflet advice alone). Primary outcome was 6-month change in insulin secretion, insulin sensitivity, and disposition index. Secondary outcomes included patient-reported outcomes, cardiometabolic parameters, clinical outcomes, and safety endpoints. RESULTS Between August 17, 2015 and December 18, 2017, 130 individuals were recruited, of whom 103 completed the study (drop-out rate 20.8%). Active versus passive intervention was not associated with any change in glucose metabolism: insulin secretion (mean difference, -446; 95% confidence interval [CI], -3184 to 2292; P = 0.748), insulin sensitivity (mean difference, -0.45; 95% CI, -1.34 to 0.44; P = 0.319), or disposition index (mean difference, -940; 95% CI, -5655 to 3775; P = 0.693). Clinically, active versus passive lifestyle intervention resulted in reduced incidence of posttransplantation diabetes (7.6% versus 15.6%, respectively, P = 0.123), reduction in fat mass (mean difference, -1.537 kg; 95% CI, -2.947 to -0.127; P = 0.033), and improvement in weight (mean difference, -2.47 kg; 95% CI, -4.01 to -0.92; P = 0.002). No serious adverse events were noted. CONCLUSIONS Active lifestyle intervention led by renal dietitians did not improve surrogate markers of glucose metabolism. Further investigation is warranted to determine if clinical outcomes can be improved using this methodology.
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2.
Short- and long-term effectiveness of a smartphone application for improving measures of adiposity: A randomised clinical trial - EVIDENT II study.
Gomez-Marcos, MA, Patino-Alonso, MC, Recio-Rodriguez, JI, Agudo-Conde, C, Romaguera-Bosch, M, Magdalena-Gonzalez, O, Gomez-Arranz, A, Mendizabal-Gallastegui, N, Angel Fernandez-Diez, J, Gomez-Sanchez, L, et al
European journal of cardiovascular nursing. 2018;(6):552-562
Abstract
BACKGROUND Evidence on the efficacy of smartphone applications (apps) for reducing body weight and other measurements of adiposity sustainably is not conclusive. OBJECTIVE To evaluate the effect of adding an app for 3 months to traditional counselling on physical activity (PA) and a heart-healthy diet for the modification of measurements of adiposity at 3 and 12 months after intervention. METHODS This randomised clinical trial included 833 subjects. The counselling and app group (IG) had 415 subjects, while 418 were included in the counselling only group (CG). The primary outcome was adiposity measurements at 3 and 12 months after intervention. The secondary outcome was the effect of the intervention by sex. INTERVENTION Counselling on a heart-healthy diet and PA was given to both groups. The IG also received training in the use of a smartphone app designed to promote a heart-healthy diet and PA, and this group was given access to this application for 3 months. Outcome measurements included waist circumference (WC), body mass index (BMI) and Clínica Universidad de Navarra - body adiposity estimator (CUN-BAE). RESULTS In the IG at 12 months, the following decreased: WC -0.72 cm (95% confidence interval [CI]: -2.35 to -0.02) and CUN-BAE -0.35 (95% CI: -0.63 to -0.06). These decreases were only observed in women. After baseline adjustment, the beneficial effect was maintained in the IG compared to the CG at 12 months in terms of WC (-0.67; 95% CI: -0.29 to -0.02) and CUN-BAE (-0.57; 95% CI: -1.10 to -0.04), but only in women. CONCLUSIONS An intervention of nutritional counselling and PA plus the smartphone app with personalised recommendations compared to CG showed beneficial results in terms of reduction of abdominal obesity and the percentage of body fat in women, but not in men.
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3.
Diabetes Education and Glycemic Control.
Lyon, C, Fields, H, Langner, S, DeSanto, K
American family physician. 2018;(4):269-270
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4.
7-Year follow-up of a lifestyle intervention in overweight children: Comparison to an untreated control group.
Reinehr, T, Bucksch, J, Müller, A, Finne, E, Kolip, P
Clinical nutrition (Edinburgh, Scotland). 2018;(5):1558-1562
Abstract
BACKGROUND & AIMS We present the 7-year follow-up analysis in overweight children and adolescents, who had participated originally in a randomized control trial of a lifestyle intervention. We compared them to an untreated population-based control group to demonstrate the effectiveness of the intervention. METHODS Degree of overweight (BMI-SDS) was determined in 32 overweight children (mean age 11.5 ± 1.5yrs, 65.6% females, mean BMI 23.7 ± 1.5 kg/m2) at onset of intervention (T0), end of 6-month intervention (T1), 12 months (T2) and 7 years after end of intervention (T3). A total of 76 overweight children derived from a representative national population survey served as control group. RESULTS The participants in the intervention group reduced significantly their BMI-SDS between T0-T1 (mean ± standard deviation -0.28 ± 0.28, p < 0.001) and demonstrated no significant changes between T1-T2 (mean ± standard deviation -0.10 ± 0.34) and between T2-T3 (median +0.07; interquartile range: -0.54-0.62). BMI-SDS at T3 was significantly (p = 0.015) lower compared to T0. At T3, 46.8% of the participants in the intervention were normal-weight. The reduction in BMI-SDS between T0-T3 was significantly (p = 0.043) greater in the intervention group (median -0.26; interquartile range -0.87-0.23 BMI-SDS) compared to the control group (mean ± standard deviation -0.05 ± 0.77). CONCLUSIONS The lifestyle intervention led to a significant reduction of overweight in the 7-year follow-up period. This decrease in BMI-SDS was significantly greater than the changes in BMI-SDS in a control group. This study is registered at clinicaltrials.gov (NCT00422916).
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5.
Effect of non-surgical weight management on weight and glycaemic control in people with type 2 diabetes: A comparison of interventional and non-interventional outcomes at 3 years.
Botha, S, Forde, L, MacNaughton, S, Shearer, R, Lindsay, R, Sattar, N, Morrison, D, Welsh, P, Logue, J
Diabetes, obesity & metabolism. 2018;(4):879-888
Abstract
AIMS: To examine the long-term effectiveness of lifestyle weight management interventions, recommended in clinical guidelines for patients with type 2 diabetes mellitus (T2DM) and obesity. MATERIALS AND METHODS Electronic health records were used to follow 23 208 patients with T2DM and obesity in Glasgow, UK, for up to 3 years between 2005 and 2014. Patients were stratified by referral to and attendance at a lifestyle weight management intervention, and by attainment of a target weight loss of ≥5 kg over 7 to 9 sessions ("successful completers"). Outcomes were change in weight, glycated haemoglobin (HbA1c) and diabetes medications. RESULTS A total of 3471 potentially eligible patients were referred to the service, and fewer than half of these attended (n = 1537). Of those who attended 7 to 9 sessions, >40% successfully completed and achieved 5-kg weight loss (334/808). Successful completers maintained greater weight loss (change at 3 years -8.03 kg; 95% confidence interval [CI] -9.44 to -6.62) than the non-completers (-3.26 kg; 95% CI -4.01 to -2.51; P < .001) and those not referred to the service (-1.00 kg; 95% CI -1.15 to -0.85; P < .001). Successful completers were the only patient group who did not increase their use of diabetes medication and insulin over 3 years. In adjusted models, successful completers had a clinically significant reduction in HbA1c (-3.7 mmol/mol; 95% CI -5.82 to -1.51) after 3 years; P ≤ .001) compared with non-completers and unsuccessful completers. CONCLUSIONS A real-life structured weight management intervention in patients with diabetes can reduce weight in the medium term, result in improved glycaemic control with fewer medications, and may be more effective than pharmacological alternatives. Challenges include getting a higher proportion of patients referred to and engaged with interventions.
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6.
Effects of preparatory and action planning instructions on situation-specific and general fruit and snack intake.
de Bruijn, GJ, Nguyen, MH, Rhodes, RE, van Osch, L
Appetite. 2017;:161-170
Abstract
Evidence to date suggests heterogeneity in the effects of implementation intentions on health behaviour, including diet. Additional variables and study designs may impact on their effectiveness. Preparatory action, such as making sure fruits are available for consumption, may be an important additional variable. Likewise, most implementation intention research has focused on changes in general intake, yet implementation intention instructions typically require participants to consider behaviour in specific situations. Little is known on how implementation intentions impact situation-specific intake. The present study sought to add to the evidence base by comparing (1) the effects of action planning instructions versus preparatory planning instructions on (2) both situation-specific (as formulated in the implementation intention instruction) and general intake of fruits and in-between meal snack intake frequency. Fruit intake was assessed in average pieces per day, whereas snacking intake was assessed as average frequency in days per week. Using non-probability sampling, 243 undergraduate students who intended to have a healthy diet were randomized to either a standard information control condition, an action planning condition, or a preparatory planning condition. Planning manipulations were based on previous work. Two weeks later, general and situation-specific intake was assessed again in 181 participants. Data were analysed using 2 (time) x 3 (conditions) analyses of variance. Results showed that both planning manipulations were successful in decreasing snack intake frequency in the specified situation, with larger effect sizes for the action planning condition than for the preparatory planning condition. No effects were found on general snack intake frequency or fruit intake. Future planning interventions should more explicitly compare changes in situational and general intake, as well as simultaneously assessed decreases in unhealthy intake and increases in healthy intake.
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7.
Comparing a telephone- and a group-delivered diabetes prevention program: Characteristics of engaged and non-engaged postpartum mothers with a history of gestational diabetes.
Lim, S, Dunbar, JA, Versace, VL, Janus, E, Wildey, C, Skinner, T, O'Reilly, S
Diabetes research and clinical practice. 2017;:254-262
Abstract
AIMS: To explore the acceptability of a telephone- or a group-delivered diabetes prevention program for women with previous gestational diabetes and to compare the characteristics associated with program engagement. METHODS Postpartum women participated in a lifestyle modification program delivered by telephone (n=33) or group format (n=284). Semi-structured interviews on barriers and enablers to program engagement (defined as completing≥80% sessions) were conducted before (Group) and after (Group and Telephone) interventions. The Health Action Process Approach theory was used as the framework for inquiry. Psychological measures were compared between engagement subgroups before and after group-delivered intervention. RESULTS In the telephone-delivered program 82% participants met the engagement criteria compared with 38% for the group-delivered program. Engaged participants (Group) had significantly higher risk perception, outcome expectancy, and activity self-efficacy at baseline (P<0.05). There was a greater decrease in body weight (-1.45±3.9 vs -0.26±3.5, P=0.024) and waist circumference (-3.56±5.1 vs -1.24±5.3, P=0.002) for engaged vs non-engaged participants following group program completion. CONCLUSIONS Telephone delivery was associated with greater engagement in postpartum women. Engagement was associated with greater reduction in weight and waist circumference. Further studies are required to confirm the effectiveness of telephone-delivered program for diabetes prevention in postpartum women.
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8.
Use of a web-based educational intervention to improve knowledge of healthy diet and lifestyle in women with Gestational Diabetes Mellitus compared to standard clinic-based education.
Sayakhot, P, Carolan-Olah, M, Steele, C
BMC pregnancy and childbirth. 2016;(1):208
Abstract
BACKGROUND This study introduced a web-based educational intervention for Australian women with gestational diabetes mellitus (GDM). The aim was to improve knowledge on healthy diet and lifestyle in GDM. Evaluation of the intervention explored women's knowledge and understanding of GDM, healthy diet, healthy food, and healthy lifestyle, after using the web-based program compared to women receiving standard clinic-based GDM education. METHODS A total of 116 women, aged 18-45 years old, newly diagnosed with GDM, participated (Intervention (n) = 56 and control (n) = 60). Women were randomly allocated to the intervention or control groups and both groups attended a standard GDM education class. Group 1(Intervention) additionally used an online touch screen/computer program. All women completed a questionnaire following the computer program and/or the education class. All questions evaluating levels of knowledge had more than one correct answer and scores were graded from 0 to 1, with each correct component receiving a score, eg. 0.25 per each correct answer in a 4 answer question. Chi-square test was performed to compare the two groups regarding knowledge of GDM. RESULTS Findings indicated that the majority of women in the intervention group reported correct answers for "types of carbohydrate foods" for pregnant women with GDM, compared to the control group (62.5 % vs 58.3 %, respectively). Most women in both groups had an excellent understanding of "fruits and vegetables" (98.2 % vs 98.3 %), and the majority of women in the intervention group understood that they should exercise daily for 30 min, compared to the control group (92.9 % vs 91.7 %). Both groups had a good understanding across all categories, however, the majority of women in the intervention group scored all correct answers (score = 1) in term of foetal effects (17.9 % vs 13.3 %, respectively), maternal predictors (5.4 % vs 5 %), care requirements (39.3 % vs 23.3 %), GDM perceptions (48.2 % vs 46.7 %) and GDM treatment (67.9 % vs 61.7 %), compared to women in the control group. CONCLUSION The study suggested that both approaches, standard education and standard education plus web-based program, resulted in excellent knowledge scores, but not statistically significant difference between groups. Multiple and immediate access to the web-based education program at home may prove useful as a source of reference for women with GDM. Future study comparing results pre and post intervention is needed. TRIAL REGISTRATION ACTRN12615000697583 ; Date registered: 03/07/2015; Retrospectively registered.
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Comprehensive dietary education in treated gout patients does not further improve serum urate.
Holland, R, McGill, NW
Internal medicine journal. 2015;(2):189-94
Abstract
BACKGROUND/AIM: This study aims to investigate the influence of dietary education in patients with gout on a stable dose of urate-lowering therapy (ULT). METHODS Males and females aged >18 years with a history of gout, receiving an appropriate and stable dose of ULT, were recruited from two tertiary hospitals and randomised into two groups. The control group received basic advice regarding the importance of compliance with therapy and the benefit of weight loss. The intervention group received comprehensive dietary advice based on the British Society of Rheumatology Guidelines. Both groups received education at baseline and 3 months. Serum urate was measured at baseline, 3 months and 6 months, and a questionnaire was completed at baseline and at 6 months. The primary outcome of the study was to compare the change in serum urate between groups. RESULTS Thirty patients were recruited into the study. There was no difference in serum urate between the control and intervention group at 6 months (0.29 mmol/L vs 0.29 mmol/L at baseline and 0.27 mmol/L vs 0.30 mmol/L at 6 months). The intervention group showed a statistically significant improvement in knowledge (8/13 in control group at baseline to 9/13 at 6 months vs 8/13 in intervention group at baseline to 12/13 at 6 months, P < 0.05) and self-reported dietary modification (1 in control vs 7 in intervention P < 0.05) at 6 months. CONCLUSION This randomised controlled trial shows that in patients on ULT, providing education on diet does not lead to any clinically significant difference in serum urate at 6 months.
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10.
Prospective randomized controlled trial comparing the outcomes and costs of two eyecare adherence interventions in diabetes patients.
Pizzi, LT, Zangalli, CS, Murchison, AP, Hale, N, Hark, L, Dai, Y, Leiby, BE, Haller, JA
Applied health economics and health policy. 2015;(2):253-63
Abstract
OBJECTIVE Diabetic retinopathy is one of the leading causes of vision impairment among adults in the USA. While it is suggested that diabetics receive annual dilated fundus examinations (DFE), many patients do not adhere to these recommendations. This paper investigates the outcomes and costs of an educational and telephone intervention on DFE follow-up adherence in patients with diabetes. METHODS In a prospective trial, 356 diabetic patients due for a DFE at an urban eye clinic were randomly assigned to usual care (UC; reference case), mailed intervention (MI), or telephone intervention (TI). UC patients (n = 119) received a standard form letter. MI patients (n = 117) received a personalized letter encouraging scheduling of an eye examination with an educational brochure about diabetic eye disease. TI patients (n = 120) received personal calls (up to three attempts) to schedule a follow-up with standard form letter. The primary outcome was obtaining a DFE within 90 days of suggested return. Costs (US$ 2013) included time costs for staff, phone charges, supplies, and postage. Since TI involved greater cost components compared to MI, univariate sensitivity analysis examined the impact of reducing phone costs. RESULTS Patients were mostly female (66 %) and African American (70 %) with a mean age of 61 years. TI patients were more likely to schedule DFE [65 vs. 42 %; relative risk (RR) 1.54; CI 1.20-1.96; P < 0.001] versus UC patients. Obtaining a DFE within 90 days of suggested return was also significantly higher among TI patients compared to UC patients (51 vs. 36 %, RR 1.41; CI 1.05-1.89; P = 0.024). MI patients were slightly less likely to schedule DFE versus UC patients (38 vs. 42 %, RR 0.90; CI 0.66-1.22; P = NSS) and obtain a DFE (32 vs. 36 %; RR 0.90; CI 0.63-1.28; P = NSS). The total cost of TI was US$798.28 or US$6.65/patient and the cost/follow-up DFE was US$26.05. Sensitivity analyses revealed that the cost/follow-up can be greatly reduced but remains greater compared to UC (US$2.76 if US$0.25/call, US$11.13 if $1/call; US$22.29 if US$2/call). CONCLUSIONS Personal phone assistance in scheduling DFE follow-up is more effective but also more costly. Follow-up research has been initiated to determine whether automated phone reminders can achieve similar effectiveness at a lower cost.