Purpose: The purpose of the study was to explore the thoughts, feelings, motivations, and assignment preferences of community health center patients with type 2 diabetes considering participation in a 2-year lifestyle intervention trial aimed at weight loss and increased physical activity. The reasons for patients' delivery mode preferences were also explored to aid in the design of future interventions for controlled trials.
Methods: Using structured telephone interview guides, 57 patients with type 2 diabetes receiving primary care at 3 community health centers affiliated with an academic medical center were interviewed regarding the perceived pros and cons of each of the 3 possible treatment assignments: telephone conference group, in-person group, or individual medical nutrition therapy.
Sci Diabetes Self Manag Care
August 2023
Background: Understanding the effect lifestyle intervention (LI) has on important psychological and behavioral variables that are associated with weight loss can help inform LI design, content, and delivery.
Objective: The aim was to determine the modifiable psychological and behavioral factors that are associated with percent weight loss (%WL) and their relative importance in predicting %WL at 12, 24, and 36 months in the REAL HEALTH-Diabetes randomized controlled trial LI.
Design: This is a secondary analysis of LI arms of the REAL HEALTH-Diabetes randomized controlled trial LI cohort over a 24-month intervention period and 12-month follow-up period.
Background: Food insecurity is associated with worse glycemic management for individuals with type 2 diabetes mellitus (T2DM), but whether medically tailored meals (MTM), a food insecurity intervention, can improve glycemic management is unclear.
Objective: To describe the protocol for a trial assessing whether an MTM plus lifestyle intervention improves hemoglobin A1c (HbA1c) and participant-reported outcomes, relative to a food subsidy (money that can be spent on foods participants choose), for adults with both T2DM and food insecurity.
Methods: The Food as Medicine for Diabetes (FAME-D) randomized clinical trial (goal n = 200) is a pragmatic trial with an active comparator.
How people wake up and regain alertness in the hours after sleep is related to how they are sleeping, eating, and exercising. Here, in a prospective longitudinal study of 833 twins and genetically unrelated adults, we demonstrate that how effectively an individual awakens in the hours following sleep is not associated with their genetics, but instead, four independent factors: sleep quantity/quality the night before, physical activity the day prior, a breakfast rich in carbohydrate, and a lower blood glucose response following breakfast. Furthermore, an individual's set-point of daily alertness is related to the quality of their sleep, their positive emotional state, and their age.
View Article and Find Full Text PDFBackground: The menopause transition is associated with unfavourable alterations in health. However, postprandial metabolic changes and their mediating factors are poorly understood.
Methods: The PREDICT 1 UK cohort (n=1002; pre- n=366, peri- n=55, and post-menopausal females n=206) assessed phenotypic characteristics, anthropometric, diet and gut microbiome data, and fasting and postprandial (0-6 h) cardiometabolic blood measurements, including continuous glucose monitoring (CGM) data.
Objective: The Reach Ahead for Lifestyle and Health (REAL HEALTH)-Diabetes study assessed the comparative effectiveness of two Look AHEAD (Action for Health in Diabetes)-adapted lifestyle intervention (LI) arms targeting weight loss in type 2 diabetes compared with medical nutrition therapy (MNT) referral. At 1 year, LI had greater weight loss than MNT. This study reports outcomes at 24 (end of LI) and 36 months.
View Article and Find Full Text PDFThe Breast Cancer Weight Loss (BWEL) trial is a randomized controlled trial designed to determine whether weight loss after a breast cancer diagnosis can reduce the risk of cancer recurrence in women with overweight or obesity. The BWEL trial will compare the efficacy of a telephone-based weight-loss intervention plus health education materials versus health education materials alone on invasive disease-free survival in 3,181 women with stage II or III breast cancer and BMI > 27 kg/m . This report provides a detailed description of the goals and methods of the lifestyle intervention and the evidence supporting the intervention used in the BWEL trial.
View Article and Find Full Text PDFAims/hypothesis: Sleep, diet and exercise are fundamental to metabolic homeostasis. In this secondary analysis of a repeated measures, nutritional intervention study, we tested whether an individual's sleep quality, duration and timing impact glycaemic response to a breakfast meal the following morning.
Methods: Healthy adults' data (N = 953 [41% twins]) were analysed from the PREDICT dietary intervention trial.
Objective: Across the Diabetes Prevention Program (DPP) follow-up, cumulative diabetes incidence remained lower in the lifestyle compared with the placebo and metformin randomized groups and could not be explained by weight. Collection of self-reported physical activity (PA) (yearly) with cross-sectional objective PA (in follow-up) allowed for examination of PA and its long-term impact on diabetes prevention.
Research Design And Methods: Yearly self-reported PA and diabetes assessment and oral glucose tolerance test results (fasting glucose semiannually) were collected for 3,232 participants with one accelerometry assessment 11-13 years after randomization ( = 1,793).
Background: We evaluated whether diet quality is a predictor of weight loss and reduced diabetes risk, independent of caloric intake in the Diabetes Prevention Program (DPP) cohort, a randomized clinical trial of adults at risk for diabetes.
Methods: This secondary analysis included 2914 participants with available data (964 intensive lifestyle (ILS), 977 metformin, 973 placebo). Dietary intake was assessed using a 117-item food frequency questionnaire.
An amendment to this paper has been published and can be accessed via a link at the top of the paper.
View Article and Find Full Text PDFMetabolic responses to food influence risk of cardiometabolic disease, but large-scale high-resolution studies are lacking. We recruited n = 1,002 twins and unrelated healthy adults in the United Kingdom to the PREDICT 1 study and assessed postprandial metabolic responses in a clinical setting and at home. We observed large inter-individual variability (as measured by the population coefficient of variation (s.
View Article and Find Full Text PDFObesity (Silver Spring)
May 2020
Objective: This study evaluated weight changes after cessation of the 10-year intensive lifestyle intervention (ILI) in the Look AHEAD (Action for Health in Diabetes) study. It was hypothesized that ILI participants would be more likely to gain weight during the 2-year observational period following termination of weight-loss-maintenance counseling than would participants in the diabetes support and education (DSE) control group.
Methods: Look AHEAD was a randomized controlled trial that compared the effects of ILI and DSE on cardiovascular morbidity and mortality in participants with overweight/obesity and type 2 diabetes.
Background: Intensive lifestyle interventions (LI) improve outcomes in obesity and type 2 diabetes but are not currently available in usual care.
Objective: To compare the effectiveness and costs of two group LI programs, in-person LI and telephone conference call (telephone LI), to medical nutrition therapy (MNT) on weight loss in primary care patients with type 2 diabetes.
Design: A randomized, assessor-blinded, practice-based clinical trial in three community health centers and one hospital-based practice affiliated with a single health system.
Background: Medically-tailored meal programs that provide home-delivered medically-appropriate food are an emerging intervention when type 2 diabetes co-occurs with food insecurity (limited or uncertain access to nutritious food owing to cost). We sought to understand the experiences of medically-tailored meal program participants.
Methods: We conducted semi-structured interviews with participants in a randomized trial of medically-tailored meals (NCT02426138) until reaching content saturation.
Purpose: The purpose of this study is to identify barriers to weight loss and physical activity, as well as approaches used by coaches, in a real-world, community sample of adults with metabolic syndrome (at risk for type 2 diabetes) who participated in a Diabetes Prevention Program (DPP)-adapted weight loss intervention and compare findings to data from the screened and highly selected DPP sample.
Methods: SHINE (Support, Health Information, Nutrition, and Exercise) was a telephonic DPP adaptation. Primary care staff delivered the DPP curriculum, and lifestyle coaches provided monthly direction to achieve weight loss.
Coronary artery disease (CAD) is more frequent among individuals with dysglycemia. Preventive interventions for diabetes can improve cardiometabolic risk factors (CRFs), but it is unclear whether the benefits on CRFs are similar for individuals at different genetic risk for CAD. We built a 201-variant polygenic risk score (PRS) for CAD and tested for interaction with diabetes prevention strategies on 1-year changes in CRFs in 2,658 Diabetes Prevention Program (DPP) participants.
View Article and Find Full Text PDFContemp Clin Trials Commun
September 2019
Background: Aims: The REAL HEALTH Diabetes Study is a practice-based randomized clinical trial that compares the effectiveness of lifestyle intervention aimed at weight reduction to medical nutrition therapy in primary care patients with type 2 diabetes. This paper describes a tiered approach to recruitment, the resultant enrollment rates of sequentially more intensive recruitment strategies, and identifies barriers to participation.
Methods: Potential participants were identified using patient health registries and classified by recruitment site.