Effect of Isocaloric, Time-Restricted Eating on Body Weight in Adults With Obesity : A Randomized Controlled Trial.

BACKGROUND: Time-restricted eating (TRE) lowers body weight in many studies. Whether TRE induces weight loss independent of reductions in calorie intake, as seen in rodent studies, is unknown. OBJECTIVE: To determine the effect of TRE versus a usual eating pattern (UEP) on body weight in the setting of stable caloric intake. DESIGN: Randomized, isocaloric feeding study. (ClinicalTrials.gov: NCT03527368). SETTING: Clinical research unit. PARTICIPANTS: Adults with obesity and prediabetes or diet-controlled diabetes. INTERVENTION: Participants were randomly assigned 1:1 to TRE (10-hour eating window, 80% of calories before 1 p.m.) or UEP (≤16-hour window, ≥50% of calories after 5 p.m.) for 12 weeks. Both groups had the same nutrient content and were isocaloric with total calories determined at baseline. MEASUREMENTS: Primary outcome was change in body weight at 12 weeks. Secondary outcomes were fasting glucose, homeostatic model assessment for insulin resistance (HOMA-IR), glucose area under the curve by oral glucose tolerance test, and glycated albumin. We used linear mixed models to evaluate the effect of interventions on outcomes. RESULTS: All 41 randomly assigned participants (mean age, 59 years; 93% women; 93% Black race; mean BMI, 36 kg/m2) completed the intervention. Baseline weight was 95.6 kg (95% CI, 89.6 to 101.6 kg) in the TRE group and 103.7 kg (CI, 95.3 to 112.0 kg) in the UEP group. At 12 weeks, weight decreased by 2.3 kg (CI, 1.0 to 3.5 kg) in the TRE group and by 2.6 kg (CI, 1.5 to 3.7 kg) in the UEP group (average difference TRE vs. UEP, 0.3 kg [CI, -1.2 to 1.9 kg]). Change in glycemic measures did not differ between groups. LIMITATION: Small, single-site study; baseline differences in weight by group. CONCLUSION: In the setting of isocaloric eating, TRE did not decrease weight or improve glucose homeostasis relative to a UEP, suggesting that any effects of TRE on weight in prior studies may be due to reductions in caloric intake. PRIMARY FUNDING SOURCE: American Heart Association.

START Diabetes Prevention: A Multi-Level Strategy for Primary Care Clinics.

Background: Prediabetes, a high-risk state for developing diabetes, affects more than 1 in 3 adults nationally. However, <5% of people with prediabetes are receiving any treatment for prediabetes. Prior intervention studies for increasing prediabetes treatment uptake have largely focused on individual barriers with few multi-level interventions that address clinician- and system-level barriers. Objective: To measure the effectiveness of a multi-level intervention on uptake of prediabetes treatment in a primary care clinic. Design: Pragmatic study of the START (Screen, Test, Act, Refer and Treat) Diabetes Prevention intervention. Participants: The START Diabetes Prevention intervention was implemented in a suburban primary care clinic outside of Baltimore compared to a control clinic in the same area over a 12-month period. Intervention: START Diabetes Prevention intervention included a structured workflow, shared decision-making resources and electronic health record clinical decision support tools. Main Measures: Uptake of prediabetes treatment, defined as Diabetes Prevention Program referral, metformin prescription and/or medical nutrition referral within 30 days of any PCC visit. Key Results: We demonstrated greater uptake of preventive treatment among patients with prediabetes in the intervention clinic vs. control clinic receiving usual care (11.6% vs. 6.7%, p<0.001). More patients in the intervention vs. control clinic reported their PCC discussed prediabetes with them (60% vs. 48%, p=0.002) and more felt overall that they understood what their doctor was telling them about prediabetes and that their opinion was valued. The START Diabetes Prevention Strategy had greater acceptability and usefulness to PCCs at the study end compared to baseline. Conclusions: A low-touch multi-level intervention is effective in increasing prediabetes treatment uptake. The intervention was also acceptable and feasible for clinicians, and enhanced patient understanding and discussions of prediabetes with their clinicians.

Using the Translating Research into Practice framework to develop a diabetes prevention intervention in primary care: a mixed-methods study.

BACKGROUND: Pre-diabetes affects one-third of US adults and increases the risk of type 2 diabetes. Effective evidence-based interventions, such as the Diabetes Prevention Program, are available, but a gap remains in effectively translating and increasing uptake of these interventions into routine care. METHODS: We applied the Translating Research into Practice (TRiP) framework to guide three phases of intervention design and development for diabetes prevention: (1) summarise the evidence, (2) identify local barriers to implementation and (3) measure performance. In phase 1, we conducted a retrospective cohort analysis of linked electronic health record claims data to evaluate current practices in the management of pre-diabetes. In phase 2, we conducted in-depth interviews of 16 primary care physicians, 7 payor leaders and 31 patients to elicit common barriers and facilitators for diabetes prevention. In phase 3, using findings from phases 1 and 2, we developed the core elements of the intervention and performance measures to evaluate intervention uptake. RESULTS: In phase 1 (retrospective cohort analysis), we found few patients with pre-diabetes received diabetes prevention interventions. In phase 2 (stakeholder engagement), we identified common barriers to include a lack of knowledge about pre-diabetes among patients and about the Diabetes Prevention Program among clinicians. In phase 3 (intervention development), we developed the START Diabetes Prevention Clinical Pathway as a systematic change package to address barriers and facilitators identified in phases 1 and 2, performance measures and a toolkit of resources to support the intervention components. CONCLUSIONS: The TRiP framework supported the identification of evidence-based care practices for pre-diabetes and the development of a well-fitted, actionable intervention and implementation plan designed to increase treatment uptake for pre-diabetes in primary care settings. Our change package can be adapted and used by other health systems or clinics to target prevention of diabetes or other related chronic conditions.

Differences in weight-loss outcomes among race-gender subgroups by behavioural intervention delivery mode: An analysis of the POWER trial.

Prior in-person behavioural intervention studies have documented differential weight loss between men and women and by race, with Black women receiving the least benefit. Remotely delivered interventions are now commonplace, but few studies have compared outcomes by race-gender groups and delivery modality. We conducted a secondary analysis of POWER, a randomized trial (NCT00783315) designed to determine the effectiveness of 2 active, lifestyle-based, weight loss interventions (remote vs. in-person) compared to a control group. Participants with obesity and at least one cardiovascular disease risk factor (N = 415) were recruited in the Baltimore, MD area. Data from 233 white and 170 Black individuals were used for this analysis. Following an intention-to-treat approach, we compared the mean percent weight loss at 24 months by race-gender subgroups using repeated-measures, mixed-effects models. Everyone lost weight in the active interventions however, weight loss differed by race and gender. white and Black men had similar results for both interventions (white: in-person (-7.6%) remote (-7.4%); Black: in-person (-4.7%) remote (-4.4%)). In contrast, white women lost more weight with the in-person intervention (in-person (-7.2%) compared to the remote (-4.4%)), whereas Black women lost less weight in the in-person group compared to the remote intervention at 24 months (-2.0% vs. -3.0%, respectively; p for interaction <.001). We found differences between the effectiveness of the 2 weight loss interventions-in-person or remote-in white and Black women at 24 months. Future studies should consider intervention modality when designing weight loss interventions for women.

Sex Specific Associations of Sex hormone With Brain Volumes and Cerebral Blood Flow: A Cross Sectional Observational Study Within the Look AHEAD Type 2 Diabetes Cohort.

Background: Females have greater brain volume and cerebral blood flow than males when controlling for intracranial volume and age. Brain volume decreases after menopause, suggesting a role of sex hormones. We studied the association of sex hormones with brain volume, white matter hyperintensity volumes and cerebral blood flow in people with Type 2 Diabetes and with overweight and obesity conditions that accelerate brain atrophy. Methods: We analyzed data from 215 participants with overweight or obesity and Type 2 Diabetes from the Look AHEAD Brain Magnetic Resonance Imaging ancillary study (mean age 68 years, 73% postmenopausal female). Estradiol and total testosterone levels were measured with electrochemoluminescence assays. The ratio of brain measurements to intracranial volume was analyzed to account for body size. We analyzed sex hormones as quantitative measures in males, whereas in females we grouped those with detectable vs. undetectable hormone levels (Estradiol <73 pmol/L [20 pg/mL]: 79%; Total Testosterone < 0.07 mmol/L [0.02 ng/mL]: 37% undetectable in females). Results: Females with detectable total testosterone levels had higher brain volume to intracranial volume ratio (median [25th, 75th percentile]: 0.85 [0.84, 0.86]) as compared to those with undetectable Total Testosterone levels (0.84 [0.83, 0.86]; rank sum p=0.04). This association was attenuated after age and body mass index adjustment (p=0.08). Neither white matter hyperintensity volumes or cerebral blood flow in females, nor any brain measures in males, were significantly associated with Estradiol or Total Testosterone. Conclusions: In postmenopausal females with Type 2 Diabetes with overweight and obesity, detectable levels of total testosterone were associated greater brain volume relative to intracranial volume, suggesting a protective role for testosterone in female brain health. Our findings are limited by a small sample size and low sensitivity of hormone assays. Our suggestive findings can be combined with future larger studies to assess clinically important differences. Trial Registration: NCT00017953.

Exercise and QUality diet After Leukemia (EQUAL): A randomized weight loss trial among adult survivors of childhood leukemia in the Childhood Cancer Survivor Study.

BACKGROUND: Obesity is prevalent in childhood cancer survivors and interacts with cancer treatments to potentiate risk for cardiovascular (CV) death. We tested a remote weight-loss intervention that was effective among adults with CV risk factors in a cohort of adult survivors of childhood acute lymphoblastic leukemia (ALL) with overweight/obesity. METHODS: In this phase 3 efficacy trial, survivors of ALL enrolled in the Childhood Cancer Survivor Study with body mass index (BMI)≥25 kg/m2 were randomized to a remotely-delivered weight-loss intervention versus self-directed weight loss, stratified by history of cranial radiotherapy (CRT). The primary endpoint was the difference in weight loss at 24-months in an intent-to-treat analysis. Analyses were performed using linear mixed effects models. RESULTS: Among 358 survivors (59% female, median attained age: 37 years, IQR: 33-43), baseline mean (SD) weight was 98.6 kg (24.0) for the intervention group (n=181) and 94.9 kg (20.3) for controls (n=177). Adherence to the intervention was poor; 15% of individuals in the intervention completed 24/30 planned coaching calls. Weight at 24-months was available for 274 (77%) participants. After controlling for CRT, sex, race/ethnicity, and age, the mean (SE) change in weight from baseline to 24-months was -0.4 kg (0.8) for intervention and 0.2 kg (0.6) for control participants (p=0.59). CONCLUSIONS: A remote weight-loss intervention that was successful among adults with CV conditions did not result in significant weight loss among adult survivors of childhood ALL. IMPACT: Future interventions in this population must be tailored to the unique needs of survivors to encourage engagement and adherence.