Project description:BackgroundCurrently there are limited data as to whether dietary intake can be improved during pragmatic weight loss interventions in primary care in underserved individuals.MethodsPatients with obesity were recruited into the PROPEL trial, which randomized 18 clinics to either an intensive lifestyle intervention (ILI) or usual care (UC). At baseline and months 6, 12, and 24, fruit and vegetable (F/V) intake and fat intake was determined. Outcomes were analyzed by repeated-measures linear mixed-effects multilevel models and regression models, which included random cluster (clinic) effects. Secondary analyses examined the effects of race, sex, age, and food security status.ResultsA total of 803 patients were recruited. 84.4% were female, 67.2% African American, 26.1% received Medicaid, and 65.5% made less than $40,000. No differences in F/V intake were seen between the ILI and UC groups at months 6, 12, or 24. The ILI group reduced percent fat at months 6, 12, and 24 compared to UC. Change in F/V intake was negatively correlated with weight change at month 6 whereas change in fat intake was positively associated with weight change at months 6, 12, and 24 for the ILI group.ConclusionsThe pragmatic weight loss intervention in primary care did not increase F/V intake but did reduce fat intake in an underserved population with obesity. F/V intake was negatively associated with weight loss at month 6 whereas percent fat was positively correlated with weight loss throughout the intervention. Future efforts better targeting both increasing F/V intake and reducing fat intake may promote greater weight loss in similar populations.Trial registrationNCT Registration: NCT02561221.
Project description:BackgroundEvidence of the effectiveness of treatment for obesity delivered in primary care settings in underserved populations is lacking.MethodsWe conducted a cluster-randomized trial to test the effectiveness of a high-intensity, lifestyle-based program for obesity treatment delivered in primary care clinics in which a high percentage of the patients were from low-income populations. We randomly assigned 18 clinics to provide patients with either an intensive lifestyle intervention, which focused on reduced caloric intake and increased physical activity, or usual care. Patients in the intensive-lifestyle group participated in a high-intensity program delivered by health coaches embedded in the clinics. The program consisted of weekly sessions for the first 6 months, followed by monthly sessions for the remaining 18 months. Patients in the usual-care group received standard care from their primary care team. The primary outcome was the percent change from baseline in body weight at 24 months.ResultsAll 18 clinics (9 assigned to the intensive program and 9 assigned to usual care) completed 24 months of participation; a median of 40.5 patients were enrolled at each clinic. A total of 803 adults with obesity were enrolled: 452 were assigned to the intensive-lifestyle group, and 351 were assigned to the usual-care group; 67.2% of the patients were Black, and 65.5% had an annual household income of less than $40,000. Of the enrolled patients, 83.4% completed the 24-month trial. The percent weight loss at 24 months was significantly greater in the intensive-lifestyle group (change in body weight, -4.99%; 95% confidence interval [CI], -6.02 to -3.96) than in the usual-care group (-0.48%; 95% CI, -1.57 to 0.61), with a mean between-group difference of -4.51 percentage points (95% CI, -5.93 to -3.10) (P<0.001). There were no significant between-group differences in serious adverse events.ConclusionsA high-intensity, lifestyle-based treatment program for obesity delivered in an underserved primary care population resulted in clinically significant weight loss at 24 months. (Funded by the Patient-Centered Outcomes Research Institute and others; PROPEL ClinicalTrials.gov number, NCT02561221.).
Project description:BackgroundIntensive lifestyle interventions (ILIs) stimulate weight loss in underserved patients with obesity, but the mediators of weight change are unknown.ObjectivesWe aimed to identify the mediators of weight change during an ILI compared with usual care (UC) in underserved patients with obesity.MethodsThe PROPEL (Promoting Successful Weight Loss in Primary Care in Louisiana) trial randomly assigned 18 clinics (n = 803) to either an ILI or UC for 24 mo. The ILI group received an intensive lifestyle program; the UC group had routine care. Body weight was measured; further, eating behaviors (restraint, disinhibition), dietary intake (percentage fat intake, fruit and vegetable intake), physical activity, and weight- and health-related quality of life constructs were measured through questionnaires. Mediation analyses assessed whether questionnaire variables explained between-group variations in weight change during 2 periods: baseline to month 12 (n = 779) and month 12 to month 24 (n = 767).ResultsThe ILI induced greater weight loss at month 12 compared with UC (between-group difference: -7.19 kg; 95% CI: -8.43, -6.07 kg). Improvements in disinhibition (-0.33 kg; 95% CI: -0.55, -0.10 kg), percentage fat intake (-0.25 kg; 95% CI: -0.50, -0.01 kg), physical activity (-0.26 kg; 95% CI: -0.41, -0.09 kg), and subjective fatigue (-0.28 kg; 95% CI: -0.46, -0.10 kg) at month 6 during the ILI partially explained this between-group difference. Greater weight loss occurred in the ILI at month 24, yet the ILI group gained 2.24 kg (95% CI: 1.32, 3.26 kg) compared with UC from month 12 to month 24. Change in fruit and vegetable intake (0.13 kg; 95% CI: 0.05, 0.21 kg) partially explained this response, and no variables attenuated the weight regain of the ILI group.ConclusionsIn an underserved sample, weight change induced by an ILI compared with UC was mediated by several psychological and behavioral variables. These findings could help refine weight management regimens in underserved patients with obesity.This trial was registered at clinicaltrials.gov as NCT02561221.
Project description:This study investigated associations between cardiovascular health (CVH), adiposity, and food insecurity by race, sex, and health literacy in a sample of 800 underserved patients with obesity (body mass index [BMI] ≥ 30 kg/m2). CVH was assessed using American Heart Association Life's Simple 7 (LS7) and adiposity was estimated using BMI and waist circumference (WC). Mixed models including interaction terms between food insecurity and sex, race, and health literacy were analyzed for LS7, BMI, and WC. Stratified models were analyzed as indicated by significant interactions. Mean BMI and WC were 37.3 kg/m2 (4.6 SD) and 113.5 cm (12.4 SD), respectively. Among patients, 31% were food insecure and 31% had low health literacy. There were significant positive associations between food insecurity and BMI (p = 0.03) and WC (p = 0.03) in the overall sample. In sex-stratified models, women who were food insecure had higher BMI (p = 0.02) and WC (p = 0.007) than their food secure counterparts. Further, food insecure patients with better health literacy had greater BMI (p = 0.004) and WC (p = 0.007) than their food secure counterparts. Results suggest that adiposity is a greater burden in food insecure patients, which may be an important consideration for obesity treatment in underserved populations.
Project description:BackgroundFood insecure children are at increased risk for medical and developmental problems. Effective screening and intervention are needed.MethodsOur purpose was to (1) evaluate the validity and stability of a single item food insecurity (FI) screen. (2) Assess whether use may lead to decreased FI. Part of a larger cluster randomized controlled trial, pediatric residents were assigned to SEEK or control groups. A single FI question (part of a larger questionnaire) was used on SEEK days. SEEK residents learned to screen, assess, and address FI. A subset of SEEK and control clinic parents was recruited for the evaluation. Parents completed the USDA Food Security Scale ("gold standard"), upon recruitment and 6-months later. Validity, positive and negative predictive values (PPV, NPV) was calculated. The proportion of screened families with initial and subsequent FI was measured. Screening effectiveness was evaluated by comparing SEEK and control screening rates and receipt of Supplemental Nutrition Assistance Program (SNAP) benefits between initial and 6-month assessments.ResultsFI screen stability indicated substantial agreement (Cohen's kappa =0.69). Sensitivity and specificity was 59% and 87%, respectively. The PPV was 70%; NPV was 81%. SEEK families had a larger increase in screening rates than control families (24% vs. 4.1%, p<0.01). SEEK families were more likely to maintain SNAP enrollment (97% vs. 81%, p=0.05). FI rates remained stable at approximately 30% for both groups.ConclusionsA single question screen can identify many families with FI, and may help maintain food program enrollment. Screening may not be adequate to alleviate FI.
Project description:ObjectiveThe aim of this study was to report the results of five weight-loss interventions in primary care settings in underserved patients and to compare the level of pragmatism across the interventions using the Pragmatic Explanatory Continuum Indicator Summary (PRECIS-2) tool.MethodsData from 54 primary care clinics (2,210 patients) were pooled from the Promoting Successful Weight Loss in Primary Care in Louisiana (PROPEL) and Rural Engagement in Primary Care for Optimizing Weight Reduction (REPOWER) cluster-randomized trials. Clinics were randomized to one of five comparators: PROPEL usual care, PROPEL combination of in-clinic and telephone visits, REPOWER in-clinic individual visits, REPOWER in-clinic group visits, or REPOWER telephone group visits.ResultsAt 24 months, weight loss (kilograms) was -0.50 (95% CI: -1.77 to 0.76), -3.05 (-4.10 to -2.01), -4.30 (-5.35 to -3.26), -4.79 (-5.83 to -3.75), and -4.80 (-5.96 to -3.64) in the PROPEL usual care, REPOWER in-clinic individual visits, REPOWER telephone group visits, REPOWER in-clinic group visits, and PROPEL in-clinic and telephone visits arms, respectively. At 24 months, percentage of weight loss was -0.360 (-1.60 to 0.88), -3.00 (-4.02 to -1.98), -4.23 (-5.25 to -3.20), -4.67 (-5.69 to -3.65), and -4.69 (-5.82 to -3.56), respectively, in the five arms. The REPOWER in-clinic individual visits intervention was the most pragmatic and reflects the current Centers for Medicare and Medicaid Services funding model, although this intervention produced the least weight loss.ConclusionsClinically significant weight loss over 6 months in primary care settings is achievable using a variety of lifestyle-based treatment approaches. Longer-term weight-loss maintenance is more difficult to achieve.
Project description:The aim of this study was to compute intra-class correlations (ICCs) for weight-related and patient-reported outcomes in a cluster randomized clinical trial (cRCT) for weight loss. Baseline and follow-up data from the Promoting Successful Weight Loss in Primary Care in Louisiana (PROPEL) cRCT were used in this analysis. ICCs were computed for baseline and follow-up measures, and changes in body weight, cardiometabolic risk factors and health-related and weight-related quality of life at 6, 12, 18 and 24 months. Baseline ICCs ranged from 0 for PROMIS measures of anxiety and fatigue to 0.055 for total cholesterol (median = 0.019). The ICCs were higher for changes and decreased over time during follow-up. The ICCs for changes were highest in the pooled sample (intervention and usual care combined) followed by the intervention and usual care groups, respectively. The results demonstrated significant ICCs for several outcomes in a weight loss cRCT. The ICCs differed in magnitude depending on whether baseline versus longitudinal data were used, whether data were combined across treatment arms or were considered separately, and varied across the follow-up period. All these factors must be considered when choosing an ICC to inform sample size estimates for future weight loss cRCTs conducted in primary care settings.
Project description:ObjectiveTo disentangle the relationships among food insecurity, health care utilization, and health care expenditures.Data sources/study settingWe use national data on 13 465 adults (age ≥ 18) from the 2016 Medical Expenditure Panel Survey (MEPS), the first year of the food insecurity measures.Study designWe employ two-stage empirical models (probit for any health care use/expenditure, ordinary least squares, and generalized linear models for amount of utilization/expenditure), controlling for demographics, health insurance, poverty status, chronic conditions, and other predictors.Principal findingsOur results show that the likelihood of any health care expenditure (total, inpatient, emergency department, outpatient, and pharmaceutical) is higher for marginal, low, and very low food secure individuals. Relative to food secure households, very low food secure households are 5.1 percentage points (P < .001) more likely to have any health care expenditure, and have total health care expenditures that are 24.8 percent higher (P = .011). However, once we include chronic conditions in the models (ie, high blood pressure, heart disease, stroke, emphysema, high cholesterol, cancer, diabetes, arthritis, and asthma), these underlying health conditions mitigate the differences in expenditures by food insecurity status (only the likelihood of any having any health care expenditure for very low food secure households remains statistically significant).ConclusionsPolicy makers and government agencies are focused on addressing deficiencies in social determinants of health and the resulting impacts on health status and health care utilization. Our results indicate that chronic conditions are strongly associated with food insecurity and higher health care spending. Efforts to alleviate food insecurity should consider the dual burden of chronic conditions. Finally, future research can address specific mechanisms underlying the relationships between food security, health, and health care.
Project description:IntroductionScreening for food insecurity in clinical settings is recommended, but implementation varies widely. This study evaluated the prevalence of screening for food insecurity and other social risks in telehealth versus in-person encounters during the COVID-19 pandemic and changes in screening before versus after widespread COVID-19 vaccine availability.MethodsThese cross-sectional analyses used electronic health record and ancillary clinic data from a national network of 400+ community health centers with a shared electronic health record. Food insecurity screening was characterized in 2022 in a sample of 275,465 first encounters for routine primary care at any network clinic during March 11, 2020-December 31, 2021. An adjusted multivariate multilevel probit model estimated screening prevalence on the basis of encounter mode (in-person versus telehealth) and time period (initial pandemic versus after vaccine availability) in a random subsample of 11,000 encounters.ResultsEncounter mode was related to food insecurity screening (p<0.0001), with an estimated 9.2% screening rate during in-person encounters, compared with 5.1% at telehealth encounters. There was an interaction between time period and encounter mode (p<0.0001), with higher screening prevalence at in-person versus telehealth encounters after COVID-19 vaccines were available (11.7% vs 4.9%) than before vaccines were available (7.8% vs 5.2%).ConclusionsFood insecurity screening in first primary care encounters is low overall, with lower rates during telehealth visits and the earlier phase of the COVID-19 pandemic. Future research should explore the methods for enhancing social risk screening in telehealth encounters.
Project description:ImportanceAmong individuals with obesity, 5% or greater weight loss can improve health. Weight management treatments (WMT) include nutrition counseling, very low-calorie meal replacement (MR), antiobesity medications (AOM), and bariatric surgery; however, little is known about how these WMT are associated with weight change among individual patients and populations.ObjectiveTo characterize weight status and WMT use among primary care patients and assess associations between WMT and weight trajectories.Design, setting, and participantsRetrospective, population-based cohort study of primary care patients from 1 academic health system in Michigan between October 2015 and March 2020 using cross-sectional analysis to compare obesity prevalence and WMT utilization. For patients with obesity and WMT exposure or matched controls, a multistate Markov model assessing associations between WMT and longitudinal weight status trajectories was used. Data were analyzed from October 2021 to October 2023.ExposuresCross-sectional exposure was year: 2017 or 2019. Trajectory analysis exposures were WMT: nutrition counseling, MR, AOM, and bariatric surgery.Main outcomes and measuresCross-sectional analysis compared mean body mass index (BMI), obesity prevalence, and, among patients with obesity, prospective WMT use. The trajectory analysis examined longitudinal weight status using thresholds of ±5% and 10% of baseline weight with primary outcomes being the 1-year probabilities of 5% or greater weight loss for each WMT.ResultsAdult patients (146 959 participants) consisted of 83 636 female participants (56.9%); 8940 (6.1%) were Asian, 14 560 (9.9%) were Black, and 116 664 (79.4%) were White. Patients had a mean (SD) age of 49.6 (17.7) years and mean (SD) BMI of 29.2 (7.2). Among 138 682 patients, prevalence of obesity increased from 39.2% in 2017 to 40.7% in 2019; WMT use among patients with obesity increased from 5.3% to 7.1% (difference: 1.7%; 95% CI, 1.3%-2.2%). In a multistate model (10 180 patients; 33 549 patient-years), the 1-year probability of 5% or greater weight loss without WMT exposure was 15.6% (95% CI, 14.3%-16.5%) at reference covariates. In contrast, the probability of 5% or greater weight loss was more likely with year-long exposures to any WMT (nutrition counseling: 23.1%; 95% CI, 21.3%-25.1%; MR: 54.6%; 95% CI, 46.5%-61.2%; AOM: 27.8%; 95% CI, 25.0%-30.5%; bariatric surgery: 93.0%; 95% CI, 89.7%-95.0%).Conclusions and relevanceIn this cohort study of primary-care patients with obesity, all WMT increased the patient-level probability of achieving 5% or greater weight loss, but current rates of utilization are low and insufficient to reduce weight at the population level.