Weight Loss in Underserved Patients - A Cluster-Randomized Trial.

BACKGROUND: Evidence of the effectiveness of treatment for obesity delivered in primary care settings in underserved populations is lacking. METHODS: We 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. RESULTS: All 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. CONCLUSIONS: A 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.).

Physical activity and weight loss in a pragmatic weight loss trial.

The purpose of this study was to determine the association between changes in physical activity and changes in body weight in a cluster-randomized weight loss trial conducted in an underserved population in Louisiana. This study reports analyses conducted in the intervention group only, which was a 24-month multi-component weight loss program delivered by health coaches embedded in primary care clinics. Physical activity was assessed at baseline and at 6, 12, and 24 months of follow-up and changes in body weight were expressed as percent weight change from baseline. Among the sample of 402 patients, percent changes in body weight (mean ± SE) across increasing tertiles of changes in walking between baseline and 24 months were -3.2 ± 1.0%, -5.5 ± 0.9%, and -7.3 ± 0.9%, respectively (p = 0.001). Changes in body weight across increasing tertiles of changes in moderate-to-vigorous-intensity activity between baseline and 24 months were -4.3 ± 1.0%, -5.0 ± 0.9%, and -7.0 ± 0.9%, respectively (p = 0.04). In conclusion, this multi-component intervention resulted in clinically significant weight loss, and greater increases in physical activity over the intervention period were associated with greater percent reductions in body weight. These results are consistent with those from other studies conducted primarily in non-underserved populations.

Dietary intake during a pragmatic cluster-randomized weight loss trial in an underserved population in primary care.

BACKGROUND: Currently there are limited data as to whether dietary intake can be improved during pragmatic weight loss interventions in primary care in underserved individuals. METHODS: Patients 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. RESULTS: A 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. CONCLUSIONS: The 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 REGISTRATION: NCT Registration: NCT02561221.

Exploring barriers to SARS-CoV-2 testing uptake in underserved black communities in Louisiana.

OBJECTIVE: To collect qualitative data on approaches that can potentially reduce barriers to, and create strategies for, increasing SARS-CoV-2 testing uptake in underserved Black communities in Louisiana. METHODS: A series of eight focus groups, including 41 participants, were conducted in primarily Black communities. The Nominal Group Technique (NGT) was used to determine perceptions of COVID-19 as a disease, access to testing, and barriers limiting testing uptake. RESULTS: Common barriers to SARS-CoV-2 testing were identified as lack of transportation, misinformation/lack of information, lack of time/long wait times, fear of the test being uncomfortable and/or testing positive, the cost of testing, and lack of computer/smartphone/internet. The most impactful approaches identified to increase testing uptake included providing testing within the local communities; testing specifically in heavily traveled areas such as supermarkets, churches, schools, and so forth; providing incentives; engaging local celebrities; and providing information to the community through health fairs, or through churches and schools. The strategies that were deemed to be the easiest to implement revolved around communication about testing, with suggested strategies involving churches, local celebrities or expert leaders, social media, text messages, public service announcements, post cards, or putting up signs in neighborhoods. Providing transportation to testing sites, providing incentives, and bringing the testing to neighborhoods and schools were also identified as easy to implement strategies. CONCLUSIONS: Several strategies to increase testing uptake were identified in this population. These strategies need to be tested for effectiveness in real-world settings using experimental and observational study designs.

Effects of a 2-Year Primary Care Lifestyle Intervention on Cardiometabolic Risk Factors: A Cluster-Randomized Trial.

BACKGROUND: Intensive lifestyle interventions (ILIs) are the first-line approach to effectively treat obesity and manage associated cardiometabolic risk factors. Because few people have access to ILIs in academic health centers, primary care must implement similar approaches for a meaningful effect on obesity and cardiometabolic disease prevalence. To date, however, effective lifestyle-based obesity treatment in primary care is limited. We examined the effectiveness of a pragmatic ILI for weight loss delivered in primary care among a racially diverse, low-income population with obesity for improving cardiometabolic risk factors over 24 months. METHODS: The PROPEL trial (Promoting Successful Weight Loss in Primary Care in Louisiana) randomly allocated 18 clinics equally to usual care or an ILI and subsequently enrolled 803 (351 usual care, 452 ILI) adults (67% Black, 84% female) with obesity from participating clinics. The usual care group continued to receive their normal primary care. The ILI group received a 24-month high-intensity lifestyle-based obesity treatment program, embedded in the clinic setting and delivered by health coaches in weekly sessions initially and monthly sessions in months 7 through 24. RESULTS: As recently demonstrated, participants receiving the PROPEL ILI lost significantly more weight over 24 months than those receiving usual care (mean difference, -4.51% [95% CI, -5.93 to -3.10]; P<0.01). Fasting glucose decreased more in the ILI group compared with the usual care group at 12 months (mean difference, -7.1 mg/dL [95% CI, -12.0 to -2.1]; P<0.01) but not 24 months (mean difference, -0.8 mg/dL [95% CI, -6.2 to 4.6]; P=0.76). Increases in high-density lipoprotein cholesterol were greater in the ILI than in the usual care group at both time points (mean difference at 24 months, 4.6 mg/dL [95% CI, 2.9-6.3]; P<0.01). Total:high-density lipoprotein cholesterol ratio and metabolic syndrome severity (z score) decreased more in the ILI group than in the usual care group at both time points, with significant mean differences of the change of -0.31 (95% CI, -0.47 to -0.14; P<0.01) and -0.21 (95% CI, -0.36 to -0.06; P=0.01) at 24 months, respectively. Changes in total cholesterol, low-density lipoprotein cholesterol, triglycerides, and blood pressure did not differ significantly between groups at any time point. CONCLUSIONS: A pragmatic ILI consistent with national guidelines and delivered by trained health coaches in primary care produced clinically relevant improvements in cardiometabolic health in an underserved population over 24 months. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02561221.

Comparison of weight loss data collected by research technicians versus electronic medical records: the PROPEL trial.

BACKGROUND/OBJECTIVES: Pragmatic trials are increasingly used to study the implementation of weight loss interventions in real-world settings. This study compared researcher-measured body weights versus electronic medical record (EMR)-derived body weights from a pragmatic trial conducted in an underserved patient population. SUBJECTS/METHODS: The PROPEL trial randomly allocated 18 clinics to usual care (UC) or to an intensive lifestyle intervention (ILI) designed to promote weight loss. Weight was measured by trained technicians at baseline and at 6, 12, 18, and 24 months. A total of 11 clinics (6 UC/5 ILI) with 577 enrolled patients also provided EMR data (n = 561), which included available body weights over the period of the trial. RESULTS: The total number of assessments were 2638 and 2048 for the researcher-measured and EMR-derived body weight values, respectively. The correlation between researcher-measured and EMR-derived body weights was 0.988 (n = 1 939; p < 0.0001). The mean difference between the EMR and researcher weights (EMR-researcher) was 0.63 (2.65 SD) kg, and a Bland-Altman graph showed good agreement between the two data collection methods; the upper and lower boundaries of the 95% limits of agreement are -4.65 kg and +5.91 kg, and 71 (3.7%) of the values were outside the limits of agreement. However, at 6 months, percent weight loss in the ILI compared to the UC group was 7.3% using researcher-measured data versus 5.5% using EMR-derived data. At 24 months, the weight loss maintenance was 4.6% using the technician-measured data versus 3.5% using EMR-derived data. CONCLUSION: At the group level, body weight data derived from researcher assessments and an EMR showed good agreement; however, the weight loss difference between ILI and UC was blunted when using EMR data. This suggests that weight loss studies that rely on EMR data may require larger sample sizes to detect significant effects. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov number NCT02561221.

Body mass index and movement behaviors among schoolchildren from 13 countries across a continuum of human development indices: A multinational cross-sectional study.

OBJECTIVE: This study describes the distributions of body mass index (BMI) and movement behaviors among schoolchildren from 13 countries across a continuum of human development. METHODS: Data were from a cross-sectional study of 9-11-year-old children (n = 8055) recruited from 269 urban schools in 13 countries, and an additional 7 rural schools in one of these countries (Mozambique). BMI was derived from objectively measured heights and weights. Moderate- to vigorous-intensity physical activity (MVPA), sedentary time (SED), and sleep duration were assessed by waist-worn Actigraph GT3X+ accelerometers. Linear models were used to describe the distributions of BMI z-scores, MVPA, SED, and sleep among sites across varying Human Development Indices (HDIs). RESULTS: Mean MVPA, SED, and sleep duration were 63.1 ± 27.3 minutes/day, 508.7 ± 72.4 minutes/day, and 8.8 ± 0.9 hours/night, respectively. Overall, 2.1% of the sample were thin, 19.5% overweight, and 11.7% were obese. Density curves (BMI z-scores and SED) for urban children in Mozambique showed significantly higher mean values compared with rural children. Boys had significantly higher mean MVPA compared with girls. Mean BMI z-scores were positively associated (ß = .02; P = .004) with HDI, mean daily MVPA minutes were negatively associated (ß = -.38; P = .025) with HDI, and mean SED time was positively associated with HDI (ß = 1.18; P = .049). No significant association (ß = .01; P = .29) was observed between sleep duration and HDI. CONCLUSION: Our findings show distinct differences in BMI and movement behavior profiles between urban and rural children in Mozambique. Mean BMI z-scores, MVPA, and SED differed by country HDI. These findings support the need to include both rural and urban participants in study samples.

Association between breakfast frequency and physical activity and sedentary time: a cross-sectional study in children from 12 countries.

BACKGROUND: Existing research has documented inconsistent findings for the associations among breakfast frequency, physical activity (PA), and sedentary time in children. The primary aim of this study was to examine the associations among breakfast frequency and objectively-measured PA and sedentary time in a sample of children from 12 countries representing a wide range of human development, economic development and inequality. The secondary aim was to examine interactions of these associations between study sites. METHODS: This multinational, cross-sectional study included 6228 children aged 9-11 years from the 12 International Study of Childhood Obesity, Lifestyle and the Environment sites. Multilevel statistical models were used to examine associations between self-reported habitual breakfast frequency defined using three categories (breakfast consumed 0 to 2 days/week [rare], 3 to 5 days/week [occasional] or 6 to 7 days/week [frequent]) or two categories (breakfast consumed less than daily or daily) and accelerometry-derived PA and sedentary time during the morning (wake time to 1200 h) and afternoon (1200 h to bed time) with study site included as an interaction term. Model covariates included age, sex, highest parental education, body mass index z-score, and accelerometer waking wear time. RESULTS: Participants averaged 60 (s.d. 25) min/day in moderate-to-vigorous PA (MVPA), 315 (s.d. 53) min/day in light PA and 513 (s.d. 69) min/day sedentary. Controlling for covariates, breakfast frequency was not significantly associated with total daily or afternoon PA and sedentary time. For the morning, frequent breakfast consumption was associated with a higher proportion of time in MVPA (0.3%), higher proportion of time in light PA (1.0%) and lower min/day and proportion of time sedentary (3.4 min/day and 1.3%) than rare breakfast consumption (all p ≤ 0.05). No significant associations were found when comparing occasional with rare or frequent breakfast consumption, or daily with less than daily breakfast consumption. Very few significant interactions with study site were found. CONCLUSIONS: In this multinational sample of children, frequent breakfast consumption was associated with higher MVPA and light PA time and lower sedentary time in the morning when compared with rare breakfast consumption, although the small magnitude of the associations may lack clinical relevance. TRIAL REGISTRATION: The International Study of Childhood Obesity, Lifestyle and the Environment (ISCOLE) is registered at (Identifier NCT01722500 ).

Relationships Between Outdoor Time, Physical Activity, Sedentary Time, and Body Mass Index in Children: A 12-Country Study.

PURPOSE: This study investigated the relationship between outdoor time and physical activity (PA), sedentary time (SED), and body mass index z scores among children from 12 lower-middle-income, upper-middle-income, and high-income countries. METHODS: In total, 6478 children (54.4% girls) aged 9-11 years participated. Outdoor time was self-reported, PA and SED were assessed with ActiGraph GT3X+ accelerometers, and height and weight were measured. Data on parental education, neighborhood collective efficacy, and accessibility to neighborhood recreation facilities were collected from parent questionnaires. Country latitude and climate statistics were collected through national weather data sources. Gender-stratified multilevel models with parental education, climate, and neighborhood variables as covariates were used to examine the relationship between outdoor time, accelerometry measures, and body mass index z scores. RESULTS: Each additional hour per day spent outdoors was associated with higher moderate- to vigorous-intensity PA (boys: +2.8 min/d; girls: +1.4 min/d), higher light-intensity PA (boys: +2.0 min/d; girls: +2.3 min/d), and lower SED (boys: -6.3 min/d; girls: -5.1 min/d). Effect sizes were generally weaker in lower-middle-income countries. Outdoor time was not associated with body mass index z scores. CONCLUSIONS: Outdoor time was associated with higher PA and lower SED independent of climate, parental education, and neighborhood variables, but effect sizes were small. However, more research is needed in low- and middle-income countries.

Normative Peak 30-Min Cadence (Steps per Minute) Values for Older Adults: NHANES 2005-2006.

Walking cadence (steps per minute) is associated with the intensity of ambulatory behavior. This analysis provides normative values for peak 30-min cadence, an indicator of "natural best effort" during free-living behavior. A sample of 1,196 older adults (aged from 60 to 85+) with accelerometer data from the National Health and Nutrition Examination Survey 2005-2006 was used. Peak 30-min cadence was calculated for each individual. Quintile-defined values were computed, stratified by sex and age groups. Smoothed sex-specific centile curves across the age span were fitted using the LMS method. Peak 30-min cadence generally trended lower as age increased. The uppermost quintile value was >85 steps/min (men: 60-64 years), and the lowermost quintile value was <22 steps/min (women: 85+). The highest 95th centile value was 103 steps/min (men: 64-70 years), and the lowest 5th centile value was 15 steps/min (women: 85+). These normative values may be useful for evaluating older adults' "natural best effort" during free-living ambulatory behavior.

Normative steps/day and peak cadence values for united states children and adolescents: National Health and Nutrition Examination Survey 2005-2006.

OBJECTIVE: To provide sex-and-age specific normative values for children and adolescents' accelerometer-determined steps/day, and peak 60-minute cadence adjusted to a pedometer-based scale. STUDY DESIGN: The analysis sample was 2610 children and adolescents (1329 girls) from the 2005-2006 National Health and Nutrition Examination Survey. Accelerometer data were adjusted by eliminating steps counted when activity counts/min <500. Peak 60-minute cadence represented the 60 highest minutes of accumulated steps, averaged over monitored days. Normative data included quintile-defined categories of adjusted steps/day and peak 60-minute cadence for 7 age groups (6-7, 8-9, 10-11, 12-13, 14-15, 16-17, and 18-19 years). LMSChartmakerPro produced 10 age-group-specific smoothed curves (5 for each sex) showing the 5th, 25th, 50th, 75th, and 95th percentiles, respectively, for steps/day and peak 60-minute cadence. RESULTS: Steps/day was inversely associated with age in both boys and girls. The age-associated reduction was apparent in only small decrements for boys; the girl's reduction was steeper. Boys appeared to maintain or increase their peak 60-minute cadence with increased age between 8 and 15 years of age, with a reduction apparent over the last 2 age groups investigated. The peak 60-minute cadence was more variable for girls; a similar sharp reduction (3-6 steps/min) in tandem with the steps/day was apparent between 10- to 11-year-old girls and 12- to 13-year-old girls. CONCLUSIONS: We provided detailed information and normative data pertaining to steps/d and peak 60-minute cadence in US children and adolescents. Like well-known body mass index growth curves, these data may be useful for scientists and clinical practitioners.

Improving wear time compliance with a 24-hour waist-worn accelerometer protocol in the International Study of Childhood Obesity, Lifestyle and the Environment (ISCOLE).

BACKGROUND: We compared 24-hour waist-worn accelerometer wear time characteristics of 9-11 year old children in the International Study of Childhood Obesity, Lifestyle and the Environment (ISCOLE) to similarly aged U.S. children providing waking-hours waist-worn accelerometer data in the 2003-2006 National Health and Nutrition Examination Survey (NHANES). METHODS: Valid cases were defined as having ≥4 days with ≥10 hours of waking wear time in a 24-hour period, including one weekend day. Previously published algorithms for extracting total sleep episode time from 24-hour accelerometer data and for identifying wear time (in both the 24-hour and waking-hours protocols) were applied. The number of valid days obtained and a ratio (percent) of valid cases to the number of participants originally wearing an accelerometer were computed for both ISCOLE and NHANES. Given the two surveys' discrepant sampling designs, wear time (minutes/day, hours/day) from U.S. ISCOLE was compared to NHANES using a meta-analytic approach. Wear time for the 11 additional countries participating in ISCOLE were graphically compared with NHANES. RESULTS: 491 U.S. ISCOLE children (9.92±0.03 years of age [M±SE]) and 586 NHANES children (10.43 ± 0.04 years of age) were deemed valid cases. The ratio of valid cases to the number of participants originally wearing an accelerometer was 76.7% in U.S. ISCOLE and 62.6% in NHANES. Wear time averaged 1357.0 ± 4.2 minutes per 24-hour day in ISCOLE. Waking wear time was 884.4 ± 2.2 minutes/day for U.S. ISCOLE children and 822.6 ± 4.3 minutes/day in NHANES children (difference = 61.8 minutes/day, p < 0.001). Wear time characteristics were consistently higher in all ISCOLE study sites compared to the NHANES protocol. CONCLUSIONS: A 24-hour waist-worn accelerometry protocol implemented in U.S. children produced 22.6 out of 24 hours of possible wear time, and 61.8 more minutes/day of waking wear time than a similarly implemented and processed waking wear time waist-worn accelerometry protocol. Consistent results were obtained internationally. The 24-hour protocol may produce an important increase in wear time compliance that also provides an opportunity to study the total sleep episode time separate and distinct from physical activity and sedentary time detected during waking-hours. TRIAL REGISTRATION: ClinicalTrials.gov NCT01722500 .

A model for presenting accelerometer paradata in large studies: ISCOLE.

BACKGROUND: We present a model for reporting accelerometer paradata (process-related data produced from survey administration) collected in the International Study of Childhood Obesity Lifestyle and the Environment (ISCOLE), a multi-national investigation of >7000 children (averaging 10.5 years of age) sampled from 12 different developed and developing countries and five continents. METHODS: ISCOLE employed a 24-hr waist worn 7-day protocol using the ActiGraph GT3X+. Checklists, flow charts, and systematic data queries documented accelerometer paradata from enrollment to data collection and treatment. Paradata included counts of consented and eligible participants, accelerometers distributed for initial and additional monitoring (site specific decisions in the face of initial monitoring failure), inadequate data (e.g., lost/malfunction, insufficient wear time), and averages for waking wear time, valid days of data, participants with valid data (≥4 valid days of data, including 1 weekend day), and minutes with implausibly high values (≥20,000 activity counts/min). RESULTS: Of 7806 consented participants, 7372 were deemed eligible to participate, 7314 accelerometers were distributed for initial monitoring and another 106 for additional monitoring. 414 accelerometer data files were inadequate (primarily due to insufficient wear time). Only 29 accelerometers were lost during the implementation of ISCOLE worldwide. The final locked data file consisted of 6553 participant files (90.0% relative to number of participants who completed monitoring) with valid waking wear time, averaging 6.5 valid days and 888.4 minutes/day (14.8 hours). We documented 4762 minutes with implausibly high activity count values from 695 unique participants (9.4% of eligible participants and <0.01% of all minutes). CONCLUSIONS: Detailed accelerometer paradata is useful for standardizing communication, facilitating study management, improving the representative qualities of surveys, tracking study endpoint attainment, comparing studies, and ultimately anticipating and controlling costs. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01722500.

Initial weight loss and early intervention adherence predict long-term weight loss during the Promoting Successful Weight Loss in Primary Care in Louisiana lifestyle intervention.

OBJECTIVE: This study tested whether initial weight change (WC), self-weighing, and adherence to the expected WC trajectory predict longer-term WC in an underserved primary-care population with obesity. METHODS: Data from the intervention group (n = 452; 88% women; 74% Black; BMI 37.3 kg/m2 [SD: 4.6]) of the Promoting Successful Weight Loss in Primary Care in Louisiana trial were analyzed. Initial (2-, 4-, and 8-week) percentage WC was calculated from baseline clinic weights and daily at-home weights. Weights were considered adherent if they were on the expected WC trajectory (10% at 6 months with lower [7.5%] and upper [12.5%] bounds). Linear mixed-effects models tested whether initial WC and the number of daily and adherent weights predicted WC at 6, 12, and 24 months. RESULTS: Percentage WC during the initial 2, 4, and 8 weeks predicted percentage WC at 6 (R2 = 0.15, R2 = 0.28, and R2 = 0.50), 12 (R2 = 0.11, R2 = 0.19, and R2 = 0.32), and 24 (R2 = 0.09, R2 = 0.11, and R2 = 0.16) months (all p < 0.01). Initial daily and adherent weights were significantly associated with WC as individual predictors, but they only marginally improved predictions beyond initial weight loss alone in multivariable models. CONCLUSIONS: These results highlight the importance of initial WC for predicting long-term WC and show that self-weighing and adherence to the expected WC trajectory can improve WC prediction.

Association of Abdominal Visceral Adiposity and Total Fat Mass with Cancer Incidence and Mortality in White and Black Adults.

BACKGROUND: Race modifies the association between anthropometric measures of obesity and cancer risk. However, the degree to which abdominal visceral adipose tissue (VAT) and total fat mass (FM) are associated with cancer risk is not known. METHODS: The sample included 3,017 White and 1,347 Black adults who were assessed between 1995 and 2016 and followed for outcome assessment through 2017. Abdominal VAT and FM were measured using imaging techniques. The co-primary endpoints were diagnosis of histologically confirmed invasive cancer (excluding nonmelanoma skin cancer) or death from cancer. Multivariable Cox proportional hazards models quantified the HR of incident cancer and cancer mortality. RESULTS: There were 353 incident cancer cases and 75 cancer deaths in an average of 12.9 years of follow-up. Both VAT [HR, 1.21; 95% confidence interval (CI), 1.09-1.36] and FM (HR, 1.25; 95% CI, 1.10-1.43) were significantly associated with incident cancer, while VAT (HR, 1.28; 95% CI, 1.01-1.61) was significantly associated with cancer mortality after adjustment for several covariates. VAT remained significantly associated with cancer incidence (HR, 1.22; 95% CI, 1.03-1.46) after additional inclusion of FM in the multivariable model, but not vice versa. There were no significant sex- or race-interactions. CONCLUSIONS: VAT was associated with risk of cancer and cancer mortality in this cohort, and the associations did not differ by sex or race. The association between VAT and incident cancer was largely independent of total FM. IMPACT: Our results suggest that utility of anthropometry in assessing obesity-related cancer risk may need to be further refined by including more direct measures of adiposity.

Intraclass correlation coefficients for weight loss cluster randomized trials in primary care: The PROPEL trial.

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.

Mediators of weight change in underserved patients with obesity: exploratory analyses from the Promoting Successful Weight Loss in Primary Care in Louisiana (PROPEL) cluster-randomized trial.

BACKGROUND: Intensive lifestyle interventions (ILIs) stimulate weight loss in underserved patients with obesity, but the mediators of weight change are unknown. OBJECTIVES: We aimed to identify the mediators of weight change during an ILI compared with usual care (UC) in underserved patients with obesity. METHODS: The 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). RESULTS: The 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. CONCLUSIONS: In 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.

Obesity and cancer death in white and black adults: A prospective cohort study.

OBJECTIVE: This study aimed to determine whether race modifies the association between obesity and cancer death. METHODS: The Pennington Center Longitudinal Study included 18,296 adults; 35.0% were male and 34.3% were Black. The primary end point was death from cancer. RESULTS: During a follow-up of 14.3 years, 346 cancer deaths occurred. Among men, race modified the association of BMI and cancer death (pinteraction = 0.045); compared with a BMI of 22 kg/m2 , a BMI of 35 in White men was associated with a hazard ratio of 1.74 (95% CI: 1.38-2.21), and in Black men, the hazard ratio was 0.64 (95% CI: 0.45-0.90). Among women, race did not modify the association of BMI and cancer death (pinteraction =0.43); however, compared with a BMI of 22, a BMI of 35 in White women was associated with a hazard ratio of 1.42 (95% CI: 1.18-1.70) and in Black women, the hazard ratio was 0.99 (95% CI: 0.82-1.20). CONCLUSIONS: In this diverse cohort of adults, having obesity was associated with an increased risk of cancer death in White men and women. In contrast, having obesity was associated with a reduced risk of cancer death in Black men and did not influence risk in Black women.

Obesity and Cancer Risk in White and Black Adults: A Prospective Cohort Study.

OBJECTIVE: Anthropometric measures of obesity, including BMI and waist circumference (WC), do not quantify excess adiposity and metabolic abnormalities consistently across racial populations. This study tested the hypothesis that participant race modifies the association of anthropometric measures of obesity and cancer risk. METHODS: This prospective cohort (The Pennington Center Longitudinal Study) included 18,296 adults, 6,405 (35.0%) male sex and 6,273 (34.3%) Black race. The primary exposures were BMI (weight in kilograms/height in meters squared) and WC (centimeters). The primary end point was the time from study enrollment to diagnosis of histologically confirmed invasive cancer. RESULTS: During a median follow-up of 14.0 years (interquartile range: 9.8-19.0 years), invasive cancer occurred in 1,350 participants. Among men, race modified the association of BMI (Pinteraction = 0.02) and WC (Pinteraction = 0.01) with cancer incidence; compared with a BMI of 22 kg/m2 , a BMI of 35 kg/m2 in White men was associated with a hazard ratio of 1.83 (95% CI: 1.58-2.12), whereas in Black men, the hazard ratio was 0.89 (95% CI: 0.72-1.11). Among women, race did not modify the association of BMI (Pinteraction = 0.41) or WC (Pinteraction = 0.36) with cancer incidence. CONCLUSIONS: In this diverse cohort of adults, participant race and sex modified the prognostic associations of anthropometric measures of obesity and cancer risk.

Trends in Adiposity and Food Insecurity Among US Adults.

Importance: Food insecurity is a pervasive public health issue in the US that is associated with greater body weight. Objective: To examine national trends in food insecurity among US adults from 1999 to 2016 according to surrogate measures of adiposity (body mass index [BMI] and waist circumference [WC]). Design, Setting, and Participants: This cross-sectional study analyzed nationally representative data obtained from nine 2-year cycles (1999 to 2000 through 2015 to 2016) of the National Health and Nutrition Examination Survey in the US. The sample comprised adult survey participants aged 20 years or older. Data analyses were performed from July 1, 2019, to March 31, 2020. Main Outcomes and Measures: The primary outcome was food insecurity. Data on BMI (calculated as weight in kilograms divided by height in meters squared) were categorized as follows: normal weight (BMI, <25), overweight (BMI, 25-29.9), and obese (BMI, ≥30). Data on WC were categorized as follows: less high risk (men: ≤102 cm; women: ≤88 cm) or high risk (men: >102 cm; women: >88 cm). Food insecurity prevalence by adiposity was further analyzed using key demographic characteristics, including sex and race/ethnicity (non-Hispanic White, non-Hispanic Black, Hispanic, and Other). Results: Among the 46 145 adults in the final sample, the mean (SD) age was 46.9 (0.2) years. Of this sample, 23 957 were women (52.0%; 95% CI, 51.6%-52.5%) and 20 825 were non-Hispanic White adults (68.8%; 95% CI, 66.6%-71.0%). The estimated prevalence of food insecurity was 18.2% (95% CI, 15.3%-21.2%) in the 2015 to 2016 cycle, a statistically significant change from 8.7% (95% CI, 7.3%-10.2%) in the 1999 to 2000 cycle. Among all adiposity categories, food insecurity prevalence significantly increased from the 1999 to 2000 cycle to the 2015 to 2016 cycle. The prevalence of food insecurity was highest in adults with obesity (22.6%; 95% CI, 19.5%-25.8%; P for trend <.001). For both men and women, food insecurity prevalence significantly increased from the 1999 to 2000 cycle (men: 8.8% [95% CI, 6.9%-10.6%]; women: 8.7% [95% CI, 7.0%-10.5%]) to the 2015 to 2016 cycle (men: 17.2% [95% CI, 14.1%-20.2%]; women: 19.2% [95% CI, 16.2%-22.2%]; P for trends <.001). For non-Hispanic White and non-Hispanic Black adults, food insecurity prevalence increased from the 1999 to 2000 cycle (non-Hispanic White: 6.0% [95% CI, 4.0%-8.0%]; non-Hispanic Black: 12.4% [95% CI, 9.6%-15.2%]) to the 2015 to 2016 cycle (non-Hispanic White: 13.0% [95% CI, 9.8%-16.3%]; non-Hispanic Black: 29.1% [95% CI, 24.2%-34.0%]; P for trends <.001). For Hispanic adults, food insecurity prevalence significantly increased in those with obesity (1999-2000: 19.1% [95% CI, 12.0%-26.1%]; 2015-2016: 37.6% [95% CI, 33.7%-41.5%]; P for trend ≤.001) and in both less-high-risk WC (1999-2000: 19.6% [95% CI, 12.8%-26.4%]; 2015-2016: 32.5% [95% CI, 27.3%-37.7%]; P for trend = .02) and high-risk WC categories (1999-2000: 19.3% [95% CI, 12.7%-25.9%]; 2015-2016: 36.7% [95% CI, 31.7%-41.7%]; P for trend <.001). Conclusions and Relevance: In this cross-sectional study, the estimated prevalence of food insecurity appeared to increase from 1999 to 2016 and across all levels of adiposity. These results suggest the need for multidisciplinary approaches to address the association between food insecurity and obesity in the US.