Associations between food and beverage purchases and skin carotenoids among diverse small food retail store customers.

OBJECTIVE: To determine if customer purchases at small food stores are associated with healthfulness of the diet as approximated by skin carotenoids. DESIGN: This is a cross-sectional survey of customers in small food stores regarding demographics and food purchases. Food and beverage purchases were classified as 'healthy' or 'non-healthy' and 'carotenoid' v. 'non-carotenoid' using a systematic classification scheme. Fruit and vegetable intake was objectively assessed using a non-invasive device to measure skin carotenoids. Associations between variables of interest were examined using Pearson's correlation coefficients, t tests and multiple linear regression analyses. SETTING: Twenty-two small food retail stores in rural (n 7 stores) and urban (n 15) areas of North Carolina. PARTICIPANTS: Customers of small food stores. RESULTS: Of study participants (n 1086), 55·1 % were male, 60·0 % were African American/Black and 4·2 % were Hispanic, with a mean age of 43·5 years. Overall, 36 % purchased at least one healthy item, and 7·6 % of participants purchased a carotenoid-containing food/beverage. Healthy foods and beverages purchased included produce, lean meats, 100 % juices, plain popcorn, plain nuts, milk and yogurt. Unhealthy items included non-100 % juices, crackers, chips, candy, cakes and donuts. Purchase of a healthy or carotenoid-containing item was positively associated with skin carotenoid scores (P = 0·002 and 0·006, respectively). CONCLUSIONS: A relatively small proportion of customers purchased any healthy or carotenoid-containing foods and beverages, and those who did purchase healthy options had higher skin carotenoid scores. Future research should confirm these findings in different populations.

A four-year observational study to examine the dietary impact of the North Carolina Healthy Food Small Retailer Program, 2017-2020.

BACKGROUND: The North Carolina (NC) Healthy Food Small Retailer Program (HFSRP) was passed into law with a $250,000 appropriation (2016-2018) providing up to $25,000 in funding to small food stores for equipment to stock healthier foods and beverages. This paper describes an observational natural experiment documenting the impact of the HFSRP on store food environments, customers' purchases and diets. METHODS: Using store observations and intercept surveys from cross-sectional, convenience customer samples (1261 customers in 22 stores, 2017-2020; 499 customers in 7 HFSRP stores, and 762 customers in 15 Comparison stores), we examined differences between HFSRP and comparison stores regarding: (1) change in store-level availability, quality, and price of healthy foods/beverages; (2) change in healthfulness of observed food and beverage purchases ("bag checks"); and, (3) change in self-reported and objectively-measured (Veggie Meter®-assessed skin carotenoids) customer dietary behaviors. Differences (HFSRP vs. comparison stores) in store-level Healthy Food Supply (HFS) and Healthy Eating Index-2010 scores were assessed using repeated measure ANOVA. Intervention effects on diet were assessed using difference-in-difference models including propensity scores. RESULTS: There were improvements in store-level supply of healthier foods/beverages within 1 year of program implementation (0 vs. 1-12 month HFS scores; p = 0.055) among HFSRP stores only. Comparing 2019 to 2017 (baseline), HFSRP stores' HFS increased, but decreased in comparison stores (p = 0.031). Findings indicated a borderline significant effect of the intervention on self-reported fruit and vegetable intake (servings/day), though in the opposite direction expected, such that fruit and vegetable intake increased more among comparison store than HFSRP store customers (p = 0.05). There was no significant change in Veggie Meter®-assessed fruit and vegetable intake by customers shopping at the intervention versus comparison stores. CONCLUSIONS: Despite improvement in healthy food availability, there was a lack of apparent impact on dietary behaviors related to the HFSRP, which could be due to intervention dose or inadequate statistical power due to the serial cross-sectional study design. It may also be that individuals buy most of their food at larger stores; thus, small store interventions may have limited impact on overall eating patterns. Future healthy retail policies should consider how to increase intervention dose to include more product marketing, consumer messaging, and technical assistance for store owners.

Dietary patterns and associations with BMI in low-income, ethnic minority youth in the USA according to baseline data from four randomised controlled trials.

Few studies have derived data-driven dietary patterns in youth in the USA. This study examined data-driven dietary patterns and their associations with BMI measures in predominantly low-income, racial/ethnic minority US youth. Data were from baseline assessments of the four Childhood Obesity Prevention and Treatment Research (COPTR) Consortium trials: NET-Works (534 2-4-year-olds), GROW (610 3-5-year-olds), GOALS (241 7-11-year-olds) and IMPACT (360 10-13-year-olds). Weight and height were measured. Children/adult proxies completed three 24-h dietary recalls. Dietary patterns were derived for each site from twenty-four food/beverage groups using k-means cluster analysis. Multivariable linear regression models examined associations of dietary patterns with BMI and percentage of the 95th BMI percentile. Healthy (produce and whole grains) and Unhealthy (fried food, savoury snacks and desserts) patterns were found in NET-Works and GROW. GROW additionally had a dairy- and sugar-sweetened beverage-based pattern. GOALS had a similar Healthy pattern and a pattern resembling a traditional Mexican diet. Associations between dietary patterns and BMI were only observed in IMPACT. In IMPACT, youth in the Sandwich (cold cuts, refined grains, cheese and miscellaneous) compared with Mixed (whole grains and desserts) cluster had significantly higher BMI (ß = 0·99 (95 % CI 0·01, 1·97)) and percentage of the 95th BMI percentile (ß = 4·17 (95 % CI 0·11, 8·24)). Healthy and Unhealthy patterns were the most common dietary patterns in COPTR youth, but diets may differ according to age, race/ethnicity or geographic location. Public health messages focused on healthy dietary substitutions may help youth mimic a dietary pattern associated with lower BMI.

Perceived barriers and facilitators to participating in the North Carolina Healthy Food Small Retailer Program: a mixed-methods examination considering investment effectiveness.

OBJECTIVE: The North Carolina Legislature appropriated funds in 2016-2019 for the Healthy Food Small Retailer Program (HFSRP), providing small retailers located in food deserts with equipment to stock nutrient-dense foods and beverages. The study aimed to: (1) examine factors facilitating and constraining implementation of, and participation in, the HFSRP from the perspective of storeowners and (2) measure and evaluate the impact and effectiveness of investment in the HFSRP. DESIGN: The current analysis uses both qualitative and quantitative assessments of storeowner perceptions and store outcomes, as well as two innovative measures of policy investment effectiveness. Qualitative semi-structured interviews and descriptive quantitative approaches, including monthly financial reports and activity forms, and end-of-programme evaluations were collected from participating HFSRP storeowners. SETTING: Eight corner stores in North Carolina that participated in the two cohorts (2016-2018; 2017-2019) of the HFSRP. PARTICIPANTS: Owners of corner stores participating in the HFSRP. RESULTS: All storeowners reported that the HFSRP benefitted their stores. In addition, the HFSRP had a positive impact on sales across each category of healthy food products. Storeowners reported that benefits would be enhanced with adjustments to programme administration and support. Specific suggestions included additional information regarding which healthy foods and beverages to stock; inventory management; handling of perishable produce; product display; modified reporting requirements and a more efficient process of delivering and maintaining equipment. CONCLUSIONS: All storeowners reported several benefits of the HFSRP and would recommend that other storeowners participate. The barriers and challenges they reported inform potential approaches to ensuring success and sustainability of the HFSRP and similar initiatives underway in other jurisdictions.

Associations between shopping patterns, dietary behaviours and geographic information system-assessed store accessibility among small food store customers.

OBJECTIVE: To examine associations between geographic information systems (GIS)-assessed accessibility to small food stores, shopping patterns and dietary behaviours among small food store customers. DESIGN: Residential addresses and customer shopping patterns (frequency of shopping, and previous purchase of fruits and vegetables) were gathered through customer intercept surveys. Addresses were geocoded, and GIS-assessed distance and driving time from the participants' residence to the store were calculated. Dietary status and behaviours were assessed using an objective non-invasive measure of skin carotenoids, the National Cancer Institute Fruit and Vegetable Screener, and items to assess sugary beverage intake. Associations between distance and driving time, demographics, shopping frequency, prior reported purchase of fruits and vegetables at the store and dietary behaviours were examined. SETTING: Small food stores (n 22) across North Carolina. PARTICIPANTS: Cross-sectional convenience samples of English-speaking customers aged 18 years or older (n 692). RESULTS: Participants living closer to the small store had lower income and formal education, were more likely to be Black, more likely to have previously bought fruits and vegetables at the store and more frequently shopped at the store. In adjusted models, skin carotenoids (n 644) were positively associated with distance to the store from home in miles (P = 0·01). CONCLUSIONS: Customers who lived closer to the stores were more frequent shoppers and more likely to have previously purchased fruits and vegetables at the store yet had lower skin carotenoids. These results support continued efforts to examine how to increase the availability and promotion of healthful foods at small food retail stores.

Snacking characteristics and patterns and their associations with diet quality and BMI in the Childhood Obesity Prevention and Treatment Research Consortium.

OBJECTIVE: To describe snacking characteristics and patterns in children and examine associations with diet quality and BMI. DESIGN: Children's weight and height were measured. Participants/adult proxies completed multiple 24 h dietary recalls. Snack occasions were self-identified. Snack patterns were derived for each sample using exploratory factor analysis. Associations of snacking characteristics and patterns with Healthy Eating Index-2010 (HEI-2010) score and BMI were examined using multivariable linear regression models. SETTING: Childhood Obesity Prevention and Treatment Research (COPTR) Consortium, USA: NET-Works, GROW, GOALS and IMPACT studies. PARTICIPANTS: Predominantly low-income, racial/ethnic minorities: NET-Works (n 534, 2-4-year-olds); GROW (n 610, 3-5-year-olds); GOALS (n 241, 7-11-year-olds); IMPACT (n 360, 10-13-year-olds). RESULTS: Two snack patterns were derived for three studies: a meal-like pattern and a beverage pattern. The IMPACT study had a similar meal-like pattern and a dairy/grains pattern. A positive association was observed between meal-like pattern adherence and HEI-2010 score (P for trend < 0⋅01) and snack occasion frequency and HEI-2010 score (ß coefficient (95 % CI): NET-Works, 0⋅14 (0⋅04, 0⋅23); GROW, 0⋅12 (0⋅02, 0⋅21)) among younger children. A preference for snacking while using a screen was inversely associated with HEI-2010 score in all studies except IMPACT (ß coefficient (95 % CI): NET-Works, -3⋅15 (-5⋅37, -0⋅92); GROW, -2⋅44 (-4⋅27, -0⋅61); GOALS, -5⋅80 (-8⋅74, -2⋅86)). Associations with BMI were almost all null. CONCLUSIONS: Meal-like and beverage patterns described most children's snack intake, although patterns for non-Hispanic Blacks or adolescents may differ. Diets of 2-5-year-olds may benefit from frequent meal-like pattern snack consumption and diets of all children may benefit from decreasing screen use during eating occasions.

A non-invasive assessment of skin carotenoid status through reflection spectroscopy is a feasible, reliable and potentially valid measure of fruit and vegetable consumption in a diverse community sample.

OBJECTIVE: To assess the feasibility, reliability and validity of reflection spectroscopy (RS) to assess skin carotenoids in a racially diverse sample. DESIGN: Study 1 was a cross-sectional study of corner store customers (n 479) who completed the National Cancer Institute Fruit and Vegetable Screener as well as RS measures. Feasibility was assessed by examining the time it took to complete three RS measures, reliability was assessed by examining the variation between three RS measures, and validity was examined by correlation with self-reported fruit and vegetable consumption. In Study 2, validity was assessed in a smaller sample (n 30) by examining associations between RS measures and dietary carotenoids, fruits and vegetables as calculated from a validated FFQ and plasma carotenoids. SETTING: Eastern North Carolina, USA. RESULTS: It took on average 94·0 s to complete three RS readings per person. The average variation between three readings for each participant was 6·8 %. In Study 2, in models adjusted for age, race and sex, there were statistically significant associations between RS measures and (i) FFQ-estimated carotenoid intake (P<0·0001); (ii) FFQ-estimated fruit and vegetable consumption (P<0·010); and (iii) plasma carotenoids (P<0·0001). CONCLUSIONS: RS is a potentially improved method to approximate fruit and vegetable consumption among diverse participants. RS is portable and easy to use in field-based public health nutrition settings. More research is needed to investigate validity and sensitivity in diverse populations.

Effect of a Behavioral Intervention for Underserved Preschool-Age Children on Change in Body Mass Index: A Randomized Clinical Trial.

Importance: Prevention of obesity during childhood is critical for children in underserved populations, for whom obesity prevalence and risk of chronic disease are highest. Objective: To test the effect of a multicomponent behavioral intervention on child body mass index (BMI, calculated as weight in kilograms divided by height in meters squared) growth trajectories over 36 months among preschool-age children at risk for obesity. Design, Setting, and Participants: A randomized clinical trial assigned 610 parent-child pairs from underserved communities in Nashville, Tennessee, to a 36-month intervention targeting health behaviors or a school-readiness control. Eligible children were between ages 3 and 5 years and at risk for obesity but not yet obese. Enrollment occurred from August 2012 to May 2014; 36-month follow-up occurred from October 2015 to June 2017. Interventions: The intervention (n = 304 pairs) was a 36-month family-based, community-centered program, consisting of 12 weekly skills-building sessions, followed by monthly coaching telephone calls for 9 months, and a 24-month sustainability phase providing cues to action. The control (n = 306 pairs) consisted of 6 school-readiness sessions delivered over the 36-month study, conducted by the Nashville Public Library. Main Outcomes and Measures: The primary outcome was child BMI trajectory over 36 months. Seven prespecified secondary outcomes included parent-reported child dietary intake and community center use. The Benjamini-Hochberg procedure corrected for multiple comparisons. Results: Participants were predominantly Latino (91.4%). At baseline, the mean (SD) child age was 4.3 (0.9) years; 51.9% were female. Household income was below $25 000 for 56.7% of families. Retention was 90.2%. At 36 months, the mean (SD) child BMI was 17.8 (2.2) in the intervention group and 17.8 (2.1) in the control group. No significant difference existed in the primary outcome of BMI trajectory over 36 months (P = .39). The intervention group children had a lower mean caloric intake (1227 kcal/d) compared with control group children (1323 kcal/d) (adjusted difference, -99.4 kcal [95% CI, -160.7 to -38.0]; corrected P = .003). Intervention group parents used community centers with their children more than control group parents (56.8% in intervention; 44.4% in control) (risk ratio, 1.29 [95% CI, 1.08 to 1.53]; corrected P = .006). Conclusions and Relevance: A 36-month multicomponent behavioral intervention did not change BMI trajectory among underserved preschool-age children in Nashville, Tennessee, compared with a control program. Whether there would be effectiveness for other types of behavioral interventions or implementation in other cities would require further research. Trial Registration: ClinicalTrials.gov Identifier: NCT01316653.

Beyond the dinner table: who's having breakfast, lunch and dinner family meals and which meals are associated with better diet quality and BMI in pre-school children?

OBJECTIVE: Having frequent family dinners is associated with better diet quality in children; however, it is unknown whether the frequency of certain family meal types (i.e. dinner) is more strongly associated with better child weight and diet quality compared with other meal types (i.e. breakfast, lunch). Thus, the current study examined the frequency of eating breakfast, lunch or dinner family meals and associations with pre-school children's overall diet quality (HEI-2010) and BMI percentile. DESIGN: Cross-sectional baseline data (2012-2014) from two randomized controlled childhood obesity prevention trials, NET-Works and GROW, were analysed together. SETTING: Studies were carried out in community and in-home settings in urban areas of Minnesota and Tennessee, USA. SUBJECTS: Parent-child (ages 2-5 years) pairs from Minnesota (n 222 non-Hispanics; n 312 Hispanics) and Tennessee (n 545 Hispanics; n 55 non-Hispanics) participated in the study. RESULTS: Over 80 % of families ate breakfast or lunch family meals at least once per week. Over 65 % of families ate dinner family meals ≥5 times/week. Frequency of breakfast family meals and total weekly family meals were significantly associated with healthier diet quality for non-Hispanic pre-school children (P<0·05), but not for Hispanic children. Family meal frequency by meal type was not associated with BMI percentile for non-Hispanic or Hispanic pre-school children. CONCLUSIONS: Breakfast family meal frequency and total weekly family meal frequency were associated with healthier diet quality in non-Hispanic pre-school children but not in Hispanic children. Longitudinal research is needed to clarify the association between family meal type and child diet quality and BMI percentile.

Body mass index at early adulthood, subsequent weight change and cancer incidence and mortality.

Obesity later in adulthood is associated with increased risks of many cancers. However, the effect of body fatness in early adulthood, and change in weight from early to later adulthood on cancer risk later in life is less clear. We used data from 13,901 people aged 45-64 in the Atherosclerosis Risk in Communities cohort who at baseline (1987-1989) self-reported their weight at the age of 25 and had weight and height measured. Incident cancers were identified through 2006 and cancer deaths were ascertained through 2009. Multivariable Cox proportional hazard models were used to relate body mass index (BMI) at age 25 and percent weight change from age 25 to baseline to cancer incidence and mortality. After adjusting for weight change from age 25 until baseline, a 5 kg/m(2) increment in BMI at age 25 was associated with a greater risk of incidence of all cancers in women [hazard ratio (95% confidence interval): 1.10 (1.02-1.20)], but not in men. Associations with incident endometrial cancer were strong [1.83 (1.47-2.26)]. After adjusting for BMI at age 25, a 5% increment in weight from age 25 to baseline was associated with a greater risk of incident postmenopausal breast cancer [1.05 (1.02-1.07)] and endometrial cancer [1.09 (1.04-1.14)] in women and incident colorectal cancer [1.05 (1.00-1.10)] in men. Excess weight during young adulthood and weight gain from young to older adulthood may be independently associated with subsequent cancer risk. Excess weight and weight gain in early adulthood should be avoided.

Long- and short-term weight change and incident coronary heart disease and ischemic stroke: the Atherosclerosis Risk in Communities Study.

Weight gain increases the prevalence of obesity, a risk factor for cardiovascular disease. Nevertheless, unintentional weight loss can be a harbinger of health problems. The Atherosclerosis Risk in Communities Study (1987-2009) included 15,792 US adults aged 45-64 years at baseline and was used to compare associations of long-term (30 years) and short-term (3 years) weight change with the risks of coronary heart disease (CHD) and ischemic stroke. Age-, gender-, and race-standardized incidence rates were 4.9 (95% confidence interval (CI): 4.6, 5.2) per 1,000 person-years for CHD and 2.5 (95% CI: 2.3, 2.8) per 1,000 person-years for stroke. After controlling for baseline body mass index and other covariates, long-term weight gain (since age 25 years) of more than 2.7% was associated with elevated CHD risk, and any long-term weight gain was associated with increased stroke risk. Among middle-aged adults, short-term (3-year) weight loss of more than 3% was associated with elevated immediate CHD risk (hazard ratio = 1.46, 95% CI: 1.18, 1.81) and stroke risk (hazard ratio = 1.45, 95% CI: 1.10, 1.92). Risk tended to be larger in adults whose weight loss did not occur through dieting. Avoidance of weight gain between early and middle adulthood can reduce risks of CHD and stroke, but short-term, unintentional weight loss in middle adulthood may be an indicator of immediate elevated risk that has not previously been well recognized.

Ultra-processed food consumption and BMI-Z among children at risk for obesity from low-income households.

OBJECTIVE: To evaluate the association between baseline ultra-processed food consumption in early childhood and child BMI Z-score over 36 months. METHODS: We conducted a prospective cohort analysis as a secondary data analysis of the Growing Right Onto Wellness randomised trial. Dietary intake was measured via 24-h diet recalls. The primary outcome was child BMI-Z, measured at baseline and at 3-, 9-, 12-, 24- and 36-month timepoints. Child BMI-Z was modelled using a longitudinal mixed-effects model, adjusting for covariates and stratifying by age. RESULTS: Among 595 children, median (Q1-Q3) baseline age was 4.3 (3.6-5.0) years, 52.3% of the children were female, 65.4% had normal weight, 33.8% were overweight, 0.8% were obese and 91.3% of parents identified as Hispanic. Model-based estimates suggest that, compared with low ultra-processed consumption (300 kcals/day), high ultra-processed intake (1300 kcals/day) was associated with a 1.2 higher BMI-Z at 36 months for 3-year-olds (95% CI = 0.5, 1.9; p < 0.001) and a 0.6 higher BMI-Z for 4-year-olds (95% CI = 0.2, 1.0; p = 0.007). The difference was not statistically significant for 5-year-olds or overall. CONCLUSIONS: In 3- and 4-year-old children, but not in 5-year-old children, high ultra-processed food intake at baseline was significantly associated with higher BMI-Z at 36-month follow-up, adjusting for total daily kcals. This suggests that it might not be only the total number of calories in a child's daily intake that influences child weight status, but also the number of calories from ultra-processed foods.

Reliability and validity of assigning ultraprocessed food categories to 24-h dietary recall data.

BACKGROUND: The Nova classification system categorizes foods into 4 processing levels, including ultraprocessed foods (UPFs). Consumption of UPFs is extensive in the United States, and high UPF consumption is associated with chronic disease risk. A reliable and valid method to Nova-categorize foods would advance understanding of UPF consumption and its relationship to health outcomes. OBJECTIVES: Test the reliability and validity of training coders and assigning Nova categories to individual foods collected via 24-h dietary recalls. DESIGN: A secondary analysis of 24-h dietary recalls from 610 children who participated in a randomized controlled trial and were 3-5 y old at baseline was conducted. The Nutrition Data System for Research (NDSR) software was used to collect 2-3 dietary recalls at baseline and yearly for 3 y. Trained and certified coder pairs independently categorized foods into one of 4 Nova categories (minimally processed, processed culinary ingredients, processed, and ultraprocessed). Interrater reliability was assessed by percent concordance between coder pairs and by Cohen's κ coefficient. Construct validity was evaluated by comparing the average daily macronutrient content of foods between Nova categories. RESULTS: In 5546 valid recall days, 3099 unique foods were categorized: minimally processed (18%), processed culinary ingredients (0.4%), processed (15%), and ultraprocessed (67%). Coder concordance = 88.3%, and κ coefficient = 0.75. Descriptive comparisons of macronutrient content across 66,531 diet recall food entries were consistent with expectations. On average, UPFs were 62% (SD 19) of daily calories, and a disproportionally high percentage of daily added sugar (94%; SD 16) and low percentage of daily protein (47%; SD 24). Minimally processed foods were 30% (SD 17) of daily calories, and a disproportionally low percentage of daily added sugar (1%; SD 8) and high percentage of daily protein (43%; SD 24). CONCLUSIONS: This method of Nova classifying NDSR-based 24-h dietary recalls was reliable and valid for identifying individual intake of processed foods, including UPFs.

Validation of a new scoring approach of a child dietary questionnaire for use in early childhood among low-income, Latino populations.

BACKGROUND: Measuring diet quality in early childhood requires time-intensive and costly measurements (e.g., 24-hour diet recall) that are especially burdensome for low-income, minority populations. This study aimed to validate a new method for calculating overall diet quality among low-income, Latino preschoolers. METHODS: This study was an observational study using data from a randomized controlled trial. Participants included parents of Latino preschoolers who reported child diet quality at baseline, 4-month, 7-month, 12-month, and 13-month follow-up. At each timepoint parents responded to a 28-item child dietary questionnaire (CDQ), based on the National Health and Nutrition Examination Survey (NHANES) dietary module, which generated the number of times/day that a child ate each of 28 foods in the past month. These 28 items were then used to create a total standardized child diet quality index (possible range 0-100), using a percent of maximum method. Parents were asked to complete three 24-hour diet recalls at the 13-month follow-up, from which the 2015 Healthy Eating Index (HEI) was derived. Construct validity was evaluated by Spearman's rank correlations between the new child diet quality index and the 2015 HEI at the 13-month follow-up. Test-retest reliability was assessed by intraclass correlation coefficients (ICC) for sequential pairs of time points. RESULTS: Among 71 eligible parent-child pairs, mean child age was 4.2 (SD = 0.8) years, 50.7% of children were female, and mean child body mass index (BMI) was 17.8 (SD = 2.0) kg/m2. Mean Child Diet Quality Index was 45.2 (SD = 3.2) and mean HEI was 68.4 (SD = 10.5). Child Diet Quality Index and HEI total scores were significantly correlated (r = 0.37; p = 0.001). Test-retest ICCs were statistically significant between all sequential pairs of time points. CONCLUSION: The new approach for calculating a measure of overall diet quality from the previously-validated 28-item dietary questionnaire demonstrated modest construct validity. When time and resources are limited, this new measure of overall diet quality may be an appropriate choice among low-income, Latino preschoolers. TRIAL REGISTRATION: This reports presents observational data collected as a part of a clinical trial, which was registered on clinicaltrials.gov prior to participant enrollment (NCT03141151).

Efficacy of a Commercial Weight Management Program Compared With a Do-It-Yourself Approach: A Randomized Clinical Trial.

Importance: Given the prevalence of obesity, accessible and effective treatment options are needed to manage obesity and its comorbid conditions. Commercial weight management programs are a potential solution to the lack of available treatment, providing greater access at lower cost than clinic-based approaches, but few commercial programs have been rigorously evaluated. Objective: To compare the differences in weight change between individuals randomly assigned to a commercial weight management program and those randomly assigned to a do-it-yourself (DIY) approach. Design, Setting, and Participants: This 1-year, randomized clinical trial conducted in the United States, Canada, and United Kingdom between June 19, 2018, and November 30, 2019, enrolled 373 adults aged 18 to 75 years with a body mass index (BMI; calculated as weight in kilograms divided by height in meters squared) of 25 to 45. Assessors were blinded to treatment conditions. Interventions: A widely available commercial weight management program that included reduced requirements for dietary self-monitoring and recommendations for a variety of DIY approaches to weight loss. Main Outcomes and Measures: The primary outcomes were the difference in weight change between the 2 groups at 3 and 12 months. The a priori hypothesis was that the commercial program would result in greater weight loss than the DIY approach at 3 and 12 months. Analyses were performed on an intention-to-treat basis. Results: The study include 373 participants (272 women [72.9%]; mean [SD] BMI, 33.8 [5.2]; 77 [20.6%] aged 18-34 years, 74 [19.8%] aged 35-43 years, 82 [22.0%] aged 44-52 years, and 140 [37.5%] aged 53-75 years). At 12 months, retention rates were 88.8% (166 of 187) for the commercial weight management program group and 95.7% (178 of 186) for the DIY group. At 3 months, participants in the commercial program had a mean (SD) weight loss of -3.8 (4.1) kg vs -1.8 (3.7) kg among those in the DIY group. At 12 months, participants in the commercial program had a mean (SD) weight loss of -4.4 (7.3) kg vs -1.7 (7.3) kg among those in the DIY group. The mean difference between groups was -2.0 kg (97.5% CI, -2.9 to -1.1 kg) at 3 months (P < .001) and -2.6 kg (97.5% CI, -4.3 to -0.8 kg) at 12 months (P < .001). A greater percentage of participants in the commercial program group than participants in the DIY group achieved loss of 5% of body weight at both 3 months (40.7% [72 of 177] vs 18.6% [34 of 183]) and 12 months (42.8% [71 of 166] vs 24.7% [44 of 178]). Conclusions and Relevance: Adults randomly assigned to a commercial weight management program with reduced requirements for dietary self-monitoring lost more weight and were more likely to achieve weight loss of 5% at 3 and 12 months than adults following a DIY approach. This study contributes data on the efficacy of commercial weight management programs and DIY weight management approaches. Trial Registration: ClinicalTrials.gov Identifier: NCT03571893.

The National Heart Lung and Blood Institute Disparities Elimination through Coordinated Interventions to Prevent and Control Heart and Lung Disease Alliance.

OBJECTIVE: To describe the National Heart Lung and Blood Institute (NHLBI) sponsored Disparities Elimination through Coordinated Interventions to Prevent and Control Heart and Lung Disease (DECIPHeR) Alliance to support late-stage implementation research aimed at reducing disparities in communities with high burdens of cardiovascular and/or pulmonary disease. STUDY SETTING: NHBLI funded seven DECIPHeR studies and a Coordinating Center. Projects target high-risk diverse populations including racial and ethnic minorities, urban, rural, and low-income communities, disadvantaged children, and persons with serious mental illness. Two projects address multiple cardiovascular risk factors, three focus on hypertension, one on tobacco use, and one on pediatric asthma. STUDY DESIGN: The initial phase supports planning activities for sustainable uptake of evidence-based interventions in targeted communities. The second phase tests late-stage evidence-based implementation strategies. DATA COLLECTION/EXTRACTION METHODS: Not applicable. PRINCIPAL FINDINGS: We provide an overview of the DECIPHeR Alliance and individual study designs, populations, and settings, implementation strategies, interventions, and outcomes. We describe the Alliance's organizational structure, designed to promote cross-center partnership and collaboration. CONCLUSIONS: The DECIPHeR Alliance represents an ambitious national effort to develop sustainable implementation of interventions to achieve cardiovascular and pulmonary health equity.

A community-based, multi-level, multi-setting, multi-component intervention to reduce weight gain among low socioeconomic status Latinx children with overweight or obesity: The Stanford GOALS randomised controlled trial.

BACKGROUND: There are few long-term studies of interventions to reduce in low socioeconomic status children with overweight or obesity. The Stanford GOALS trial evaluated a 3-year, community-based, multi-level, multi-setting, multi-component (MMM) systems intervention, to reduce weight gain among low socioeconomic status, Latinx children with overweight or obesity. METHODS: We did a two-arm, parallel group, randomised, open-label, active placebo-controlled trial with masked assessment over 3 years. Families from low-income, primarily Latinx communities in Northern California, CA, USA, with 7-11-year-old children with overweight or obesity were randomly assigned to a MMM intervention or a Health Education (HE) comparison intervention. The MMM intervention included home environment changes and behavioural counselling, community after school team sports, and reports to primary health-care providers. The primary outcome was child BMI trajectory over three years. Secondary outcomes included one- and two-year changes in BMI. This trial is registered with ClinicalTrials.govNCT01642836. FINDINGS: Between July 13, 2012, and Oct 3, 2013, 241 families were recruited and randomly assigned to MMM (n=120) or HE (n=121). Children's mean age was 9·5 (SD 1·4) years, 134 (56%) were female and 107 (44%) were male, and 236 (98%) were Latinx. 238 (99%) children participated in year 1, 233 (97%) in year 2, and 227 (94%) in year 3 of follow-up assessments. In intention-to-treat analysis, over 3 years, the difference between intervention groups in BMI trajectory was not significant (mean adjusted difference -0·25 [95% CI -0·90 to 0·40] kg/m2; Cohen's d=0.10; p=0·45). Children in the MMM intervention group gained less BMI over 1 year than did children in the HE intervention group (-0·73 [-1·07 to -0·39] kg/m2, d=0.55); the same was true over 2 years (-0·63 [-1·13 to -0·14] kg/m2; d =0.33). No differential adverse events were observed. INTERPRETATION: The MMM intervention did not reduce BMI gain versus HE over 3 years but the effects over 1 and 2 years in this rigorous trial show the promise of this systems intervention approach for reducing weight gain and cardiometabolic risk factors in low socioeconomic status communities. FUNDING: US National Institutes of Health.

Baseline diet quality of predominantly minority children and adolescents from households characterized by low socioeconomic status in the Childhood Obesity Prevention and Treatment Research (COPTR) Consortium.

BACKGROUND: The Healthy Eating Index (HEI-2010) is a measure of diet quality that examines conformance with the Dietary Guidelines for Americans. The objectives of this study were to estimate baseline diet quality of predominantly low-income minority children using the HEI-2010 and to identify the most important HEI components to target for dietary intervention. METHODS: Two or three baseline 24 h dietary recalls were collected in-person or over telephone between May 2012 and June 2014 from 1,745 children and adolescents from four randomized clinical trials in the Childhood Obesity Prevention and Treatment Research (COPTR) Consortium. Nine adequacy and three moderation food components were calculated and averaged to determine overall HEI scores. The overall HEI-2010 scores were categorized as ≥81, 51-80, or ≤ 50 based on the HEI-2005 classification. For each study, mean overall and component HEI scores were estimated using linear regression models. RESULTS: Mean (95% CI) overall HEI scores ranged from 47.9 (46.8, 49.0) to 64.5 (63.6, 65.4). Only 0.3 to 8.1% of children and adolescents had HEI-2010 score ≥ 81. The average component score for green and beans was less than 30% of maximum score for all trials. In contrast, the average component score for protein, dairy (except for IMPACT), and empty calories (except forIMPACT) was more than 80% of maximum score. CONCLUSIONS: Based on HEI-2010 scores, few children and adolescents consumed high quality diets. Dietary interventions for children and adolescents should focus on improving intakes of green vegetables and beans. CLINICAL TRIAL REGISTRY NUMBERS: GROW study (clinical trial # NCT01316653); NET-Works study (clinical trial #NCT01606891); Stanford Goals (clinical trial #NCT01642836); IMPACT (clinical trial # NCT01514279).

Recruitment strategies for predominantly low-income, multi-racial/ethnic children and parents to 3-year community-based intervention trials: Childhood Obesity Prevention and Treatment Research (COPTR) Consortium.

BACKGROUND: The recruitment of participants into community-based randomized controlled trials studying childhood obesity is often challenging, especially from low-income racial/ethnical minorities and when long-term participant commitments are required. This paper describes strategies used to recruit and enroll predominately low-income racial/ethnic minority parents and children into the Childhood Obesity Prevention and Treatment Research (COPTR) consortium. METHODS: The COPTR consortium has run four independent 3-year, multi-level (individual, family, school, clinic, and community) community-based randomized controlled trials. Two were prevention trials in preschool children and the other two were treatment trials in pre-adolescents and adolescent youth. All trials reported monthly participant recruitment numbers using a standardized method over the projected 18-24 months of recruitment. After randomization of participants was completed, recruitment staff and investigators from each trial retrospectively completed a survey of recruitment strategies and their perceived top three recruitment strategies and barriers. RESULTS: Recruitment was completed in 15-21 months across trials, enrolling a total of 1745 parent-child dyads- out of 6314 screened. The number of children screened per randomized child was 4.6 and 3.5 in the two prevention trials, and 3.1 and 2.5 in the two treatment trials. Recruitment strategies reported included: (1) careful planning, (2) working with trusting community partners, (3) hiring recruitment staff who were culturally sensitive, personality appropriate, and willing to work flexible hours, (4) contacting potential participants actively and repeatedly, (5) recruiting at times and locations convenient for participants, (6) providing incentives to participants to complete baseline measures, (7) using a tracking database, (8) evaluating whether participants understand the activities and expectations of the study, and (9) assessing participants' motivation for participating. Working with community partners, hiring culturally sensitive staff, and contacting potential participants repeatedly were cited by two trials among their top three strategies. The requirement of a 3-year commitment to the trial was cited by two trials to be among the top three recruitment barriers. CONCLUSIONS: Comprehensive strategies that include community partnership support, culturally sensitive recruitment staff, and repeated contacts with potential participants can result in successful recruitment of low-income racial/ethnic minority families into obesity prevention and treatment trials. TRIAL REGISTRATION: NET-Works trial: ClinicalTrials.gov, NCT01606891 . Registered on 28 May 2012. GROW trial: ClinicalTrials.gov, NCT01316653 . Registered on 16 March 2011. GOALS trial: ClinicalTrials.gov, NCT01642836 . Registered on 17 July 2012. IMPACT trial: ClinicalTrials.gov, NCT01514279 . Registered on 23 January 2012.

Two Family Interventions to Reduce BMI in Low-Income Urban Youth: A Randomized Trial.

BACKGROUND: Our primary aim was to evaluate the effects of 2 family-based obesity management interventions compared with a control group on BMI in low-income adolescents with overweight or obesity. METHODS: In this randomized clinical trial, 360 urban-residing youth and a parent were randomly assigned to 1 of 2 behaviorally distinct family interventions or an education-only control group. Eligible children were entering the sixth grade with a BMI ≥85th percentile. Interventions were 3 years in length; data were collected annually for 3 years. Effects of the interventions on BMI slope (primary outcome) over 3 years and a set of secondary outcomes were assessed. RESULTS: Participants were primarily African American (77%), had a family income of <25 000 per year, and obese at enrollment (68%). BMI increased over time in all study groups, with group increases ranging from 0.95 to 1.08. In an intent-to-treat analysis, no significant differences were found in adjusted BMI slopes between either of the family-based interventions and the control group (P = .35). No differences were found between the experimental and control groups on secondary outcomes of diet, physical activity, sleep, perceived stress, or cardiometabolic factors. No evidence of effect modification of the study arms by sex, race and/or ethnicity, household income, baseline levels of child and parent obesity, or exposure to a school fitness program were found. CONCLUSIONS: In this low-income, adolescent population, neither of the family-based interventions improved BMI or health-related secondary outcomes. Future interventions should more fully address poverty and other social issues contributing to childhood obesity.