Are the Risk of Generalizability Biases Generalizable? A Meta-Epidemiological Study.

Background: Preliminary studies (e.g., pilot/feasibility studies) can result in misleading evidence that an intervention is ready to be evaluated in a large-scale trial when it is not. Risk of Generalizability Biases (RGBs, a set of external validity biases) represent study features that influence estimates of effectiveness, often inflating estimates in preliminary studies which are not replicated in larger-scale trials. While RGBs have been empirically established in interventions targeting obesity, the extent to which RGBs generalize to other health areas is unknown. Understanding the relevance of RGBs across health behavior intervention research can inform organized efforts to reduce their prevalence. Purpose: The purpose of our study was to examine whether RGBs generalize outside of obesity-related interventions. Methods: A systematic review identified health behavior interventions across four behaviors unrelated to obesity that follow a similar intervention development framework of preliminary studies informing larger-scale trials (i.e., tobacco use disorder, alcohol use disorder, interpersonal violence, and behaviors related to increased sexually transmitted infections). To be included, published interventions had to be tested in a preliminary study followed by testing in a larger trial (the two studies thus comprising a study pair). We extracted health-related outcomes and coded the presence/absence of RGBs. We used meta-regression models to estimate the impact of RGBs on the change in standardized mean difference (ΔSMD) between the preliminary study and larger trial. Results: We identified sixty-nine study pairs, of which forty-seven were eligible for inclusion in the analysis (k = 156 effects), with RGBs identified for each behavior. For pairs where the RGB was present in the preliminary study but removed in the larger trial the treatment effect decreased by an average of ΔSMD=-0.38 (range - 0.69 to -0.21). This provides evidence of larger drop in effectiveness for studies containing RGBs relative to study pairs with no RGBs present (treatment effect decreased by an average of ΔSMD =-0.24, range - 0.19 to -0.27). Conclusion: RGBs may be associated with higher effect estimates across diverse areas of health intervention research. These findings suggest commonalities shared across health behavior intervention fields may facilitate introduction of RGBs within preliminary studies, rather than RGBs being isolated to a single health behavior field.

Differences in dietary acceptability, restraint, disinhibition, and hunger among African American participants randomized to either a vegan or omnivorous soul food diet.

The Nutritious Eating with Soul study was a 24-month, randomized behavioral nutrition intervention among African American adults. This present study, which is a secondary analysis of the NEW Soul study, examined changes in dietary acceptability, restraint, disinhibition, and hunger. Participants (n = 159; 79% female, 74% with ≥ college degree, mean age 48.4 y) were randomized to either a soul food vegan (n = 77) or soul food omnivorous (n = 82) diet and participated in a two-year behavioral nutrition intervention. Questionnaires assessing dietary acceptability (Food Acceptability Questionnaire; FAQ) and dietary restraint, disinhibition, and hunger (Three-Factor Eating Questionnaire; TFEQ) were completed at baseline, 3, 6, 12, and 24 months. Mixed models were specified with main effects (group and time) and interaction effects (group by time) to estimate mean differences in FAQ and TFEQ scores using intent-to-treat analysis. After adjusting for employment, education, food security status, sex, and age, there were no differences in any of the FAQ items, total FAQ score, dietary restraint, disinhibition, and hunger at any timepoint except for one item of the FAQ at 12 months. Participants in the vegan group reported a greater increase in satisfaction after eating a meal than the omnivorous group (mean difference 0.80 ± 0.32, 95% CI 0.18, 1.42; P = 0.01). This is one of the first studies to examine differences in dietary acceptability, hunger, and other eating factors among African American adults randomized to either a vegan or omnivorous soul food diet. The findings highlight that plant-based eating styles are equally acceptable to omnivorous eating patterns and have similar changes in hunger, restraint, and disinhibition. These results suggest that plant-based eating styles can be an acceptable dietary pattern to recommend for cardiovascular disease prevention and may result in greater post-meal satisfaction.

Community Health Worker Implementation and Cost Analysis of a Plant-Based Nutrition Program.

OBJECTIVE: This study describes program implementation through a research-restaurant partnership and assesses participant satisfaction, program costs, and percent body weight changes. METHODS: Participants (n = 60) in a virtual synchronous (n = 43) or virtual asynchronous (n = 17) 12-week plant-based nutrition program received restaurant vouchers. Class satisfaction data were collected weekly. Assessments were completed at baseline, 3 months, and 9 months, along with interviews (n = 13) between 3 and 9 months. The costing approach estimated costs per participant. Interviews were coded using a content analysis and constant comparative method. RESULTS: Participants rated the intervention favorably. Program costs were $198.63/participant, and participants' willingness to pay postintervention was $101.50 ± $63.90. Participants shared satisfaction with course content, the restaurant partnership, and suggestions for future delivery. No changes in participants' percent body weight were observed between 3 and 9 months (P = 0.98), indicating maintenance of 3-month weight loss. CONCLUSIONS AND IMPLICATIONS: A research-restaurant partnership successfully implemented a nutrition program and generated positive feedback. With the lifting of coronavirus disease 2019 pandemic restrictions, future research can now test alternative implementation methods (in person vs online) in other restaurants.

"Mindset Matters": Perseverance, a balanced approach and structured support as facilitators of whole foods plant-based adoption.

Whole foods plant-based diets (WFPBD) show potential for preventing and addressing chronic diseases. However, concerns exist about their acceptability and feasibility. Research on firsthand WFPBD adoption experiences is limited but crucial for promoting dietary change. In a 12-week remotely delivered lifestyle modification program using an ad libitum WFPBD, twenty weight-loss seeking adults (ages 18-75) with overweight or obesity completed self-report surveys and semi-structured interviews via Zoom. The study aimed to explore: (1) experiences with WFPBD adoption; (2) factors that helped or hindered adherence; and (3) perceived salient benefits. Interviews were analyzed inductively through a conventional content analysis, and associations between variables examined with correlational analyses. Participants overall reported WFPBD adoption being a positive, new experience, with an equal number (30%) finding it easy/easier than expected as challenging. Key cited challenges included overwhelm, different eating habits in the household, and meal preparation. Key cited facilitators included adopting an incremental approach to dietary change, persisting after setbacks, and having simple go-to meals. Greater self-compassion and family support, and less sabotage from friends and family corresponded to greater dietary change (rs > 0.45, ps < .05). Participants valued accountability, structure, human support, nutrition psychoeducation and recipes in the program. Three categories emerged regarding perceived benefits of following the WFPBD: physical health benefits, improvements to eating habits, and greater perceived control/agency over health. Results indicate that future interventions should include psychological strategies alongside nutrition education to enhance self-efficacy, address household barriers, and combat feelings of overwhelm through sufficient structure, support, and meal preparation guidance. Messaging around WFPBD may benefit from discussing prevailing positive experiences with adoption, common benefits experienced, and options for an incremental approach given that feasibility and acceptability concerns may deter efforts.

Harnessing technology and gamification to increase adult physical activity: a cluster randomized controlled trial of the Columbia Moves pilot.

BACKGROUND: The use of health technologies and gamification to promote physical activity has increasingly been examined, representing an opportunistic method for harnessing social support inherent within existing social ties. However, these prior studies have yielded mixed findings and lacked long-term follow-up periods. Thus, a pilot cluster randomized controlled trial was conducted to gauge the feasibility and preliminary efficacy of a digital gamification-based physical activity promotion approach among teams of insufficiently active adults with existing social ties. METHODS: Teams (N = 24; 116 total participants) were randomized to either a 12-week intervention (Fitbit, step goals, app, feedback; TECH) or the same program plus gamification (TECH + Gamification). Mixed effects models were used to compare group differences in treatment adherence, and changes in social support, steps, and moderate-to-vigorous physical activity at 12 weeks and 52 weeks from baseline, adjusted for sociodemographic characteristics and team size. RESULTS: TECH had a lower mean number of days of Fitbit self-monitoring versus TECH + Gamification during the intervention (adjusted difference: -.30; 95% CI, -.54 to -.07; P = .01). Post-intervention, TECH had 47% lower odds of self-monitoring 7 days per week versus TECH + Gamification (.53; 95% CI, .31 to .89; P = .02). No differences were observed between TECH + Gamification and TECH in increases in social support (0.04; 95% CI, -.21 to .29; P = .76), ActiGraph-measured daily steps (-425; 95% CI, -1065 to 215; P = .19), or moderate-to-vigorous physical activity minutes (-3.36; 95% CI, -8.62 to 1.91; P = .21) from baseline to 12 weeks or in the regression of these improvements by 1 year (Ps > .05). Although not significant in the adjusted models (Ps > .05), clinically meaningful differences in Fitbit-measured daily steps (TECH, 7041 ± 2520; TECH + Gamification, 7988 ± 2707) and active minutes (TECH, 29.90 ± 29.76; TECH + Gamification, 36.38 ± 29.83) were found during the intervention. CONCLUSIONS: A gamified physical activity intervention targeting teams of adults with existing social ties was feasible and facilitated favorable, clinically meaningful additive physical activity effects while in place but did not drive enhanced, long-term physical activity participation. Future investigations should explore optimal team dynamics and more direct ways of leveraging social support (training teams; gamifying social support). TRIAL REGISTRATION: Clinicaltrials.gov ( NCT03509129 , April 26, 2018).

"It's Gonna Be Okay"-A Qualitative Exploration of the COVID-19 Pandemic's Effects on African American Participants During a Dietary Intervention Study.

BACKGROUND: African American adults are at increased risk for chronic diseases. Limited research exists regarding how the COVID-19 pandemic affected African American adults in behavioral interventions. OBJECTIVE: This study assessed how the early months of the COVID-19 pandemic, before vaccine availability and widespread testing, affected stress, nutrition, and exercise behaviors of African American adults participating in a dietary intervention study. DESIGN: This was a qualitative interview study conducted with participants from both diet groups as part of the ongoing Nutritious Eating with Soul (NEW Soul) study. NEW Soul is a 2-year, randomized dietary intervention study with participants randomized to follow a vegan (intervention) or low-fat omnivorous diet (control), with both diets focused on soul food. PARTICIPANTS/SETTING: Participants (n = 20) came from 2 cohorts of the larger intervention study in South Carolina and were purposefully recruited based on high and low attendance at intervention sessions. Participants in the first cohort were near the end of the intervention, and participants in the second cohort were near the mid-point. The interviews were conducted from June to July 2020. MAIN OUTCOME MEASURES: Outcomes included participants' experiences related to stress, nutrition, and exercise behaviors during the early months of the COVID-19 pandemic. ANALYSIS: Interviews were recorded and transcribed verbatim. Interview transcripts were coded by two coders using NVivo software. Interviews were coded through content analysis using a constant comparative method. RESULTS: Participants discussed the following 3 themes in relation to health behaviors: increased stress, change in routines, and advice to follow health goals. CONCLUSIONS: Findings provide perspectives for designing interventions for African American adults establishing new routines to overcome setbacks and changes in routines created by the COVID-19 pandemic.

Interpersonal and Environmental Protective Factors and Their Associations With Children's Weight Status.

Both external structure (ie, participating in extracurricular activities) and family factors (ie, parental emotional support) have separately been linked with children's physical health and well-being, however, their combined effects are less well known. The current study examined the longitudinal associations between participating in structured out-of-school activities and parent reports of warmth/emotional support with children's weight status (ie, zBMI) over time. Utilizing longitudinal data from the United States-based Early Childhood Longitudinal Study, Kindergarten Class of 2010 to 2011 (ECLS-K:2011), we employed a confirmatory factor analysis (CFA) and a latent variable cross-lagged path analysis to examine if emotional supportiveness and participation in structured activities predicted lower zBMI over the course of 1 year. The final sample included 18 135 participants. Mean age of the participants was 8.12 years (±0.38 years), and 51% of children were male. Mean zBMI was 0.54 (±1.12). Structure at baseline predicted increased zBMI in year 2 (ß = .03, P = .02) but did not predict parent emotional supportiveness at year 2 (ß = -.05, P = .09). Parent emotional supportiveness at baseline predicted greater zBMI at year 2 (ß = .02, P = <.01) but did not predict structure at year 2 (ß = .02, P = .39). zBMI at baseline did not predict structure (ß = .02, P = .25) or parent emotional supportiveness at year 2 (ß = -.01, P = .55). Our findings were inconsistent with our hypothesis with regard to directionality. Continued refinement about the role of internal structure (ie, family, and parenting practices) may inform public health prevention strategies to support the well-being of children and families.

A 12-Week Randomized Intervention Comparing the Healthy US, Mediterranean, and Vegetarian Dietary Patterns of the US Dietary Guidelines for Changes in Body Weight, Hemoglobin A1c, Blood Pressure, and Dietary Quality among African American Adults.

BACKGROUND: The US Dietary Guidelines (USDG) form the basis of nutrition guidelines, but the research informing the 3 USDG dietary patterns (Healthy US-Style [H-US], Mediterranean [Med], and vegetarian [Veg]) has been drawn largely from observational studies among White populations. OBJECTIVES: The Dietary Guidelines 3 Diets study was a 3-arm, 12-wk randomly assigned intervention among African American (AA) adults at risk of type 2 diabetes mellitus that tested the 3 USDG dietary patterns. METHODS: The AAs (ages 18-65 y, BMI 25-49.9 kg/m2, and BMI was measured in kg/m2) with ≥3 type 2 diabetes mellitus risk factors were recruited. Weight, HbA1c, blood pressure, and dietary quality (healthy eating index [HEI]) were collected at baseline and 12 wk. In addition, participants attended weekly online classes that were designed using material from the USDG/MyPlate. Repeated measures, mixed models with maximum likelihood estimation, and robust computation of standard errors were tested. RESULTS: Of the 227 participants screened, 63 were eligible (83% female; age 48.0 ± 10.6 y, BMI 35.9 ± 0.8 kg/m2) and randomly assigned to the Healthy US-Style Eating Pattern (H-US) (n = 21, 81% completion), healthy Mediterranean-style eating pattern (Med) (n = 22, 86% completion), or healthy vegetarian eating pattern (Veg) (n = 20, 70% completion) groups. Within-group, but not between groups, weight loss was significant (-2.4 ± 0.7 kg H-US, -2.6 ± 0.7 kg Med, -2.4 ± 0.8 kg Veg; P = 0.97 between group). There was also no significant difference between groups for changes in HbA1c (0.03 ± 0.05% H-US, -0.10 ± 0.05% Med, 0.07 ± 0.06% Veg; P = 0.10), systolic BP (-5.5 ± 2.7 mmHg H-US, -3.2 ± 2.5 mmHg Med, -2.4 ± 2.9 mmHg Veg; P = 0.70), diastolic blood pressure (-5.2 ± 1.8 mmHg H-US, -2.0 ± 1.7 mmHg Med, -3.4 ± 1.9 mmHg Veg; P = 0.41), or HEI (7.1 ± 3.2 H-US, 15.2 ± 3.1 Med, 4.6 ± 3.4 Veg; P = 0.06). Post hoc analyses showed that the Med group had significantly greater improvements in HEI compared to the Veg group (difference = -10.6 ± 4.6; 95% CI: -19.7, -1.4; P = 0.02). CONCLUSIONS: The present study demonstrates that all 3 USDG dietary patterns lead to significant weight loss among AA adults. However, none of the outcomes were significantly different between groups. This trial was registered at clinicaltrials.gov as NCT04981847.

NEW Soul in the neighborhood-reach and effectiveness of a dissemination and implementation feasibility study.

Dissemination and implementation (D&I) studies of dietary interventions for African Americans are limited. Restaurants may be an innovative setting to deliver dietary interventions. Purpose: Assess weight loss, self-efficacy for healthy eating, diet quality, and quality of life in African Americans in two groups: virtual synchronous and virtual asynchronous. Guided by RE-AIM, the Nutritious Eating with Soul @ Rare Variety Café Feasibility study included nutrition education, accountability partners for support, and cooking demonstrations led by a community health worker and was delivered across two cohorts in a non-randomized design. The intervention was conducted over 12 consecutive weekly classes. Due to the COVID-19 pandemic, intervention delivery was online. African Americans between 18-65 years old with overweight/obesity, not currently following a plant-based diet or taking medications to control diabetes, and living in a southeastern city were recruited. Participants completed in-person weight assessments and online surveys at baseline and post-intervention. Linear mixed models analyzed changes in outcomes and differences in 3-month outcomes between groups. All models controlled for age and sex. Regarding Reach, 199 participants expressed interest, and 60 enrolled. Among the full sample, participants decreased body weight -2.6 ± 0.5 kg (p < .0001) and increased self-efficacy 1.6 ± 0.7 points (p = .03). No differences in 3-month outcomes between groups were observed. This D&I feasibility study successfully recruited participants during the COVID-19 pandemic and produced significant results. The successful online intervention delivery compared to in-person suggests the potential for greater D&I in vegan soul food restaurants. As restrictions are loosened, future studies will test in-person delivery.

Guided by RE-AIM, the Nutritious Eating with Soul @ Rare Variety Feasibility Trial (NEW Soul @ RV) assessed Reach and Effectiveness outcomes in participants in a soul food, plant-based dissemination and implementation study. The research team successfully partnered with a local restaurant to host and deliver the intervention. Due to the COVID-19 pandemic, the intervention was delivered using two intervention groups: virtual synchronous and virtual asynchronous. The dissemination and implementation feasibility study successfully recruited African American participants leading to a meaningful primary outcome in weight loss as well as improvements in a secondary outcome of diet self-efficacy. Findings emphasize the potential for greater dissemination and implementation of NEW Soul @ RV throughout African American vegan soul food restaurants.

Effect of a Plant-Based vs Omnivorous Soul Food Diet on Weight and Lipid Levels Among African American Adults: A Randomized Clinical Trial.

Importance: More African American individuals die from cardiovascular disease (CVD) than any other chronic disease condition. Despite this disparity, African American individuals are underrepresented in nutrition and CVD interventions. Objective: To compare the effects of an entirely plant-based (vegan) or low-fat omnivorous (omni) diet on change in body weight and lipids during a 2-year intervention. Design, Setting, and Participants: The Nutritious Eating With Soul (NEW Soul) study was a 2-year, randomized clinical trial conducted in 2 cohorts (2018-2020 and 2019-2021) that took place in a university teaching kitchen in Columbia, South Carolina (before March 2020), and via online videoconference sessions (after March 2020). Participants included African American adults aged 18 to 65 years with overweight or obesity (body mass index of 25.0-49.9) and without type 2 diabetes, uncontrolled thyroid disease, recent weight loss, or pregnancy. Data assessors and statisticians were blinded to study condition. Data analysis was performed from March to June 2022. Interventions: The intervention included weekly nutrition classes for 6 months biweekly classes for 6 months, and monthly classes for 12 months. Dietary interventions either emphasized no animal product intake (vegan) or a low-fat omnivorous diet (omni). Both dietary patterns emphasized soul food cuisine (traditional African American southern foodways). Main Outcomes and Measures: Primary outcomes included change in body weight and lipid measures at 12 months. Results: There were 568 participants who completed an online screening questionnaire; 409 were excluded and 159 were randomized (77 to the vegan group and 82 to the omni group). Of the 159 participants (mean [SD] age, 48.4 [10.6] years; 126 female [79%]) who began the study, the main outcome of body weight was obtained for 121 participants (76%) at 12 months. There were no differences in outcomes between groups, including 12-month changes in weight (mean, -2.39 kg [95% CI, -3.48 to -1.30 kg] for the vegan group vs -2.03 kg [95% CI, -3.07 to -1.00 kg] for the omni group; P = .64), total cholesterol (-1.05 mg/dL [95% CI, -9.60 to 7.50 mg/dL] for the vegan group vs 1.66 mg/dL [95% CI, -7.20 to 10.50 mg/dL] for the omni group; P = .67), or low-density lipoprotein cholesterol (mean, -2.56 mg/dL [95% CI, -9.52 to 4.40 mg/dL] for the vegan group vs -0.79 mg/dL [95% CI, -7.98 to 6.40 mg/dL] for the omni group; P = .73). Weight loss at 12 months among cohort 1, whose weight was assessed in 2019 before the COVID-19 pandemic, was significantly greater than that for cohort 2, whose weight was assessed summer 2020 during COVID-19 (-3.45 kg [95% CI, -4.67 to -2.22 kg] vs -1.24 kg [95% CI, -2.24 to -0.25 kg]; P = .01). Conclusions and Relevance: In this randomized clinical trial examining weight loss and CVD risk factor reduction among African American adults, there were no differences between the groups, and the magnitude of changes overall was small. Trial Registration: ClinicalTrials.gov Identifier: NCT03354377.

Effects of a behavioral intervention on physical activity, diet, and health-related quality of life in pregnant women with elevated weight: results of the HIPP randomized controlled trial.

BACKGROUND: Physical activity (PA), diet, and health-related quality of life (HRQOL) are related to maternal and infant health, but interventions to improve these outcomes are needed in diverse pregnant women with elevated weight. METHODS: Health In Pregnancy and Postpartum (HIPP) was a randomized controlled trial. Women who were pregnant (N=219, 44% African American, 56% white) with overweight or obesity but otherwise healthy were randomized to a behavioral intervention grounded in Social Cognitive Theory (n=112) or to standard care (n=107). The intervention group received an in-depth counseling session, a private Facebook group, and 10 content-based counseling calls with accompanying behavioral podcasts followed by weekly or biweekly counseling calls until delivery. The standard care group received monthly mailings and 10 podcasts focused on healthy pregnancy. PA (SenseWear armband), diet (ASA24), and HRQOL (SF-12) measures were obtained from blinded assessors at baseline (<16 weeks) and late pregnancy (32 weeks). Mixed model repeated measures regression models tested treatment (Group x Time) and within-group effects. We hypothesized that intervention participants would have higher levels of PA, a better-quality diet, and higher HRQOL than standard care participants. Exploratory analyses examined whether changes in outcomes over time differed according to whether participants had recommended, excessive, or inadequate weight gain. RESULTS: Treatment effects favored intervention participants for vegetable intake (d=0.40, p<0.05) and % whole grains (d=0.60, p<0.01). HRQOL mental component improved in both groups, but less in intervention than standard care participants (d=-0.33, p<0.05). Time effects demonstrated that total PA, steps/day, and HRQOL physical component declined significantly in both groups. Within-group effects showed that diet quality significantly improved in intervention participants. Moderate-intensity PA declined significantly in standard care participants, whereas light-intensity PA declined and sedentary behavior increased significantly in intervention participants. Finally, exploratory analyses showed that total PA and light PA increased whereas sedentary behavior decreased among those meeting guidelines for weight gain, with opposite patterns seen among those with excessive or inadequate weight gain. CONCLUSIONS: The intervention improved several dietary outcomes but had modest impacts on PA and HRQOL, underscoring the challenge of behavior change during pregnancy. TRIAL REGISTRATION: This trial was registered in ClinicalTrials.gov on 10/09/2014. NCT02260518.

Process evaluation methods and results from the Health in Pregnancy and Postpartum (HIPP) randomized controlled trial.

BACKGROUND: Excessive gestational weight gain has increased over time and is resistant to intervention, especially in women living with overweight or obesity. This study described the process evaluation methods and findings from a behavioral lifestyle intervention for African American and white women living with overweight and obesity that spanned pregnancy (≤ 16 weeks gestation) through 6 months postpartum. METHODS: The Health in Pregnancy and Postpartum (HIPP) study tested a theory-based behavioral intervention (vs. standard care) to help women (N = 219; 44% African American, 29.1 ± 4.8 years) living with overweight or obesity meet weight gain guidelines in pregnancy and lose weight in postpartum. Participants completed process evaluation surveys at 32 weeks gestation (n = 183) and 6 months postpartum (n = 168) regarding their perceptions of most and least helpful aspects of the intervention. A database tracked delivery and receipt of intervention components (in-depth counseling session, telephone calls, podcasts). Descriptive statistics are used to report fidelity, dose, and participants' perceptions. We also tested whether dose of behavioral intervention components was associated with gestational weight gain and 6-month postpartum weight retention with linear regression models controlling for baseline age and gestational weeks, receipt of Medicaid, race, parity, and marital status. A content analysis was used to code and analyze responses to open-ended survey questions. RESULTS: Over 90% of participants (both groups) would recommend the program to a friend. Implementation fidelity was moderately high and greater in pregnancy than postpartum for all intervention components. Dose received and participants' ratings of the in-depth counseling session and telephone calls were more favorable than podcasts. The Facebook group was not perceived to be very helpful, likely because of low participant interaction. Although podcasts were created to reinforce call topics, this redundancy was viewed negatively by some. More calls completed and more podcasts downloaded related to lower gestational weight gain (p < .05). CONCLUSION: Study findings underscore challenges in engaging this important but busy population, especially during the postpartum period. TRIAL REGISTRATION: The study was registered at clinicaltrials.gov (NCT02260518) on 10/09/2014. https://clinicaltrials.gov/ct2/show/NCT02260518 .

Dietary Inflammatory Index and sleep quality and duration among pregnant women with overweight or obesity.

STUDY OBJECTIVES: Sleep disturbances, which can worsen during pregnancy, have been linked to inflammatory processes. This study tested the hypothesis that more pro-inflammatory diets during pregnancy are associated with a decrease in sleep quality and shorter sleep duration. METHODS: The Health in Pregnancy and Postpartum study promoted a healthy lifestyle in pregnant women with pre-pregnancy overweight or obesity (n = 207). Data from <16 weeks and 32 weeks gestation were used. Sleep was measured using BodyMedia's SenseWear® armband. Diet was assessed using two 24-hr dietary recalls. Energy-density Dietary Inflammatory Index (E-DIITM) scores were calculated from micro and macronutrients. Linear mixed-effects models estimated the impact of the E-DII score on sleep parameters. RESULTS: Women with more pro-inflammatory diets, compared to those with more anti-inflammatory diets, were more likely to be nulliparous (51% vs. 25%, p = 0.03), frequent consumers of fast food (29% vs. 10% consuming on 4-6 days during the previous week, p = 0.01), ever-smokers (21% vs. 6%, p = 0.02), and younger (mean age 29.2 vs. 31.3 years, p = 0.02). For every one-unit increase (i.e., more pro-inflammatory) in the E-DII score, sleep latency increased by 0.69 min (p < 0.01). Among European Americans only, every one-unit higher E-DII was associated with a 2.92-min longer wake-after-sleep-onset (p = 0.02). CONCLUSION: An E-DII score that is 5 points lower (i.e., more anti-inflammatory) would equate to about 105 min of additional sleep per week among European American women. Anti-inflammatory diets may help to counteract detriments in sleep during pregnancy, especially among European American women. Additional work is needed among African American women. CLINICAL TRIALS IDENTIFIER: Name: Promoting Health in Pregnancy and Postpartum (HIPP); URL: https://clinicaltrials.gov/ct2/show/NCT02260518; Registration Identifier: NCT02260518.

Socially Distanced Data Collection: Lessons Learned Using Electronic Bluetooth Scales to Assess Weight.

Introduction. Electronic Bluetooth scales (e-scales) may be useful for remote weight assessment. This study analyzed predictors of engagement with e-scales and feasibility for remote weight assessment. Method. Due to COVID-19 restrictions, participants (n = 150, 100% African American, 79% female, average age 48.2 ± 10.6 years) in an ongoing trial were invited to receive an e-scale. Participants had 1 month to complete a weigh-in. Email, text, and phone call reminders were sent. Data were analyzed using descriptive approaches and logistic regression. Results. Seventy-five participants (50% of sample) elected to receive an e-scale. Older participants (t = -2.01, p = .05) and a greater proportion of females (χ2 = 7.8, p < .01) signed up to receive an e-scale. An average of 2.6 ± 1.3 reminders was required. Most participants who received an e-scale completed a weigh-in (n = 70). Discussion. Half the sample elected to receive an e-scale. Strategies to increase willingness among men and younger adults to sign up to receive an e-scale are needed.

Association of Body Mass Index and Plant-Based Diet with Cognitive Impairment among Older Chinese Adults: A Prospective, Nationwide Cohort Study.

To examine the association of body mass index (BMI) and a plant-based diet (PBD) with cognitive impairment in older adults, this cohort study used data from the Chinese Longitudinal Healthy Longevity Survey (CLHLS), a national, community-based, longitudinal, prospective study in China. Cognitive function was evaluated via the Mini-Mental State Examination (MMSE). Diet was assessed using a simplified food frequency questionnaire (FFQ), and PBD patterns were estimated using the overall plant-based diet index (PDI), the healthful plant-based diet index (hPDI), and the unhealthful plant-based diet index (uPDI). BMI was measured objectively during the physical examination. Cox proportional hazard models and restricted cubic spline analyses were used. A total of 4792 participants with normal cognition at baseline were included, and 1077 participants were identified as having developed cognitive impairment during the 24,156 person-years of follow-up. A reverse J-shaped association was observed between BMI and cognitive impairment (p = 0.005 for nonlinearity). Participants who were overweight (HR = 0.79; 95% CI 0.66-0.95) and obese (HR = 0.72; 95% CI 0.54-0.96) had a decreased risk of cognitive impairment, while those who were underweight (HR = 1.42; 95% CI 1.21-1.66) had an increased risk. Lower PDI, lower hPDI, and higher uPDI were associated with an increased risk of cognitive impairment (HR = 1.32; 95% CI 1.16-1.50 for PDI; HR = 1.46; 95% CI 1.29-1.66 for hPDI; HR = 1.21; 95% CI 1.06-1.38 for uPDI). The protective effect of being overweight on cognitive impairment was more pronounced among participants with a higher PDI (HR = 0.74; 95% CI 0.57-0.95) than those with a lower PDI (HR = 0.87; 95% CI 0.67-1.12), among participants with a higher hPDI (HR = 0.73; 95% CI 0.57-0.94) than those with a lower hPDI (HR = 0.93; 95% CI 0.72-1.10), and among participants with a lower uPDI (HR = 0.61; 95% CI 0.46-0.80) than those with a higher uPDI (HR = 1.01; 95% CI 0.80-1.27). Our results support the positive associations of overweight status, obesity, an overall PBD, and a healthful PBD with cognitive function in older adults. A lower adherence to an overall PBD, a healthful PBD, and a higher adherence to an unhealthful PBD may attenuate the protective effect of being overweight on cognitive function.

The IMAGINE Intervention: Impacting Physical Activity, Body Fat, Body Mass Index, and Dietary Inflammatory Index.

Background: Many behavior-change interventions focused on nutrition and physical activity (PA) have been implemented to prevent disease and promote optimal health. Purpose: This study examined changes in PA with Energy-adjusted Dietary Inflammatory Index (E-DII™) and chronic disease risk factors in participants of a multicomponent intervention. Methods: Data from the Inflammation Management Intervention (IMAGINE) were used. Participants self-selected into the intervention or control group. At baseline and 12 weeks (post-intervention), participants completed three unannounced 24-hour dietary recalls (24HR), anthropometric measures (height, weight), and a dual x-ray absorptiometry scan. PA was measured using Sensewear® armbands. E-DII scores were calculated from the 24HR. Descriptive statistics and t-tests summarized variables and multiple regression assessed relationships between PA and body mass index (BMI), total body fat percent, and E-DII scores. Results: Intervention participants increased moderate-to-vigorous PA (MVPA) and lowered BMI, total body fat, and E-DII scores compared to controls. Every 10-minute increase in post-intervention MVPA was associated with 1.6 kg/m2 lower BMI (p<0.01) and 2.4% lower body fat percent (p<0.01) among control participants, after adjusting for covariates. Every 10-minute increase in post-intervention MVPA was associated with 0.3 lower (i.e., less inflammatory) post-intervention E-DII (p=0.01) scores among intervention participants, after adjusting for covariates. Conclusion: Participants who changed dietary intake changed PA. While changes were in expected directions, this intervention's emphasis on dietary behaviors compared to PA may have attenuated the relationship between PA and study outcomes.

Developing criteria for research translation decision-making in community settings: a systematic review and thematic analysis informed by the Knowledge to Action Framework and community input.

BACKGROUND: There is a pressing need to translate empirically supported interventions, products, and policies into practice to prevent and control prevalent chronic diseases. According to the Knowledge to Action (K2A) Framework, only those interventions deemed "ready" for translation are likely to be disseminated, adopted, implemented, and ultimately institutionalized. Yet, this pivotal step has not received adequate study. The purpose of this paper was to create a list of criteria that can be used by researchers, in collaboration with community partners, to help evaluate intervention readiness for translation into community and/or organizational settings. METHODS: The identification and selection of criteria involved reviewing the K2A Framework questions from the "decision to translate" stage, conducting a systematic review to identify characteristics important for research translation in community settings, using thematic analysis to select unique research translation decision criteria, and incorporating researcher and community advisory board feedback. RESULTS: The review identified 46 published articles that described potential criteria to decide if an intervention appears ready for translation into community settings. In total, 17 unique research translation decision criteria were identified. Of the 8 themes from the K2A Framework that were used to inform the thematic analysis, all 8 were included in the final criteria list after research supported their importance for research translation decision-making. Overall, the criteria identified through our review highlighted the importance of an intervention's public health, cultural, and community relevance. Not only are intervention characteristics (e.g., evidence base, comparative effectiveness, acceptability, adaptability, sustainability, cost) necessary to consider when contemplating introducing an intervention to the "real world," it is also important to consider characteristics of the target setting and/or population (e.g., presence of supporting structure, support or buy-in, changing sociopolitical landscape). CONCLUSIONS: Our research translation decision criteria provide a holistic list for identifying important barriers and facilitators for research translation that should be considered before introducing an empirically supported intervention into community settings. These criteria can be used for research translation decision-making on the individual and organizational level to ensure resources are not wasted on interventions that cannot be effectively translated in community settings to yield desired outcomes.

"They Eat What They Eat, I Eat What I Eat": Examining the Perspectives and Experiences of African Americans Who Adopt Plant-Based Diets.

Adopting a plant-rich or plant-based diet is one of the major recommendations for addressing obesity, overweight, and related health conditions in the United States. Currently, research on African Americans' food choices in the context of plant-based diets is limited. The primary aim of this study was to understand food-related experiences and perceptions of African Americans who were participating in the Nutritious Eating with Soul (NEW Soul) study, a culturally tailored dietary intervention focused on increasing the consumption of plant-based foods. The roles of gender and ethnicity were also examined to identify how eating patterns were chosen or maintained. Twenty-one African American adults in South Carolina, who were randomly assigned to either a vegan diet (n = 11) or a low-fat omnivorous diet (n = 10) in the NEW Soul study, completed one-on-one, qualitative interviews. Emerging themes included awareness, being in control, and identity. The study revealed that access to social support and coping strategies for addressing negative comments about plant-based food choices may be important components to include in future nutrition interventions focused on African Americans.

Remotely Delivered Behavioral Weight Loss Intervention Using an Ad Libitum Plant-Based Diet: Pilot Acceptability, Feasibility, and Preliminary Results.

BACKGROUND: Many traditional lifestyle interventions use calorie prescriptions, but most individuals have difficulty sustaining calorie tracking and thus weight loss. In contrast, whole food plant-based diets (WFPBDs) have previously shown significant weight loss without this issue. However, most WFPBD interventions are face-to-face and time-intensive, and do not leverage gold standard behavioral strategies for health behavior change. OBJECTIVE: This open pilot trial was the first to evaluate the feasibility of a fully featured, remotely delivered behavioral weight loss intervention using an ad libitum WFPBD. METHODS: Over 12 weeks, participants (N=15) with overweight or obesity received a newly designed program that integrated behavioral weight loss and a WFPBD prescription via weekly web-based modules and brief phone coaching calls. Assessments were performed at baseline, midtreatment (6 weeks), and after treatment (12 weeks). RESULTS: The intervention was rated as highly acceptable (mean 4.40 out of 5, SE 0.18), and attrition was low (6.7%). In all, intention-to-treat analyses revealed that 69% (10.4/15) of the participants lost 5% of their weight (mean -5.89, SE 0.68 kg). Predefined benchmarks for quality of life were met. CONCLUSIONS: A pilot digital behavioral weight loss intervention with a non-energy-restricted WFPBD was feasible, and the mean acceptability was high. Minimal contact time (80-150 minutes of study interventionist time per participant over 12 weeks) led to clinically relevant weight loss and dietary adherence for most participants (10.4/15, 69% and 11.8/15, 79%, respectively), and quality of life improvements (reliable change indices >1.53). We hope that this work will serve as a springboard for future larger scale randomized controlled studies evaluating the efficacy of such programs for weight loss, dietary change, and quality of life. TRIAL REGISTRATION: ClinicalTrials.gov NCT04892030; https://clinicaltrials.gov/ct2/show/NCT04892030.

The Fasting and Shifted Timing (FAST) of Eating Study: A pilot feasibility randomized crossover intervention assessing the acceptability of three different fasting diet approaches.

BACKGROUND AND AIMS: The aim of this study is to assess the acceptability of following three different fasting protocols [Early Time-restricted Feeding (eTRF; eating majority of kcals before 5pm), Time-restricted Feeding (TRF; restricting feeding window to 8 h/d), or Alternate Day Fasting (ADF; complete fasting every other day)]. METHODS: In this remotely delivered six-week crossover intervention, participants were randomly assigned to follow either an eTRF, TRF, or ADF diet for one week, followed by a one-week washout period. Participants followed all three diets and completed questionnaires assessing self-reported weight, energy intake, dietary acceptability (Food Acceptability Questionnaire), and facilitators and barriers to adhering to each diet. Differences in main outcomes (e.g., dietary acceptability and weight loss) were assessed via repeated measures ANOVA. RESULTS: A total of 32 of participants began the study (mean BMI of 32.6 ± 6.0 kg/m2). There were no differences in kcals or weight loss among the three diets. Dietary acceptability was higher on the TRF diet (54.1 ± 8.2) than the eTRF (50.2 ± 6.6, p = 0.02) or ADF (48.0 ± 7.9, p = 0.004) diets. The majority of participants (71%) indicated the TRF diet was the easiest to follow and 75% said that ADF was the most difficult. Participants cited having a mobile app to track their diet and being provided with menu plans would help facilitate adherence with their diets. CONCLUSIONS: This study found that acceptability was highest for an TRF diet and lowest for ADF, with no differences in weight loss or change in energy intake among the TRF, ADF, or eTRF groups. GOV IDENTIFIER: NCT04527952.