Protocol of the HARMONY study: A culturally relevant, randomized-controlled, stress management intervention to reduce cardiometabolic risk in African American women.

BACKGROUND: African American Women (AAW) are at high risk for stress-related cardiometabolic (CM) conditions including obesity, heart disease, and diabetes. Prior interventions lack attention to culturally-nuanced stress phenomena (Superwoman Schema [SWS], contextualized stress, and network stress), which are positively and significantly associated with unhealthy eating and sedentary behavior. PURPOSE: The HARMONY Study is designed to test a culturally tailored mindfulness-based stress management intervention to address SWS, contextualized stress, and network stress as potential barriers to adherence to healthy exercise and eating goals. The study will help AAW build on their strengths to promote cardiometabolic health by enhancing positive reappraisal, self-regulation, and self-efficacy as protective factors against chronic stress-inducing biobehavioral morbidity and mortality risk. METHODS: This two-arm, randomized-controlled trial will test the effects of two group-based, online interventions. HARMONY 1 includes culturally-tailored exercise and nutrition education. HARMONY 2 includes mindfulness-based stress reduction, exercise, and nutrition education. We aim to recruit 200 AAW ≥ 18 years old with CM risk. RESULTS: Primary outcomes (actigraphy and carotenoid levels) and secondary outcomes (body composition, inflammatory markers, glucose metabolism, and stress) are being collected at baseline and 4-, 8-, and 12-months post-intervention. Intent-to-treat, data analytic approaches will be used to test group differences for the primary outcomes. DISCUSSION: This study is the first to address culturally-nuanced stress phenomena in AAW (SWS, network stress, and contextualized stress) using culturally-tailored stress management, exercise, and nutrition educational approaches to reduce biobehavioral CM risk among AAW. Quantitative and qualitative results will inform the development of scalable and sustainable CM risk-reduction programming for AAW. TRIAL REGISTRATION: The Multiple PIs registered the clinical trial (Identifier: NCT04705779) and reporting of summary results in ClinicalTrials.gov in accordance with the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information, within the required timelines.

Rural African American Women With Severe Obesity: A Cross-Sectional Analysis of Lifestyle Behaviors and Psychosocial Characteristics.

PURPOSE: To examine differences in lifestyle behavioral and psychosocial factors between rural African American women with Class 3 obesity and those with overweight, and Class 1-2 obesity. DESIGN: Cross-sectional study. SETTING: Rural Southeastern United States. SUBJECTS: Participants included 289 African American women with a mean age of 56 years, 66% with a high school education or less, and a mean body mass index (BMI) of 38.6 kg/m2; 35% (n = 102) were classified with Class 3 obesity. MEASURES: We objectively measured height, weight, and physical activity steps/day. Self-reported dietary and physical activity behaviors, general health-related quality of life, mental health, and social support were measured with validated surveys. ANALYSIS: Chi-Square analysis for categorical variables and analysis of variance (ANOVA) - via multiple linear regression - for continuous variables. RESULTS: There were no significant demographic differences between BMI groups, except for age, where women with Class 3 obesity were on average younger (51 vs 58 y, P < .001). Although dietary behaviors did not differ significantly between groups, we observed significant group differences in self-reported and objective measures of physical activity. The age-adjusted difference in means for self-reported total physical activity minutes/wk. was 91 minutes, with women categorized with Class 3 obesity reporting significantly fewer weekly minutes than those with overweight/Class 1-2 obesity (64.3 vs 156.4 min/wk. respectively, P < .01). Among psychosocial variables, only in the physical component scores of health-related quality of life did we find significant group differences - lower physical well-being among women with Class 3 obesity compared to those with overweight/Class 1-2 obesity (P = .02). CONCLUSION: For African American women with Class 3 obesity living in rural setting, these findings suggest behavioral weight loss interventions may need to target physical activity strategies that address physical, psychosocial, and environmental barriers.

A Mixed-Method Evaluation of a Rural Elementary School Implementing the Coordinated Approach to Child Health (CATCH) Program.

Despite children living in rural US areas having 26% greater odds of being affected by obesity compared to those living in urban areas, the implementation of evidence-based programs in rural schools is rare. We collected quantitative data (weight and height) from 272 racially and ethnically diverse students at baseline, and qualitative data from students (4 focus groups), parents, and school staff (16 semi-structured interviews and 29 surveys) to evaluate program outcomes and perceptions. At the 2-year follow-up, paired data from 157 students, represented by racial/ethnic groups of 59% non-Hispanic White, 31% non-Hispanic Black, and 10% Hispanic, showed an overall mean change (SD) in BMI z-score of -0.04 (0.59), a decrease of -0.08 (0.69) in boys, and a significant -0.18 (0.33) decrease among Hispanic students. Boys had a mean decrease in obesity prevalence of 3 percentage points (from 17% to 14%), and Hispanic students had the largest mean decrease in BMI percentile. Qualitative data showed positive perceptions of the CATCH program and its implementation. This community-engaged research, with collaboration from an academic institution, a health department, a local wellness coalition, and a rural elementary school, demonstrated successful CATCH program implementation and showed promising outcomes in mean BMI changes.

Deaf Weight Wise: A novel randomized clinical trial with Deaf sign language users.

OBJECTIVE: The goal of this study was to address the absence of evidence-based weight-control programs developed for use with Deaf people. METHODS: Community-based participatory research informed the design of the Deaf Weight Wise (DWW) trial and intervention. DWW focuses primarily on healthy lifestyle and weight through change in diet and exercise. The study enrolled 104 Deaf adults aged 40 to 70 years with BMI of 25 to 45 from community settings in Rochester, New York, and randomized participants to immediate intervention (n = 48) or 1-year delayed intervention (n = 56). The delayed intervention serves as a no-intervention comparison until the trial midpoint. The study collected data five times (every 6 months) from baseline to 24 months. All DWW intervention leaders and participants are Deaf people who use American Sign Language (ASL). RESULTS: At 6 months, the difference in mean weight change for the immediate-intervention arm versus the delayed-intervention arm (no intervention yet) was -3.4 kg (multiplicity-adjusted p = 0.0424; 95% CI: -6.1 to -0.8 kg). Most (61.6%) in the immediate arm lost ≥5% of baseline weight versus 18.1% in the no-intervention-yet arm (p < 0.001). Participant engagement indicators include mean attendance of 11/16 sessions (69%), and 92% completed 24-month data collection. CONCLUSION: DWW, a community-engaged, culturally appropriate, and language-accessible behavioral weight loss intervention, was successful with Deaf ASL users.

Motivating Weight Loss Among Black Adults in Relationships: Recommendations for Weight Loss Interventions.

BACKGROUND: Black men and women have the highest rates of obesity in the United States. Behavioral weight loss programs incorporating intimate partners may be effective in combating obesity among this population. Yet, current participation in these programs is low. Identifying motivations and triggers to weight loss may provide insight in designing programs to increase participation. AIM: To determine triggers and motivations for weight loss among Black men and women in committed relationships to inform development of weight loss interventions. METHOD: Twenty semi-structured interviews, based on an integrated theoretical framework of interdependence and communal coping and the social cognitive theory, were conducted among Black heterosexual couples where one or both individuals intentionally lost ≥5% of their body weight in the last 6 months in a metropolitan region in a southern state. Interviews were transcribed and coded. Themes were identified following multi-rater coding and direct and conventional content analysis. Recommendations were developed from emergent themes. RESULTS: Among individuals with recent weight loss, personal relevancy and awareness (health awareness and self-awareness) were identified as personal triggers for weight loss initiation. Health concerns and appearance were general motivations among the total sample. CONCLUSION: Emphasizing the impact of weight on daily functioning and quality of life, and increasing awareness of personal weight status and health consequences, may increase weight loss initiation and participation in weight loss programs among Black men and women in committed relationships. Findings also highlight strategies to improve recruitment and retention and guide intervention development and implementation for this population.

How Physicians Can Assess and Address Dietary Behaviors to Reduce Chronic Disease Risk.

With the growing burden of diet-related chronic disease impacting the public's health, nutrition counseling in a primary care setting is essential and can be accomplished through brief and creative approaches. This article reviews an example of a brief dietary assessment and counseling tool and counseling strategies focusing on dietary behavior changes that emphasize impact on health outcomes, ease of behavior change, and affordability. These, plus integrating office supports, are practical ways to start the conversation about improving diet quality with patients. Collaborative efforts in nutrition care, particularly through collaboration with registered dietitians, present a valuable opportunity to meet the nutrition care needs of patients. Additionally, this article reviews screening for eating disorders, food insecurity, and dietary supplement use.

The impact of COVID-19 on Black women who binge-eat: a qualitative study.

BACKGROUND: Although studies have traced the impact of COVID-19 on those with eating disorders, little is known about the specific impact of the pandemic on Black American women who report disordered eating behaviors and are at risk for eating disorders. Thus, the purpose of this study is to investigate the impact of COVID-19 on Black women who binge-eat. METHODS: We recruited a purposive sample during the first wave of COVID-19 from the southeastern United States. Participants identified as Black women, reported binge-eating episodes in the last 28 days, and agreed to participate in a semi-structured interview. Prior to the interview, participants were administered a socio-demographic survey and the Eating Disorder Examination-Questionnaire. Interviews were transcribed verbatim and analyzed independently using qualitative content analysis and open coding to identify relevant codes and themes. RESULTS: On average, participants (N = 20) were 43.05 ± 16.2 years of age and reported 5.6 ± 5.7 binge-eating episodes in the last 28 days. We identified six themes to describe participants' experiences managing their eating behavior during COVID-19: (1) food as a coping strategy; (2) lack of control around food; (3) increased time in a triggering environment (e.g., being at home with an easy availability of food); (4) lack of structure and routine; (5) challenges with limited food availability; and (6) positive impact of the pandemic. CONCLUSION: In this study, Black women reported challenges managing their eating behavior during COVID-19. Results could inform the development and tailoring of treatments for Black women reporting disordered eating behaviors. LEVEL OF EVIDENCE: Level V, qualitative interviews.

A Hybrid Implementation-Effectiveness Study of a Community Health Worker-Delivered Intervention to Reduce Cardiovascular Disease Risk in a Rural, Underserved Non-Hispanic Black Population: The CHANGE Study.

PURPOSE: To evaluate the implementation and effectiveness of the Carolina Heart Alliance Networking for Greater Equity (CHANGE) Program, an adapted evidence-based cardiovascular disease risk reduction intervention delivered by Community Health Workers (CHW) to rural adults. DESIGN: Hybrid implementation-effectiveness study with a pre-post design. SETTING: North Carolina Federally Qualified Health Center and local health department in a rural, medically underserved area. SAMPLE: Participants (n = 255) included 87% Non-Hispanic Black with a mean age of 57 years; 84% had diagnosed hypertension, 55% had diabetes, and 65% had hypercholesterolemia. INTERVENTION: A CHW-delivered, low-intensity, 4-month behavioral lifestyle intervention promoting a southern-style Mediterranean dietary pattern and physical activity. MEASURES: We measured number and representativeness of participants reached and retained, intervention delivery fidelity, weight, blood pressure, and self-reported dietary and physical activity behaviors. ANALYSIS: Pre-post changes at 4 months were analyzed using paired t-tests. RESULTS: Study participants completed 90% of planned intervention contacts; 87% were retained. Intervention delivery fidelity measures showed participants receiving a mean of 3.5 counseling visits, 2.7 booster calls, and on average completing 1.7 modules, setting 1.8 goals, and receiving 1.3 referrals per visit. There were significant mean reductions in systolic (-2.5 mmHg, P < .05) and diastolic blood pressure (-2.1 mmHg, P < .01); the proportion of participants with systolic blood pressure <130 increased by 7 % points (P = .05), and diastolic pressure <80 by 9 percentage points (P < .01). Dietary behaviors improved significantly with average weekly servings of nuts increased by .5 serving (P < .0001), and fruits and vegetables by .8 daily serving (P < .0001). Physical activity also increased on average by 45 min./week (P < .001). Weight did not change significantly. CONCLUSIONS: The CHANGE program showed both implementation and program effectiveness and adds to the evidence supporting CHW-delivered lifestyle interventions to reduce CVD risk among rural, Non-Hispanic Black, and medically underserved populations.

The Multi-Caregiver Role and Its Relationship to Behavioral Adherence and Weight Among Treatment Engaged Black Women.

PURPOSE: To examine the relationship between the multiple caregiver role and its perceived barriers to self-care on behavioral adherence in a weight loss intervention. DESIGN: A secondary analysis of data from a behavioral weight loss intervention. SETTING: The study was conducted in two cohorts from March 2016 to February 2017 at the University of North Carolina at Chapel Hill. SUBJECTS: Eighty-one Black women with overweight/obesity (age = 48.4 ± 10.9 years [M ± SD], BMI = 36.4 ± 4.5 kg/m2 [M ± SD]). MEASURES: Identification with the multiple caregiver role and barriers was assessed with the Multiple Caregiving Measurement Instrument. Weight was measured with a digital scale and height with a stadiometer. The Block food frequency questionnaire evaluated dietary intake. Moderate-to-vigorous physical activity (MVPA) was measured objectively with an accelerometer. Study adherence was measured by session attendance, self-weighing, and self-monitoring (diet and physical activity) frequency. ANALYSIS: Generalized linear models were used to examine the relationship between the multiple caregiver scales and the outcomes of interest, controlling for study arm, cohort, and income. Chi-square tests tested correlations. RESULTS: Greater identification with the multiple caregiver role was associated with decreased session attendance (ß = -.56 [SE = .27], P < .05) and a trend towards weight gain (ß = .36, [SE = .19], P = .07). Greater multiple caregiver barriers score predicted a decrease in fruit/vegetable intake (ß = -.17 [SE = .07], P < .05). All regression results are unstandardized. Negative correlations between multiple caregiver barriers and MVPA (r = -.24, P = .06) and daily self-weighing (r = -.19, P = .10) approached significance. CONCLUSIONS: Participants' identification with multiple caregiving role and barriers can reduce adherence, behavior and weight change. Interventions to address Black women's multiple roles and barriers during weight loss are needed to maximize outcomes.

Tailoring implementation strategies for scale-up: Preparing to take the Med-South Lifestyle program to scale statewide.

Background: Tailoring implementation strategies for scale-up involves engaging stakeholders, identifying implementation determinants, and designing implementation strategies to target those determinants. The purpose of this paper is to describe the multiphase process used to engage stakeholders in tailoring strategies to scale-up the Med-South Lifestyle Program, a research-supported lifestyle behavior change intervention that translates the Mediterranean dietary pattern for the southeastern US. Methods: Guided by Barker et al. framework, we tailored scale-up strategies over four-phases. In Phase 1, we engaged stakeholders from delivery systems that implement lifestyle interventions and from support systems that provide training and other support for statewide scale-up. In Phase 2, we partnered with delivery systems (community health centers and health departments) to design and pilot test implementation strategies (2014-2019). In Phase 3, we partnered with both delivery and support systems to tailor Phase 2 strategies for scale-up (2019-2021) and are now testing those tailored strategies in a type 3 hybrid study (2021-2023). This paper reports on the Phase 3 methods used to tailor implementation strategies for scale-up. To identify determinants of scale-up, we surveyed North Carolina delivery systems (n = 114 community health centers and health departments) and elicited input from delivery and support system stakeholders. We tailored strategies to address identified determinants by adapting the form of Phase 2 strategies while retaining their functions. We pilot tested strategies in three sites and collected data on intermediate, implementation, and effectiveness outcomes. Findings: Determinants of scale-up included limited staffing, competing priorities, and safety concerns during COVID-19, among others. Tailoring yielded two levels of implementation strategies. At the level of the delivery system, strategies included implementation teams, an implementation blueprint, and cyclical small tests of change. At the level of the support system, strategies included training, educational materials, quality monitoring, and technical assistance. Findings from the pilot study provide evidence for the implementation strategies' reach, acceptability, and feasibility, with mixed findings on fidelity. Strategies were only moderately successful at building delivery system capacity to implement Med-South. Conclusions: This paper describes the multiphase approach used to plan for Med-South scale-up, including the methods used to tailor two-levels of implementation strategies by identifying and targeting multilevel determinants.

Did the 2015 USPSTF Abnormal Blood Glucose Recommendations Change Clinician Attitudes or Behaviors? A Mixed-Method Assessment.

BACKGROUND: In 2015, the US Preventive Services Task Force (USPSTF) revised clinical recommendations to more broadly recommend abnormal blood glucose screening and more clearly recommend referral to behavioral interventions for adults with prediabetes. OBJECTIVE: To assess the effects of the 2015 USPSTF recommendation changes on abnormal blood glucose screening and referral to behavioral interventions, and to examine physicians' perceptions of the revised recommendation. DESIGN: We utilized a sequential, dependent mixed-methods triangulation design. PARTICIPANTS: A total of 33,444 patients meeting USPSTF abnormal blood glucose screening criteria within 15 health system-affiliated primary care practices and 20 primary care physicians in North Carolina. MAIN MEASURES: We assessed monthly abnormal blood glucose screening rate and monthly referral rate to behavioral interventions. To estimate trend changes in outcomes, we used segmented linear regression analysis of interrupted time-series data. We gathered physicians' perspectives on the 2015 USPSTF abnormal blood glucose recommendation including awareness of, agreement with, adoption of, and adherence to the recommendation. To analyze qualitative data, we used directed content analysis. KEY RESULTS: There was a slight significant change in trend in abnormal blood glucose screening rates post-recommendation. There was a slight, statistically significant decrease in referral rates to behavioral interventions post-recommendation. Physicians were generally unaware of the revisions to the 2015 USPSTF abnormal blood glucose recommendation; however, once the recommendations were described, physicians agreed with the screening recommendation but felt that the behavioral intervention referral recommendation was hard to implement. CONCLUSION: The 2015 USPSTF abnormal blood glucose guideline had little to no effect on abnormal blood glucose screening or referral to behavioral interventions in North Carolina practices. Potential interventions to improve these rates could include clinical decision tools embedded in the electronic health record and better referral systems for community-based diabetes prevention programs.

Race and gender differences in abnormal blood glucose screening and clinician response to prediabetes: A mixed-methods assessment.

The projected three-fold increase in diabetes burden by 2060 in the United States will affect certain race and gender groups disproportionately. The objective of this mixed-methods study was to assess differences in prediabetes screening and clinician response to prediabetes by patient race and gender. We utilized data from 18,742 patients seen between 11/1/15 and 4/30/17 who met criteria for blood glucose screening by the 2015 US Preventive Service Task Force recommendation and had at least one visit to a primary care practice within a large, academic health system located in North Carolina. We utilized generalized estimating equations with logistic regression to assess race and gender differences in two outcomes: prediabetes screening and clinician response to prediabetes. We conducted twenty in-depth interviews (October 2018-May 2019) with physicians to assess their approach to screening for and treating prediabetes. Black patients had 11% higher odds (95% CI:1.02-1.20) of being screened for prediabetes than White patients. Men had 19% higher odds (95% CI:1.09-1.30) of being screened for prediabetes than women. There were no significant differences in clinician response to prediabetes by patient race or gender. Qualitatively, physicians reported a non-systematic approach to prediabetes screening and follow-up care related to: 1) System-level barriers to screening and treatment; 2) Implicit bias; 3) Patient factors; and 4) Physician preferences for prediabetes treatment. Targeted risk-based screening for prediabetes along with increased treatment for prediabetes are critical for preventing diabetes and reducing diabetes-related disparities.

Strengthening community-clinical linkages to reduce cardiovascular disease risk in rural NC: feasibility phase of the CHANGE study.

BACKGROUND: Community Health Workers (CHW) are recommended for delivery of interventions to prevent cardiovascular disease, but there is insufficient evidence to guide implementation of CHW interventions in rural, medically underserved areas. METHODS: Using a hybrid implementation-effectiveness design, we evaluated the implementation and effectiveness of an adapted, evidence-based cardiovascular disease risk reduction intervention among rural high-risk adults. CHWs at a community health center and local health department recruited, enrolled and counseled participants during 4 monthly home visits and 3 brief phone contacts. Participant data collection included pre- and post-intervention measurements of blood pressure, weight, and dietary and physical activity behaviors. We evaluated implementation with measures of intervention reach and delivery fidelity. Statistical analyses included descriptive statistics and paired t-tests. RESULTS: Study participants (n = 105) had a mean age of 62 years and included 88% Non-Hispanic Blacks and 82% females. Recruitment strategies resulted in the enrollment of 38% of interested and eligible participants who received 80% of the planned intervention visits and phone contacts. Mean differences in pre-/post-intervention measures showed significant mean reductions in blood pressure (- 5.4 mmHg systolic, p = .006; - 2.3 mmHg diastolic, p = .04) and body weight (- 3.8 lb., p = .02). Self-reported dietary and physical activity behaviors also improved significantly. CONCLUSION: This feasibility study demonstrated preliminary implementation and program effectiveness of a CHW-delivered intervention to reduce cardiovascular disease risk factors. Additionally, it identified areas for future refinements to strategies that strengthen community-clinical linkages with an integrated role of CHWs in rural health care delivery. If results from this feasibility study can be enhanced in a larger sample, there would be significant potential to positively impact the excess burden of chronic diseases that adversely impact rural, low-income, and medically underserved populations. TRIAL REGISTRATION: ClinicalTrials.gov: NCT03582696.

Comparative effectiveness of a standard behavioral and physical activity enhanced behavioral weight loss intervention in Black women.

Black women typically lose small amounts of weight in behavioral weight loss interventions, partially due to low engagement in physical activity. Culturally relevant enhancement of the physical activity component may improve weight loss. This study compared the effectiveness of a culturally-relevant, physical activity-enhanced behavioral weight loss intervention to a standard behavioral weight loss intervention in Black women (n = 85) over 6 months. The study was conducted in two cohorts from March 2016 to February 2017 at the University of North Carolina at Chapel Hill. Participants had an average age of 48.30 ± 11.02 years with an average body mass index of 36.46 ± 4.50 kg/m2. Standard and enhanced groups' weight change (-2.83 kg and -2.08 kg, respectively) and change in physical activity (43.93 min/ week and 15.29 min/week, respectively) did not differ between groups. Significantly more standard group participants lost 5% of baseline weight compared to enhanced group participants. This study produced typical weight loss results in Black women. Behavioral weight loss treatment remains moderately effective for Black women. Strategies to increase attendance and self-monitoring, and the inclusion of cultural contexts to weight-related behaviors are needed to improve outcomes.

Reducing cardiovascular disease in a rural community.

In this case report, we describe the one-year formative phase of a five-year study to develop, implement, and test a community health worker (CHW)-delivered cardiovascular disease (CVD) prevention intervention. The purpose of the formative phase was to engage community partners in the adaptation of an existing evidence-based CVD prevention intervention to fit the needs and preferences of a rural, predominantly African-American community. The formative work was guided by a framework for adapting evidence-based interventions and involved engaging stakeholders in assessing the intervention's fit with the local context and then applying assessment findings to iteratively adapt the intervention's contents, materials, and delivery methods. Findings from the formative work were then applied to develop CHW position descriptions, workflow diagrams, and a training plan. Findings also were applied to adapt intervention materials and protocols to fit the needs of the community. This case report illustrates how community-engaged formative work can be applied to adapt an evidence-based intervention to fit community needs and resources.

Racial Differences in Weight Loss Mediated by Engagement and Behavior Change.

Objective: We set out to determine if a primarily Internet-delivered behavioral weight loss intervention produced differential weight loss in African American and non-Hispanic White women, and to identify possible mediators. Design: Data for this analysis were from a randomized controlled trial, collected at baseline and 4-months. Setting: The intervention included monthly face-to-face group sessions and an Internet component that participants were recommended to use at least once weekly. Participants: We included overweight or obese African American and non-Hispanic White women (n=170), with at least weekly Internet access, who were able to attend group sessions. Intervention: Monthly face-to-face group sessions were delivered in large or small groups. The Internet component included automated tailored feedback, self-monitoring tools, written lessons, video resources, problem solving, exercise action planning tools, and social support through message boards. Main Outcome Measure: Multiple linear regression was used to evaluate race group differences in weight change. Results: Non-Hispanic White women lost more weight than African American women (-5.03% vs.-2.39%, P=.0002). Greater website log-ins and higher change in Eating Behavior Inventory score in non-Hispanic White women partially mediated the race-weight loss relationship. Conclusions: The weight loss disparity may be addressed through improved website engagement and adoption of weight control behaviors.

Perceived barriers and preferred components for physical activity interventions in African-American survivors of breast or endometrial cancer with type 2 diabetes: the S.U.C.C.E.S.S. framework.

PURPOSE: African-American (AA) female cancer survivors share a disproportionate burden of diabetes compared to their white counterparts. Our objectives were to explore the perspectives of AA survivors with type 2 diabetes on perceived barriers to physical activity (PA) and preferences for a PA intervention and develop a framework for a PA program after cancer treatment. METHODS: Trained interviewers conducted semi-structured interviews with AA survivors of breast or endometrial cancer with diabetes (total n = 20; 16 breast, 4 endometrial). Thirteen open-ended questions were posed to stimulate discussions, which were audio recorded and transcribed verbatim. Two investigators independently reviewed transcriptions and extracted coded quotations to identify major themes. RESULTS: Median age of participants was 63 years. Nine themes were identified that focused on post-treatment physical symptoms (e.g., lymphedema, bone/joint pain, depression symptoms and self-motivation as barriers to PA, exercise routines tailored to physical limitations and peer partners and program leaders who understand their emotional health needs). The S.U.C.C.E.S.S. framework summarizes the survivors' preferences for an effective lifestyle intervention: Support efforts to maintain PA, Understand physical and depression symptoms, Collaborate with multi-disciplinary provider, Coordinate in-person intervention activities, Encourage partnerships among survivors for comorbidity risk reduction, develop Sustainable coping strategies for side effects of treatment, and Share local community resources. CONCLUSIONS: Survivors verbalized the need for a multi-disciplinary team to assist with their psychosocial needs and physical limitations to achieve their PA goals, as integrated into the S.U.C.C.E.S.S. IMPLICATIONS FOR CANCER SURVIVORS: The S.U.C.C.E.S.S. framework reflects the perspectives of survivors with type 2 diabetes and may help to inform post-treatment programs.

Randomized trial comparing group size of periodic in-person sessions in a remotely delivered weight loss intervention.

BACKGROUND: Few randomized studies have examined differential effects of group size in behavioral weight control, especially in hybrid programs that include Internet treatment approaches. METHODS: Randomized controlled trial (n = 195) comparing a 4 month hybrid internet weight loss program coupled with monthly face to face groups of 100 persons (Large Group, LG; 1 group) or to the same approach with monthly groups of 20 persons (Small Group, SG; 4 groups). Repeated-measures mixed-model analysis with age and race as covariates were used to estimate primary (weight) and secondary outcomes, and to test group differences in change over time. RESULTS: The sample was 46.3 years old ±10.4, 90.3% female, and 51.9% non-white, with BMI 37.9 ± 8.4 kg/m2. Participants in the LG were more likely to return for the 4-month assessment visit than those in the SG (p = 0.04). Participants randomized to both the LG and SG conditions experienced significant WL over time (no between group difference: -4.1 kg and -3.7 kg, respectively) and weight loss was positively associated with attendance at monthly meetings and logins to the website. Satisfaction with the program was high and similar in both groups (94.4% reported that they were "satisfied" or "very satisfied"). CONCLUSIONS: Using a hybrid approach of in-person and online weight loss interventions may be an effective way to reach larger and more diverse populations. Delivering the face to face component of the intervention in groups larger than those traditionally delivered (20-25 people) could increase the cost-effectiveness of group-based behavioral weight loss interventions. CLINICAL TRIALS REGISTRATION NUMBER: NCT01615471 . Registered June 6, 2012. Registered retrospectively.