Weight Gain Prevention Outcomes From a Pragmatic Digital Health Intervention With Community Health Center Patients: Randomized Controlled Trial.

BACKGROUND: The prevalence of obesity and its associated comorbidities continue to rise in the United States. Populations who are uninsured and from racial and ethnic minority groups continue to be disproportionately affected. These populations also experience fewer clinically meaningful outcomes in most weight loss trials. Weight gain prevention presents a useful strategy for individuals who experience barriers to weight loss. Given the often-limited weight management resources available to patients in primary care settings serving vulnerable patients, evaluating interventions with pragmatic designs may help inform the design of comprehensive obesity care delivered in primary care. OBJECTIVE: This study aims to evaluate the effectiveness of Balance, a 2-arm, 12-month pragmatic randomized controlled trial of a digital weight gain prevention intervention, delivered to patients receiving primary care within federally qualified community health centers. METHODS: Balance was a 2-arm, 12-month pragmatic randomized controlled trial of a digital weight gain prevention intervention delivered to individuals who had a BMI of 25-40 kg/m2, spoke English or Spanish, and were receiving primary care within a network of federally qualified community health centers in North Carolina. The Balance intervention was designed to encourage behavioral changes that result in a slight energy deficit. Intervention participants received tailored goal setting and tracking, skills training, self-monitoring, and responsive health coaching from registered dietitians. Weight was measured at regular primary care visits and documented in the electronic health record. We compared the percentage of ≤3% weight gain in each arm at 24 months after randomization-our primary outcome-using individual empirical best linear unbiased predictors from the linear mixed-effects model. We used individual empirical best linear unbiased predictors from participants with at least 1 electronic health record weight documented within a 6-month window centered on the 24-month time point. RESULTS: We randomized 443 participants, of which 223 (50.3%) participants were allocated to the intervention arm. At baseline, participants had a mean BMI of 32.6 kg/m2. Most participants were Latino or Hispanic (n=200, 45.1%) or non-Latino or Hispanic White (n=115, 26%). In total, 53% (n=235) of participants had at least 1 visit with weight measured in the primary time window. The intervention group had a higher proportion with ≤3% weight gain at 6 months (risk ratio=1.12, 95% CI 0.94-1.28; risk difference=9.5, 95% CI -4.5 to 16.4 percentage points). This difference attenuated to the null by 24 months (risk ratio=1.00, 95% CI 0.82-1.20; risk difference=0.2, 95% CI -12.1 to 11.0 percentage points). CONCLUSIONS: In adults with overweight or obesity receiving primary care at a community health center, we did not find long-term evidence to support the dissemination of a digital health intervention for weight gain prevention. TRIAL REGISTRATION: ClinicalTrials.gov NCT03003403; https://clinicaltrials.gov/study/NCT03003403. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s12889-019-6926-7.

Feasibility, Acceptability, and Initial Efficacy of a Digital Intervention to Improve Consumption of Foods Received within a National Nutrition Assistance Program.

Many mothers are vulnerable to poor diet quality, particularly those living in low-income households. The Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) provides nutrient-rich foods through its benefits packages, but many WIC participants are not redeeming them. We assessed the feasibility and acceptability of a digital intervention to support redemption and consumption of WIC-approved foods to ultimately improve diet quality. We enrolled 54 maternal-child dyads receiving WIC benefits to receive three to four weekly text messages for 12 weeks focused on behavioral goals to improve consumption of WIC-approved foods. We assessed engagement with weekly tracking messages and satisfaction and collected 24 h dietary recalls to assess preliminary efficacy on dietary intake. Participants were mostly non-Hispanic white (63%) and working (63%), and responded to 7.4 (standard deviation: 4.6) of the 12 weekly messages. Half (n = 27) were high engagers (responded to 80% or more of weekly messages), with 28% (n = 15) responding to all messages. Most felt the feedback (94%) and tips (87%) were helpful and would recommend the program (91%). More were consuming leafy green vegetables compared to baseline (p = 0.01). Mothers of children enrolled in WIC found a text messaging intervention focused on consumption of WIC-approved foods enjoyable and helpful.

The Patient's Point of View: Characterizing Patient-Level Factors Associated with Perceptions of Health Care.

Purpose: We explored the association between perception of care, as measured by the Interpersonal Processes of Care (IPC) survey, and patient-level factors, including (1) Trust in physicians; (2) Perceived empathy; (3) Stereotype threat; (4) Perceived everyday discrimination; and (5) Self-Reported Health. Methods: Fifty participants from diverse racial backgrounds and education levels were surveyed. We examined the associations between the five patient-level factors and each subdomain of the IPC using multiple linear regression. We added a race interaction term to assess whether associations between IPC subdomains and predictors differed by race. We tested for correlation among factors found to be significantly associated with the IPC. Results: In adjusted analyses, trust in the physician, perceived empathy from the provider, and perceived everyday discrimination were significantly associated with most subdomains of the IPC. There was no significant race interaction. Conclusion: This exploratory study suggests that empathy, trust, and perceived everyday discrimination are significantly linked to patient perception of quality care, which are linked to clinical outcomes. Results present modifiable factors that may potentially improve patient care. Practice Implications: Increased efforts to improve clinician communication of empathy and general communication skill may have a positive effect on quality of care.

Self-Monitoring via Digital Health in Weight Loss Interventions: A Systematic Review Among Adults with Overweight or Obesity.

OBJECTIVE: Self-monitoring is a core component of behavioral obesity treatment, but it is unknown how digital health has been used for self-monitoring, what engagement rates are achieved in these interventions, and how self-monitoring and weight loss are related. METHODS: This systematic review examined digital self-monitoring in behavioral weight loss interventions among adults with overweight or obesity. Six databases (PubMed, Embase, Scopus, PsycInfo, CINAHL, and ProQuest Dissertations & Theses) were searched for randomized controlled trials with interventions ≥ 12 weeks, weight outcomes ≥ 6 months, and outcomes on self-monitoring engagement and their relationship to weight loss. RESULTS: Thirty-nine studies from 2009 to 2019 met inclusion criteria. Among the 67 interventions with digital self-monitoring, weight was tracked in 72% of them, diet in 81%, and physical activity in 82%. Websites were the most common self-monitoring modality, followed by mobile applications, wearables, electronic scales, and, finally, text messaging. Few interventions had digital self-monitoring engagement rates ≥ 75% of days. Rates were higher in digital- than in paper-based arms in 21 out of 34 comparisons and lower in just 2. Interventions with counseling had similar rates to standalone interventions. Greater digital self-monitoring was linked to weight loss in 74% of occurrences. CONCLUSIONS: Self-monitoring via digital health is consistently associated with weight loss in behavioral obesity treatment.

A Digital Behavioral Weight Gain Prevention Intervention in Primary Care Practice: Cost and Cost-Effectiveness Analysis.

BACKGROUND: Obesity is one of the largest drivers of health care spending but nearly half of the population with obesity demonstrate suboptimal readiness for weight loss treatment. Black women are disproportionately likely to have both obesity and limited weight loss readiness. However, they have been shown to be receptive to strategies that prevent weight gain. OBJECTIVE: The aim of this study was to evaluate the costs and cost-effectiveness of a digital weight gain prevention intervention (Shape) for black women. Shape consisted of adaptive telephone-based coaching by health system personnel, a tailored skills training curriculum, and patient self-monitoring delivered via a fully automated interactive voice response system. METHODS: A cost and cost-effectiveness analysis based on a randomized clinical trial of the Shape intervention was conducted from the payer perspective. Costs included those of delivering the program to 91 intervention participants in the trial and were summarized by program elements: self-monitoring, skills training, coaching, and administration. Effectiveness was measured in quality-adjusted life years (QALYs). The primary outcome was the incremental cost per QALY of Shape relative to usual care. RESULTS: Shape cost an average of US $758 per participant. The base-case model in which quality of life benefits decay linearly to zero 5 years post intervention cessation, generated an incremental cost-effectiveness ratio (ICER) of US $55,264 per QALY. Probabilistic sensitivity analyses suggest an ICER below US $50,000 per QALY and US $100,000 per QALY in 39% and 98% of simulations, respectively. Results are highly sensitive to durability of benefits, rising to US $165,730 if benefits end 6 months post intervention. CONCLUSIONS: Results suggest that the Shape intervention is cost-effective based on established benchmarks, indicating that it can be a part of a successful strategy to address the nation's growing obesity epidemic in low-income at-risk communities.

Intervening during and after pregnancy to prevent weight retention among African American women.

Efforts to prevent postpartum weight retention in extant clinical trials of African American women have proven exceedingly challenging. The primary purpose of this pilot study was to determine whether a behavioral intervention implemented in early pregnancy through 6 months postpartum could increase the proportion of African American women who were at or below their early pregnancy weights by 6 months postpartum. We additionally evaluated whether mothers' postpartum weight loss could be maintained at 12 months postpartum. Participants were 66 socioeconomically disadvantaged African American women (36% overweight, 64% obese) randomly assigned to a behavioral intervention or usual care group. The intervention, implemented from early pregnancy to 6 months postpartum, promoted weight control through: (1) empirically supported behavior change goals; (2) interactive self-monitoring text messages; (3) weekly to monthly health coach calls; and (4) skills training and support through Facebook. In modified intent-to-treat analyses, participants assigned to the intervention were significantly more likely to be at or below their early pregnancy weights by 6 months postpartum compared to usual care (56% vs. 29%, p = 0.04). At 12 months postpartum, the maternal weight difference between intervention and usual care groups was not maintained (41% vs. 38% respectively at or below early pregnancy weights, p = 0.83). Findings suggest that a combined pregnancy and postpartum weight control intervention improves 6 month weight outcomes in socioeconomically disadvantaged African American women with obesity. Longer interventions may be needed to overcome late postpartum weight gain among this high risk group. Clinical trial registration number: ClinicalTrials.gov identifier NCT01530776.

Factors related to obesity and overweight among Black adolescent girls in the United States.

In the United States, Black adolescents have the highest prevalence of pediatric obesity and overweight among girls. While Black girls are disproportionately affected, the reasons for this health disparity remain unclear. The authors conducted a systematic review to investigate the factors related to obesity and overweight among Black adolescent girls. The authors searched four databases for relevant English-language publications using all publication years through 2015. Fifty-one studies met the inclusion criteria and were used for this review. Using a configuration approach to synthesis, three categories were identified, paralleling the bioecological theory of human development: (1) individual, (2) interpersonal, and (3) community and societal factors. A description of each factor's association with obesity among Black adolescent girls is presented. From this review, the authors identified a diverse and vast set of individual, interpersonal, and community and societal factors explored for their relationship with obesity and overweight. Given the insufficient repetition and limited significant findings among most factors, the authors believe that multiple gaps in knowledge exist across all categories regarding the factors related to obesity and overweight among Black adolescent girls. To improve the quality of research in this area, suggested research directions and methodological recommendations are provided.

Linking patients with community resources: use of a free YMCA membership among low-income black women.

Given the increasing interest in expanding obesity prevention efforts to cover community-based programs, we examined whether individuals would access a YMCA for physical activity promotion. We provided a no-cost 12-month YMCA membership to socioeconomically disadvantaged black women who were randomized to the intervention arm of a weight gain prevention trial (n = 91). Analyses examined associations of membership activation and use with baseline psychosocial, contextual, health-related, and sociodemographic factors. Many participants (70.3 %) activated their memberships; however, use was low (42.2 % had no subsequent visits, 46.9 % had one to ten visits). There were no predictors of membership activation, but individuals living below/borderline the federal poverty line were more likely to use the center (1+ visits), as were those who met physical activity guidelines at baseline. More comprehensive and intensive interventions may be necessary to promote use of community resources-even when provided free-among high-risk populations of women with obesity that live in rural areas of the USA.

Health Literacy and Weight Change in a Digital Health Intervention for Women: A Randomized Controlled Trial in Primary Care Practice.

In the United States, 90 million adults have low health literacy. An important public health challenge is developing obesity treatment interventions suitable for those with low health literacy. The objective of this study was to examine differences in sociodemographic and clinical characteristics as well as weight and intervention engagement outcomes by health literacy. We randomized 194 participants to usual care or to the Shape Program intervention, a 12-month digital health treatment aimed at preventing weight gain among overweight and Class I obese Black women in primary care practice. We administered the Newest Vital Sign instrument to assess health literacy. More than half (55%) of participants had low health literacy, which was more common among those with fewer years of education and lower income. There was no effect of health literacy on 12-month weight change or on intervention engagement outcomes (completion of coaching calls and interactive voice response self-monitoring calls). Low health literacy did not preclude successful weight gain prevention in the Shape Program intervention. Goal-focused behavior change approaches like that used in Shape may be particularly helpful for treating and engaging populations with low health literacy.

Using technology to promote postpartum weight loss in urban, low-income mothers: a pilot randomized controlled trial.

OBJECTIVE: To examine the feasibility, acceptability, and initial efficacy of a technology-based weight loss intervention for urban, low-income mothers. METHODS: Eighteen obese, ethnic minority, socioeconomically disadvantaged mothers in the first year after childbirth were randomly assigned to either: 1) technology-based intervention, which included empirically supported behavior-change strategies, daily skills, and self-monitoring text messages with personalized feedback, biweekly counseling calls from a health coach, and access to a Facebook support group, or 2) usual-care control. RESULTS: After 14 weeks of treatment, the technology-based intervention participants had significantly greater weight loss (-2.9 ± 3.6 kg) than usual care (0.5 ± 2.3 kg; adjusted mean difference: -3.2 kg, 95% confidence interval -6.2 to -0.1 kg, P = .04). One-third of intervention participants (3 of 9) and no control participants lost > 5% of their initial body weight at follow up. CONCLUSIONS AND IMPLICATIONS: Results suggest the potential for using technology to deliver a postpartum weight loss intervention among low-income racial/ethnic minorities.

Physically active, low-income African American women: an exploration of activity maintenance in the context of sociodemographic factors associated with inactivity.

Increasing physical activity among low-income African American women is an important target for addressing racial and economic disparities in chronic conditions and related risk factors. While barriers to physical activity for women have been examined empirically, successful strategies for navigating those barriers among physically active, low-income women have not been thoroughly explored. Informed by grounded theory, we conducted in-depth individual interviews between 2007-2010 with 14 low-income African American women who were physically active at nationally recommended levels for one year or more. We analyzed the data using thematic analysis techniques. Key themes emerged in three main categories: motivation for maintaining active lifestyle, strategies for maintaining physical activity, and challenges to maintaining physical activity. Important motivations included getting or staying healthy, social connections, and gratification. Two planning strategies emerged: flexibility and freedom. Critical challenges included financial constraints, physical strain and history of sedentary relapse. The motivations, strategies and challenges reported by low-income African American women who successfully maintained an active lifestyle provided important information for developing effective health promotion strategies for their inactive and underactive counterparts. A qualitative, asset-based approach to physical activity research contributes rich data to bridge the gap between epidemiological knowledge and community health improvement.

A randomized comparative effectiveness study of Healthy Directions 2--a multiple risk behavior intervention for primary care.

OBJECTIVE: To evaluate the effectiveness of the Healthy Directions 2 (HD2) intervention in the primary care setting. METHODS: HD2 was a cluster randomized trial (conducted 3/09-11/11). The primary sampling unit was provider (n=33), with secondary sampling of patients within provider (n=2440). Study arms included: 1) usual care (UC); 2) HD2--a patient self-guided intervention targeting 5 risk behaviors; and 3) HD2 plus 2 brief telephone coaching calls (HD2+CC). The outcome measure was the proportion of participants with a lower multiple risk behavior (MRB) score by follow-up. RESULTS: At baseline, only 4% of the participants met all behavioral recommendations. Both HD2 and HD2+CC led to improvements in MRB score, relative to UC, with no differences between the two HD2 conditions. Twenty-eight percent of the UC participants had improved MRB scores at 6 months, vs. 39% and 43% in HD2 and HD2+CC, respectively (ps≤.001); results were similar at 18 months (p≤.05). The incremental cost of one risk factor reduction in MRB score was $310 for HD2 and $450 for HD2+CC. CONCLUSIONS: Self-guided and coached intervention conditions had equivalent levels of effect in reducing multiple chronic disease risk factors, were relatively low cost, and thus are potentially useful for routine implementation in similar health settings.

Socioeconomic status and obesity in Cairo, Egypt: a heavy burden for all.

Studies have generally shown a positive association between socioeconomic status (SES) and obesity in low-income countries, but few have tested this relationship in the Middle East where obesity prevalence is extraordinarily high and the nutrition profile more closely resembles developed world contexts. The objective of this study is to examine the SES-obesity association in Cairo, Egypt. Multinomial regression analyses were conducted and predicted probabilities were found for overweight and obesity status among adult men and women in a stratified analysis. Data were taken from the 2007 Cairo Urban Inequity Study which collected information on 3993 individuals from 50 neighborhoods in the Cairo Governorate. Five different measures of SES were utilized - education, household expenditures, household assets, subjective wealth, and father's education. No significant associations were found between most measures of SES and overweight/obesity in this population. Overweight and obesity are prevalent across the SES spectrum. These findings suggest that obesity programs and policies should be targeted at all SES groups in Cairo, although specific mechanisms may vary by SES and should be explored further in future studies.

Factors associated with choice of web or print intervention materials in the healthy directions 2 study.

BACKGROUND: Many U.S. adults have multiple behavioral risk factors, and effective, scalable interventions are needed to promote population-level health. In the health care setting, interventions are often provided in print, although accessible to nearly everyone, are brief (e.g., pamphlets), are not interactive, and can require some logistics around distribution. Web-based interventions offer more interactivity but may not be accessible to all. Healthy Directions 2 was a primary care-based cluster randomized controlled trial designed to improve five behavioral cancer risk factors among a diverse sample of adults (n = 2,440) in metropolitan Boston. Intervention materials were available via print or the web. Purpose. To (a) describe the Healthy Directions 2 study design and (b) identify baseline factors associated with whether participants opted for print or web-based materials. METHODS: Hierarchical regression models corrected for clustering by physician were built to examine factors associated with choice of intervention modality. RESULTS: At baseline, just 4.0% of participants met all behavioral recommendations. Nearly equivalent numbers of intervention participants opted for print and web-based materials (44.6% vs. 55.4%). Participants choosing web-based materials were younger, and reported having a better financial status, better perceived health, greater computer comfort, and more frequent Internet use (p < .05) than those opting for print. In addition, Whites were more likely to pick web-based material than Black participants. CONCLUSIONS: Interventions addressing multiple behaviors are needed in the primary care setting, but they should be available in web and print formats as nearly equal number of participants chose each option, and there are significant differences in the population groups using each modality.

Use of RE-AIM to Address Health Inequities: Application in a low-income community health center based weight loss and hypertension self-management program.

BACKGROUND: While health inequities are well documented, and there are helpful frameworks to understand health disparities, implementation frameworks are also needed to focus the design, evaluation and reporting on interventions targeting populations at increased risk. PURPOSE: Describe how the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, and Maintenance) can be used for these purposes and illustrate its application in the context of a randomized, pragmatic weight-loss and hypertension self-management intervention. METHODS: RE-AIM was used to both plan and evaluate the Be Fit Be Well program for urban community health center patients. RESULTS: The RE-AIM framework helped to focus attention on and produce high rates of adoption and reach. Implementation rates varied across components. Weight losses were statistically significant, but not clinically significant. They were robust across a variety of patient characteristics, and the program was relatively low cost. Individual weight losses and blood pressure reductions were maintained throughout the 24-month period, but the program was not sustained at any of the three settings. CONCLUSION: Implementation frameworks such as RE-AIM can help design pragmatic interventions that focus on both the context for disparities reduction and the ultimate goal of public health impact.

Economic analyses of the Be Fit Be Well program: a weight loss program for community health centers.

BACKGROUND: The U.S. Preventive Services Task Force has released new guidelines on obesity, urging primary care physicians to provide obese patients with intensive, multi-component behavioral interventions. However, there are few studies of weight loss in real world nonacademic primary care, and even fewer in largely racial/ethnic minority, low-income samples. OBJECTIVE: To evaluate the recruitment, intervention and replications costs of a 2-year, moderate intensity weight loss and blood pressure control intervention. DESIGN: A comprehensive cost analysis was conducted, associated with a weight loss and hypertension management program delivered in three community health centers as part of a pragmatic randomized trial. PARTICIPANTS: Three hundred and sixty-five high risk, low-income, inner city, minority (71 % were Black/African American and 13 % were Hispanic) patients who were both hypertensive and obese. MAIN MEASURES: Measures included total recruitment costs and intervention costs, cost per participant, and incremental costs per unit reduction in weight and blood pressure. KEY RESULTS: Recruitment and intervention costs were estimated $2,359 per participant for the 2-year program. Compared to the control intervention, the cost per additional kilogram lost was $2,204 /kg, and for blood pressure, $621 /mmHg. Sensitivity analyses suggest that if the program was offered to a larger sample and minor modifications were made, the cost per participant could be reduced to the levels of many commercially available products. CONCLUSIONS: The costs associated with the Be Fit Be Well program were found to be significantly more expensive than many commercially available products, and much higher than the amount that the Centers for Medicare and Medicaid reimburse physicians for obesity counseling. However, given the serious and costly health consequences associated with obesity in high risk, multimorbid and socioeconomically disadvantaged patients, the resources needed to provide interventions like those described here may still prove to be cost-effective with respect to producing long-term behavior change.

The efficacy of a daily self-weighing weight loss intervention using smart scales and e-mail.

OBJECTIVE: To examine the impact of a weight loss intervention that focused on daily self-weighing for self-monitoring as compared to a delayed control group among 91 overweight adults. DESIGN AND METHODS: The 6-month intervention included a cellular-connected "smart" scale for daily weighing, web-based weight loss graph, and weekly e-mails with tailored feedback and lessons. An objective measure of self-weighing frequency was obtained. Weight was measured in clinic at 3 and 6 months. Caloric intake and expenditure, and perceptions of daily self-weighing were also measured. RESULTS: Using intent-to-treat analyses, the intervention group lost significantly more weight compared to the control group [mean (95% CI); 3 months: -4.41% (-5.5, -3.3) vs. -0.37% (-1.5, 0.76); 6 months: -6.55% (-7.7, -5.4) vs. -0.35% (-1.5, 0.79); group × time interaction: P < 0.001] and a greater percentage achieved 5% (42.6% vs. 6.8%; P < 0.0001) and 10% (27.7% vs. 0%; P < 0.0001) weight loss. On average, the intervention group self-weighed more days/week (6.1 ± 1.1 vs. 1.1 ± 1.5; P < 0.0001) and consumed fewer calories/day compared to the control group [mean (95% CI); 6 months: 1,509 (1,291, 1,728) vs. 1,856 (1,637, 2,074); group × time interaction: P = 0.006]. Among intervention participants, daily self-weighing was perceived positively. CONCLUSIONS: These results indicate that an intervention focusing on daily self-weighing can produce clinically significant weight loss.