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.

Building Meaningful Patient Engagement in Research: Case Study From ADVANCE Clinical Data Research Network.

BACKGROUND: Strategies to engage patients to improve and enhance research and clinical care are increasingly being implemented in the United States, yet little is known about best practices for or the impacts of meaningful patient engagement. OBJECTIVE: We describe and reflect on our patient stakeholder groups, engagement framework, experiences, and lessons learned in engaging patients in research, from generating proposal ideas to disseminating findings. SETTING: The ADVANCE (Accelerating Data Value Across a National Community Health Center Network) clinical data research network is the nation's largest clinical dataset on the safety net, with outpatient clinical data from 122 health systems (1109 clinics) in 23 states. RESULTS: Patients stakeholders codeveloped the ADVANCE engagement framework and its implementation in partnership with network leaders. In phase I of ADVANCE, patients were involved with designing studies (input on primary outcome measures and methods) and usability testing (of the patient portal). In phase II, the network is prioritizing research training, dissemination opportunities, an "ambassador" program to pair more experienced patient stakeholders with those less experienced, and evaluation of engagement activities and impacts. DISCUSSION: The ADVANCE framework for patient engagement has successfully involved a diverse group of patients in the design, implementation, and interpretation of comparative effectiveness research. Our experience and framework can be used by other organizations and research networks to support patient engagement activities.

The effect of a weight gain prevention intervention on moderate-vigorous physical activity among black women: the Shape Program.

BACKGROUND: Rates of physical inactivity are high among Black women living in the United States with overweight or obesity, especially those living in the rural South. This study was conducted to determine if an efficacious weight gain prevention intervention increased moderate-vigorous physical activity (MVPA). METHODS: The Shape Program, a weight gain prevention intervention implemented in community health centers in rural North Carolina, was designed for socioeconomically disadvantaged Black women with overweight or obesity. MVPA was measured using accelerometers, and summarized into 1- and 10-min bouts. We employed analyses of covariance (ANCOVA) to assess the relationship between changes in MVPA over 12 months, calculated as a change score, and intervention assignment (intervention versus usual care). RESULTS: Participants completing both baseline and 12-month accelerometer assessments (n = 121) had a mean age of 36.1 (SD = 5.43) years and a mean body mass index of 30.24 kg/m2 (SD = 2.60). At baseline, 38% met the physical activity recommendation (150 min of MVPA/week) when assessed using 10-min bouts, and 76% met the recommendation when assessed using 1-min bouts. There were no significant differences in change in MVPA participation among participants randomized to the intervention from baseline to 12-months using 1-min bouts (adjusted intervention mean [95% CI]: 20.50 [-109.09 to 150.10] vs. adjusted usual care mean [95% CI]: -80.04 [-209.21 to 49.13], P = .29), or 10-min bouts (adjusted intervention mean [95% CI]: 7.39 [-83.57 to 98.35] vs. adjusted usual care mean [95% CI]: -17.26 [-107.93 to 73.40], P = .70). CONCLUSIONS: Although prior research determined that the Shape intervention promoted weight gain prevention, MVPA did not increase significantly among intervention participants from baseline to 12 months. The classification of bouts had a marked effect on the prevalence estimates of those meeting physical activity recommendations. More research is needed to understand how to promote increased MVPA in weight gain prevention interventions. TRIAL REGISTRATION: This study is registered at www.clinicaltrials.gov database (No. NCT00938535. Retrospectively Registered 7/10/2009).

The effect of a "maintain, don't gain" approach to weight management on depression among black women: results from a randomized controlled trial.

OBJECTIVES: We evaluated the effect of a weight gain prevention intervention (Shape Program) on depression among socioeconomically disadvantaged overweight and obese Black women. METHODS: Between 2009 and 2012, we conducted a randomized trial comparing a 12-month electronic health-based weight gain prevention intervention to usual primary care at 5 central North Carolina community health centers. We assessed depression with the Patient Health Questionnaire (PHQ-8). We analyzed change in depression score from baseline to 12- and 18-month follow-up across groups with mixed models. We used generalized estimating equation models to analyze group differences in the proportion above the clinical threshold for depression (PHQ-8 score ≥ 10). RESULTS: At baseline, 20% of participants reported depression. Twelve-month change in depression scores was larger for intervention participants (mean difference = -1.85; 95% confidence interval = -3.08, -0.61; P = .004). There was a significant reduction in the proportion of intervention participants with depression at 12 months with no change in the usual-care group (11% vs 19%; P = .035). All effects persisted after we controlled for weight change and medication use. We saw similar findings at 18 months. CONCLUSIONS: The Shape Program, which includes no mention of mood, improved depression among socioeconomically disadvantaged Black women.

Adherence to self-monitoring via interactive voice response technology in an eHealth intervention targeting weight gain prevention among Black women: randomized controlled trial.

BACKGROUND: eHealth interventions are effective for weight control and have the potential for broad reach. Little is known about the use of interactive voice response (IVR) technology for self-monitoring in weight control interventions, particularly among populations disproportionately affected by obesity. OBJECTIVE: This analysis sought to examine patterns and predictors of IVR self-monitoring adherence and the association between adherence and weight change among low-income black women enrolled in a weight gain prevention intervention. METHODS: The Shape Program was a randomized controlled trial comparing a 12-month eHealth behavioral weight gain prevention intervention to usual care among overweight and obese black women in the primary care setting. Intervention participants (n=91) used IVR technology to self-monitor behavior change goals (eg, no sugary drinks, 10,000 steps per day) via weekly IVR calls. Weight data were collected in clinic at baseline, 6, and 12 months. Self-monitoring data was stored in a study database and adherence was operationalized as the percent of weeks with a successful IVR call. RESULTS: Over 12 months, the average IVR completion rate was 71.6% (SD 28.1) and 52% (47/91) had an IVR completion rate ≥80%. At 12 months, IVR call completion was significantly correlated with weight loss (r =-.22; P=.04) and participants with an IVR completion rate ≥80% had significantly greater weight loss compared to those with an IVR completion rate <80% (-1.97 kg, SE 0.67 vs 0.48 kg, SE 0.69; P=.01). Similar outcomes were found for change in body mass index (BMI; mean difference -0.94 kg, 95% CI -1.64 to -0.24; P=.009). Older, more educated participants were more likely to achieve high IVR call completion. Participants reported positive attitudes toward IVR self-monitoring. CONCLUSIONS: Adherence to IVR self-monitoring was high among socioeconomically disadvantaged black women enrolled in a weight gain prevention intervention. Higher adherence to IVR self-monitoring was also associated with greater weight change. IVR is an effective and useful tool to promote self-monitoring and has the potential for widespread use and long-term sustainability. TRIAL REGISTRATION: Clinicaltrials.gov NCT00938535; http://www.clinicaltrials.gov/ct2/show/NCT00938535.

Daily text messaging for weight control among racial and ethnic minority women: randomized controlled pilot study.

BACKGROUND: Daily self-monitoring of diet and physical activity behaviors is a strong predictor of weight loss success. Text messaging holds promise as a viable self-monitoring modality, particularly among racial/ethnic minority populations. OBJECTIVE: This pilot study evaluated the feasibility of a text messaging intervention for weight loss among predominantly black women. METHODS: Fifty obese women were randomized to either a 6-month intervention using a fully automated system that included daily text messages for self-monitoring tailored behavioral goals (eg, 10,000 steps per day, no sugary drinks) along with brief feedback and tips (n=26) or to an education control arm (n=24). Weight was objectively measured at baseline and at 6 months. Adherence was defined as the proportion of text messages received in response to self-monitoring prompts. RESULTS: The average daily text messaging adherence rate was 49% (SD 27.9) with 85% (22/26) texting self-monitored behavioral goals 2 or more days per week. Approximately 70% (16/23) strongly agreed that daily texting was easy and helpful and 76% (16/21) felt the frequency of texting was appropriate. At 6 months, the intervention arm lost a mean of 1.27 kg (SD 6.51), and the control arm gained a mean of 1.14 kg (SD 2.53; mean difference -2.41 kg, 95% CI -5.22 to 0.39; P=.09). There was a trend toward greater text messaging adherence being associated with greater percent weight loss (r=-.36; P=.08), but this did not reach statistical significance. There was no significant association between goal attainment and text messaging adherence and no significant predictors of adherence. CONCLUSIONS: Given the increasing penetration of mobile devices, text messaging may be a useful self-monitoring tool for weight control, particularly among populations most in need of intervention. TRIAL REGISTRATION: Clinicaltrials.gov: NCT00939081; http://clinicaltrials.gov/show/NCT00939081 (Archived by WebCite at http://www.webcitation.org/6KiIIcnk1).

Weight gain prevention among black women in the rural community health center setting: the Shape Program.

BACKGROUND: Nearly 60% of black women are obese. Despite their increased risk of obesity and associated chronic diseases, black women have been underrepresented in clinical trials of weight loss interventions, particularly those conducted in the primary care setting. Further, existing obesity treatments are less effective for this population. The promotion of weight maintenance can be achieved at lower treatment intensity than can weight loss and holds promise in reducing obesity-associated chronic disease risk. Weight gain prevention may also be more consistent with the obesity-related sociocultural perspectives of black women than are traditional weight loss approaches. METHODS/DESIGN: We conducted an 18-month randomized controlled trial (the Shape Program) of a weight gain prevention intervention for overweight black female patients in the primary care setting. Participants include 194 premenopausal black women aged 25 to 44 years with a BMI of 25-34.9 kg/m2. Participants were randomized either to usual care or to a 12-month intervention that consisted of: tailored obesogenic behavior change goals, self-monitoring via interactive voice response phone calls, tailored skills training materials, 12 counseling calls with a registered dietitian and a 12-month YMCA membership.Participants are followed over 18 months, with study visits at baseline, 6-, 12- and 18-months. Anthropometric data, blood pressure, fasting lipids, fasting glucose, and self-administered surveys are collected at each visit. Accelerometer data is collected at baseline and 12-months.At baseline, participants were an average of 35.4 years old with a mean body mass index of 30.2 kg/m2. Participants were mostly employed and low-income. Almost half of the sample reported a diagnosis of hypertension or prehypertension and 12% reported a diagnosis of diabetes or prediabetes. Almost one-third of participants smoked and over 20% scored above the clinical threshold for depression. DISCUSSION: The Shape Program utilizes an innovative intervention approach to lower the risk of obesity and obesity-associated chronic disease among black women in the primary care setting. The intervention was informed by behavior change theory and aims to prevent weight gain using inexpensive mobile technologies and existing health center resources. Baseline characteristics reflect a socioeconomically disadvantaged, high-risk population sample in need of evidence-based treatment strategies. TRIAL REGISTRATION: The trial is registered with clinicaltrials.gov NCT00938535.

Discordant Patient and Clinician Perspectives on the Potential Value of Genetic Services in Safety-Net Clinics.

PURPOSE: As new genetic services become available, their implementation in safety-net settings must be studied. METHODS: We interviewed stakeholders (patients and primary care clinicians) from federally qualified health centers to discuss the utility, acceptability, and priority of new genetic services. We presented scenarios tailored for each audience describing carrier testing, diagnostic testing for a developmental delay, and hereditary cancer syndrome testing. We summarized transcripts using the framework method and compared patient and clinician perspectives. RESULTS: Clinicians questioned the relevance and priority of genetic services. Hereditary cancer testing was perceived most favorably by clinicians, who focused on actionability, cost, and access to downstream care. Patients stated that access to genetic services was important and that there should be parity across safety-net and higher-resourced settings. CONCLUSIONS: Genetic services with clear clinical impact are more acceptable to clinicians in safety-net clinics. Clinicians may be underestimating patients' interest in expanded genetic services.

Effectiveness of an App and Provider Counseling for Obesity Treatment in Primary Care.

INTRODUCTION: Obesity treatment is less successful for socioeconomically disadvantaged populations, particularly when delivered in primary care. Digital health strategies can extend the reach of clinical obesity treatments to care settings serving patients at highest risk. METHODS: Track was an effectiveness RCT of a 12-month digital weight-loss intervention, embedded within a community health center system. Participants were 351 adult patients (aged 21-65 years) with obesity and hypertension, diabetes, and hyperlipidemia. Patients were randomized to usual care (n=175) or an intervention (n=176) comprising app-based self-monitoring of behavior change goals with tailored feedback, a smart scale, dietitian-delivered counseling calls, and clinician counseling informed by app-generated recommendations, delivered via electronic health record. The primary outcome was 12-month weight change. Randomization began on June 18, 2013, final assessments were completed on September 10, 2015. Data analysis was conducted in 2016 and 2017. The trial retained 92% of usual care and 96% of intervention participants at 12 months. RESULTS: The Track intervention produced larger weight losses relative to usual care at 6 months (net effect: -4.4 kg, 95% CI= -5.5, -3.3, p<0.001) and 12 months (net effect: -3.8 kg, 95% CI= -5.0, -2.5, p<0.001). Intervention participants were more likely to lose ≥5% of their baseline weight at 6 months (43% vs 6%, p<0.001) and 12 months (40% vs 17%, p<0.001). Intervention participants completing ≥80% of expected self-monitoring episodes (-3.5 kg); counseling calls (-3.0 kg); or self-weighing days (-4.4 kg) lost significantly more weight than less engaged intervention participants (all p<0.01). CONCLUSIONS: A digital obesity treatment, integrated with health system resources, can produce clinically meaningful weight-loss outcomes among socioeconomically disadvantaged primary care patients with elevated cardiovascular disease risk. TRIAL REGISTRATION: This study is registered at www.clinicaltrials.gov NCT01827800.

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.

Track: A randomized controlled trial of a digital health obesity treatment intervention for medically vulnerable primary care patients.

INTRODUCTION: Obesity continues to disproportionately affect medically vulnerable populations. Digital health interventions may be effective for delivering obesity treatment in low-resource primary care settings. METHODS: Track is a 12-month randomized controlled trial of a digital health weight loss intervention in a community health center system. Participants are 351 obese men and women aged 21 to 65years with an obesity-related comorbidity. Track participants are randomized to usual primary care or to a 12-month intervention consisting of algorithm-generated tailored behavior change goals, self-monitoring via mobile technologies, daily self-weighing using a network-connected scale, skills training materials, 18 counseling phone calls with a Track coach, and primary care provider counseling. Participants are followed over 12months, with study visits at baseline, 6, and 12months. Anthropometric data, blood pressure, fasting lipids, glucose and HbA1C and self-administered surveys are collected. Follow-up data will be collected from the medical record at 24months. RESULTS: Participants are 68% female and on average 50.7years old with a mean BMI of 35.9kg/m(2). Participants are mainly black (54%) or white (33%); 12.5% are Hispanic. Participants are mostly employed and low-income. Over 20% of the sample has hypertension, diabetes and hyperlipidemia. Almost 27% of participants currently smoke and almost 20% score above the clinical threshold for depression. CONCLUSIONS: Track utilizes an innovative, digital health approach to reduce obesity and chronic disease risk among medically vulnerable adults in the primary care setting. Baseline characteristics reflect a socioeconomically disadvantaged, high-risk patient population in need of evidence-based obesity treatment.

A text messaging-assisted randomized lifestyle weight loss clinical trial among overweight adults in Beijing.

OBJECTIVE: The impact of a text messaging-assisted lifestyle weight loss intervention on weight change among overweight adults in Beijing was examined. METHODS: It was a 6-month randomized two arm clinical trial. The control group received a brief advice session after randomization. The intervention group received three group sessions, five coaching calls, and a daily text message prompting participants to follow predetermined lifestyle goals. RESULTS: A total of 123 participants were randomized. At 6 months, controls gained 0.24 ± 0.28 kg (0.21% ± 0.38%) (NS) while intervention participants lost 1.6 ± 0.28 kg (2.31% ± 0.38%) (p < 0.0001). Intervention participants decreased waist circumference (WC) (-2.69 ± 0.43 cm, p < 0.0001), percent body fat (%BF) (-0.66% ± 0.19%, p = 0.0007), and systolic/diastolic blood pressure (SBP/DBP) significantly (-1.71 ± 1.12/-3.24 ± 0.87 mmHg), while the controls had no change in WC and %BF and increased SBP/DBP by 2.43 ± 1.14/1.20 ± 0.88 mmHg (between groups: p = 0.01/p = 0.0004). CONCLUSIONS: This text message-assisted lifestyle intervention was effective in reducing weight, WC, %BF, and improving BP. Coupled with the scalable feature of the intervention, this finding is intriguing in light of the potential reach of the intervention for countries like China where mobile phone penetration is high and the obesity rate continues to rise.

Availability of and ease of access to calorie information on restaurant websites.

OBJECTIVE: Offering calories on restaurant websites might be particularly important for consumer meal planning, but the availability of and ease of accessing this information are unknown. METHODS: We assessed websites for the top 100 U.S. chain restaurants to determine the availability of and ease of access to calorie information as well as website design characteristics. We also examined potential predictors of calorie availability and ease of access. RESULTS: Eighty-two percent of restaurants provided calorie information on their websites; 25% presented calories on a mobile-formatted website. On average, calories could be accessed in 2.35±0.99 clicks. About half of sites (51.2%) linked to calorie information via the homepage. Fewer than half had a separate section identifying healthful options (46.3%), or utilized interactive meal planning tools (35.4%). Quick service/fast casual, larger restaurants, and those with less expensive entrées and lower revenue were more likely to make calorie information available. There were no predictors of ease of access. CONCLUSION: Calorie information is both available and largely accessible on the websites of America's leading restaurants. It is unclear whether consumer behavior is affected by the variability in the presentation of calorie information.

Behavioral treatment for weight gain prevention among black women in primary care practice: a randomized clinical trial.

IMPORTANCE: Few weight loss treatments produce clinically meaningful weight loss outcomes among black women, particularly in the primary care setting. New weight management strategies are necessary for this population. Weight gain prevention might be an effective treatment option, with particular benefits for overweight and class 1 obese black women. OBJECTIVE: To compare changes in weight and cardiometabolic risk during a 12-month period among black women randomized to a primary care-based behavioral weight gain prevention intervention, relative to usual care. DESIGN, SETTING, AND PARTICIPANTS: Two-arm randomized clinical trial (the Shape Program). We recruited patients from a 6-site community health center system. We randomized 194 overweight and class 1 obese (body mass index [calculated as weight in kilograms divided by height in meters squared], 25-34.9) premenopausal black women aged 25 to 44 years. Enrollment began on December 7, 2009; 12- and 18-month assessments were completed in February and October 2, 2012. INTERVENTIONS: The medium-intensity intervention included tailored behavior change goals, weekly self-monitoring via interactive voice response, monthly counseling calls, tailored skills training materials, and a gym membership. MAIN OUTCOMES AND MEASURES: Twelve-month change in weight and body mass index and maintenance of change at 18 months. RESULTS: Participants had a mean age of 35.4 years, a mean weight of 81.1 kg, and a mean body mass index of 30.2 at baseline. Most were socioeconomically disadvantaged (79.7% with educational level less than a college degree; 74.3% reporting annual income <$30,000). The 12-month weight change was larger among intervention participants (mean [SD], -1.0 [0.5] kg), relative to usual care (0.5 [0.5] kg; mean difference, -1.4 kg [95% CI, -2.8 to -0.1 kg]; P = .04). At month 12, 62% of intervention participants were at or below their baseline weights compared with 45% of usual-care participants (P = .03). By 18 months, intervention participants maintained significantly larger changes in weight (mean difference, -1.7 kg; 95% CI, -3.3 to -0.2 kg). CONCLUSIONS AND RELEVANCE: A medium-intensity primary care-based behavioral intervention demonstrated efficacy for weight gain prevention among socioeconomically disadvantaged black women. A "maintain, don't gain" approach might be a useful alternative treatment for reducing obesity-associated disease risk among some premenopausal black women. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00938535.