Evaluation of a Digital Diabetes Prevention Program Adapted for Low-Income Patients, 2016-2018.

INTRODUCTION: We examined the effects of a digitally delivered, type 2 diabetes mellitus prevention program (DPP) for a low-income population. METHODS: We conducted a nonrandomized clinical trial with matched controls. The intervention group was offered a digital DPP, a web-based and mobile-based program including 52 weeks of participation in an educational curriculum, health coaching, and peer support. RESULTS: A total of 227 participants enrolled. At baseline, 34.6 was the mean body mass index, and 5.8 was the mean HbA1c. For the intervention group, mean weight loss was 4.4% at the 12-month follow-up. CONCLUSION: The modified DPP successfully engaged participants and resulted in weight loss. Low-income patients with prediabetes benefitted from a digitally delivered diabetes intervention. This prevention method should be accessible to a low-income population.

Effects of Counseling by Peer Human Advisors vs Computers to Increase Walking in Underserved Populations: The COMPASS Randomized Clinical Trial.

Importance: Effective and practical treatments are needed to increase physical activity among those at heightened risk from inactivity. Walking represents a popular physical activity that can produce a range of desirable health effects, particularly as people age. Objective: To test the hypothesis that counseling by a computer-based virtual advisor is no worse than (ie, noninferior to) counseling by trained human advisors for increasing 12-month walking levels among inactive adults. Design, Setting, and Participants: A cluster-randomized, noninferiority parallel trial enrolled 245 adults between July 21, 2014, and July 29, 2016, with follow-up through September 15, 2017. Data analysis was performed from March 15 to December 20, 2018. The evidence-derived noninferiority margin was 30 minutes of walking per week. Participants included inactive adults aged 50 years and older, primarily of Latin American descent and capable of walking without significant limitations, from 10 community centers in Santa Clara and San Mateo counties, California. Interventions: All participants received similar evidence-based, 12-month physical activity counseling at their local community center, with the 10 centers randomized to a computerized virtual advisor program (virtual) or a previously validated peer advisor program (human). Main Outcomes and Measures: The primary outcome was change in walking minutes per week over 12 months using validated interview assessment corroborated with accelerometry. Both per-protocol and intention-to-treat analysis was performed. Results: Among the 245 participants randomized, 193 were women (78.8%) and 241 participants (98.4%) were Latino. Mean (SD) age was 62.3 (8.4) years (range, 50-87 years), 107 individuals (43.7%) had high school or less educational level, mean BMI was 32.8 (6.8), and mean years residence in the US was 47.4 (17.0) years. A total of 231 participants (94.3%) completed the study. Mean 12-month change in walking was 153.9 min/wk (95% CI, 126.3 min/wk to infinity) for the virtual cohort (n = 123) and 131.9 min/wk (95% CI, 101.4 min/wk to infinity) for the human cohort (n = 122) (difference, 22.0, with lower limit of 1-sided 95% CI, -20.6 to infinity; P = .02); this finding supports noninferiority. Improvements emerged in both arms for relevant clinical risk factors, sedentary behavior, and well-being measures. Conclusions and Relevance: The findings of this study indicate that a virtual advisor using evidence-based strategies produces significant 12-month walking increases for older, lower-income Latino adults that are no worse than the significant improvements achieved by human advisors. Changes produced by both programs are commensurate with those reported in previous investigations of these behavioral interventions and provide support for broadening the range of light-touch physical activity programs that can be offered to a diverse population. Trial Registration: ClinicalTrials.gov Identifier: NCT02111213.

Testing the effectiveness of physical activity advice delivered via text messaging vs. human phone advisors in a Latino population: The On The Move randomized controlled trial design and methods.

Physical inactivity is a key risk factor for a range of chronic diseases and conditions, yet, approximately 50% of U.S. adults fall below recommended levels of regular aerobic physical activity (PA). This is particularly true for ethnic minority populations such as Latino adults for whom few culturally adapted programs have been developed and tested. Text messaging (SMS) represents a convenient and accessible communication channel for delivering targeted PA information and support, but has not been rigorously evaluated against standard telehealth advising programs. The objective of the On The Move randomized controlled trial is to test the effectiveness of a linguistically and culturally targeted SMS PA intervention (SMS PA Advisor) versus two comparison conditions: a) a standard, staff-delivered phone PA intervention (Telephone PA Advisor) and b) an attention-control arm consisting of a culturally targeted SMS intervention to promote a healthy diet (SMS Nutrition Advisor). The study sample (N = 350) consists of generally healthy, insufficiently active Latino adults ages 35 years and older living in five northern California counties. Study assessments occur at baseline, 6, and 12 months, with a subset of participants completing 18-month assessments. The primary outcome is 12-month change in walking, and secondary outcomes include other forms of PA, assessed via validated self-report measures and supported by accelerometry, and physical function and well-being variables. Potential mediators and moderators of intervention success will be explored to better determine which subgroups do best with which type of intervention. Here we present the study design and methods, including recruitment strategies and yields. Trial Registration: clinicaltrial.gov Identifier = NCT02385591.

Outcomes of a Digital Health Program With Human Coaching for Diabetes Risk Reduction in a Medicare Population.

OBJECTIVE: To examine the outcomes of a Medicare population who participated in a program combining digital health with human coaching for diabetes risk reduction. METHOD: People at risk for diabetes enrolled in a program combining digital health with human coaching. Participation and health outcomes were examined at 16 weeks and 6 and 12 months. RESULTS: A total of 501 participants enrolled; 92% completed at least nine of 16 core lessons. Participants averaged 19 of 31 possible opportunities for weekly program engagement. At 12 months, participants lost 7.5% ( SD = 7.8%) of initial body weight; among participants with clinical data, glucose control improved (glycosylated hemoglobin [HbA1c] change = -0.14%, p = .001) and total cholesterol decreased (-7.08 mg/dL, p = .008). Self-reported well-being, depression, and self-care improved ( p < .0001). DISCUSSION: This Medicare population demonstrated sustained program engagement and improved weight, health, and well-being. The findings support digital programs with human coaching for reducing chronic disease risk among older adults.

Evaluation of a digital diabetes prevention program adapted for the Medicaid population: Study design and methods for a non-randomized, controlled trial.

Previous studies have shown that lifestyle modification can successfully prevent or delay development of type 2 diabetes. This trial aimed to test if an underserved, low-income population would engage in a digital diabetes prevention program and successfully achieve lifestyle changes to reduce their risk of type 2 diabetes. Participants were recruited from three health care facilities serving low-income populations. The inclusion criteria were: a recent blood test indicating prediabetes, body mass index (BMI) > 24 kg/m2, age 18-75 years, not pregnant, not insured, Medicaid insured or Medicaid-eligible, internet or smartphone access, and comfort reading and writing in English or Spanish. A total of 230 participants were enrolled and started the intervention. Participants' average age was 48 years, average BMI = 34.8, average initial HbA1c = 5.8, 81% were female, and 45% were Spanish speaking. Eighty percent had Medicaid insurance, 18% were uninsured, and 2% were insured by a medical safety net plan. Participants completed a health assessment including measured anthropometrics, HbA1c test, and self-report questionnaires at baseline, 6 and 12 months. The 52-week digital diabetes prevention program included weekly educational curriculum, human health coaching, connected tracking tools, and peer support from a virtual group. Qualitative data on implementation was collected with semi-structured interviews with key informants to understand the barriers, keys to success, and best practices in the adoption of the program within the clinical setting. This paper describes the study design and methodology of a digital diabetes prevention program and early lessons learned related to recruitment, enrollment, and data collection.

Evaluation of a Digital Behavioral Counseling Program for Reducing Risk Factors for Chronic Disease in a Workforce.

OBJECTIVE: To evaluate a digitally delivered, intensive behavioral counseling program for a workforce at risk for obesity-related chronic disease. METHODS: Employees were offered a digital health program modeled after the diabetes prevention program (DPP). Annual workforce health assessments were used to examine changes in chronic disease risk factors between participants (n = 634) relative to a matched comparison group (n = 1268). RESULTS: Overall, employees were gaining an average of 3.5 pounds annually before program inception. Program engagement was positive; 83% completed the majority of the curriculum and 31% lost at least 5% of their starting weight. Compared with non-participating peers, participants demonstrated reduced weight, improved fasting blood glucose, and improved nutritional intake after a year. CONCLUSIONS: The digital health program was effective for engaging employees in health behavior change. Digital options facilitate widespread implementation.

Testing the comparative effects of physical activity advice by humans vs. computers in underserved populations: The COMPASS trial design, methods, and baseline characteristics.

While physical inactivity is a key risk factor for a range of chronic diseases and conditions associated with aging, a significant proportion of midlife and older adults remain insufficiently active. This is particularly true for ethnic minority populations such as Latino adults for whom few culturally adapted programs have been developed and tested. The major objective of this 12-month cluster-randomized controlled trial is to test the comparative effectiveness of two linguistically and culturally adapted, community-based physical activity interventions with the potential for broad reach and translation. Ten local community centers serving a sizable number of Latino residents were randomized to receive one of two physical activity interventions. The Virtual Advisor program employs a computer-based embodied conversational agent named "Carmen" to deliver interactive, individually tailored physical activity advice and support. A similar intervention program is delivered by trained Peer Advisors. The target population consists of generally healthy, insufficiently active Latino adults ages 50years and older living within proximity to a designated community center. The major outcomes are changes in walking and other forms of physical activity measured via self-report and accelerometry. Secondary outcomes include physical function and well-being variables. In addition to these outcome analyses, comparative cost analysis of the two programs, potential mediators of intervention success, and baseline moderators of intervention effects will be explored to better determine which subgroups do best with which type of intervention. Here we present the study design and methods, including recruitment strategies and yield as well as study baseline characteristics. TRIAL REGISTRATION: clinicaltrial.gov Identifier=NCT02111213.

Clinical and Economic Impact of a Digital, Remotely-Delivered Intensive Behavioral Counseling Program on Medicare Beneficiaries at Risk for Diabetes and Cardiovascular Disease.

BACKGROUND: Type 2 diabetes and cardiovascular disease impose substantial clinical and economic burdens for seniors (age 65 and above) and the Medicare program. Intensive Behavioral Counseling (IBC) interventions like the National Diabetes Prevention Program (NDPP), have demonstrated effectiveness in reducing excess body weight and lowering or delaying morbidity onset. This paper estimated the potential health implications and medical savings of a digital version of IBC modeled after the NDPP. METHODS AND FINDINGS: Participants in this digital IBC intervention, the Omada program, include 1,121 overweight or obese seniors with additional risk factors for diabetes or heart disease. Weight changes were objectively measured via participant use of a networked weight scale. Participants averaged 6.8% reduction in body weight within 26 weeks, and 89% of participants completed 9 or more of the 16 core phase lessons. We used a Markov-based microsimulation model to simulate the impact of weight loss on future health states and medical expenditures over 10 years. Cumulative per capita medical expenditure savings over 3, 5 and 10 years ranged from $1,720 to 1,770 (3 years), $3,840 to $4,240 (5 years) and $11,550 to $14,200 (10 years). The range reflects assumptions of weight re-gain similar to that seen in the DPP clinical trial (lower bound) or minimal weight re-gain aligned with age-adjusted national averages (upper bound). The estimated net economic benefit after IBC costs is $10,250 to $12,840 cumulative over 10 years. Simulation outcomes suggest reduced incidence of diabetes by 27-41% for participants with prediabetes, and stroke by approximately 15% over 5 years. CONCLUSIONS: A digital, remotely-delivered IBC program can help seniors at risk for diabetes and cardiovascular disease achieve significant weight loss, reduces risk for diabetes and cardiovascular disease, and achieve meaningful medical cost savings. These findings affirm recommendations for IBC coverage by the U.S. Preventive Services Task Force.

Cost-effectiveness of the LIFE Physical Activity Intervention for Older Adults at Increased Risk for Mobility Disability.

BACKGROUND: Losing the ability to walk safely and independently is a major concern for many older adults. The Lifestyle Interventions and Independence for Elders study recently demonstrated that a physical activity (PA) intervention can delay the onset of major mobility disability. Our objective is to examine the resources required to deliver the PA intervention and calculate the incremental cost-effectiveness compared with a health education intervention. METHODS: The Lifestyle Interventions and Independence for Elders study enrolled 1,635 older adults at risk for mobility disability. They were recruited at eight field centers and randomly assigned to either PA or health education. The PA program consisted of 50-minute center-based exercise 2× weekly, augmented with home-based activity to achieve a goal of 150 min/wk of PA. Health education consisted of weekly workshops for 26 weeks, and monthly sessions thereafter. Analyses were conducted from a health system perspective, with a 2.6-year time horizon. RESULTS: The average cost per participant over 2.6 years was US$3,302 and US$1,001 for the PA and health education interventions, respectively. PA participants accrued 0.047 per person more Quality-Adjusted Life-Years (QALYs) than health education participants. PA interventions costs were slightly higher than other recent PA interventions. The incremental cost-effectiveness ratios were US$42,376/major mobility disability prevented and US$49,167/QALY. Sensitivity analyses indicated that results were relatively robust to varied assumptions. CONCLUSIONS: The PA intervention costs and QALYs gained are comparable to those found in other studies. The ICERS are less than many commonly recommended medical treatments. Implementing the intervention in non-research settings may reduce costs further.