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

ABSTRACT: 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.

SUBMITTER: Kim SE

PROVIDER: S-EPMC6052649 | biostudies-literature | 2018 Jun

REPOSITORIES: biostudies-literature

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

Kim Sue E SE Castro Sweet Cynthia M CM Gibson Eliza E Madero Erica N EN Rubino Barbara B Morrison Janina J Rosen Debra D Imberg Wendy W Cousineau Michael R MR

Contemporary clinical trials communications 20180506

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 ma ...[more]

PMID: 30035241

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Project description:IntroductionThe prevalence of type 2 diabetes is rising steeply. National Health Service England (NHSE) is exploring the potential of a digital diabetes prevention programme (DDPP) and has commissioned a pilot with embedded evaluation.Methods and analysisThis study aims to determine whether, and if so, how, should NHSE implement a national DDPP, using a mixed-methods pretest and post-test design, underpinned by two theoretical frameworks: the Coventry, Aberdeen and London - Refined (CALO-RE) taxonomy of behavioural change techniques for the digital interventions and the Consolidated Framework for Implementation Research (CFIR) for implementation processes. In eight pilot areas across England, adults with non-diabetic hyperglycaemia (NDH) (glycated haemoglobin (HbA1c) 42-47 mmol/mol or fasting plasma glucose 5.5-6.9 mmol/L) and adults without NDH who are overweight (body mass index (BMI) >25 kg/m2) or obese (BMI >30 kg/m2) will be referred to one of five digitally delivered diabetes prevention interventions. The primary outcomes are reduction in HbA1c and weight (for people with NDH) and reduction in weight (for people who are overweight or obese) at 12 months. Secondary outcomes include use of the intervention, satisfaction, physical activity, patient activation and resources needed for successful implementation. Quantitative data will be collected at baseline, 6 months and 12 months by the digital intervention providers. Qualitative data will be collected through semistructured interviews with commissioners, providers, healthcare professionals and patients. Quantitative data will be analysed descriptively and using generalised linear models to determine whether changes in outcomes are associated with demographic and intervention factors. Qualitative data will be analysed using framework analysis, with data pertaining to implementation mapped onto the CFIR.Ethics and disseminationThe study has received ethical approval from the Public Health England Ethics and Research Governance Group (reference R&D 324). Dissemination will include a report to NHSE to inform future policy and publication in peer-reviewed journals.

Project description:IntroductionHealthy Beginnings is an established nurse-led early childhood obesity prevention program that promotes healthy infant feeding practices and active play in the early years of life. To improve engagement with culturally and linguistically diverse populations, the Healthy Beginnings program delivered by telephone was culturally adapted and implemented with Arabic- and Chinese-speaking mothers in Sydney, Australia. The cultural adaptation process has been published separately. In this article, we aimed to evaluate the feasibility of the culturally adapted program.MethodsIn 2018-2019, the culturally adapted Healthy Beginnings program was implemented with Arabic- and Chinese-speaking women recruited from antenatal clinics in Sydney. At four staged timepoints (from third trimester until 6 months of age), mothers were sent culturally adapted health promotion booklets and text messages and offered four support calls from bi-cultural child and family health nurses in Arabic and Chinese. A mixed methods evaluation included a) baseline and 6-month telephone surveys, followed by b) semi-structured follow-up interviews with a subset of participating mothers and program delivery staff. Main outcomes of this feasibility study were reach (recruitment and retention), intervention dose delivered (number of nurse support calls completed) and acceptability (appropriateness based on cognitive and emotional responses).ResultsAt recruitment, 176 mothers were eligible and consented to participate. Of 163 mothers who completed the baseline survey, 95% completed the program (n = 8 withdrew) and 83% completed the 6-month survey (n = 70 Arabic- and n = 65 Chinese-speaking mothers). Most mothers (n = 127, 78%) completed at least one nurse support call. The qualitative analysis of follow-up interviews with 42 mothers (22 Arabic- and 20 Chinese-speaking mothers) and 10 program delivery staff highlighted the perceived value of the program and the positive role of bi-cultural nurses and in-language resources. Mothers who completed more nurse support calls generally expressed greater acceptability.ConclusionsThe culturally adapted Healthy Beginnings program was feasible to deliver and acceptable to Arabic- and Chinese-speaking mothers. Our results highlight the importance of in-language resources and individualised bi-cultural nurse support by telephone for supporting culturally and linguistically diverse migrant families with infant feeding and active play. These findings support the potential for program refinements and progression to an effectiveness trial.

Project description:BackgroundThe Healthier You National Health Service Digital Diabetes Prevention Programme (NHS-digital-DPP) is a 9-month digital behavior change intervention delivered by 4 independent providers that is implemented nationally across England. No studies have explored the design features included by service providers of digital diabetes prevention programs to promote engagement, and little is known about how participants of nationally implemented digital diabetes prevention programs such as this one make use of them.ObjectiveThis study aimed to understand engagement with the NHS-digital-DPP. The specific objectives were to describe how engagement with the NHS-digital-DPP is promoted via design features and strategies and describe participants' early engagement with the NHS-digital-DPP apps.MethodsMixed methods were used. The qualitative study was a secondary analysis of documents detailing the NHS-digital-DPP intervention design and interviews with program developers (n=6). Data were deductively coded according to an established framework of engagement with digital health interventions. For the quantitative study, anonymous use data collected over 9 months for each provider representing participants' first 30 days of use of the apps were obtained for participants enrolled in the NHS-digital-DPP. Use data fields were categorized into 4 intervention features (Track, Learn, Coach Interactions, and Peer Support). The amount of engagement with the intervention features was calculated for the entire cohort, and the differences between providers were explored statistically.ResultsData were available for 12,857 participants who enrolled in the NHS-digital-DPP during the data collection phase. Overall, 94.37% (12,133/12,857) of those enrolled engaged with the apps in the first 30 days. The median (IQR) number of days of use was 11 (2-25). Track features were engaged with the most (number of tracking events: median 46, IQR 3-22), and Peer Support features were the least engaged with, a median value of 0 (IQR 0-0). Differences in engagement with features were observed across providers. Qualitative findings offer explanations for the variations, including suggesting the importance of health coaches, reminders, and regular content updates to facilitate early engagement.ConclusionsAlmost all participants in the NHS-digital-DPP started using the apps. Differences across providers identified by the mixed methods analysis provide the opportunity to identify features that are important for engagement with digital health interventions and could inform the design of other digital behavior change interventions.

Project description:The largest and longest clinical trial of metformin for the prevention of diabetes is the Diabetes Prevention Program/Diabetes Prevention Program Outcomes Study (DPP/DPPOS). In this review, we summarise data from the DPP/DPPOS, focusing on metformin for diabetes prevention, as well as its long-term glycaemic and cardiometabolic effects and safety in people at high-risk of developing diabetes. The DPP (1996-2001) was a RCT of 3234 adults who, at baseline, were at high-risk of developing diabetes. Participants were assigned to masked placebo (n = 1082) or metformin (n = 1073) 850 mg twice daily, or intensive lifestyle intervention (n = 1079). The masked metformin/placebo intervention phase ended approximately 1 year ahead of schedule because of demonstrated efficacy. Primary outcome was reported at 2.8 years. At the end of the DPP, all participants were offered lifestyle education and 88% (n = 2776) of the surviving DPP cohort continued follow-up in the DPPOS. Participants originally assigned to metformin continued to receive metformin, unmasked. The DPP/DPPOS cohort has now been followed for over 15 years with prospective assessment of glycaemic, cardiometabolic, health economic and safety outcomes. After an average follow-up of 2.8 years, metformin reduced the incidence of diabetes by 31% compared with placebo, with a greater effect in those who were more obese, had a higher fasting glucose or a history of gestational diabetes. The DPPOS addressed the longer-term effects of metformin, showing a risk reduction of 18% over 10 and 15 years post-randomisation. Metformin treatment for diabetes prevention was estimated to be cost-saving. At 15 years, lack of progression to diabetes was associated with a 28% lower risk of microvascular complications across treatment arms, a reduction that was no different among treatment groups. Recent findings suggest metformin may reduce atherosclerosis development in men. Originally used for the treatment of type 2 diabetes, metformin, now proven to prevent or delay diabetes, may serve as an important tool in battling the growing diabetes epidemic. Long-term follow-up, currently underway in the DPP/DPPOS, is now evaluating metformin's potential role, when started early in the spectrum of dysglycaemia, on later-stage comorbidities, including cardiovascular disease and cancer.Trial registrationClinicalTrials.gov NCT00038727 and NCT00004992.

Project description:BACKGROUND:In the United States, 86 million adults have pre-diabetes. Evidence-based interventions that are both cost effective and widely scalable are needed to prevent diabetes. OBJECTIVE:Our goal was to develop a fully automated diabetes prevention program and determine its effectiveness in a randomized controlled trial. METHODS:Subjects with verified pre-diabetes were recruited to participate in a trial of the effectiveness of Alive-PD, a newly developed, 1-year, fully automated behavior change program delivered by email and Web. The program involves weekly tailored goal-setting, team-based and individual challenges, gamification, and other opportunities for interaction. An accompanying mobile phone app supports goal-setting and activity planning. For the trial, participants were randomized by computer algorithm to start the program immediately or after a 6-month delay. The primary outcome measures are change in HbA1c and fasting glucose from baseline to 6 months. The secondary outcome measures are change in HbA1c, glucose, lipids, body mass index (BMI), weight, waist circumference, and blood pressure at 3, 6, 9, and 12 months. Randomization and delivery of the intervention are independent of clinic staff, who are blinded to treatment assignment. Outcomes will be evaluated for the intention-to-treat and per-protocol populations. RESULTS:A total of 340 subjects with pre-diabetes were randomized to the intervention (n=164) or delayed-entry control group (n=176). Baseline characteristics were as follows: mean age 55 (SD 8.9); mean BMI 31.1 (SD 4.3); male 68.5%; mean fasting glucose 109.9 (SD 8.4) mg/dL; and mean HbA1c 5.6 (SD 0.3)%. Data collection and analysis are in progress. We hypothesize that participants in the intervention group will achieve statistically significant reductions in fasting glucose and HbA1c as compared to the control group at 6 months post baseline. CONCLUSIONS:The randomized trial will provide rigorous evidence regarding the efficacy of this Web- and Internet-based program in reducing or preventing progression of glycemic markers and indirectly in preventing progression to diabetes. TRIAL REGISTRATION:ClinicalTrials.gov NCT01479062; http://clinicaltrials.gov/show/NCT01479062 (Archived by WebCite at http://www.webcitation.org/6U8ODy1vo).

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

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

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