Long-Term Effectiveness of the TIME Intervention to Improve Diabetes Outcomes in Low-Income Settings: a 2-Year Follow-Up.

BACKGROUND: We previously found that a 6-month multidimensional diabetes program, TIME (Telehealth-Supported, Integrated Community Health Workers, Medication-Access) resulted in improved clinical outcomes. OBJECTIVE: To follow TIME participant clinical outcomes for 24 months PARTICIPANTS: Low-income Latino(a)s with type 2 diabetes DESIGN AND INTERVENTION: We collected post-intervention clinical data for five cohorts (n = 101, mean n = 20/cohort) who participated in TIME programs from 2018 to 2020 in Houston, Texas. MAIN MEASURES: We gathered HbA1c (primary outcome), weight, body mass index (BMI), and blood pressure data at baseline, 6 months (intervention end), and semiannually thereafter until 24 months after baseline to assess sustainability. We also evaluated participant loss to follow-up until 24 months. KEY RESULTS: Participants decreased HbA1c levels during the intervention (p < 0.0001) and maintained these improvements at each timepoint from baseline to 24 months (p range: < 0.0001 to 0.015). Participants reduced blood pressure levels during TIME and maintained these changes at each timepoint from baseline until 18 months (systolic p range < 0.0001 to 0.0005, diastolic p range: < 0.0001 to 0.008) but not at 24 months (systolic: p = 0.065; diastolic: p = 0.85). There were no significant weight changes during TIME or post-intervention: weight (p range = 0.07 to 0.77), BMI (p range = 0.11 to 0.71). Attrition rates (loss to follow-up during the post-intervention period) were 5.9% (6 months), 24.8% (12 months), 35.6% (18 months), and 41.8% (24 months). CONCLUSIONS: It is possible for vulnerable populations to maintain long-term glycemic and blood pressure improvements using a multiple dimensional intervention. Attrition rates rose over time but show promise given the majority of post-intervention timepoints occurred during the COVID-19 pandemic when low-income populations were most susceptible to suboptimal healthcare access. Future studies are needed to evaluate longitudinal outcomes of diabetes interventions conducted by local clinics rather than research teams.

Mentored implementation to initiate a diabetes program in an underserved community: a pilot study.

INTRODUCTION: Community clinics often face pragmatic barriers, hindering program initiation and replication of controlled research trial results. Mentoring is a potential strategy to overcome these barriers. We piloted an in-person and telehealth mentoring strategy to implement the Telehealth-supported, Integrated Community Health Workers (CHWs), Medication-access, group visit Education (TIME) program in a community clinic. RESEARCH DESIGN AND METHODS: Participants (n=55) were low-income Latino(a)s with type 2 diabetes. The study occurred in two, 6-month phases. Phase I provided proof-of-concept and an observational experience for the clinic team; participants (n=37) were randomized to the intervention (TIME) or control (usual care), and the research team conducted TIME while the clinic team observed. Phase II provided mentorship to implement TIME, and the research team mentored the clinic team as they conducted TIME for a new single-arm cohort of participants (n=18) with no previous exposure to the program. Analyses included baseline to 6-month comparisons of diabetes outcomes (primary outcome: hemoglobin A1c (HbA1c)): phase I intervention versus control, phase II (within group), and research-run (phase I intervention) versus clinic-run (phase II) arms. We also evaluated baseline to 6-month CHW knowledge changes. RESULTS: Phase I: compared with the control, intervention participants had superior baseline to 6-month improvements for HbA1c (mean change: intervention: -0.73% vs control: 0.08%, p=0.016), weight (p=0.044), target HbA1c (p=0.035), hypoglycemia (p=0.021), medication non-adherence (p=0.0003), and five of six American Diabetes Association (ADA) measures (p<0.001-0.002). Phase II: participants had significant reductions in HbA1c (mean change: -0.78%, p=0.006), diastolic blood pressure (p=0.004), body mass index (0.012), weight (p=0.010), medication non-adherence (p<0.001), and six ADA measures (p=0.007-0.005). Phase I intervention versus phase II outcomes were comparable. CHWs improved knowledge from pre-test to post-tests (p<0.001). CONCLUSIONS: A novel, mentored approach to implement TIME into a community clinic resulted in improved diabetes outcomes. Larger studies of longer duration are needed to fully evaluate the potential of mentoring community clinics.

Changes in mood and health-related quality of life in Look AHEAD 6 years after termination of the lifestyle intervention.

OBJECTIVE: The Action for Health in Diabetes (Look AHEAD) study previously reported that intensive lifestyle intervention (ILI) reduced incident depressive symptoms and improved health-related quality of life (HRQOL) over nearly 10 years of intervention compared with a control group (the diabetes support and education group [DSE]) in participants with type 2 diabetes and overweight or obesity. The present study compared incident depressive symptoms and changes in HRQOL in these groups for an additional 6 years following termination of the ILI in September 2012. METHODS: A total of 1,945 ILI participants and 1,900 DSE participants completed at least one of four planned postintervention assessments at which weight, mood (via the Patient Health Questionnaire-9), antidepressant medication use, and HRQOL (via the Medical Outcomes Scale, Short Form-36) were measured. RESULTS: ILI participants and DSE participants lost 3.1 (0.3) and 3.8 (0.3) kg [represented as mean (SE); p = 0.10], respectively, during the 6-year postintervention follow-up. No significant differences were observed between groups during this time in incident mild or greater symptoms of depression, antidepressant medication use, or in changes on the physical component summary or mental component summary scores of the Short Form-36. In both groups, mental component summary scores were higher than physical component summary scores. CONCLUSIONS: Prior participation in the ILI, compared with the DSE group, did not appear to improve subsequent mood or HRQOL during 6 years of postintervention follow-up.