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Abstract Background The HEARTS technical package was developed by the World Health Organization to address the implementation gap in cardiovascular disease prevention in low- and middle-income countries. Guatemala is a middle-income country that is currently implementing HEARTS. National authorities in Guatemala are interested in exploring how hypertension and diabetes management can be integrated in HEARTS implementation. The objective of this study is to conduct a feasibility and acceptability pilot trial of integrated hypertension and diabetes management based on HEARTS in the publicly funded primary care system in Guatemala. Methods A single-arm pilot trial for 6 months will be carried out in 11 Ministry of Health primary care facilities starting in September 2023. A planned sample of 100 adult patients diagnosed with diabetes (n = 45), hypertension (n = 45), or both (n = 10) will be enrolled. The intervention will consist of HEARTS-aligned components: Training health workers on healthy-lifestyle counseling and evidence-based treatment protocols, strengthening access to medications and diagnostics, training on risk-based cardiovascular disease management, team-based care and task sharing, and systems monitoring and feedback, including implementation of a facility-based electronic monitoring tool at the individual level. Co-primary outcomes of feasibility and acceptability will be assessed using an explanatory sequential mixed-methods design. Secondary outcomes include clinical effectiveness (treatment with medication, glycemic control, and blood pressure control), key implementation outcomes (adoption, fidelity, usability, and sustainability), and patient-reported outcome measures (diabetes distress, disability, and treatment burden). Using an implementation mapping approach, a Technical Advisory Committee will develop implementation strategies for subsequent scale-up planning. Discussion This trial will produce evidence on implementing HEARTS-aligned hypertension and diabetes care in the MOH primary care system in Guatemala. Results also will inform future HEARTS projects in Guatemala and other low- and middle-income countries. Trial registration ClinicalTrials.gov ID NCT06080451. The trial was prospectively registered on October 12, 2023.

Abstract Background Front-of-package warning labels (FOPWL) have been adopted in many countries aiming at reducing the consumption of unhealthy food and drink products and have also been considered in Guatemala. The aim of the study is to evaluate the efficacy of FOPWL versus Guidelines for Daily Amount (GDA) on products’ healthfulness perception (HP), purchase intention (PI) and the objective understanding of the nutrient content (UNC) in Guatemala. Methods Participants (children and adults) (n = 356) were randomly assigned to evaluate either FOPWL or GDA during a crossover cluster randomized experiment in rural and urban areas across 3 phases of exposure. During phase 1, participants evaluated mock-up images of single products (single task) and compared pairs of products within the same food category (comparison task) without any label. In phase 2, participants evaluated labels only (without any product), and during phase 3, they evaluated the same products and questions from phase 1, now depicting the assigned front-of-package label. We generated indicators for single-task questions and scores for comparison tasks, one for each HP, PI and UNC questions. We used intention-to-treat, difference-in-difference regression analysis to test whether exposure to FOPWL was associated with HP, PI and UNC, compared to GDA. We also tested models for children and adults and by area (rural/urban) separately adjusting for sociodemographic variables. Results In single tasks, FOPWL significantly decreased the PI (β -18.1, 95%CI -23.3, -12.8; p

Abstract Background and Aims Metabolic conditions such as obesity, type 2 diabetes, metabolic syndrome, and nonalcoholic fatty liver disease (NAFLD) are highly prevalent in Guatemala and increase the risk for a number of disorders, including hepatocellular carcinoma (HCC). Aflatoxin B1 (AFB1) levels are also notably elevated in the population and are known to be associated with HCC risk. Whether AFB1 also contributes to the high prevalence of the metabolic disorders has not been previously examined. Therefore, the purpose of this study was to assess the association between AFB1 and the metabolic conditions. Methods Four‐hundred twenty‐three individuals were included in the study, in which AFB1‐albumin adduct levels were measured in sera. Metabolic conditions included diabetes, obesity, central obesity, metabolic syndrome, and NAFLD. Crude and adjusted prevalence odds ratios (PORs) and 95% confidence intervals (95% CI) were estimated for the associations between the metabolic conditions and AFB1‐albumin adduct levels categorized into quartiles. Results The study found a significant association between AFB1‐albumin adduct levels and diabetes (Q4 vs Q1 POR = 3.74, 95%CI: 1.71‐8.19; P‐trend .003). No associations were observed between AFB1‐albumin adduct levels and the other conditions. Conclusions As diabetes is the metabolic condition most consistently linked to HCC, the possible association between AFB1 exposure and diabetes may be of public health importance. Further studies are warranted to replicate the findings and examine potential mechanisms.

Abstract Background Benchmarking the implementation of healthy food environment public policies against international best practices may accelerate the government response to prevent obesity and non-communicable diseases (NCDs) in the countries. The aim of the study was to determine the extent of food environment policy implementation in Guatemala and to identify and prioritize actions for the government to accelerate their implementation. Methods The INFORMAS Healthy Food Environment Policy Index (Food-EPI from the International Network for Food and Obesity/NCDs Research, Monitoring and Action Support) was used. Evidence of implementation for 50 good practice indicators within the seven food policies and six infrastructure support domains was compiled, and subsequently validated by Guatemalan government officials. A national civil society expert panel on public health and nutrition performed an online assessment of the implementation of healthy food environment policies against best international practices. The level of agreement among evaluators was measured using the Gwet second order agreement coefficient (AC2). The expert panel recommended actions for each indicator during on-site workshops and those actions were prioritized by importance and achievability. Results The expert panel rated implementation at zero for 26% of the indicators, very low for 28% of indicators, low for 42%, and medium for 4% of indicators (none were rated high). Indicators at medium implementation were related to the use of evidence for developing policies and ingredient list/nutrition information panels on packaged foods. Seventy-seven actions were recommended prioritizing the top 10 for immediate action. The Gwet AC2 was 0.73 (95% CI 0.67–0.80), indicating a good concordance among experts. Conclusions In the Food-EPI of Guatemala, almost all indicators of good practice had a low or less level of implementation. The expert panel proposed 12 priority actions to accelerate policy implementation to tackle obesity and NCDs in the country.

Abstract Background Uncontrolled hypertension represents a substantial and growing burden in Guatemala and other low and middle-income countries. As a part of the formative phase of an implementation research study, we conducted a needs assessment to define short- and long-term needs and opportunities for hypertension services within the public health system. Methods We conducted a multi-method, multi-level assessment of needs related to hypertension within Guatemala’s public system using the World Health Organization’s health system building blocks framework. We conducted semi-structured interviews with stakeholders at national (n = 17), departmental (n = 7), district (n = 25), and community (n = 30) levels and focus groups with patients (3) and frontline auxiliary nurses (3). We visited and captured data about infrastructure, accessibility, human resources, reporting, medications and supplies at 124 health posts and 53 health centers in five departments of Guatemala. We conducted a thematic analysis of transcribed interviews and focus group discussions supported by matrix analysis. We summarized quantitative data observed during visits to health posts and centers. Results Major challenges for hypertension service delivery included: gaps in infrastructure, insufficient staffing and high turnover, limited training, inconsistent supply of medications, lack of reporting, low prioritization of hypertension, and a low level of funding in the public health system overall. Key opportunities included: prior experience caring for patients with chronic conditions, eagerness from providers to learn, and interest from patients to be involved in managing their health. The 5 departments differ in population served per health facility, accessibility, and staffing. All but 7 health posts had basic infrastructure in place. Enalapril was available in 74% of health posts whereas hydrochlorothiazide was available in only 1 of the 124 health posts. With the exception of one department, over 90% of health posts had a blood pressure monitor. Conclusions This multi-level multi-method needs assessment using the building blocks framework highlights contextual factors in Guatemala’s public health system that have been important in informing the implementation of a hypertension control trial. Long-term needs that are not addressed within the scope of this study will be important to address to enable sustained implementation and scale-up of the hypertension control approach.

Abstract Background Indigenous Maya women in Guatemala show some of the worst maternal health indicators worldwide. Our objective was to test acceptability, feasibility and impact of a co-designed group psychosocial intervention (Women’s Circles) in a population with significant need but no access to mental health services. Methods A parallel group pilot randomised study was undertaken in five rural Mam and three periurban K’iche’ communities. Participants included 84 women (12 per community, in seven of the communities) randomly allocated to intervention and 71 to control groups; all were pregnant and/or within 2 years postpartum. The intervention consisted of 10 sessions co-designed with and facilitated by 16 circle leaders. Main outcome measures were: maternal psychosocial distress (HSCL-25), wellbeing (MHC-SF), self-efficacy and engagement in early infant stimulation activities. In-depth interviews also assessed acceptability and feasibility. Results The intervention proved feasible and well accepted by circle leaders and participating women. 1-month post-intervention, wellbeing scores (p-value 0.008) and self-care self-efficacy (0.049) scores were higher among intervention compared to control women. Those women who attended more sessions had higher wellbeing (0.007), self-care and infant-care self-efficacy (0.014 and 0.043, respectively), and early infant stimulation (0.019) scores. Conclusions The pilot demonstrated acceptability, feasibility and potential efficacy to justify a future definitive randomised controlled trial. Co-designed women’s groups provide a safe space where indigenous women can collectively improve their functioning and wellbeing. Trial registration ISRCTN13964819. Registered 26 June 2018, retrospectively registered.

Abstract Background Latin America is facing an increasing burden of nutrition-related non-communicable disease. Little is known about dietary patterns in Guatemalan adults and how dietary patterns are associated with cardio-metabolic disease (CMD) risk. Methods This analysis is based on data from a 2002–04 follow-up study of the INCAP Nutrition Supplementation Trial Longitudinal Cohort. Diet data were collected using a validated, semi-quantitative food frequency questionnaire. We derived dietary patterns using principal components analysis. CMD risk was assessed by anthropometry (body mass index, waist circumference), biochemistry (fasting blood glucose and lipids), and clinical (blood pressure) measures. We used sex-stratified multivariable log binomial models to test associations between dietary pattern tertile and CMD risk factors. The sample included 1428 participants (681 men and 747 women) ages 25–43 years. Results We derived three dietary patterns (traditional, meat-based modern, and starch-based modern), collectively explaining 24.2% of variance in the diet. Dietary patterns were not associated with most CMD risk factors; however, higher starch-based modern tertiles were associated with increased prevalence of low highdensity lipoprotein cholesterol (HDL-c) in men (Prevalence Ratio (PR) 1.17, 95% Confidence Interval (CI) 1.01, 1.20 for tertile 2; PR 1.20, 95% CI 1.00, 1.44 for tertile 3; p trend 0.04). Higher traditional tertiles were associated with increased prevalence of abdominal obesity in women (PR 1.24, 95% CI 1.07, 1.43 for tertile 2; PR 1.19, 95% CI 1.02, 1.39 for tertile 3; p trend 0.02) but marginally significant reduced prevalence of low HDL-c in men (PR 0.88, 95% CI 0.76, 1.00 for tertile 2; PR 0.85, 95% CI 0.72, 1.00 for tertile 3; p trend 0.05). Conclusion Our findings suggest the presence of two ‘modern' dietary patterns in Guatemala – one of which was associated with increased prevalence of low HDL-c in men. The association between the traditional dietary pattern and some CMD risk factors may vary by sex.