Core outcome sets for trials of interventions to prevent and to treat multimorbidity in adults in low and middle-income countries: the COSMOS study.

INTRODUCTION: The burden of multimorbidity is recognised increasingly in low- and middle-income countries (LMICs), creating a strong emphasis on the need for effective evidence-based interventions. Core outcome sets (COS) appropriate for the study of multimorbidity in LMICs do not presently exist. These are required to standardise reporting and contribute to a consistent and cohesive evidence-base to inform policy and practice. We describe the development of two COS for intervention trials aimed at preventing and treating multimorbidity in adults in LMICs. METHODS: To generate a comprehensive list of relevant prevention and treatment outcomes, we conducted a systematic review and qualitative interviews with people with multimorbidity and their caregivers living in LMICs. We then used a modified two-round Delphi process to identify outcomes most important to four stakeholder groups (people with multimorbidity/caregivers, multimorbidity researchers, healthcare professionals and policymakers) with representation from 33 countries. Consensus meetings were used to reach agreement on the two final COS. REGISTRATION: https://www.comet-initiative.org/Studies/Details/1580. RESULTS: The systematic review and qualitative interviews identified 24 outcomes for prevention and 49 for treatment of multimorbidity. An additional 12 prevention and 6 treatment outcomes were added from Delphi round 1. Delphi round 2 surveys were completed by 95 of 132 round 1 participants (72.0%) for prevention and 95 of 133 (71.4%) participants for treatment outcomes. Consensus meetings agreed four outcomes for the prevention COS: (1) adverse events, (2) development of new comorbidity, (3) health risk behaviour and (4) quality of life; and four for the treatment COS: (1) adherence to treatment, (2) adverse events, (3) out-of-pocket expenditure and (4) quality of life. CONCLUSION: Following established guidelines, we developed two COS for trials of interventions for multimorbidity prevention and treatment, specific to adults in LMIC contexts. We recommend their inclusion in future trials to meaningfully advance the field of multimorbidity research in LMICs. PROSPERO REGISTRATION NUMBER: CRD42020197293.

[Exploring Needs, Motivations, and Limitations Towards Healthy Eating and Digital Resources: A Qualitative Study in a Mexican Primary Education Setting]. / Exploración de necesidades, motivaciones y limitaciones en relación con la alimentación saludable y recursos digitales: un estudio cualitativo en un entorno de educación primaria en México.

OBJECTIVE: To explore the needs, motivations, and limitations related to healthy eating and digital materials, as well as to identify patterns for their design as a strategy aimed at Mexican families. DESIGN: A qualitative observational study of the phenomenon through focus group sessions. LOCATION: A public primary education center in the city of Querétaro, Mexico. PARTICIPANTS: Children aged 9 to 11 years and parents, mothers, or caregivers with children in primary education. METHOD: Twelve sessions were conducted with three groups of students and two sessions with parents, mothers, or caregivers using an interview guide. Various digital materials, developed based on social cognitive theory, were presented during the sessions. The sessions were recorded with the participants' or their guardians' prior consent and transcribed for analysis. Coding was performed for key points of analysis, and information saturation was confirmed. RESULTS: Students expressed motivation towards digital material that promotes play and experimentation, especially within the family context. The main perceived barrier was the caregivers' resistance to change. Parents expressed motivation and a need for explanatory material on diseases, with economic and time-related barriers. CONCLUSIONS: Digital material based on social cognitive theory, designed to improve nutrition, can be an effective strategy in nutritional education if it considers the circumstances of the target population. It is advisable to include affective and behavioral elements to achieve meaningful learning within households.

Dietary Energy Density Is Associated with Biomarkers of Chronic Diseases-A Cross-Sectional Study of School-Aged Children in Rural Mexico.

Background: Dietary energy density (DED) is associated with chronic disease markers in adults. However, results in children are still controversial. Objective: To evaluate the DED of children and its association with obesity and biomarkers of chronic disease. Methods: In this cross-sectional study, we recruited 284 children (6-10 y) from rural Mexico. Dietary intake was assessed using three 24-h recalls. DED was calculated for "foods only" (DEDfo) and for "foods and beverages" (DEDfb). Weight, height, and body fat percent (dual-energy X-ray absorptiometry) were measured. Inflammatory cytokines, lipid profile, leptin, and insulin resistance were determined from a fasting blood sample. Results: DEDfo was 1.91 ± 0.36 kcal/g and DEDfb was 1.36 ± 0.31 kcal/g. Higher DEDfo and DEDfb were associated with higher risk to have insulin resistance [odds ratio (OR) = 3.92, 95% confidence interval (CI): 1.66, 9.22, P < 0.01; OR = 3.51, 95% CI: 1.25, 9.87, P = 0.02, respectively]. Higher DEDfo was associated with higher risk of higher leptin levels (OR = 3.17, 95% CI: 1.01, 10.23). Also, DEDfo and DEDfb were associated with higher concentrations of cholesterol (ß = 11.67, 95% CI: 1.81, 19.53, P = 0.03; and ß = 11.74, 95% CI: 2.69, 20.74 P = 0.01, respectively) and higher odds of having high insulin concentrations (OR = 2.52, 95% CI: 1.26, 5.06, P = 0.01; and OR = 2.95, 95% CI: 1.30, 6.70, P = 0.01). DEDfo and DEDfb were not associated with any measure of obesity and inflammatory cytokines in the adjusted models. Conclusions: DED was associated with higher leptin and cholesterol concentrations, and having insulin resistance, but not with any measure of obesity or inflammation. Reducing DED may reduce risk of cardiovascular disease and improve insulin sensitivity in school-aged children.

Design and Validation of a Food Frequency Questionnaire to Evaluate the Consumption of Trans Fatty Acids in the Adult Population (FFQ-TFA).

Instruments for estimating the intake of food components can be useful in the prevention and/or treatment of diseases related to improper diet. There is, at present, no scientifically validated instrument for estimating consumption of trans fatty acids (TFA) in the Mexican population. The objective of this study was to design and validate such an instrument: a questionnaire that can be used to estimate consumption of TFA from food products. The questionnaire was applied to 162 students from the Autonomous University of Querétaro (UAQ). There were two phases to the study: (1) design of a food frequency questionnaire to assess consumption of trans fatty acids (FFQ-TFA) and an eating practices questionnaire (EPQ-TFA); (2) validation of the instrument. Content validity was measured by expert review and by Aiken's V method, obtaining an overall score of 0.895. As final tests for the FFQ-TFA analysis, criterion validity was measured using Spearman's correlation (r = 0.717, p < 0.01) and a linear regression (B = 0.668), considering the results of the 24-h dietary recall (24 HR); and reproducibility or temporal stability was measured using Pearson's correlation (r = 0.406, p < 0.01). Subsequently, a Pearson correlation was applied between TFA consumption estimated by the FFQ-TFA-2 and the global score from the EPQ-TFA-2 (r = 0.351, p < 0.01). A Pearson correlation was applied between the EPQ-TFA-1 and the EPQ-TFA-2 (r = 0.575, p < 0.01). TFA consumption per day was 2.49 ± 1.32 g in the participating population, which was 1.04 ± 0.51% of their total kcal consumption.

Content of industrially produced trans fatty acids in breast milk: An observational study.

Breast milk may contain industrially produced trans fatty acids (TFAs), which can affect the content of essential fatty acids (EFAs). This could have significant implications for the child's development. The fatty acids present in breast milk can be modified by adjusting the mother's diet. The objective of this study was to determine the content of industrially produced TFAs present in colostrum, transitional milk, and mature milk produced by mothers between 18 and 45 years of age in the state of Querétaro, Mexico, based on a longitudinal observational study. The TFA content in the breast milk of 33 lactating women was analyzed using gas chromatography. The mothers' consumption of TFAs was also estimated by analyzing a log prepared through 24-hr dietary recall (24HR) obtained in each period. The TFA content in the mothers' diet was similar across the colostrum, transitional milk, and mature milk phases: 1.64 ± 1.25 g, 1.39 ± 1.01, and 1.66 ± 1.13 g, respectively. The total TFA content was 1.529% ± 1.648% for colostrum; 0.748% ± 1.033% for transitional milk and 0.945% ± 1.368% for mature milk. Elaidic acid was the TFA in the highest concentration in all three types of milk. No correlation was found between the content of industrially produced TFAs in breast milk and the anthropometric measurements of the mother or between the estimated consumption of TFAs and the content of TFAs in breast milk. Elaidic acid and total content of TFAs were negatively correlated (p < .05) with the content of docosahexaenoic acid (DHA) (0.394 ± 0.247) (R = -0.382) in colostrum. The concentration of TFAs was found to correlate with the composition of EFAs in milk.

Desarrollo y validación de escalas para medir el valor que las mujeres dan a la saciedad y a la alimentación: un factor crítico para el tratamiento de la obesidad / Development and validation of scales to measure women's eating and satiation values: a criti- cal factor in the treatment of obesity

La sobrevaloración de la alimentación y de la saciedad en familias que viven en un medio influenciado por la globalización y desarrollo de la industria alimentaria, puede estar teniendo un efecto sinérgico en el desarrollo de la obesidad y sus comorbilidades en países de ingreso medio. El objetivo de este trabajo fue desarrollar y validar escalas para medir el valor otorgado a la alimentación y la saciedad en mujeres. Se desarrolló un instrumento y se aplicó en querétaro, México (n=243), se midieron variables socioeconómicas y de percepción de peso corporal. Se realizó análisis factorial explorato- rio, confirmatorio y ANOVA. Las escalas del valor que las mujeres dan a la alimentación como base del bienestar, a la saciedad y a la alimentación como base del bienestar del hijo, se validaron (α-Cronbach>0.66) y se confirmaron (CFI>0.98;RMSEA<0.05). Los puntajes de valor de la alimentación y de la saciedad se asociaron con un menor nivel socioeconómico y educativo, inseguridad alimentaria en el pasado, menor intención de perder peso y con percepción bajo peso en los hijos. En conclusión, las es- calas para medir el valor de la alimentación y la saciedad tienen validez para ser utilizadas en futuros estudios; su utilización puede contribuir a desarrollar estrategias que consideren la verdadera motivación de la alimentación en los segmentos poblacionales más desfavorecidos(AU)

The overvaluation of eating and satiation in families whose environment has been influenced by globalization and the food industry, could be inducing obesity and its co-morbidities in midd- le income countries. The objective was to develop and validate scales to measure women's eating and satiation values. A measurement instrument was developed and ad- ministered to women from querétaro, Mexico (n=243), it also measured socioeconomic (SE) and body weight per- ception variables. Analyses included exploratory and con- firmatory factorial analyses and ANOVA. The scales that represented the value of feeding as basis of wealth, the va- lue of satiation and the value of feeding a child as the basis of the child's wealth, were validated (Cronbach-α>0.66) and confirmed (CFI >0.98; RMSEA<0.05).The scores were associated with a lower SE status, lower education level, childhood food insecurity, low intention to lose weight and with an underweighted child perception. In conclusion, the scales that measure the value of eating and satiation have the validity to be used in future studies; its utilization can contribute to develop strategies to improve eating behavior of underprivileged population segments, that take into consideration the real motives of eating(AU)

A Double-Blind, Active-Controlled Clinical Trial of Sodium Bicarbonate and Calcium Gluconate in the Treatment of Bilateral Osteoarthritis of the Knee.

OBJECTIVE: To evaluate the effect of intra-articular injections of sodium bicarbonate with a single (SBCG1) or double dose (SBCG2) of calcium gluconate administered monthly compared with methylprednisolone (MP) for treatment of knee osteoarthritis. METHODS: A 3-month, randomized, double-blind clinical trial with patients diagnosed with knee osteoarthritis (OA). The outcome variables were the Western Ontario-McMaster University Osteoarthritis Index (WOMAC) and the Lequesne functional index. RESULTS: After 3 months, all treatments significantly improved in overall WOMAC and Lequesne scores. Mean changes (95% confidence interval) in WOMAC total score and the Lequesne index, respectively, for SBCG1 (-12.5 [-14.3, -10.7]; -9.0 [-11.4, -6.7]) and SBCG2 (-12.3 [-14.3, -10.4]; -8.9 [-10.4, -7.4]) were significantly greater than for MP (-5.0 [-7.2, -2.8]; -3.2 [-4.9, -1.5]) (P < .001). CONCLUSIONS: Intra-articular injections of sodium bicarbonate and calcium gluconate are useful for short-term relief of OA symptoms in patients with bilateral knee osteoarthritis. Both treatments are more effective than MP injections in the reduction of knee OA symptoms. TRIAL REGISTRATION: Clinicaltrials.gov NCT00977444.

Effectiveness of intra-articular injections of sodium bicarbonate and calcium gluconate in the treatment of osteoarthritis of the knee: a randomized double-blind clinical trial.

BACKGROUND: A novel therapeutic management of osteoarthritis (OA) of the knee was assessed. The study aimed to evaluate the effect of monthly sodium bicarbonate with a single (SBCG1) or double dose (SBCG2) of calcium gluconate injections on OA of the knee; as well as the efficacy and safety of both SBCG interventions in the long term. METHODS: A double-blind parallel-group clinical trial with 74 knee OA patients was performed during 12 months, both SBCG interventions were followed-up for another 6mo after intervention. The outcome variables were the Western Ontario-McMaster University Osteoarthritis Index (WOMAC), the Lequesne's functional index and joint-space width changes from serial radiographs. RESULTS: After 12 months, group SBCG1 decreased -14.8 (95% CI:-14.2, -17.0) and group SBCG2 decreased -14.6 (-16.9, -12.4) in the global WOMAC score, the mean changes represent 80% and 82% lessened pain, respectively. In the Lequesne Functional Index scale, SBCG1 decreased -11.9 (-10.4, -14.2) and SBCG2 decreased -11.9 (-13.8, -10.0), representing 66 and 69% of improvement. Both mean scores were maintained after intervention discontinued. SBCG2 improved the knees' joint space width more than SBCG1 at 3 and 18 months. Both SBCG interventions were well tolerated after 12 months of treatment CONCLUSION: A solution of sodium bicarbonate and calcium gluconate is effective on reducing the symptoms associated with OA. Its beneficial effect is maintained for one year of continuous monthly administration and at least for 6 months after the administration is discontinued. When the dose of calcium gluconate is increased, it prevents further narrowing of joint-space. TRIAL REGISTRATION: Clinicaltrials.gov NCT00977444 September 11, 2009.

Specific micronutrient concentrations are associated with inflammatory cytokines in a rural population of Mexican women with a high prevalence of obesity.

It has been recognised recently that obese individuals have lower concentrations of micronutrients and this may affect the concentrations of inflammatory cytokines. A cross-sectional study was carried out to evaluate the association of specific micronutrients' status with chronic inflammation caused by obesity in 280 women (36·1 (SD 7·5) years) from seven rural communities in Mexico. Measurements of weight, height and waist circumference were made on all women and body composition was determined by dual-energy X-ray absorptiometry. Concentrations of the cytokines IL-1, TNF-α, IL-6, IL-10 and IL-12, lipid profile, and the micronutrients Zn and vitamins A, C and E were determined in fasting blood samples. Ordered logistic regression models were used to determine associations between categorised cytokine levels and micronutrients. It was found that 80% of women were overweight or obese, and had significantly higher concentrations of C-reactive protein than normal-weight women (P= 0·05). The risk of higher levels of TNF-α, IL-6, IL-10 and IL-12 was reduced significantly among women with higher Zn concentrations (OR 0·63, 95% CI 0·42, 0·96, P= 0·03; OR 0·57, 95% CI 0·39, 0·86, P= 0·025; OR 0·63, 95% CI 0·41, 0·96, P= 0·04; OR 0·62, 95% CI 0·41, 0·95, P= 0·03, respectively). Higher concentrations of vitamin A were slightly associated with reduced risks of higher levels of IL-1 and IL-12 (OR 0·97, 95% CI 0·95, 0·99, P= 0·03; OR 0·97, 95% CI 0·94, 0·99, P= 0·03, respectively); when adjusting for BMI, this association was lost. No associations were found between vitamin C or vitamin E:lipids concentrations and inflammatory cytokines. In conclusion, higher Zn concentrations are associated with reduced risks of higher concentration of inflammation markers in a population of women with a high prevalence of obesity.

The inclusion of a partial meal replacement with or without inulin to a calorie restricted diet contributes to reach recommended intakes of micronutrients and decrease plasma triglycerides: a randomized clinical trial in obese Mexican women.

BACKGROUND: Obesity is a major public health problem in many poor countries where micronutrient deficiencies are prevalent. A partial meal replacement may be an effective strategy to decrease obesity and increase micronutrient intake in such populations. The objective was to evaluate the efficacy of a partial meal replacement with and without inulin on weight reduction, blood lipids and micronutrients intake in obese Mexican women. METHODS: In a randomized controlled clinical trial 144 women (18-50 y) with BMI ≥ 25 kg/m², were allocated into one of the following treatments during 3 months: 1) Two doses/d of a partial meal replacement (PMR), 2) Two doses/d of PMR with inulin (PMR + I) , 3) Two doses/d of 5 g of inulin (INU) and 4) Control group (CON). All groups received a low calorie diet (LCD). Weight, height, hip and waist circumference were measured every 2 weeks and body composition, lipids and glucose concentration and nutrient intake were assessed at baseline and after 3 months. RESULTS: All groups significantly reduced weight, BMI, waist and hip circumference. Differences between groups were only observed in BMI and weight adjusted changes: At 45 days PMR group lost more weight than INU and CON groups by 0.9 and 1.2Kg, respectively. At 60 days, PMR + I and PMR groups lost more weight than in INU by 0.7 and 1Kg, respectively. Subjects in PMR, PMR + I and INU significantly decreased triglycerides. Energy intake was reduced in all groups. Fiber intake increased in PMR + I and INU groups. Some minerals and vitamins intakes were higher in PMR and PMR + I compared with INU and CON groups. CONCLUSION: Inclusion of PMR with and without inulin to a LCD had no additional effect on weight reduction than a LCD alone but reduced triglycerides and improved intake of micronutrients during caloric restriction. PMR could be a good alternative for obese populations with micronutrient deficiencies.

Zinc, vitamin A, and vitamin C status are associated with leptin concentrations and obesity in Mexican women: results from a cross-sectional study.

BACKGROUND: The prevalence of obesity among Mexican women is high and it could be related to micronutrient status. We evaluated in a cross-sectional study the associations of zinc and vitamins A, C and E concentrations with BMI, central adiposity, body fat and leptin concentration. METHODS: Women aged 37 ± 7.5 years (n = 580) from 6 rural communities in Mexico were evaluated. Anthropometric measurements included weight, height, waist and hip circumference. A fasting blood sample was taken for the analysis of glucose, lipid profile, leptin, zinc, and vitamins A, C and E. Body composition was determined by DEXA (Hologic Mod Explorer). RESULTS: The prevalence of overweight and obesity was 36% (BMI > 25 Kg/m2) and 44% (BMI > 30 Kg/m2), respectively. Prevalence of zinc and vitamins C and E deficiencies were similar in obese, overweight and normal weight women. No vitamin A deficiency was found. Vitamin C was negatively associated with BMI, waist-to-height ratio, and leptin concentrations (p < 0.05). Vitamin A was positively associated with leptin (p < 0.05). When stratifying by BMI, % body fat and waist circumference, high leptin concentrations were associated with lower zinc and lower vitamin C concentrations in women with obesity (p < 0.05) and higher vitamin A concentrations in women without obesity (p < 0.01). Vitamin E status was not associated with any markers of obesity. CONCLUSION: Zinc and vitamins A and C are associated with obesity, adiposity and leptin concentration in women from rural Mexico, and may play an important role in fat deposition. The causality of these associations needs to be confirmed.