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Diabetes is a highly prevalent disease that negatively impacts people’s health and quality of life. It can result in diabetic peripheral neuropathy (DPN) and foot complications, which in turn lead to ulcers and amputations. The international guidelines on diabetic foot included specific foot-ankle exercises as preventive strategy capable of modifying the risk factors for ulcers. Our aim is to test the effectiveness and to implement a contextually appropriate preventive intervention—a foot-ankle exercises programme alongside educational strategies—in a primary care setting to improve range of motion (ROM), strength, functionality of foot-ankle, and quality of life in people with diabetes.
This is a hybrid type 2 implementation-effectiveness study organised in four phases, being undertaken in Limeira, São Paulo. Phase 1, preimplementation, aims to gather information about the contextual characteristics, barriers, and facilitators and to form the implementation team. In phase 2, the implementation team will structure the foot-ankle programme, adapting it to the context of primary healthcare, and develop the training for health professionals. In phase 3, effectiveness of the 12 week group-based intervention will be tested by a cluster randomised controlled trial. Primary care units (18 clusters) will be randomly allocated to a control or intervention group, with a total sample of 356 people. Primary outcomes will be DPN symptoms and ankle and first metatarsal phalangeal joint ROM. Reach, adoption, and implementation will be evaluated by Reach, Effectiveness, Adoption, Implementation, and Maintenance framework. In phase 4, maintenance and expansion of the programme in the municipality will be assessed.
This protocol and the informed consent to be signed by the participants were approved by the Ethics Committee of the School of Medicine of the University of São Paulo (CAAE:63457822.0.0000.0068, 29 November 2022). The project will generate and share data in a public repository. Results will be disseminated through peer-reviewed journals, conference proceedings, and electronic communications for health professionals.
by Jacinda M. Nicklas, Laura Pyle, Andrey Soares, Jennifer A. Leiferman, Sheana S. Bull, Suhong Tong, Ann E. Caldwell, Nanette Santoro, Linda A. Barbour
BackgroundPostpartum women with overweight/obesity and a history of adverse pregnancy outcomes are at elevated risk for cardiometabolic disease. Postpartum weight loss and lifestyle changes can decrease these risks, yet traditional face-to-face interventions often fail. We adapted the Diabetes Prevention Program into a theory-based mobile health (mHealth) program called Fit After Baby (FAB) and tested FAB in a randomized controlled trial.
MethodsThe FAB program provided 12 weeks of daily evidence-based content, facilitated tracking of weight, diet, and activity, and included weekly coaching and gamification with points and rewards. We randomized women at 6 weeks postpartum 2:1 to FAB or to the publicly available Text4baby (T4B) app (active control). We measured weight and administered behavioral questionnaires at 6 weeks, and 6 and 12 months postpartum, and collected app user data.
Results81 eligible women participated (77% White, 2% Asian, 15% Black, with 23% Hispanic), mean baseline BMI 32±5 kg/m2 and age 31±5 years. FAB participants logged into the app a median of 51/84 (IQR 25,71) days, wore activity trackers 66/84 (IQR 43,84) days, logged weight 17 times (IQR 11,24), and did coach check-ins 5.5/12 (IQR 4,9) weeks. The COVID-19 pandemic interrupted data collection for the primary 12-month endpoint, and impacted diet, physical activity, and body weight for many participants. At 12 months postpartum women in the FAB group lost 2.8 kg [95% CI -4.2,-1.4] from baseline compared to a loss of 1.8 kg [95% CI -3.8,+0.3] in the T4B group (p = 0.42 for the difference between groups). In 60 women who reached 12 months postpartum before the onset of the COVID-19 pandemic, women randomized to FAB lost 4.3 kg [95% CI -6.0,-2.6] compared to loss in the control group of 1.3 kg [95% CI -3.7,+1.1] (p = 0.0451 for the difference between groups).
ConclusionsThere were no significant differences between groups for postpartum weight loss for the entire study population. Among those unaffected by the COVID pandemic, women randomized to the FAB program lost significantly more weight than those randomized to the T4B program. The mHealth FAB program demonstrated a substantial level of engagement. Given the scalability and potential public health impact of the FAB program, the efficacy for decreasing cardiometabolic risk by increasing postpartum weight loss should be tested in a larger trial.
by Elaine Cristina Teixeira, Lucas Freires Abreu, Fernando Antônio de Souza, Walter José Rodrigues Matrangolo, Karina Toledo da Silva, Luciano Soares de Lima, Hemilly Cristina Menezes de Sa, Ângela Maria Quintão Lana
Legumes shrubs such as Cratylia argentea have an ability to thrive in environments with low water availability and poor soil. On the other hand, forage grasses such as Tifton 85 have a greater demand for inputs to be productive. The objective of this study was to evaluate the performance of growing and finishing Lacaune lambs fed Cratylia argentea hay as an alternative to Tifton 85 (Cynodon spp). Twenty-four Lacaune lambs aged between five and six months (average body weight [BW] 21.50 ± 3.38 kg) were arranged in a split-plot randomized block design. The plots consisted of different Cratylia to Tifton 85 hay proportions (0, 20%, 40%, or 100%, dry matter [DM] basis) as a roughage replacement in the total diet. The subplots represented two evaluation times, entitled “initial period” and “final period”, which consisted of the early seven days of total feces and urine collection, and the last seven days of the experiment, respectively. The lambs were blocked by weight with six replicates per treatment. The results show that the level of Tifton 85 replacement for Cratylia hay in the roughage portion of the lamb diet did not influence (P > 0.05) weight gain (WG), dry matter intake or dry matter digestibility; feed conversion, feed efficiency; and the evaluated nitrogen balance variables. The digestibility coefficient of neutral detergent fiber decreased linearly as Tifton 85 replacement for Cratylia level was increased, which probably happened due to the presence of highly lignified material within the Cratylia hay. However, the alternative legume maintained animal performance of Tifton 85. In conclusion, Cratylia hay can be recommended as a potential substitute for Tifton 85 hay, which requires greater inputs for the production. Cratylia may be considered a feeding strategy for livestock production, especially for smallholder livestock systems and regions with unfavorable soil and climate.
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