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Study Protocol effectiveness of a nutritional intervention based on encouraging the consumption of unprocessed and minimally processed foods and the practice of physical activities for appropriate weight gain in overweight, adult, pregnant women: a randomized controlled trial.

ABSTRACT: BACKGROUND:Evidence from observational studies suggests that a greater intake of ultra-processed foods during pregnancy is associated with a higher chance of obesity, increased gestational weight gain, and neonatal adiposity. The aim of the present study is to evaluate the effectiveness of a nutritional intervention based on encouraging the consumption of unprocessed and minimally processed foods and the practice of physical activities for appropriate weight gain in overweight, adult, pregnant women. Additionally, the effect of the intervention on pregnancy outcomes, neonatal adiposity, and the child's weight and height will be investigated. METHODS:This is a two-armed parallel randomized controlled trial that will be conducted at primary health units in Ribeirão Preto, SP, Brazil. Adult pregnant women who are overweight and receiving prenatal care in the public health system will be included. The women will be randomly allocated into control (standard care) or intervention groups. Those enrolled in the intervention group will participate in three individualized nutritional counselling sessions based on encouraging the consumption of unprocessed and minimally processed foods and the practice of physical activities. The recruitment of the participants will be carried out at seven health facilities over 12 months, with a sample of 300 women expected. Maternal anthropometric, sociodemographic, blood pressure, biochemical, and lifestyle data will be obtained at baseline (up to the 16th week of gestation), and during a second assessment (34th to 36th gestational week). The neonate body composition will be estimated after birth, and data on pregnancy outcomes, weight and height of children at 6, 12 and 24?months of age will be further obtained from medical records. DISCUSSION:This will be the first randomized controlled trial to test the effectiveness of a nutritional intervention based on encouraging the consumption of unprocessed and minimally processed foods and the practice of physical activities for appropriate weight gain in adult, overweight, pregnant women. Furthermore, the effect of the intervention on pregnancy outcomes, neonatal adiposity and the child's weight and height will be evaluated. TRIAL REGISTRATION:Registro Brasileiro de Ensaios Clínicos (Rebec) RBR-2w9bhc July 30th 2018 (http://www.ensaiosclinicos.gov.br/rg/?q=RBR-2w9bhc+), and RBR-7yx36h June 4th 2019 (http://www.ensaiosclinicos.gov.br/rg/?q=RBR-7yx36h+0.

SUBMITTER: Sartorelli DS

PROVIDER: S-EPMC6947817 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

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Study Protocol effectiveness of a nutritional intervention based on encouraging the consumption of unprocessed and minimally processed foods and the practice of physical activities for appropriate weight gain in overweight, adult, pregnant women: a randomized controlled trial.

Sartorelli Daniela Saes DS Crivellenti Lívia Castro LC Manochio-Pina Marina Garcia MG Baroni Naiara Franco NF Carvalho Mariana Rinaldi MR Diez-Garcia Rosa Wanda RW Franco Laércio Joel LJ

BMC pregnancy and childbirth 20200107 1

<h4>Background</h4>Evidence from observational studies suggests that a greater intake of ultra-processed foods during pregnancy is associated with a higher chance of obesity, increased gestational weight gain, and neonatal adiposity. The aim of the present study is to evaluate the effectiveness of a nutritional intervention based on encouraging the consumption of unprocessed and minimally processed foods and the practice of physical activities for appropriate weight gain in overweight, adult, pr ...[more]

PMID: 31910819

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Project description:Heavy metals (HM) can be accumulated along the food chain; their presence in food is a global concern for human health because some of them are toxic even at low concentrations. Unprocessed or minimally processed foods are good sources of different nutrients, so their safety and quality composition should be guaranteed in the most natural form that is obtained for human consumption. The objective of this scoping review (ScR) is to summarize the existing evidence about the presence of HM content (arsenic (As), lead (Pb), cadmium (Cd), mercury (Hg), methylmercury (MeHg), and aluminum (Al)) in unprocessed or minimally processed foods for human consumption worldwide during the period of 2011-2020. As a second objective, we identified reported HM values in food with respect to Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO) International Food Standards for Maximum Limits (MLs) for contaminants in food. This ScR was conducted in accordance with the Joanna Briggs Institute (JBI) methodology and PRISMA Extension for Scoping Reviews (PRISMA-ScR); advance searches were performed in PubMed, ScienceDirect and FAO AGRIS (Agricultural Science and Technology Information) databases by two reviewers who independently performed literature searches with specific eligibility criteria. We classified individual foods in food groups and subgroups according to the Global Individual Information Food Consumption Data Tool (FAO/WHO GIFT). We homologated all the reported HM units to parts per million (ppm) to determine the weighted mean HM concentration per country and food group/subgroup of the articles included. Then, we compared HM concentration findings with FAO/WHO MLs. Finally, we used a Geographic Information System (GIS) to present our findings. Using our search strategy, we included 152 articles. Asia was the continent with the highest number of publications (n = 79, 51.3%), with China being the country with the largest number of studies (n = 34). Fish and shellfish (n = 58), followed by vegetables (n = 39) and cereals (n = 38), were the food groups studied the most. Fish (n = 42), rice (n = 33), and leafy (n = 28) and fruiting vegetables (n = 29) were the most studied food subgroups. With respect to the HM of interest, Cd was the most analyzed, followed by Pb, As, Hg and Al. Finally, we found that many of the HM concentrations reported exceeded the FAO/OMS MLs established for Cd, Pb and As globally in all food groups, mainly in vegetables, followed by the roots and tubers, and cereals food groups. Our study highlights the presence of HM in the most natural forms of food around the world, in concentrations that, in fact, exceed the MLs, which affects food safety and could represent a human health risk. In countries with regulations on these topics, a monitoring system is recommended to evaluate and monitor compliance with national standards. For countries without a regulation system, it is recommended to adopt international guidelines, such as those of FAO, and implement a monitoring system that supervises national compliance. In both cases, the information must be disseminated to the population to create social awareness. This is especially important to protect the population from the consumption of internal production and for the international markets of the globalized world.

Project description:Trial designExcessive gestational weight gain (GWG) can increase pregnancy morbidity and is particularly problematic for women with pregestational obesity. A lifestyle modification intervention was introduced to gravida with obesity to decrease excessive GWG as compared to usual care (UC).MethodsA randomized controlled trial was conducted to improve healthy lifestyle behaviors to manage appropriate GWG. Consenting participants with prepregnancy obesity and singletons ≤17 weeks were randomized to (1) Usual Care (UC): usual written educational materials and counseling by obstetric provider or (2) Enhanced Care (EC): UC plus (a) personalized letter from physician detailing appropriate GWG; (b) access to individualized GWG chart; (c) ongoing counseling with registered dietitian/nutritionist (RDN). The primary outcome was proportion with GWG ≤9.1 kg, as this is upper limit recommended by Institute of Medicine (IOM). Total GWG and GWG as less than/within/greater than IOM recommendations (in aggregate and stratified by obesity class), and pregnancy/neonatal outcomes were evaluated as secondary outcomes.ResultsAnalyses included 105 participants in EC and 109 in UC arms. The groups had similar demographics: 46% with class I obesity, 26% class II, and 28% class III. There were no group differences for any GWG, pregnancy, or neonatal outcomes when analyzed in aggregate. As compared to those randomized to the EC arm, participants in UC arm with class I obesity gained 1.4 kg less and those with class II obesity were significantly more likely to gain within IOM guidelines (14.8% vs. 40.0%, adjusted p = 0.04). Participants with class III obesity randomized to EC arm were more likely to gain within IOM guidelines as compared to participants randomized to UC arm (29.0% vs. 6.7%, adjusted p = 0.02).ConclusionThere were no differences in GWG observed between groups when analyzing participants in aggregate. However, a physician's letter detailing appropriate GWG, patient portal access to a personalized GWG chart, and RDN consultation were helpful for encouraging GWG within IOM guidelines for women with prepregnancy class III obesity. Women with class I or II obesity had better GWG outcomes without these additional interventions.

Project description:BackgroundAn increasingly large share of diet comes from ultra-processed foods (UPFs), which are assemblages of food substances designed to create durable, convenient and palatable ready-to-eat products. There is increasing evidence that high UPF consumption is indicative of poor diet and is associated with obesity and metabolic disorders. This study sought to examine the relationship between percent of energy intake from ultra-processed foods (PEI-UPF) during pregnancy and maternal gestational weight gain, maternal lipids and glycemia, and neonatal body composition. We also compared the PEI-UPF indicator against the US government's Healthy Eating Index-2010 (HEI-2010).MethodsData were used from a longitudinal study performed in 2013-2014 at the Women's Health Center and Obstetrics & Gynecology Clinic in St. Louis, MO, USA. Subjects were pregnant women in the normal and obese weight ranges, as well as their newborns (n = 45). PEI-UPF and the Healthy Eating Index-2010 (HEI-2010) were calculated for each subject from a one-month food frequency questionnaire (FFQ). Multiple regression (ANCOVA-like) analysis was used to analyze the relationship between PEI-UPF or HEI-2010 and various clinical outcomes. The ability of these dietary indices to predict clinical outcomes was also compared with the predictive abilities of total energy intake and total fat intake.ResultsAn average of 54.4 ± 13.2% of energy intake was derived from UPFs. A 1%-point increase in PEI-UPF was associated with a 1.33 kg increase in gestational weight gain (p = 0.016). Similarly, a 1%-point increase in PEI-UPF was associated with a 0.22 mm increase in thigh skinfold (p = 0.045), 0.14 mm in subscapular skinfold (p = 0.026), and 0.62 percentage points of total body adiposity (p = 0.037) in the neonate.DiscussionPEI-UPF (percent of energy intake from ultra-processed foods) was associated with and may be a useful predictor of increased gestational weight gain and neonatal body fat. PEI-UPF was a better predictor of all tested outcomes than either total energy or fat intake, and a better predictor of the three infant body fat measures than HEI-2010. UPF consumption should be limited during pregnancy and diet quality should be maximized in order to improve maternal and neonatal health.

Project description:Ultra-processed foods are associated with chronic diseases, cardiometabolic factors and obesity. According to the NOVA system, foods are classified into four categories (from 1 = unprocessed to 4 = ultra-processed foods). The purpose of the present study was to assess the consumption of minimally processed foods (MPF) and ultra-processed foods (UPF) in university students and their relationship with obesity, Mediterranean diet adherence and meal patterns. In total, 346 students (269 women) of the University of Peloponnese participated. A food frequency questionnaire was used, and the MedDietScore was calculated. The % energy contribution of MPF and UPF was calculated. The identification of meal patterns was performed via principal component analysis. Both multivariate regression and Spearman's correlations were used to measure the association of UPF/MPF consumption with anthropometric indices (body mass index, BMI and waist circumference, WC), Mediterranean diet adherence and early/late meal patterns. UPF and MPF provided 40.7 ± 13.6% and 44.3 ± 11.9% (mean ± standard deviation) of energy intake, respectively. In multi-adjusted linear regression models UPF consumption (% energy) was positively associated with WC in men but it was not related to BMI (total sample, men, women). UPF consumption was negatively related to the MedDietScore (Spearman rho = -0.214, p < 0.001) and an "early eating" pattern (Spearman rho = -0.120, p = 0.029) and positively associated with a "late eating" meal pattern (Spearman rho = 0.190, p = 0.001). MPF consumption was positively associated with the MedDietScore (Spearman rho = 0.309, p < 0.001) and an "early eating" pattern (Spearman rho = 0.240, p < 0.001). In conclusion, UPF consumption was positively related to WC in male university students. Nutritional and sociodemographic correlates of UPF consumption, such as low Mediterranean diet adherence and having a "late eating" pattern serve as a basis to better understand the UPF consumption-central obesity relation in young adults and should be considered in nutrition education programs for young adults.

Dataset Information

Study Protocol effectiveness of a nutritional intervention based on encouraging the consumption of unprocessed and minimally processed foods and the practice of physical activities for appropriate weight gain in overweight, adult, pregnant women: a randomized controlled trial.

Publications

Study Protocol effectiveness of a nutritional intervention based on encouraging the consumption of unprocessed and minimally processed foods and the practice of physical activities for appropriate weight gain in overweight, adult, pregnant women: a randomized controlled trial.

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