Diet, inflammation and obesity in adults: a nutritional intervention study

INTERVENTION: This is a parallel, two‐open‐arms randomized controlled clinical study where families were randomly assigned by simple randomization in: Intervention group with 30 participants who received four home visits over three months (basal first month second month and third month with individualized nutritional counseling to increase the consumption of whole grains legumes vegetables vegetables fruits meats lean meat fish and dairy products with low fat content and reduce the consumption of sweet red meat sugary drinks refined cereals, ultra‐processed foods and alcoholic beverages without prescription of energy restriction). The control group with 23 participants received standard care from Primary Health Care with assessments at the beginning and after three months. At the end of the follow‐up, the control group received the same nutritional guidance as the intervention group CONDITION: C18.654.726.750.500 Inflammation; diet ; Obesity PRIMARY OUTCOME: An average reduction of 0.88 points in the energy‐adjusted Diet Inflammatory Index is expected to be found in the intervention group compared to the control group. The measure was evaluated using the Food Frequency Questionnaire of 120 items with Diet Inflammatory Index calculation using 28 dietary parameters adjusted per 1000 kilocalories according to the methodology of Shivappa and collaborators. The statistical analysis used a mixed linear model for repeated measurements with group and time as fixed factors and subjects as a random factor. The sample size was calculated based on this primary outcome using G‐Power version 3.1.2, with an alpha error of 0,05 and Cohen effect size d equals 0.35 SECONDARY OUTCOME: It is expected to find a significant increase in the intake of vitamins A and C in the intervention group compared to the control group. The outcome was measured using a 120‐item Food Frequency Questionnaire with nutritional calculations based on TACO and USDA tables It is expected to find a significant reduction in the energy‐adjusted Diet Inflammatory Inde Xin both women and men in the intervention group. The outcome was measured using the Food Frequency Questionnaire with energy‐adjusted Diet Inflammatory Inde Xcalculation stratified by sex, using paired t‐tests for intra‐group comparisons and independent t‐tests or Mann‐Whitney tests for inter‐group comparisons It is expected to find a significant reduction in the intake of energy, carbohydrates, total fat, saturated fat, and trans fat in the intervention group compared to the control group. The outcome was measured using a 120‐item Food Frequency Questionnaire with nutritional calculations based on TACO and USDA tables INCLUSION CRITERIA: Adults and older adults aged greater than or equal to 18 years with overweight or obesity defined as Body Mass Inde Xgreater than or equal to 25 kilograms per square meter for adults according to World Health Organization criteria and Body Mass Inde Xgreater than or equal to 27 kilograms per square meter for older adults according to Lipschitz criteria; Participants assisted by the Family Health Strategy of a primary healthcare unit in the Grajaú district of São Paulo Brazil; Voluntary agreement to participate in the study with signature of the Informed Consent Form ICF