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Effect of a family and interdisciplinary intervention to prevent T2D: randomized clinical trial
Vargas-Ortiz K, Lira-Mendiola G, Gomez-Navarro CM, Padilla-Estrada K, Angulo-Romero F, Hernandez-Marquez JM, Villa-Martinez AK, Gonzalez-Mena JN, Macias-Cervantes MH, Reyes-Escogido ML, Guardado-Mendoza R
BMC Public Health 2020 Jan 22;20(97):Epub
clinical trial
6/10 [Eligibility criteria: No; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: No; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

BACKGROUND: Lifestyle changes can reduce the risk of T2D; however, no study has evaluated the effect of a lifestyle intervention involving patients' family. The aim of this study was to compare the impact of an interdisciplinary family (FI) versus individual intervention (II) on glucose metabolism, insulin resistance (IR), pancreatic beta-cell function and cardiovascular risk markers in patients with prediabetes, as well as to measure the impact on their families' metabolic risk. METHODS: Randomized clinical trial (RCT) to compare the impact of FI and II on IR and pancreatic beta-cell function in subjects with prediabetes. There were 122 subjects with prediabetes (and 101 family members) randomized to FI or II. Data were collected in 2015 to 2016 and analyzed in 2017 to 2018. FI group had the support of their family members, who also received personalized diet and exercise recommendations; patients and their family members attended monthly a lifestyle enhancement program. II group received personalized diet and exercise recommendations. The follow-up was for 12 months. Glucose, IR, pancreatic beta-cell function and secondary outcomes (body composition and lipid profile) were assessed at baseline, 6 and 12 months. RESULTS: FI group improved area under the glucose curve (AUC) (from 18,597 +/- 2,611 to 17,237 +/- 2,792, p = 0.004) and the Matsuda index (from 3.5 +/- 2.3 to 4.7 +/- 3.5, p = 0.05) at 12 months. II group improved Disposition Index (from 1.5 +/- 0.4 to 1.9 +/- 0.73, p < 0.0001) at 12 months. The improvements achieved in weight and lipids at 6 months, were lost in II group at 12 moths, whereas in FI persisted. Adherence up to 12 months was not different between the study groups (FI 56% versus II 60%). CONCLUSIONS: FI intervention was more effective by improving glucose AUC, insulin sensitivity and lipid profile, besides that, metabolic risk in family members of the FI group was maintained, while the risk of II group was increased. TRIAL REGISTRATION: This study was retrospectively registered at ClinicalTrials.gov on December 15, 2015 (NTC026365646).

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