Effect of therapeutic lifestyle change on metabolic syndrome in adults: a randomized controlled trial.

Metabolic syndrome (MetS) is the co-occurrence of multiple cardio-metabolic risk factors, including central obesity, hyperglycemia, hypertension, and dyslipidemia. MetS doubles the risk of CVD and increases the risk of T2DM fivefold. Therapeutic lifestyle change (TLC) has been recommended as the primary intervention for MetS. This interventional study was aimed at assessing the effect of TLC on MetS and other metabolic components. A two-arm, double-blinded community-based RCT was used among MetS-positive adults. Participants were randomly assigned to either the intervention group (IG) (n = 75) or the control group (CG) (n = 75). Participants in the IG received a TLC program focused on dietary modification, exercise, and behavioral change. A booklet and biweekly counseling were given, containing comprehensive information on MetS and its management approach. The intervention was implemented for three months. Baseline and end line data were collected. ANCOVA and GEE tests were used for continuous and categorical outcome variables, respectively. TLC improved almost all of the metabolic risk factors simultaneously, including weight, WC, BMI, TC, FBG, TG, and SBP. On average over time, the IG has - 868 g, -1.65 cm, -0.36 kg/m2, -5.51 mg/dl, -4.83 mg/dl, -5.87 mg/dl, and - 4.76 mmHg lower mean weight, WC, BMI, TC, FBG, TG, and SBP, respectively. The mean number of MetS components was significantly decreased by -0.424 among the IG compared to the CG. Likewise, the prevalence of MetS significantly decreased to 58.9% (p < 0.001) and 84.7% (p = 0.001) among the IG and CG, respectively. On average over time, the odds for recovery from MetS in the IG were 3.9 (p = 0.001) times as high as the odds for recovery in the CG. The trial resulted in a significant reduction in MetS prevalence and the majority of the anthropometric and cardio-metabolic biomarkers. Ameliorating the metabolic risk factors by implementing TLC may decrease the costs of medical therapy, hospitalization, and chronic care.Trial registration: This study was registered in the Pan African Clinical Trials Registry (with a unique identification number of PACTR201909866468898) on 30 Sep 2019.