ObjectivesTo determine the effect on weight of two Mobile technology-based (mHealth) behavioral weight loss interventions in young adults.MethodsRandomized, controlled comparative effectiveness trial in 18–35 year olds with BMI ≥ 25 kg/m2 (overweight/obese), with participants randomized to 24 months of mHealth intervention delivered by interactive smartphone application on a cell phone (CP); personal coaching enhanced by smartphone self-monitoring (PC); or Control.ResultsThe 365 randomized participants had mean baseline BMI of 35 kg/m2. Final weight was measured in 86% of participants. CP was not superior to Control at any measurement point. PC participants lost significantly more weight than Controls at 6 months (net effect −1.92 kg [CI −3.17, −0.67], p=0.003), but not at 12 and 24 months.ConclusionsDespite high intervention engagement and study retention, the inclusion of behavioral principles and tools in both interventions, and weight loss in all treatment groups, CP did not lead to weight loss and PC did not lead to sustained weight loss relative to control. Although mHealth solutions offer broad dissemination and scalability, the CITY results sound a cautionary note concerning intervention delivery by mobile applications. Effective intervention may require the efficiency of mobile technology, the social support and human interaction of personal coaching, and an adaptive approach to intervention design.Trial RegistrationClinicalTrials.gov Identifier NCT01092364.https://clinicaltrials.gov/ct2/show/NCT01092364?term=Cell+phone+intervention+for+you&rank=3
Background: Although lifestyle modifications generally are effective in lowering blood pressure (BP) among patients with unmedicated hypertension and in those treated with 1 or 2 antihypertensive agents, the value of exercise and diet for lowering BP in patients with resistant hypertension is unknown. Methods: One hundred forty patients with resistant hypertension (mean age, 63 years; 48% female; 59% Black; 31% with diabetes; 21% with chronic kidney disease) were randomly assigned to a 4-month program of lifestyle modification (C-LIFE [Center-Based Lifestyle Intervention]) including dietary counseling, behavioral weight management, and exercise, or a single counseling session providing SEPA (Standardized Education and Physician Advice). The primary end point was clinic systolic BP; secondary end points included 24-hour ambulatory BP and select cardiovascular disease biomarkers including baroreflex sensitivity to quantify the influence of the baroreflex on heart rate, high-frequency heart rate variability to assess vagally mediated modulation of heart rate, flow-mediated dilation to evaluate endothelial function, pulse wave velocity to assess arterial stiffness, and left ventricular mass to characterize left ventricular structure. Results: Between-group comparisons revealed that the reduction in clinic systolic BP was greater in C-LIFE (–12.5 [95% CI, –14.9 to –10.2] mm Hg) compared with SEPA(–7.1 [–95% CI, 10.4 to –3.7] mm Hg) ( P =0.005); 24-hour ambulatory systolic BP also was reduced in C-LIFE (–7.0 [95% CI, –8.5 to –4.0] mm Hg), with no change in SEPA (–0.3 [95% CI, –4.0 to 3.4] mm Hg) ( P =0.001). Compared with SEPA, C-LIFE resulted in greater improvements in resting baroreflex sensitivity (2.3 ms/mm Hg [95% CI, 1.3 to 3.3] versus –1.1 ms/mm Hg [95% CI, –2.5 to 0.3]; P <0.001), high-frequency heart rate variability (0.4 ln ms 2 [95% CI, 0.2 to 0.6] versus –0.2 ln ms 2 [95% CI, –0.5 to 0.1]; P <0.001), and flow-mediated dilation (0.3% [95% CI, –0.3 to 1.0] versus –1.4% [95% CI, –2.5 to –0.3]; P =0.022). There were no between-group differences in pulse wave velocity ( P =0.958) or left ventricular mass ( P =0.596). Conclusions: Diet and exercise can lower BP in patients with resistant hypertension. A 4-month structured program of diet and exercise as adjunctive therapy delivered in a cardiac rehabilitation setting results in significant reductions in clinic and ambulatory BP and improvement in selected cardiovascular disease biomarkers. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02342808.
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