Division of Cardiovascular Medicine, University of Pennsylvania, Philadelphia, PA; Leonard Davis Institute for Health Economics, University of Pennsylvania, Philadelphia, PA; Penn Cardiovascular Outcomes, Quality, and Evaluative Research Center, University of Pennsylvania, Philadelphia, PA; Institute for Translational Medicine and Therapeutics, University of Pennsylvania, Philadelphia, PA; Center for Health Economics and Behavioral Economics, University of Pennsylvania, Philadelphia, PA; Penn Center for Digital Cardiology, University of Pennsylvania, Philadelphia, PA.
Center for Health Economics and Behavioral Economics, University of Pennsylvania, Philadelphia, PA.
Am Heart J. 2023 Apr;258:85-95. doi: 10.1016/j.ahj.2022.12.010. Epub 2023 Jan 11.
Obesity is strongly associated with cardiovascular disease, particularly through its effects on blood pressure. Though maintaining a negative caloric balance leads to weight loss, many patients struggle to adhere to low calorie diets over the long term. Time-restricted eating, a subtype of intermittent fasting (IF), may be an easier dietary pattern for patients to initiate and maintain. We tested the feasibility of a bidirectional texting strategy to help patients with obesity and hypertension initiate and maintain time-restricted eating, and whether a commitment device, a pledge to behave in a certain way in the future while making nonadherence costlier, would increase adherence beyond bidirectional texting.
Patients with obesity and hypertension seen in cardiology clinics were provided education on time-restricted eating and randomized to a commitment device versus attention control. Attention control consisted of daily bidirectional text messages asking whether patients adhered to IF and weekly text messages asking participants to send their weight and blood pressure. The commitment device involved the same text messages as attention control, plus a commitment contract, setting of implementation intentions with respect to details of time-restricted eating, and involvement of a support partner who received weekly updates on the participant's adherence to time-restricted eating. The intervention lasted 12 weeks, followed by a 6-week follow-up period. The primary outcome was days per week adherent to time-restricted eating over the 18-week study period, measured by daily self-report. We also compared change from baseline weight and blood pressure between randomized groups.
A total of 37 patients were randomized and started the study-20 to attention control and 17 to the commitment device. Mean age was 60 years old, and mean BMI was 38.4 kg/m. Over the 18-week study period, the mean ± standard deviation (SD) number of days per week adherent to time-restricted eating was 4.7 ± 1.9 in the control arm and 5.4 ± 1.7 in the intervention arm (P = .23). Mean systolic blood pressure declined from 135 to 128 mm Hg among all participants (P = .006) with no difference between groups in change from baseline blood pressure (P = .74). Weight decreased from 229 to 223 pounds among all participants (P = .25) with no significant difference between groups in change from baseline weight (P = .84).
A bidirectional texting strategy was feasible for helping patients with obesity and hypertension initiate and adhere to time-restricted eating. Adding a commitment device to bidirectional texting did not increase adherence to time-restricted eating compared with attention control, nor were there significant between group changes in blood pressure or weight, but these comparisons were underpowered. A larger randomized trial of the effect of this scalable intervention, compared with usual care, on blood pressure and weight among patients with obesity and hypertension is warranted.
clinicaltrials.gov; unique identifier: NCT04836312.
肥胖与心血管疾病密切相关，尤其是通过其对血压的影响。尽管保持负热量平衡会导致体重下降，但许多患者长期难以坚持低热量饮食。限时进食，即间歇性禁食（IF）的一种亚型，可能是患者更容易开始和维持的饮食模式。我们测试了双向短信策略的可行性，以帮助肥胖和高血压患者开始并维持限时进食，以及一种承诺装置，即承诺在未来以某种方式行事，同时使不遵守行为更加昂贵，是否会超过双向短信增加依从性。
在心脏病学诊所就诊的肥胖和高血压患者接受了限时进食教育，并随机分配至承诺装置组或注意对照组。注意对照组包括每日双向短信询问患者是否遵守 IF，以及每周短信询问参与者发送体重和血压。承诺装置包括与注意对照组相同的短信，外加承诺合同、设定与限时进食细节相关的实施意图，以及涉及一位支持伙伴，每周更新参与者对限时进食的遵守情况。干预持续 12 周，随后进行 6 周的随访期。主要结局是在 18 周的研究期间每周遵守限时进食的天数，通过每日自我报告测量。我们还比较了随机分组之间基线体重和血压的变化。
共有 37 名患者被随机分配并开始研究-20 名进入注意对照组，17 名进入承诺装置组。平均年龄为 60 岁，平均 BMI 为 38.4kg/m。在 18 周的研究期间，对照组每周遵守限时进食的平均天数±标准偏差（SD）为 4.7±1.9，干预组为 5.4±1.7（P=0.23）。所有参与者的收缩压从 135 降至 128mmHg（P=0.006），两组间血压的基线变化无差异（P=0.74）。所有参与者的体重从 229 磅降至 223 磅（P=0.25），两组间体重的基线变化无显著差异（P=0.84）。
双向短信策略有助于帮助肥胖和高血压患者开始并坚持限时进食。与注意对照组相比，在双向短信的基础上增加承诺装置并没有增加对限时进食的依从性，也没有显著的组间血压或体重变化，但这些比较的效力不足。需要一项更大规模的随机试验，比较这种可扩展干预措施与常规护理相比，对肥胖和高血压患者的血压和体重的影响。
clinicaltrials.gov；唯一标识符：NCT04836312。
