School of Nursing, Johns Hopkins University, Baltimore, MD, United States.
Department of Biostatistics & Bioinformatics, Duke University, Durham, NC, United States.
J Med Internet Res. 2024 Mar 28;26:e50330. doi: 10.2196/50330.
The prevalence of obesity and its associated comorbidities continue to rise in the United States. Populations who are uninsured and from racial and ethnic minority groups continue to be disproportionately affected. These populations also experience fewer clinically meaningful outcomes in most weight loss trials. Weight gain prevention presents a useful strategy for individuals who experience barriers to weight loss. Given the often-limited weight management resources available to patients in primary care settings serving vulnerable patients, evaluating interventions with pragmatic designs may help inform the design of comprehensive obesity care delivered in primary care.
This study aims to evaluate the effectiveness of Balance, a 2-arm, 12-month pragmatic randomized controlled trial of a digital weight gain prevention intervention, delivered to patients receiving primary care within federally qualified community health centers.
Balance was a 2-arm, 12-month pragmatic randomized controlled trial of a digital weight gain prevention intervention delivered to individuals who had a BMI of 25-40 kg/m, spoke English or Spanish, and were receiving primary care within a network of federally qualified community health centers in North Carolina. The Balance intervention was designed to encourage behavioral changes that result in a slight energy deficit. Intervention participants received tailored goal setting and tracking, skills training, self-monitoring, and responsive health coaching from registered dietitians. Weight was measured at regular primary care visits and documented in the electronic health record. We compared the percentage of ≤3% weight gain in each arm at 24 months after randomization-our primary outcome-using individual empirical best linear unbiased predictors from the linear mixed-effects model. We used individual empirical best linear unbiased predictors from participants with at least 1 electronic health record weight documented within a 6-month window centered on the 24-month time point.
We randomized 443 participants, of which 223 (50.3%) participants were allocated to the intervention arm. At baseline, participants had a mean BMI of 32.6 kg/m. Most participants were Latino or Hispanic (n=200, 45.1%) or non-Latino or Hispanic White (n=115, 26%). In total, 53% (n=235) of participants had at least 1 visit with weight measured in the primary time window. The intervention group had a higher proportion with ≤3% weight gain at 6 months (risk ratio=1.12, 95% CI 0.94-1.28; risk difference=9.5, 95% CI -4.5 to 16.4 percentage points). This difference attenuated to the null by 24 months (risk ratio=1.00, 95% CI 0.82-1.20; risk difference=0.2, 95% CI -12.1 to 11.0 percentage points).
In adults with overweight or obesity receiving primary care at a community health center, we did not find long-term evidence to support the dissemination of a digital health intervention for weight gain prevention.
ClinicalTrials.gov NCT03003403; https://clinicaltrials.gov/study/NCT03003403.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s12889-019-6926-7.
在美国，肥胖及其相关合并症的患病率持续上升。没有保险的人群以及来自种族和少数民族群体的人继续受到不成比例的影响。这些人群在大多数减肥试验中也经历较少的临床有意义的结果。体重增加预防为经历减肥障碍的个体提供了一种有用的策略。鉴于为服务弱势群体的初级保健环境中的患者提供的体重管理资源往往有限，评估具有实用设计的干预措施可能有助于为在初级保健中提供全面肥胖护理提供信息。
本研究旨在评估 Balance 的有效性，这是一项为期 12 个月的 2 臂实用随机对照试验，评估一种数字体重增加预防干预措施，该干预措施提供给在北卡罗来纳州联邦合格社区卫生中心接受初级保健的患者。
Balance 是一项为期 12 个月的 2 臂实用随机对照试验，评估一种数字体重增加预防干预措施，适用于 BMI 为 25-40 kg/m、讲英语或西班牙语且在联邦合格社区卫生中心网络中接受初级保健的个体。Balance 干预旨在鼓励导致轻微能量不足的行为改变。干预参与者接受注册营养师量身定制的目标设定和跟踪、技能培训、自我监测和响应性健康指导。体重在定期的初级保健就诊时测量，并记录在电子健康记录中。我们使用线性混合效应模型中的个体经验最佳线性无偏预测值比较了 24 个月后（我们的主要结局）每个臂中≤3%体重增加的百分比。我们使用至少有 1 次电子健康记录体重记录在以 24 个月时间点为中心的 6 个月窗口内的参与者的个体经验最佳线性无偏预测值。
我们随机分配了 443 名参与者，其中 223 名（50.3%）参与者被分配到干预组。在基线时，参与者的平均 BMI 为 32.6 kg/m。大多数参与者是拉丁裔或西班牙裔（n=200，45.1%）或非拉丁裔或西班牙裔白人（n=115，26%）。总共有 53%（n=235）的参与者在主要时间窗口内至少有一次就诊时测量了体重。干预组在 6 个月时体重增加≤3%的比例更高（风险比=1.12，95%CI 0.94-1.28；风险差异=9.5，95%CI -4.5 至 16.4 个百分点）。到 24 个月时，这种差异趋于零（风险比=1.00，95%CI 0.82-1.20；风险差异=0.2，95%CI -12.1 至 11.0 个百分点）。
在接受社区卫生中心初级保健的超重或肥胖成年人中，我们没有发现长期证据支持传播数字健康干预措施来预防体重增加。
ClinicalTrials.gov NCT03003403；https://clinicaltrials.gov/study/NCT03003403。
国际注册报告标识符（IRRID）：RR2-10.1186/s12889-019-6926-7。
