Department of Public Health Sciences, School of Medicine, University of Virginia, P.O. Box 800717, Charlottesville, VA, 22908-0717, USA.
Cancer Center without Walls at the UVA Cancer Center, 16 East Main St, Christiansburg, VA, 24073, USA.
Int J Behav Nutr Phys Act. 2018 Oct 4;15(1):97. doi: 10.1186/s12966-018-0728-7.
Although reducing sugar-sweetened beverage (SSB) intake is an important behavioral strategy to improve health, no known SSB-focused behavioral trial has examined maintenance of SSB behaviors after an initial reduction. Guided by the RE-AIM framework, this study examines 6-18 month and 0-18 month individual-level maintenance outcomes from an SSB reduction trial conducted in a medically-underserved, rural Appalachia region of Virginia. Reach and implementation indicators are also reported.
Following completion of a 6-month, multi-component, behavioral RCT to reduce SSB intake (SIPsmartER condition vs. comparison condition), participants were further randomized to one of three 12-month maintenance conditions. Each condition included monthly telephone calls, but varied in mode and content: 1) interactive voice response (IVR) behavior support, 2) human-delivered behavior support, or 3) IVR control condition. Assessments included the Beverage Intake Questionnaire (BEVQ-15), weight, BMI, and quality of life. Call completion rates and costs were tracked. Analysis included descriptive statistics and multilevel mixed-effects linear regression models using intent-to-treat procedures.
Of 301 subjects enrolled in the 6-month RCT, 242 (80%) were randomized into the maintenance phase and 235 (78%) included in the analyses. SIPsmartER participants maintained significant 0-18 month decreases in SSB. For SSB, weight, BMI and quality of life, there were no significant 6-18 month changes among SIPsmartER participants, indicating post-program maintenance. The IVR-behavior participants reported greater reductions in SSB kcals/day during the 6-18 month maintenance phase, compared to the IVR control participants (- 98 SSB kcals/day, 95% CI = - 196, - 0.55, p < 0.05); yet the human-delivered behavior condition was not significantly different from either the IVR-behavior condition (27 SSB kcals/day, 95% CI = - 69, 125) or IVR control condition (- 70 SSB kcals/day, 95% CI = - 209, 64). Call completion rates were similar across maintenance conditions (4.2-4.6 out of 11 calls); however, loss to follow-up was greatest in the IVR control condition. Approximated costs of IVR and human-delivered calls were remarkably similar (i.e., $3.15/participant/month or $38/participant total for the 12-month maintenance phase), yet implications for scalability and sustainability differ.
Overall, SIPsmartER participants maintained improvements in SSB behaviors. Using IVR to support SSB behaviors is effective and may offer advantages as a scalable maintenance strategy for real-world systems in rural regions to address excessive SSB consumption.
Clinicaltrials.gov; NCT02193009 ; Registered 11 July 2014. Retrospectively registered.
尽管减少含糖饮料（SSB）的摄入是改善健康的重要行为策略，但目前尚无已知的 SSB 为重点的行为试验研究在初始减少后 SSB 行为的维持情况。本研究以 RE-AIM 框架为指导，检验了在弗吉尼亚州医疗服务不足的阿巴拉契亚农村地区进行的 SSB 减少试验中，6-18 个月和 0-18 个月的个体水平维持结果。还报告了可达性和实施指标。
在完成一项为期 6 个月的多组分行为 RCT 以减少 SSB 摄入量（SIPsmartER 条件与比较条件）后，参与者进一步随机分配到三种 12 个月的维持条件之一。每种条件都包括每月一次的电话，但模式和内容不同：1）交互式语音应答（IVR）行为支持，2）人工提供的行为支持，或 3）IVR 对照条件。评估包括饮料摄入量问卷（BEVQ-15）、体重、BMI 和生活质量。跟踪了电话完成率和成本。分析包括使用意向治疗程序的描述性统计和多层次混合效应线性回归模型。
在参加 6 个月 RCT 的 301 名受试者中，有 242 名（80%）被随机分配到维持阶段，235 名（78%）被纳入分析。SIPsmartER 参与者在 0-18 个月内保持了显著的 SSB 减少。对于 SSB、体重、BMI 和生活质量，SIPsmartER 参与者在 6-18 个月的维持期内没有出现显著的变化，表明在项目后维持。与 IVR 对照组参与者相比，IVR 行为组参与者在 6-18 个月的维持阶段报告了 SSB 千卡/天更大的减少量（-98 SSB 千卡/天，95%CI=-196，-0.55，p<0.05）；然而，人工提供的行为条件与 IVR 行为条件（27 SSB 千卡/天，95%CI=-69，125）或 IVR 对照组条件（-70 SSB 千卡/天，95%CI=-209，64）均无显著差异。维持条件下的电话完成率相似（11 次电话中完成 4.2-4.6 次）；然而，IVR 对照组的失访率最高。IVR 和人工提供的电话的近似成本非常相似（即，12 个月维持阶段每个参与者 3.15 美元/参与者/月或 38 美元/参与者），但可扩展性和可持续性的影响不同。
总体而言，SIPsmartER 参与者维持了 SSB 行为的改善。使用 IVR 来支持 SSB 行为是有效的，并且可能作为农村地区现实系统中解决过度 SSB 消费的可扩展维持策略具有优势。
Clinicaltrials.gov；NCT02193009；2014 年 7 月 11 日注册。回顾性注册。
