Bender Melinda S, Cooper Bruce A, Flowers Elena, Ma Raymond, Arai Shoshana
Family Health Care Nursing Department, University of California San Francisco, School of Nursing, United States.
Office of Research & Department of Community Health System, University of California San Francisco, School of Nursing, United States.
Contemp Clin Trials Commun. 2018 Sep 20;12:76-84. doi: 10.1016/j.conctc.2018.09.004. eCollection 2018 Dec.
Filipino Americans are at higher risk for obesity and related Type 2 diabetes (T2D) compared to other Asian subgroups and non-Hispanic whites. Yet, there are limited research studies to reduce health disparities and improve health outcomes for Filipinos. Weight loss lifestyle intervention trials such as the Diabetes Prevention Program (DPP) can reduce obesity and T2D risks through physical activity and healthy eating.
Thus, we conducted a pilot Fit&Trim (DPP-based) intervention study - a randomized controlled trial 3-month intervention augmented with mobile technology + 3-month maintenance follow-up with a waitlist control. The objective assessed the intervention feasibility and potential efficacy to reduce T2D risks in Filipino Americans with overweight/obesity. The overall study goal was a mean 5% weight reduction.
Sixty-seven eligible Filipino men and women were enrolled and randomized to either an intervention or waitlist control group. Participant retention was 91%. In (baseline to 3-months), the intervention group had greater weight reduction compared to the waitlist control (-4.3% vs. -0.88%; cross-level interaction = -0.85 (-1.4, -0.35). In (3- to 6-months), after receiving the Fit&Trim intervention, the waitlist group also had similar significant weight reduction [-4.8% (- 0.75 (-0.92, -0.58)]. A majority of intervention group (57%) also maintained their weight loss. Overall, 41% of study participants achieved a 5% weight loss.
The Fit&Trim intervention demonstrated feasibility and potential efficacy for Filipino Americans. Findings warrant a further larger, longer trial to test the Fit&Trim feasibility and effectiveness in a real-world Filipino community setting.
NCT02278939.
与其他亚洲亚组以及非西班牙裔白人相比,菲律宾裔美国人患肥胖症及相关2型糖尿病(T2D)的风险更高。然而,针对减少菲律宾裔人群健康差距并改善其健康结局的研究却很有限。诸如糖尿病预防计划(DPP)这类体重减轻生活方式干预试验,可通过体育活动和健康饮食来降低肥胖症和T2D风险。
因此,我们开展了一项基于DPP的Fit&Trim干预试点研究——一项随机对照试验,为期3个月的干预并辅以移动技术,以及为期3个月的维持期随访,并设置了候补对照组。该研究目的是评估干预措施在超重/肥胖的菲律宾裔美国人中降低T2D风险的可行性和潜在效果。研究的总体目标是平均减重5%。
67名符合条件的菲律宾男性和女性被纳入研究并随机分为干预组或候补对照组。参与者保留率为91%。在第1阶段(基线至3个月),干预组的体重减轻幅度大于候补对照组(-4.3%对-0.88%;跨层次交互作用=-0.85(-1.4,-0.35))。在第2阶段(3至6个月),候补组在接受Fit&Trim干预后,体重也有类似的显著减轻[-4.8%(-0.75(-0.92,-0.58)]。干预组中的大多数人(57%)也维持了体重减轻。总体而言,41%的研究参与者实现了减重5%。
Fit&Trim干预措施对菲律宾裔美国人显示出可行性和潜在效果。研究结果表明有必要开展进一步规模更大、时间更长的试验,以检验Fit&Trim在实际菲律宾社区环境中的可行性和有效性。
NCT02278939。