Rationale and study protocol for a randomized controlled trial to determine the effectiveness of a culturally relevant, stress management enhanced behavioral weight loss intervention on weight loss outcomes of black women.
Rationale and study protocol for a randomized controlled trial to determine the effectiveness of a culturally relevant, stress management enhanced behavioral weight loss intervention on weight loss outcomes of black women.
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DOI：
10.1186/s12889-022-12519-z
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发表时间：
2022-01-28
影响因子：
4.5
通讯作者：
Carson TL
中科院分区：
文献类型：
--
作者：
Buro AW;Baskin M;Miller D;Ward T;West DS;Gore LR;Gwede CK;Epel E;Carson TL
肥胖是一个持续存在的公共卫生问题，也是许多慢性疾病（包括至少13种不同癌症）的风险因素。与美国其他种族/性别群体相比，成年黑人女性的肥胖患病率最高（57%）。尽管行为减肥（BWL）干预措施已证明有效，但黑人女性往往比白色女性减肥更少。黑人女性报告的慢性心理压力的患病率较高，这可能有助于其肥胖症的不成比例的患病率和观察到的次优体重减轻。本研究将在一项完全随机对照试验中研究为期12个月的文化针对性，压力管理增强的BWL干预对黑人女性体重减轻和压力减轻的有效性。将患有肥胖症的成年黑人女性（n = 340）随机分配至文化上有针对性的压力管理增强的BWL干预（BWL-压力）或相同的单独BWL干预（BWL-单独）。主要结局是第6个月的体重变化。次要结果将包括压力测量的变化（例如，感知压力、皮质醇）、能量摄入和6个月时的体力活动。我们还将评估过程措施（例如，治疗依从性、治疗负担）。每个结果也将在第12个月进行评估，以评估干预的长期影响。这种新的方法，以加强以证据为基础的BWL计划与文化为目标的压力管理策略，为黑人女性解决了一个研究不足的障碍，有效的体重管理人群中的肥胖和肥胖相关的慢性疾病的高风险。这项研究将可能阐明将我们的新干预措施与研究结果联系起来的心理或行为机制。如果干预措施被证明是有效的，这项研究将对黑人女性的体重管理产生重大的临床和公共卫生影响。本研究于2020年4月6日在ClinicalTrials.gov上注册，标识符为NCT 04335799 t。
Obesity is a persistent public health concern and a risk factor for many chronic diseases including at least 13 different cancers. Adult Black females have the highest prevalence of obesity (57%) compared to other racial/gender groups in the U.S. Although behavioral weight loss (BWL) interventions have demonstrated effectiveness, Black females tend to lose less weight than White counterparts. The higher prevalence of chronic psychological stress reported by Black females may contribute to their disproportionate prevalence of obesity and observed suboptimal weight loss. This study will examine the effectiveness of a 12-month culturally-targeted, stress management-enhanced BWL intervention on weight loss and stress reduction among Black females in a fully-powered randomized, controlled trial. Adult Black females with obesity (n = 340) will be randomized to either a culturally targeted stress management-enhanced BWL intervention (BWL-Stress) or the same BWL intervention alone (BWL-alone). The primary outcome is weight change at month 6. Secondary outcomes will include changes in stress measures (e.g., perceived stress, cortisol), energy intake, and physical activity at month 6. We will also assess process measures (e.g., treatment adherence, treatment burden). Each outcome will also be evaluated at month 12 to assess longer-term effects of the intervention. This novel approach for enhancing an evidence-based BWL program with culturally-targeted stress management strategies for Black females addresses an understudied barrier to effective weight management among a population at high risk for obesity and obesity-related chronic diseases. This study will potentially elucidate psychological or behavioral mechanisms linking our novel intervention to study outcomes. If the intervention is proven to be effective, this study will have significant clinical and public health implications for weight management among Black females. This study was registered on ClinicalTrials.gov, identifier NCT04335799t, on April 6, 2020.
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影响因子：
3.3
作者：
De Pergola G;Silvestris F
通讯作者：
Silvestris F
影响因子：
11.1
作者：
Ard JD;Carson TL;Shikany JM;Li Y;Hardy CM;Robinson JC;Williams AG;Baskin ML
通讯作者：
Baskin ML
影响因子：
168.9
作者：
Bray, G. A.;Chatellier, A.;Duncan, C.;Greenway, F. L.;Levy, E.;Ryan, D. H.;Polonsky, K. S.;Tobian, J.;Ehrmann, D.;Matulik, M. J.;Clark, B.;Czech, K.;DeSandre, C.;Hilbrich, R.;McNabb, W.;Semenske, A. R.;Goldstein, B. J.;Smith, K. A.;Wildman, W.;Pepe, C.;Goldberg, R. B.;Calles, J.;Ojito, J.;Castillo-Florez, S.;Florez, H. J.;Giannella, A.;Lara, O.;Veciana, B.;Haffner, S. M.;Montez, M. G.;Lorenzo, C.;Martinez, A.;Hamman, R. F.;Testaverde, L.;Bouffard, A.;Dabelea, D.;Jenkins, T.;Lenz, D.;Perreault, L.;Price, D. W.;Steinke, S. C.;Horton, E. S.;Poirier, C. S.;Swift, K.;Caballero, E.;Jackson, S. D.;Lambert, L.;Lawton, K. E.;Ledbury, S.;Kahn, S. E.;Montgomery, B. K.;Fujimoto, W.;Knopp, R. H.;Lipkin, E. W.;Marr, M.;Murillo, A.;Trence, D.;Kitabchi, A. E.;Murphy, M. E.;Applegate, W. B.;Bryer-Ash, M.;Dagogo-Jack, S.;Frieson, S. L.;Lambeth, H.;Lichtermann, L. C.;Otkaei, H.;Rutledge, L. M. K.;Sherman, A. R.;Smith, C. M.;Soberman, J. E.;Williams-Cleaves, B.;Metzger, B. E.;Molitch, M. E.;Johnson, M. K.;Giles, M. M.;Larsen, D.;Niznik, C.;Pen, S. C.;Schinleber, P. A.;Nathan, D. M.;McKitrick, C.;Turgeon, H.;Abbott, K.;Altshuler, D.;Anderson, E.;Bissett, L.;Cagliero, E.;D'Anna, K.;Delahanty, L.;Florez, J. C.;Goldman, V.;Poulos, A.;Tseng, B.;Barrett-Connor, E.;Carrion-Petersen, M. L.;Horne, J.;Leos, D.;Mudaliar, S.;Smith, J.;Vejvoda, K.;Pi-Sunyer, F. X.;Lee, J. E.;Foo, S. T.;Hagamen, S.;Marrero, D. G.;Kelly, S. M.;Ackermann, R. T.;Fineberg, E. S.;Hadden, A.;Jackson, M. A.;Kirkman, M. S.;Mather, K. J.;Roach, P. J.;Wheeler, M. L.;Ratner, R. E.;Aroda, V.;Shapiro, S.;Bavido-Arrage, C.;Gibbs, P.;Uwaifo, Gl;Wiggins, R.;Saad, M. F.;Watson, K.;Botrous, M.;Jinagouda, S.;Budget, M.;Conzues, C.;Magpuri, P.;Ngo, K.;Xapthalamous, K.;White, N. H.;Das, S.;Santiago, A.;Brown, A. L.;Wernimont, C.;Saudek, C. D.;Whittington, T.;Clark, J. M.;Greene, A.;Jiggetts, D.;Mosley, H.;Reusing, J.;Rubin, R. R.;Stephen, S.;Utsey, E.;Schade, D. S.;Adams, K. S.;Hemphill, C.;Hyde, P.;Butler, L.;Canady, J. L.;Colleran, K.;Gonzales, Y.;Hernandez-McGinnis, D. A.;Katz, P.;King, C.;Crandall, J.;Brown-Friday, J. O.;Adorno, E.;Duffy, H.;Martinez, H.;Pompi, D.;Shamoon, H.;Walker, E. A.;Wylie-Rosett, J.;Orchard, T.;Jeffries, S.;Kramer, M. K.;Smith, M.;Kriska, A.;Pettigrew, J.;Semler, L.;Venditti, E.;Weinzierl, V.;Arakaki, R. F.;Baker-Ladao, N. K.;Isonaga, M. K.;Bermudez, N. E.;Mau, M. K.;Knowler, W. C.;Cooeyate, N.;Hoskin, M. A.;Natewa, C.;Percy, C. A.;Acton, K. J.;Andre, V. L.;Begay, S.;Bucca, B. C.;Cook, S.;Doughty, M. S.;Glass, J.;Glass, M.;Hanson, R. L.;Hassenpflug, D.;Ingraham, L. E.;Kobus, K. M.;Krakoff, J.;Manus, C.;McCabe, C.;Michaels, S.;Morgan, T.;Nelson, J. A.;Roy, R. J.;Smart, M.;Tonemah, D. P.;Wilson, C.;Fowler, S.;Brenneman, T.;Abebe, S.;Bamdad, J.;Callaghan, J.;Christophi, C. A.;Edelstein, S. L.;Gao, Y.;Gooding, R.;Gottlieb, A.;Grover, N.;Hoffman, H.;Jablonski, K.;Katz, R.;Kolinjivadi, P.;Lachin, J. M.;Ma, Y.;Reamer, S.;Sapozhnikova, A.;Sherif, H.;Temprosa, M.;Venditti, E. M.;Kriska, A. M.;Semler, L.;Weinzierl, V.;Marcovina, S.;Strylewicz, G.;Albers, J.;Prineas, R. J.;Alexander, T.;Campbell, C.;Hall, S.;Hensley, S.;Li, Y.;Mills, M.;Soliman, E.;Zhang, Z.;Fradkin, J.;Garfield, S.;Mayer-Davis, E.;Moran, R. R.;Ganiats, T.;Sarkin, A. J.
通讯作者：
Sarkin, A. J.
影响因子：
6.9
作者：
Daubenmier, Jennifer;Moran, Patricia J.;Hecht, Frederick M.
通讯作者：
Hecht, Frederick M.
影响因子：
5
作者：
Block, Jason P.;He, Yulei;Ayanian, John Z.
通讯作者：
Ayanian, John Z.