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BMC Public Health
Published in: BMC Public Health 1/2022

Open Access 01-12-2022 | Obesity | Study protocol

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

Authors: Acadia W. Buro, Monica Baskin, Darci Miller, Tayler Ward, Delia Smith West, L. Robert Gore, Clement K. Gwede, Elissa Epel, Tiffany L. Carson

Published in: BMC Public Health | Issue 1/2022

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Abstract

Background

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.

Methods

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.

Discussion

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.

Trial registration

This study was registered on ClinicalTrials.​gov, identifier NCT04335799t, on April 6, 2020.
Literature
1.
DeSantis CE, Miller KD, Goding Sauer A, Jemal A, Siegel RL. Cancer statistics for African Americans, 2019. CA Cancer J Clin. 2019;69(3):211–33.PubMedCrossRef
2.
American Cancer Society. Cancer Facts & Figures for African Americans 2019-2021 Atlanta, GA; 2019.
3.
Lauby-Secretan B, Scoccianti C, Loomis D, Grosse Y, Bianchini F, Straif K. Body fatness and Cancer--viewpoint of the IARC working group. N Engl J Med. 2016;375(8):794–8.PubMedPubMedCentralCrossRef
4.
Flegal KM, Kruszon-Moran D, Carroll MD, Fryar CD, Ogden CL. Trends in obesity among adults in the United States, 2005 to 2014. JAMA. 2016;315(21):2284–91.CrossRef
5.
6.
Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, et al. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002;346(6):393–403.PubMedCrossRef
7.
Hollis JF, Gullion CM, Stevens VJ, Brantley PJ, Appel LJ, Ard JD, et al. Weight loss during the intensive intervention phase of the weight-loss maintenance trial. Am J Prev Med. 2008;35(2):118–26.PubMedPubMedCentralCrossRef
8.
West DS, Elaine Prewitt T, Bursac Z, Felix HC. Weight loss of black, white, and Hispanic men and women in the diabetes prevention program. Obesity (Silver Spring). 2008;16(6):1413–20.CrossRef
9.
Wingo BC, Carson TL, Ard J. Differences in weight loss and health outcomes among African Americans and whites in multicentre trials. Obes Rev. 2014;15(Suppl 4):46–61.PubMedCrossRef
10.
Samuel-Hodge CD, Johnson CM, Braxton DF, Lackey M. Effectiveness of diabetes prevention program translations among African Americans. Obes Rev. 2014;15(Suppl 4):107–24.PubMedCrossRef
11.
Wardle J, Chida Y, Gibson EL, Whitaker KL, Steptoe A. Stress and adiposity: a meta-analysis of longitudinal studies. Obesity (Silver Spring). 2011;19(4):771–8.CrossRef
12.
13.
Geiker NRW, Astrup A, Hjorth MF, Sjödin A, Pijls L, Markus CR. Does stress influence sleep patterns, food intake, weight gain, abdominal obesity and weight loss interventions and vice versa? Obes Rev. 2018;19(1):81–97.PubMedCrossRef
14.
15.
Trief PM, Cibula D, Delahanty LM, Weinstock RS. Depression, stress, and weight loss in individuals with metabolic syndrome in SHINE, a DPP translation study. Obesity (Silver Spring). 2014;22(12):2532–8.CrossRef
16.
American Psychological Association (APA) Working Group on Stress and Health Disparities. Stress and health disparities: Contexts, mechanisms, and interventions among racial/ethnic and low-socioeconomic status populations. 2017.
17.
Woods-Giscombé CL, Lobel M. Race and gender matter: a multidimensional approach to conceptualizing and measuring stress in African American women. Cultur Divers Ethnic Minor Psychol. 2008;14(3):173–82.PubMedPubMedCentralCrossRef
18.
19.
Geronimus AT. The weathering hypothesis and the health of African-American women and infants: evidence and speculations. Ethn Dis. 1992;2(3):207–21.PubMed
20.
Geronimus AT, Bound J, Colen CG. Excess black mortality in the United States and in selected black and white high-poverty areas, 1980-2000. Am J Public Health. 2011;101(4):720–9.PubMedPubMedCentralCrossRef
21.
Geronimus AT, Hicken M, Keene D, Bound J. “weathering” and age patterns of allostatic load scores among blacks and whites in the United States. Am J Public Health. 2006;96(5):826–33.PubMedPubMedCentralCrossRef
22.
Geronimus AT, Hicken MT, Pearson JA, Seashols SJ, Brown KL, Cruz TD. Do US black women experience stress-related accelerated biological aging?: a novel theory and first population-based test of black-White differences in telomere length. Hum Nat. 2010;21(1):19–38.PubMedPubMedCentralCrossRef
23.
Christaki E, Kokkinos A, Costarelli V, Alexopoulos EC, Chrousos GP, Darviri C. Stress management can facilitate weight loss in Greek overweight and obese women: a pilot study. J Hum Nutr Diet. 2013;26(Suppl 1):132–9.PubMedCrossRef
24.
Cox TL, Krukowski R, Love SJ, Eddings K, DiCarlo M, Chang JY, et al. Stress management-augmented behavioral weight loss intervention for African American women: a pilot, randomized controlled trial. Health Educ Behav. 2013;40(1):78–87.PubMedCrossRef
25.
Daubenmier J, Moran PJ, Kristeller J, Acree M, Bacchetti P, Kemeny ME, et al. Effects of a mindfulness-based weight loss intervention in adults with obesity: a randomized clinical trial. Obesity (Silver Spring). 2016;24(4):794–804.CrossRef
26.
Daubenmier J, Chao MT, Hartogensis W, Liu R, Moran PJ, Acree MC, et al. Exploratory analysis of racial/ethnic and educational differences in a randomized controlled trial of a mindfulness-based weight loss intervention. Psychosom Med. 2021;83(6):503–14.PubMedCrossRef
27.
Cohen S. Perceived stress in a probability sample of the United States. The social psychology of health. In: The Claremont Symposium on Applied Social Psychology. Thousand Oaks: Sage Publications, Inc; 1988. p. 31–67.
28.
Slavich GM, Shields GS. Assessing lifetime stress exposure using the stress and adversity inventory for adults (adult STRAIN): an overview and initial validation. Psychosom Med. 2018;80(1):17–27.PubMedCrossRef
29.
Bell ML, Whitehead AL, Julious SA. Guidance for using pilot studies to inform the design of intervention trials with continuous outcomes. Clin Epidemiol. 2018;10:153–7.PubMedPubMedCentralCrossRef
30.
Ard JD, Carson TL, Shikany JM, Li Y, Hardy CM, Robinson JC, et al. Weight loss and improved metabolic outcomes amongst rural African American women in the deep south: six-month outcomes from a community-based randomized trial. J Intern Med. 2017;282(1):102–13.PubMedPubMedCentralCrossRef
31.
Diabetes Prevention Program (DPP) Research Group. The diabetes prevention program (DPP): description of lifestyle intervention. Diabetes Care. 2002;25(12):2165–71.CrossRef
32.
Diabetes Prevention Program Research Group. Long-term effects of lifestyle intervention or metformin on diabetes development and microvascular complications over 15-year follow-up: the diabetes prevention program outcomes study. Lancet Diabetes Endocrinol. 2015;3(11):866–75.PubMedCentralCrossRef
33.
Knowler WC, Fowler SE, Hamman RF, Christophi CA, Hoffman HJ, Brenneman AT, et al. 10-year follow-up of diabetes incidence and weight loss in the diabetes prevention program outcomes study. Lancet. 2009;374(9702):1677–86.PubMedCrossRef
34.
Centers for Disease Control and Prevention. Centers for Disease Control and Prevention Diabetes Prevention Recognition Program Standards and Operating Procedures. 2021.
35.
Arch JJ, Craske MG. Mechanisms of mindfulness: emotion regulation following a focused breathing induction. Behav Res Ther. 2006;44(12):1849–58.PubMedCrossRef
36.
Zeidan F, Johnson SK, Diamond BJ, David Z, Goolkasian P. Mindfulness meditation improves cognition: evidence of brief mental training. Conscious Cogn. 2010;19(2):597–605.PubMedCrossRef
37.
38.
Kreuter MW, Lukwago SN, Bucholtz DC, Clark EM, Sanders-Thompson V. Achieving cultural appropriateness in health promotion programs: targeted and tailored approaches. Health Educ Behav. 2003;30(2):133–46.PubMedCrossRef
39.
Ma X, Yue Z-Q, Gong Z-Q, Zhang H, Duan N-Y, Shi Y-T, et al. The Effect of Diaphragmatic Breathing on Attention, Negative Affect and Stress in Healthy Adults. Front Psychol. 2017;8:874.PubMedPubMedCentralCrossRef
40.
Romas J, Sharma M. Efficient time management and sound financial management. In: Romas J, Sharma M, editors. Practical Stress Management (Seventh Edition): Academic Press; 2017. p. 169–88.CrossRef
41.
Shimazu A, Schaufeli WB. Does distraction facilitate problem-focused coping with job stress? A 1 year longitudinal study. J Behav Med. 2007;30(5):423–34.PubMedCrossRef
42.
43.
West DS, DiLillo V, Bursac Z, Gore SA, Greene PG. Motivational interviewing improves weight loss in women with type 2 diabetes. Diabetes Care. 2007;30(5):1081–7.PubMedCrossRef
44.
Batch BC, Ard JD, Vollmer WM, Funk K, Appel LJ, Stevens VJ, et al. Impact of participant and interventionist race concordance on weight loss outcomes. Obesity (Silver Spring). 2013;21(4):712–7.CrossRef
45.
Resnicow K, Baranowski T, Ahluwalia JS, Braithwaite RL. Cultural sensitivity in public health: defined and demystified. Ethn Dis. 1999;9(1):10–21.PubMed
46.
47.
Ard JD, Cox TL, Zunker C, Wingo BC, Jefferson WK, Brakhage C. A study of a culturally enhanced EatRight dietary intervention in a predominately African American workplace. J Public Health Manag Pract. 2010;16(6):E1–8.PubMedPubMedCentralCrossRef
48.
West DS, Harvey JR, Krukowski RA, Prewitt TE, Priest J, Ashikaga T. Do individual, online motivational interviewing chat sessions enhance weight loss in a group-based, online weight control program? Obesity (Silver Spring). 2016;24(11):2334–40.CrossRef
49.
Harris PA, Taylor R, Minor BL, Elliott V, Fernandez M, O'Neal L, et al. The REDCap consortium: Building an international community of software platform partners. J Biomed Inform. 2019;95:103208.PubMedPubMedCentralCrossRef
50.
Kahan BC, Jairath V, Doré CJ, Morris TP. The risks and rewards of covariate adjustment in randomized trials: an assessment of 12 outcomes from 8 studies. Trials. 2014;15:139.PubMedPubMedCentralCrossRef
51.
VanderWeele TJ. Explanation in causal inference: developments in mediation and interaction. Int J Epidemiol. 2016;45(6):1904–8.PubMedPubMedCentral
52.
Valeri L, Vanderweele TJ. Mediation analysis allowing for exposure-mediator interactions and causal interpretation: theoretical assumptions and implementation with SAS and SPSS macros. Psychol Methods. 2013;18(2):137–50.PubMedPubMedCentralCrossRef
53.
Nguyen QC, Osypuk TL, Schmidt NM, Glymour MM, Tchetgen Tchetgen EJ. Practical guidance for conducting mediation analysis with multiple mediators using inverse odds ratio weighting. Am J Epidemiol. 2015;181(5):349–56.PubMedPubMedCentralCrossRef
54.
55.
Enders CK. Applied missing data analysis. New York: Guilford Press; 2010. p. xv, 377-xv.
56.
Fitzgibbon ML, Tussing-Humphreys LM, Porter JS, Martin IK, Odoms-Young A, Sharp LK. Weight loss and African-American women: a systematic review of the behavioural weight loss intervention literature. Obes Rev. 2012;13(3):193–213.PubMedCrossRef
57.
Spanakis EK, Golden SH. Race/ethnic difference in diabetes and diabetic complications. Curr Diab Rep. 2013;13(6):814–23.PubMedCrossRef
58.
Hall KD, Heymsfield SB, Kemnitz JW, Klein S, Schoeller DA, Speakman JR. Energy balance and its components: implications for body weight regulation. Am J Clin Nutr. 2012;95(4):989–94.PubMedPubMedCentralCrossRef
Metadata
Title
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
Authors
Acadia W. Buro
Monica Baskin
Darci Miller
Tayler Ward
Delia Smith West
L. Robert Gore
Clement K. Gwede
Elissa Epel
Tiffany L. Carson
Publication date
01-12-2022
Publisher
BioMed Central
Keywords
Obesity
Obesity
Published in
BMC Public Health / Issue 1/2022
Electronic ISSN: 1471-2458
DOI
https://doi.org/10.1186/s12889-022-12519-z

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