A randomized trial to decrease risk for diabetes among Cambodian Americans with depression: Intervention development, baseline characteristics and process outcomes

Julie Wagner, Angela Bermudez-Millan, Thomas Buckley, Orfeu M Buxton, Richard Feinn, Sengly Kong, Theanvy Kuoch, Nicole G Nahmod, Mary Scully, Julie Wagner, Angela Bermudez-Millan, Thomas Buckley, Orfeu M Buxton, Richard Feinn, Sengly Kong, Theanvy Kuoch, Nicole G Nahmod, Mary Scully

Abstract

Background: Depression and antidepressant medications are associated with increased risk for type 2 diabetes. It is not known if diabetes can be prevented in the setting of depression. Cambodian Americans have high rates of both depression and diabetes. This paper reports intervention development, experimental design, baseline characteristics, and process outcomes of diabetes prevention interventions for Cambodian Americans with depression, "Diabetes Risk Reduction through Eat, Walk, Sleep and Medication Therapy Management" (DREAM).

Methods: Participants were aged 35-75, Khmer speaking, at high risk for developing diabetes, and met criteria for likely depression by either a) antidepressant medication and/or b) elevated depressive symptoms at two timepoints during a study eligibility period. Treatment arms were: 1) community health educator (CHE) delivered lifestyle intervention called Eat, Walk, Sleep (EWS), 2) EWS plus pharmacist/CHE-delivered medication therapy management (EWS + MTM), and, 3) social services (SS; control).

Results: 188 participants were randomized. Treatment fidelity was high (98% checklist adherence) and on a scale from 0 to 3, participants reported high EWS treatment satisfaction (M = 2.9, SD = 0.2), group cohesion (M = 2.9, SD = 0.3), and therapeutic alliance to CHEs (M = 2.9, SD = 0.2) and to pharmacists (2.9, SD = 0.3). Attendance was challenging but highly successful; in EWS, 99% attended ≥ one session and 86% completed ≥ 24 sessions, M = 27.3 (SD = 3.7) sessions. Of those randomized to EWS + MTM, 98% attended at least one MTM session and 77%) completed ≥ 4 sessions. Retention was high, 95% at 12-month and 96% at 15-month assessments.

Conclusions: The interventions were successfully implemented. Lessons learned and suggestions for future trials are offered. ClinicalTrials.gov identifier: NCT02502929.

Keywords: Cambodian; Community based participatory research; Community health worker; Depression; Diabetes prevention; Implementation.

Conflict of interest statement

Declaration of Competing Interest

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.

Figures

Fig. 1.
Fig. 1.
Intervention sessions.
Fig. 2.
Fig. 2.
CONSORT diagram.

References

    1. Marshall GN, et al., Diabetes and cardiovascular disease risk in Cambodian refugees, J. Immigr. Minor. Health 18 (1) (2016) 110–117.
    1. Berthold SM, et al., Comorbid mental and physical health and health access in Cambodian refugees in the US, J. Community Health 39 (6) (2014) 1045–1052.
    1. Knol MJ, et al., Depression as a risk factor for the onset of type 2 diabetes mellitus. A meta-analysis, Diabetologia 49 (5) (2006) 837–845.
    1. Mezuk B, et al., Depression and type 2 diabetes over the lifespan: a meta-analysis, Diabetes Care 31 (12) (2008) 2383–2390.
    1. Hasin DS, et al., Epidemiology of adult DSM-5 major depressive disorder and its specifiers in the United States, JAMA Psychiatry 75 (4) (2018) 336–346.
    1. Marshall GN, et al., Mental health of Cambodian refugees 2 decades after resettlement in the United States, JAMA 294 (5) (2005) 571–579.
    1. Alhazmi A, et al., Macronutrient intakes and development of type 2 diabetes: a systematic review and meta-analysis of cohort studies, J. Am. Coll. Nutr 31 (4) (2012) 243–258.
    1. Rashidkhani B, et al., Dietary patterns and anthropometric indices among Iranian women with major depressive disorder, Psychiatry Res. 210 (1) (2013) 115–120.
    1. Davison KM, Kaplan BJ, Vitamin and mineral intakes in adults with mood disorders: comparisons to nutrition standards and associations with sociodemographic and clinical variables, J. Am. Coll. Nutr 30 (6) (2011) 547–558.
    1. Wilmot EG, et al., Sedentary time in adults and the association with diabetes, cardiovascular disease and death: systematic review and meta-analysis, Diabetologia 55 (11) (2012) 2895–2905.
    1. Yates T, et al., Impact of depression and anxiety on change to physical activity following a pragmatic diabetes prevention program within primary care: pooled analysis from two randomized controlled trials, Diabetes Care 42 (10) (2019) 1847–1853.
    1. Cappuccio FP, et al., Quantity and quality of sleep and incidence of type 2 diabetes: a systematic review and meta-analysis, Diabetes Care 33 (2) (2010) 414–420.
    1. Rotella F, Mannucci E, Depression as a risk factor for diabetes: a meta-analysis of longitudinal studies, J. Clin. Psychiatry 74 (1) (2013) 31–37.
    1. Knowler WC, et al., Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin, N. Engl. J. Med 346 (6) (2002) 393–403.
    1. Pan XR, et al., Effects of diet and exercise in preventing NIDDM in people with impaired glucose tolerance. The Da Qing IGT and diabetes study, Diabetes Care 20 (4) (1997) 537–544.
    1. Li G, et al., The long-term effect of lifestyle interventions to prevent diabetes in the China Da Qing diabetes prevention study: a 20-year follow-up study, Lancet 371 (9626) (2008) 1783–1789.
    1. Sakane N, et al., Prevention of type 2 diabetes in a primary healthcare setting: three-year results of lifestyle intervention in Japanese subjects with impaired glucose tolerance, BMC Public Health 11 (1) (2011) 40.
    1. Ramachandran A, et al., The Indian diabetes prevention programme shows that lifestyle modification and metformin prevent type 2 diabetes in Asian Indian subjects with impaired glucose tolerance (IDPP-1), Diabetologia 49 (2) (2006) 289–297.
    1. Islam NS, et al., A randomized-controlled, pilot intervention on diabetes prevention and healthy lifestyles in the new York City Korean community, J. Community Health 38 (6) (2013) 1030–1041.
    1. Yeh MC, et al., Translation of the diabetes prevention program for diabetes risk reduction in Chinese immigrants in new York City, Diabet. Med 33 (4) (2016) 547–551.
    1. Wong EC, et al., Characterizing the mental health care of U.S. Cambodian refugees, Psychiatr. Serv 66 (9) (2015) 980–984.
    1. Peterman JN, et al., Relationship between past food deprivation and current dietary practices and weight status among Cambodian refugee women in Lowell, MA, Am. J. Public Health 100 (10) (2010) 1930–1937.
    1. Berthold SM, et al., Social disconnection as a risk factor for health among Cambodian refugees and their offspring in the United States, J. Immigr. Minor. Health 21 (2) (2019) 290–298.
    1. Asian Pacific American Affairs Commission, Needs Assessment of Southeast Asian Population in Connecticut, 2014.
    1. Janney CA, et al., Does mental health influence weight loss in adults with prediabetes? Findings from the VA diabetes prevention program, Gen. Hosp. Psychiatry 53 (2018) 32–37.
    1. Quiñones MM, et al., Case study of an adaptation and implementation of a diabetes prevention program for individuals with serious mental illness, Transl. Behav. Med 8 (2) (2018) 195–203.
    1. Schneider KL, Sullivan JC, Pagoto SL, Translation of the diabetes prevention program into a community mental health organization for individuals with severe mental illness: a case study, Transl. Behav. Med 1 (3) (2011) 453–460.
    1. Whitegoat W, et al., Mental health in diabetes prevention and intervention programs in American Indian/Alaska Native communities, Wash Univ. J. Am. Indian Alsk. Native Health (2015) 1(1).
    1. Ackermann RT, O’Brien MJ, Evidence and challenges for translation and population impact of the diabetes prevention program, Curr. Diab. Rep 20 (3) (2020) 9.
    1. Ruggiero L, et al., Translation of the diabetes prevention program’s lifestyle intervention: role of community health workers, Curr. Diab. Rep 12 (2) (2012) 127–137.
    1. Corkery E, et al., Effect of a bicultural community health worker on completion of diabetes education in a Hispanic population, Diabetes Care 20 (3) (1997) 254–257.
    1. Viswanathan M, et al., Outcomes of community health worker interventions, Evid. Rep. Technol. Assess (Full Rep.) 181 (2009), 1–144, A1–2, B1–14, passim.
    1. Pérez-Escamilla R, et al., Impact of a community health workers-led structured program on blood glucose control among latinos with type 2 diabetes: the DIALBEST trial, Diabetes Care 38 (2) (2015) 197–205.
    1. Kuoch T, et al., The National Cambodian American Town Hall Meeting: a community dialogue on “Eat, Walk, Sleep” for health, Prog. Community Health Partnersh 8 (4) (2014) 541–547.
    1. Wagner J, et al., Patient reported outcomes of ‘Eat, Walk, Sleep’: a cardiometabolic lifestyle program for Cambodian Americans delivered by community health workers, J. Health Care Poor Underserved 26 (2) (2015) 441–452.
    1. Horowitz CR, et al., Effective recruitment of minority populations through community-led strategies, Am. J. Prev. Med 37 (6 Suppl 1) (2009) S195–S200.
    1. American Diabetes Association, Are You at Risk for Diabetes?. .
    1. International Diabetes Federation Epidemiology Task Force Consensus Group, The IDF Consensus Worldwide Definition of the Metabolic Syndrome. , 2005.
    1. van Abeelen AF, et al., Famine exposure in the young and the risk of type 2 diabetes in adulthood, Diabetes 61 (9) (2012) 2255–2260.
    1. Mollica RF, et al., Indochinese versions of the Hopkins symptom Checklist-25: a screening instrument for the psychiatric care of refugees, Am. J. Psychiatry 144 (4) (1987) 497–500.
    1. Harris PA, et al., Research electronic data capture (REDCap)–a metadata-driven methodology and workflow process for providing translational research informatics support, J. Biomed. Inform 42 (2) (2009) 377–381.
    1. Stout RL, et al., Ensuring balanced distribution of prognostic factors in treatment outcome research, J. Stud. Alcohol Suppl 12 (1994) 70–75.
    1. Wagner J, Berthold SM, Buckley T, Bermudez-Millan A, Ha T, Scully M, Kuoch T, Kong S, Fraser-King L, Horn IS, Keuky L, Remote peer learning between US and Cambodian lay health workers to improve outcomes for Cambodians with type 2 diabetes: a pilot study, Int. J. Behav. Med 27 (5) (2020) 609–614, 10.1007/s12529-020-09896-3.
    1. Wagner J, et al., Training Cambodian village health support guides in diabetes prevention: effects on Guides’ knowledge and teaching activities over 6 months, Int. J. Behav. Med 23 (2) (2016) 162–167.
    1. Hirshkowitz M, et al., National Sleep Foundation’s sleep time duration recommendations: methodology and results summary, Sleep Health 1 (1) (2015) 40–43.
    1. Lee PH, Macfarlane DJ, Lam TH, Stewart SM, et al., Int. J. Behav. Nutr. Phys. Act 8 (2011) 115.
    1. Master L, et al., Bidirectional, daily temporal associations between sleep and physical activity in adolescents, Sci. Rep 9 (1) (2019) 7732.
    1. Buysse DJ, Reynolds CF, Monk TH, Berman SR, Kupfer DJ, The Pittsburgh sleep quality index: a new instrument for psychiatric practice and research, J. Psychiatr. Res 28 (2) (1989) 193–213.
    1. National Institute for Health and Clinical Excellence, Preventing Type 2 Diabetes: Risk Identification and Interventions for Individuals at High Risk, National Institute for Health and Clinical Excellence, London, 2012.
    1. Paulweber B, et al., A European evidence-based guideline for the prevention of type 2 diabetes, Horm. Metab. Res 42 (Suppl. 1) (2010) S3–36.
    1. Aschbrenner KA, et al., Feasibility of behavioral weight loss treatment enhanced with peer support and mobile health technology for individuals with serious mental illness, Psychiatr Q. 87 (3) (2016) 401–415.
    1. Srebnik D, et al., A pilot study of the diabetes prevention program on weight loss for adults at community mental health centers, Psychiatr. Serv 66 (2) (2015) 200–203.
    1. Joint Commission of Pharmacy Practitioners, Pharmacists’ Patient Care Process, in: .
    1. Hall-Lipsy E, et al., Community health worker perspectives of an academic community medication therapy management collaboration, J. Am. Pharm. Assoc 60 (3) (2003) 475–480.e1, 2020.
    1. Wheat L, et al., Utilizing a Pharmacist-Community Health Worker Collaboration to Address Medication Adherence Barriers, 2020.
    1. Segal R, et al., Opportunities and responsibilities for pharmacists to improve their effectiveness in addressing medication adherence through culturally sensitive collaborations with community health workers, J. Am. Pharm. Assoc 60 (4) (2003) e25–e30, 2020.
    1. Buckley T, Kuoch T, Scully M, Using technology and cross-cultural teams to deliver trauma-informed medication management, Eur. J. Pub. Health (2019) 29.
    1. Harvard Catalyst, Community-Engaged Research (CEnR), Available from: , 10/26/2020.
    1. Tang TS, et al., Training peers to deliver a church-based diabetes prevention program, Diabetes Educ. 38 (4) (2012) 519–525.
    1. Murray NJ, et al., A motivational peer support program for type 2 diabetes prevention delivered by people with type 2 diabetes: the UEA-IFG feasibility study, Diabetes Educ. 38 (3) (2012) 366–376.
    1. Pickering TG, et al., Recommendations for blood pressure measurement in humans and experimental animals: part 1: blood pressure measurement in humans: a statement for professionals from the Subcommittee of Professional and Public Education of the American Heart Association Council on high blood pressure research, Circulation 111 (5) (2005) 697–716.
    1. Matthews DR, et al., Homeostasis model assessment: insulin resistance and beta-cell function from fasting plasma glucose and insulin concentrations in man, Diabetologia 28 (7) (1985) 412–419.
    1. Wagner J, et al., Community health workers assisting Latinos manage stress and diabetes (CALMS-D): rationale, intervention design, implementation, and process outcomes, Transl. Behav. Med 5 (4) (2015) 415–424.
    1. Williams JH, et al., Cultural relevancy of a diabetes prevention nutrition program for African American women, Health Promot. Pract 7 (1) (2006) 56–67.
    1. Hill J, et al., Roles, responsibilities and characteristics of lay community health workers involved in diabetes prevention programmes: a systematic review, PLoS One 12 (12) (2017), e0189069.
    1. Horowitz CR, et al., Effectively translating diabetes prevention: a successful model in a historically underserved community, Transl. Behav. Med 1 (3) (2011) 443–452.
    1. Parikh P, et al., Results of a pilot diabetes prevention intervention in East Harlem, New York City: project HEED, Am. J. Public Health 100 (Suppl. 1) (2010) S232–S239.
    1. Mayer VL, et al., Outcomes of a weight loss intervention to prevent diabetes among low-income residents of East Harlem, New York, Health Educ. Behav 46 (6) (2019) 1073–1082.
    1. Lim S, et al., A culturally adapted diabetes prevention intervention in the New York City Sikh Asian Indian community leads to improvements in health behaviors and outcomes, Health Behav. Res (2019) 2(1).
    1. Gore R, et al., Integrating community health workers into safety-net primary care for diabetes prevention: qualitative analysis of clinicians’ perspectives, J. Gen. Intern. Med 35 (4) (2020) 1199–1210.
    1. Fisher EB, et al., Peer support of complex health behaviors in prevention and disease management with special reference to diabetes: systematic reviews, Clin. Diabetes Endocrinol 3 (2017) 4.

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