Table 1.

Overview of study designs.

Study, funding source, and PI	Study design	Theoretical framework(s)	Specific aims/objectives	Population, participants, and health issue	Interventions	Health outcomes
PI: L. Sadler Minding the Baby: A Home Visiting Program for Young Families 38 , 39	Experimental—Phase II pilot study with cluster randomization by prenatal care groups from local community health centers (CHC)	Attachment & reflective functioning theories; social ecology theory	1. Test effects of MTB home visiting versus control condition with respect to maternal health & life course outcomes (delaying rapid subsequent childbearing); maternal reflective functioning; child health & attachment outcomes; rates of child abuse/neglect	Eligibility criteria: women attending group‐based prenatal care at CHC; having first child; English speaking; no drug use (CHC screens all prenatal pts.) or major psychosis or terminal illness; ages 14–26	MTB home visiting program based on: (a) evidence‐based home visiting models 40 & (b) emerging neuroscience of early parenting 41 with innovative additions including home‐based mental health treatment & focus on reflective parenting 38 , 42	Preliminary pilot study outcomes in MTB families compared with control families:
Funded by NINR, NICHD, & following foundations: Harris, AE Casey, Donaghue, Pritzker, Seedlings, Schneider, Edlow, & FAR Fund.	Intervention group—usual prenatal, pediatric, and primary healthcare at CHCs & weekly home visits 3rd trimester of pregnancy through 1st birthday‐weekly visits with NP & SW; biweekly visits during 2nd year. Control group—usual healthcare at CHCs & monthly educational materials, & holiday cards	Framework for community engagement—CBPR & Ethical Principles and Guidelines for Community‐University Research Partnerships	2. Monitor fidelity of intervention	Control group = 43 mother‐child dyads	Joint training & supervision of NPs & SWs. Manualized treatment flexible & individualized including supplemental curricula. Program maximizes interdisciplinary team & expertise of NPs & SWs	‐fewer child abuse referrals;
				Intervention group = 64 dyads		‐better compliance with pediatric immunizations & visits;
				60% of sample = adolescent mothers		‐less rapid subsequent childbearing;
						‐children with more secure attachment & less disorganized attachment
						Additional data analysis in process
PI: K. Newlin	Longitudinal, qualitative focus group interviewing with inquiry group method 43	National Black Nurses’ Association Community Collaboration Model 44	Explore faith community values, disease threat, benefits & barriers to self‐care health behavior, & community‐based actions about diabetes among Black American faith community stakeholders	Population: Faith communities with or at‐risk for T2D including diverse Black American ethnicities (Nicaraguan, Haitian, & African American) Eligibility criteria: Church member, leader, or nurse; English‐speaking; aged ≥21 years; with or at‐risk T2D. Sample size: N= 96 in 5 churches	Based on findings, community diabetes programs were developed & implemented in coordination with church nurses &/or young professionals	Analysis ongoing
1. Study Title: Faith Communities & Black Women with Type 2 Diabetes					Unit of analyses: (1) church; (2) individual
Funding period: 2006–2009. Funding: NIH F32
2. Study Title: Church‐Based Diabetes Education in Nicaragua	4‐Stage Study	CBPR model augmented by work of Springer 45 , 46	Stage 4:	Population: Creole & Miskito Indian adults with or at‐risk T2D	Stage 1: Public service announcements, church‐based screening, & standard diabetes education provided as service to communities	Stage 1 & 2
Funding period:	Stage 1: Community dialogues		(1) Test the efficacy of church‐based diabetes prevention & self‐management care & education in adults with or at‐risk for T2D	Stage 1 Eligibility criteria: Community members, leaders, & health professionals	Stage 2 &3: Same as stage 1	Barriers to care: Limited access to healthy foods, medications, & blood glucose testing supplies.
						Health beliefs about use of medications
2008–2011	Stage 2: Qualitative—focus groups		(2) Examine feasibility of implementation of intensive lifestyle intervention in faith‐based setting	Sample N= 106 community members from 3 Nicaraguan coastal towns	Stage 4:	Facilitators of care: Free access to primary care, committed physicians, nurses, & church leaders. Positive spiritual beliefs supporting daily self‐care.
Funding: Private donations; NIH T32; NYU College of Nursing‐Sponsored Research Award; NYU Global Health Challenge Grant	Stage 3: Quantitative—cross‐sectional, survey			Stage 2 Eligibility criteria: English‐speaking, aged ≥21 years, local nurse or physician, church leader, or lay community member self‐identified with or at‐risk T2D	(1) Intervention translates evidence‐based standards of diabetes self‐management education & components of Diabetes Prevention Program for low‐income Nicaraguan communities	Community goals:
	Stage 4: One‐group pretest‐posttest design			Sample N= 39 (participants); N= 4 (churches)	(2) Training church‐based nurses in intervention, data collection, & management & ethical conduct of research	Church‐based diabetes prevention & education led by nurses & community health workers under direction of physicians 47 , 48
				Stage 3 Eligibility criteria: English‐speaking, aged ≥21 years, self‐identified with or at‐risk T2D	(3) (a) Manualized intervention delivered by church‐based nurses tailored to individual & contextual factors and (b) Church‐based intervention delivered in one‐to‐one and group formats with weekly coaching visits and case management	Stage 3:
				Sample: N= 112 (participants); N= 4 (churches)		62.5% subjects with T2D: Poor glycemic control, obesity, hypertension 37.5% subjects at‐risk for T2D: Obesity & elevated body mass index (BMI) 47
				Stage 4 Eligibility criteria: English‐speaking, aged ≥21 years, self‐identified with or at‐risk T2D		Stage 4:
				Sample size (projected power analysis): N= 40 (participants); N= 1 (church)		Physiological outcomes: A1c, lipid, & blood pressure (BP) levels; psychosocial outcomes: depression & quality of life; process outcomes;
						Analysis in process
3. Study Title: Translating the Diabetes Prevention Program and Diabetes Self‐Management Education into aBlack American Faith‐Based Setting	One‐group pretest‐posttest design	RE‐AIM 49	(1) Examine the effect of a diabetes lifestyle intervention on physiological (blood glucose, HbA1c, & lipid levels in addition to BMI & BP), diabetes knowledge, & psychosocial (quality of life, depression, & diabetes risk perception) outcomes in Black women at‐risk or with T2D; (2) Examine feasibility of implementation of intensive lifestyle intervention in faith‐based setting on participation, attrition, satisfaction, & intervention fidelity	Population: Black American women with or at‐risk for T2D (church nurses requested study be limited to female adults with or at‐risk for T2D)	Intervention same as described in stage 4 above but tailored to specific individuals & community contexts	(1) Physiological outcomes: A1c, lipid, & BP levels; (2) Psychosocial outcomes: depression & quality of life; and (3) Process outcomes
Funding period: 2010–2012				Eligibility criteria: church member; female; English‐speaking; aged ≥21 years; self‐identified as with or at‐risk T2D (e.g., family history, ethnicity, obesity, advancing age)		Analysis in process
Funding: NIH KL2				Sample size projected, based on power analysis: N= 40 (participants); N= 1 (church)
PI: T. Garvey	Mixed methods	Community empowerment	Goal: Create a registry of 400 African American families affected with T2D,	African American families born or raised on the Sea Islands with T2D.	First 12 months—conducted community assessment, hired & trained staff/ volunteers, obtained formalized agreements with Federal Qualified CHC	Results from linkage analysis—novel T2D locus in an African‐American population on 14q that appears to reduce age of disease onset; confirmed two loci on chromosome. 7 53
Coinvestigator: I. Spruill	Nonexperiential design	Community‐based—Participatory Model	Aims	Enrolled 672 African American families	Identified formal & informal leaders & organized CAC, which has met quarterly since inception	Created registry & DNA bank of 652 African American families affected with T2DM
Project SuGar Sea Islands of South Carolina 50	Genetic linkage analysis	CBPR	1) Ascertain sib‐pairs and pedigrees with T2DM, obesity,	Sea Island families received suboptimal diabetes care 51 , 52	Project Sugar mobile health unit provided free diabetes screenings & education to over 7,000 residents of the Low Country	Implications for personalized medicine, and cultural specific educational interventions. Documented that Gullah families participating in study received suboptimal diabetes care 51 . Genome‐wide Association study (GWAS) not yet completed.
Funded by NIH/NIDDK, ADA,W.M. Keck Foundation	GWAS	“Coordinated research”	2) Study genes contributing to diabetes and obesity		Quarterly Newsletter to research participants
		Recruitment model used principles from CBPR with input from CAC and was called, CPR, community, plan, rewards (community involvement, flexible protocol plan, and rewards to the community)	3) Community engagement strategies, provide tangible benefits, organize a Citizen Advisory Committee
PI: C. Jenkins	Longitudinal case study of 2 counties’ efforts to decrease disparities 54	Expanded Chronic Care Model for interventions 55	Improve diabetes and foot care by 3% annually for African Americans with diabetes across 5 health systems	African Americans with diagnosed diabetes (and significant others) living in 2 counties	Community‐driven educational activities & creation of healthy learning environments where people live, work, worship, play, & seek healthcare 56	County‐wide reduction of diabetes‐related amputations by 44% 57
REACH Charleston and Georgetown Diabetes Coalition: Reducing Diabetes‐Related Amputations		CBPR for methods	Decrease disparities in amputations in African Americans by 3% annually in 2 county areas	(n≥ 45,000 participants)	Evidence‐based health systems changes using CQI teams 57	Improved diabetes care for African Americans receiving care in 5 health systems 54
Funded by CDC				Healthcare providers in 2 county area (n= 39 physicians, >250 RNs, 5 pharmacists, 6 podiatrists)	Coalition interventions focused on collaboration, trust, sound business planning for systems, community & policy changes
				Coalition members including community members and leaders, people with diabetes, and healthcare professionals