The South Asian Healthy Lifestyle Intervention (SAHELI) trial: Protocol for a mixed-methods, hybrid effectiveness implementation trial for reducing cardiovascular risk in South Asians in the United States.
Asia, Western
/ ethnology
Asian
/ education
Blood Pressure
Body Weight
Cardiovascular Diseases
/ ethnology
Cultural Competency
Diet
Emigrants and Immigrants
/ education
Exercise
Glycated Hemoglobin
Health Education
/ organization & administration
Healthy Lifestyle
Heart Disease Risk Factors
Humans
Lipids
/ blood
Research Design
Stress, Psychological
/ psychology
United States
/ epidemiology
Randomized Controlled Trials as Topic
Cardiovascular
Clinical trial
Implementation
Lifestyle intervention
Mixed-methods
Prevention
South Asian
Journal
Contemporary clinical trials
ISSN: 1559-2030
Titre abrégé: Contemp Clin Trials
Pays: United States
ID NLM: 101242342
Informations de publication
Date de publication:
05 2020
05 2020
Historique:
received:
03
12
2019
revised:
17
03
2020
accepted:
22
03
2020
pubmed:
30
3
2020
medline:
5
8
2021
entrez:
30
3
2020
Statut:
ppublish
Résumé
Intensive lifestyle interventions targeting diet and physical activity are recommended for reducing atherosclerotic cardiovascular disease (ASCVD) risk in adults. However, existing interventions often do not reach immigrant populations because of a mismatch between the social, cultural, and environmental context of immigrants and Western bio behavioral models which underpin evidence-based lifestyle interventions. The South Asian Healthy Lifestyle Intervention (SAHELI) study is a type 1 hybrid design randomized controlled trial aimed at reducing ASCVD risk in South Asian Americans, a group at higher ASCVD risk than whites and other Asian Americans. The objective is to evaluate the clinical effectiveness and implementation potential of a community-based, culturally-adapted lifestyle intervention for South Asian adults. Participants (n = 550) will be randomized to printed healthy lifestyle education materials or SAHELI, a group-based lifestyle change program that includes weekly classes for 16 weeks and 4 booster classes though month 11. SAHELI integrates evidence-based behavior change strategies with culturally-adapted strategies and group motivational interviewing to improve diet, physical activity, and stress management. Follow-up assessments will occur at 6 and 12 months. We hypothesize that the SAHELI intervention group will have greater improvements in clinical ASCVD risk factors (weight, blood pressure, glycated hemoglobin, and lipids), physical activity, and psychosocial outcomes than the print material group at 6- and 12- months. We will use mixed-methods to examine SAHELI's potential for reach, adoption, implementation, and maintenance from the perspective of multiple stakeholders. This study offers the potential to increase the reach and effectiveness of evidence-based lifestyle interventions for South Asian adults at increased risk for ASCVD.
Identifiants
pubmed: 32220632
pii: S1551-7144(20)30073-2
doi: 10.1016/j.cct.2020.105995
pmc: PMC8011000
mid: NIHMS1586240
pii:
doi:
Substances chimiques
Glycated Hemoglobin A
0
Lipids
0
Banques de données
ClinicalTrials.gov
['NCT03336255']
Types de publication
Clinical Trial Protocol
Journal Article
Research Support, N.I.H., Extramural
Langues
eng
Sous-ensembles de citation
IM
Pagination
105995Subventions
Organisme : NHLBI NIH HHS
ID : R01 HL120725
Pays : United States
Organisme : NHLBI NIH HHS
ID : R01 HL132978
Pays : United States
Organisme : NHLBI NIH HHS
ID : R21 HL113743
Pays : United States
Organisme : NCATS NIH HHS
ID : UL1 TR001422
Pays : United States
Informations de copyright
Copyright © 2020 Elsevier Inc. All rights reserved.
Références
J Appl Biobehav Res. 2017 Jun;22(2):
pubmed: 28694680
Curr Diab Rep. 2007 Oct;7(5):386-90
pubmed: 18173973
Diabetes Care. 2015 May;38(5):814-20
pubmed: 25665815
Public Health. 2018 Aug;161:50-58
pubmed: 29902781
Am J Public Health. 2010 Apr 1;100 Suppl 1:S81-7
pubmed: 20147694
J Gen Intern Med. 2012 Oct;27(10):1308-16
pubmed: 22584728
Obesity (Silver Spring). 2010 Apr;18(4):725-35
pubmed: 19696752
JAMA. 2003 May 21;289(19):2560-72
pubmed: 12748199
Health Educ Res. 2006 Oct;21(5):688-94
pubmed: 16945984
Obes Rev. 2015 Apr;16(4):304-18
pubmed: 25752449
Circulation. 2014 Jun 24;129(25 Suppl 2):S1-45
pubmed: 24222016
JAMA Cardiol. 2016 Aug 1;1(5):601-6
pubmed: 27438754
Prev Chronic Dis. 2012;9:E107
pubmed: 22652125
Med Sci Sports Exerc. 2017 Apr;49(4):848-858
pubmed: 27870795
J Immigr Minor Health. 2011 Apr;13(2):385-94
pubmed: 20131000
Health Psychol. 1985;4(2):115-35
pubmed: 4018002
Am J Prev Med. 2006 Oct;31(4 Suppl):S82-91
pubmed: 16979472
J Am Diet Assoc. 2007 Jul;107(7):1224-32
pubmed: 17682300
PLoS One. 2013 Jul 22;8(7):e68605
pubmed: 23894322
Diabetes Care. 2014 Jun;37(6):1621-8
pubmed: 24705613
Biometrics. 1991 Jun;47(2):511-21
pubmed: 1912258
Health Policy. 2006 Jul;77(2):149-65
pubmed: 16216378
Int J Behav Nutr Phys Act. 2012 Mar 02;9:22
pubmed: 22385818
Prev Med. 2017 Mar;96:79-84
pubmed: 28007496
J Behav Health Serv Res. 2012 Oct;39(4):397-416
pubmed: 23138666
J Am Heart Assoc. 2014 Nov 14;3(6):e000954
pubmed: 25398889
J Consult Clin Psychol. 2013 Apr;81(2):196-205
pubmed: 22289132
Med Care. 2012 Mar;50(3):217-26
pubmed: 22310560
Med Sci Sports Exerc. 1998 May;30(5):777-81
pubmed: 9588623
J Health Commun. 2015;20(2):165-76
pubmed: 25375276
J Clin Exp Res Cardiol. 2014 Jun 23;1(1):
pubmed: 25568891
Diabetes Care. 2010 Jan;33 Suppl 1:S62-9
pubmed: 20042775
Asian J Psychiatr. 2012 Jun;5(2):164-8
pubmed: 22813661
Psychol Assess. 2011 Jun;23(2):300-10
pubmed: 21381836
J Immigr Minor Health. 2012 Oct;14(5):774-85
pubmed: 22180198
J Health Commun. 2015 Apr;20(4):424-30
pubmed: 25647363
BMC Public Health. 2015 Oct 16;15:1064
pubmed: 26475629
Am J Prev Med. 2010 Apr;38(4):439-42
pubmed: 20307813
Ann Intern Med. 2017 May 2;166(9):628-636
pubmed: 28384781
JAMA. 2014 Sep 17;312(11):1085
pubmed: 25226462
Demography. 2002 Aug;39(3):529-40
pubmed: 12205756
Circulation. 2010 Jul 27;122(4):406-41
pubmed: 20625115
Health Educ Res. 2007 Oct;22(5):691-702
pubmed: 17138613
Int J Environ Res Public Health. 2015 Jan 09;12(1):566-94
pubmed: 25584423
J Phys Act Health. 2012 Nov;9(8):1178-86
pubmed: 22207589
Ethn Dis. 1999 Winter;9(1):10-21
pubmed: 10355471
Arch Intern Med. 2008 Nov 24;168(21):2347-54
pubmed: 19029500
Prev Med. 2010 Jan;50 Suppl 1:S97-8
pubmed: 19897065
J Clin Hypertens (Greenwich). 2005 Feb;7(2):102-9
pubmed: 15722655
Am J Health Promot. 2015 Jan-Feb;29(3):e100-8
pubmed: 24717067
Circulation. 2018 Jul 31;138(5):e76
pubmed: 30571532
Health Commun. 2012;27(8):818-28
pubmed: 22364189
Health Promot Int. 2014 Dec;29(4):768-79
pubmed: 23574693