Comparing enhanced versus standard Diabetes Prevention Program among indigenous adults in an urban setting: a randomized controlled trial
Indigenous people in the United States are at high risk for diabetes. Psychosocial stressors like historical trauma may impede success in diabetes prevention programs. A comparative effectiveness trial compared a culturally tailored diabetes prevention program (standard group) with an enhanced one t...
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| Published in | BMC public health Vol. 20; no. 1; p. 139 |
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| Main Authors | , , , , , , , , |
| Format | Journal Article |
| Language | English |
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England
BioMed Central Ltd
30.01.2020
BioMed Central BMC |
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| Abstract | Indigenous people in the United States are at high risk for diabetes. Psychosocial stressors like historical trauma may impede success in diabetes prevention programs.
A comparative effectiveness trial compared a culturally tailored diabetes prevention program (standard group) with an enhanced one that addressed psychosocial stressors (enhanced group) in 2015 to 2017. Participants were 207 Indigenous adults with a body mass index (BMI) of ≥30 and one additional criterion of metabolic syndrome, and were randomized to the standard or enhanced group. Both groups received a culturally tailored behavioral diabetes prevention program. Strategies to address psychosocial stressors were provided to the enhanced group only. Change in BMI over 12 months was the primary outcome. Secondary outcomes included change in quality of life, and clinical, behavioral, and psychosocial measures at 6 and 12 months.
The two groups did not significantly differ in BMI change at 12 months. The two groups also did not differ in any secondary outcomes at 6 or 12 months, with the exception of unhealthy food consumption; the standard group reported a larger mean decrease (95% CI) in consumption of unhealthy food compared with the enhanced group (- 4.6 [- 6.8, - 2.5] vs. -0.7 [- 2.9, 1.4], p = 0.01). At 6 months, significant improvements in weight and the physical component of the quality of life measure were observed for both groups compared with their baseline level. Compared with baseline, at 12 months, the standard group showed significant improvement in BMI (mean [95% CI], - 0.5 [- 1.0, - 0.1]) and the enhanced group showed significant improvement in the physical component of the quality of life (2.9 [0.7, 5.2]).
Adding strategies to address psychosocial barriers to a culturally tailored diabetes prevention program was not successful for improving weight loss among urban Indigenous adults.
(if applicable): NCT02266576. Registered October 17, 2014 on clinicaltrials.gov. The trial was prospectively registered. |
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| AbstractList | BACKGROUNDIndigenous people in the United States are at high risk for diabetes. Psychosocial stressors like historical trauma may impede success in diabetes prevention programs. METHODSA comparative effectiveness trial compared a culturally tailored diabetes prevention program (standard group) with an enhanced one that addressed psychosocial stressors (enhanced group) in 2015 to 2017. Participants were 207 Indigenous adults with a body mass index (BMI) of ≥30 and one additional criterion of metabolic syndrome, and were randomized to the standard or enhanced group. Both groups received a culturally tailored behavioral diabetes prevention program. Strategies to address psychosocial stressors were provided to the enhanced group only. Change in BMI over 12 months was the primary outcome. Secondary outcomes included change in quality of life, and clinical, behavioral, and psychosocial measures at 6 and 12 months. RESULTSThe two groups did not significantly differ in BMI change at 12 months. The two groups also did not differ in any secondary outcomes at 6 or 12 months, with the exception of unhealthy food consumption; the standard group reported a larger mean decrease (95% CI) in consumption of unhealthy food compared with the enhanced group (- 4.6 [- 6.8, - 2.5] vs. -0.7 [- 2.9, 1.4], p = 0.01). At 6 months, significant improvements in weight and the physical component of the quality of life measure were observed for both groups compared with their baseline level. Compared with baseline, at 12 months, the standard group showed significant improvement in BMI (mean [95% CI], - 0.5 [- 1.0, - 0.1]) and the enhanced group showed significant improvement in the physical component of the quality of life (2.9 [0.7, 5.2]). CONCLUSIONSAdding strategies to address psychosocial barriers to a culturally tailored diabetes prevention program was not successful for improving weight loss among urban Indigenous adults. TRIAL REGISTRATION(if applicable): NCT02266576. Registered October 17, 2014 on clinicaltrials.gov. The trial was prospectively registered. Background Indigenous people in the United States are at high risk for diabetes. Psychosocial stressors like historical trauma may impede success in diabetes prevention programs. Methods A comparative effectiveness trial compared a culturally tailored diabetes prevention program (standard group) with an enhanced one that addressed psychosocial stressors (enhanced group) in 2015 to 2017. Participants were 207 Indigenous adults with a body mass index (BMI) of [greater than or equai to]30 and one additional criterion of metabolic syndrome, and were randomized to the standard or enhanced group. Both groups received a culturally tailored behavioral diabetes prevention program. Strategies to address psychosocial stressors were provided to the enhanced group only. Change in BMI over 12 months was the primary outcome. Secondary outcomes included change in quality of life, and clinical, behavioral, and psychosocial measures at 6 and 12 months. Results The two groups did not significantly differ in BMI change at 12 months. The two groups also did not differ in any secondary outcomes at 6 or 12 months, with the exception of unhealthy food consumption; the standard group reported a larger mean decrease (95% CI) in consumption of unhealthy food compared with the enhanced group (- 4.6 [- 6.8, - 2.5] vs. -0.7 [- 2.9, 1.4], p = 0.01). At 6 months, significant improvements in weight and the physical component of the quality of life measure were observed for both groups compared with their baseline level. Compared with baseline, at 12 months, the standard group showed significant improvement in BMI (mean [95% CI], - 0.5 [- 1.0, - 0.1]) and the enhanced group showed significant improvement in the physical component of the quality of life (2.9 [0.7, 5.2]). Conclusions Adding strategies to address psychosocial barriers to a culturally tailored diabetes prevention program was not successful for improving weight loss among urban Indigenous adults. Trial Registration (if applicable): NCT02266576. Registered October 17, 2014 on clinicaltrials.gov. The trial was prospectively registered. Keywords: American Indian and Alaskan natives, Diabetes Prevention Program, Historical trauma, Randomized controlled trial, Body mass index, Metabolic syndrome, Quality of life Background Indigenous people in the United States are at high risk for diabetes. Psychosocial stressors like historical trauma may impede success in diabetes prevention programs. Methods A comparative effectiveness trial compared a culturally tailored diabetes prevention program (standard group) with an enhanced one that addressed psychosocial stressors (enhanced group) in 2015 to 2017. Participants were 207 Indigenous adults with a body mass index (BMI) of ≥30 and one additional criterion of metabolic syndrome, and were randomized to the standard or enhanced group. Both groups received a culturally tailored behavioral diabetes prevention program. Strategies to address psychosocial stressors were provided to the enhanced group only. Change in BMI over 12 months was the primary outcome. Secondary outcomes included change in quality of life, and clinical, behavioral, and psychosocial measures at 6 and 12 months. Results The two groups did not significantly differ in BMI change at 12 months. The two groups also did not differ in any secondary outcomes at 6 or 12 months, with the exception of unhealthy food consumption; the standard group reported a larger mean decrease (95% CI) in consumption of unhealthy food compared with the enhanced group (− 4.6 [− 6.8, − 2.5] vs. -0.7 [− 2.9, 1.4], p = 0.01). At 6 months, significant improvements in weight and the physical component of the quality of life measure were observed for both groups compared with their baseline level. Compared with baseline, at 12 months, the standard group showed significant improvement in BMI (mean [95% CI], − 0.5 [− 1.0, − 0.1]) and the enhanced group showed significant improvement in the physical component of the quality of life (2.9 [0.7, 5.2]). Conclusions Adding strategies to address psychosocial barriers to a culturally tailored diabetes prevention program was not successful for improving weight loss among urban Indigenous adults. Trial Registration (if applicable): NCT02266576. Registered October 17, 2014 on clinicaltrials.gov. The trial was prospectively registered. Indigenous people in the United States are at high risk for diabetes. Psychosocial stressors like historical trauma may impede success in diabetes prevention programs. A comparative effectiveness trial compared a culturally tailored diabetes prevention program (standard group) with an enhanced one that addressed psychosocial stressors (enhanced group) in 2015 to 2017. Participants were 207 Indigenous adults with a body mass index (BMI) of ≥30 and one additional criterion of metabolic syndrome, and were randomized to the standard or enhanced group. Both groups received a culturally tailored behavioral diabetes prevention program. Strategies to address psychosocial stressors were provided to the enhanced group only. Change in BMI over 12 months was the primary outcome. Secondary outcomes included change in quality of life, and clinical, behavioral, and psychosocial measures at 6 and 12 months. The two groups did not significantly differ in BMI change at 12 months. The two groups also did not differ in any secondary outcomes at 6 or 12 months, with the exception of unhealthy food consumption; the standard group reported a larger mean decrease (95% CI) in consumption of unhealthy food compared with the enhanced group (- 4.6 [- 6.8, - 2.5] vs. -0.7 [- 2.9, 1.4], p = 0.01). At 6 months, significant improvements in weight and the physical component of the quality of life measure were observed for both groups compared with their baseline level. Compared with baseline, at 12 months, the standard group showed significant improvement in BMI (mean [95% CI], - 0.5 [- 1.0, - 0.1]) and the enhanced group showed significant improvement in the physical component of the quality of life (2.9 [0.7, 5.2]). Adding strategies to address psychosocial barriers to a culturally tailored diabetes prevention program was not successful for improving weight loss among urban Indigenous adults. (if applicable): NCT02266576. Registered October 17, 2014 on clinicaltrials.gov. The trial was prospectively registered. Abstract Background Indigenous people in the United States are at high risk for diabetes. Psychosocial stressors like historical trauma may impede success in diabetes prevention programs. Methods A comparative effectiveness trial compared a culturally tailored diabetes prevention program (standard group) with an enhanced one that addressed psychosocial stressors (enhanced group) in 2015 to 2017. Participants were 207 Indigenous adults with a body mass index (BMI) of ≥30 and one additional criterion of metabolic syndrome, and were randomized to the standard or enhanced group. Both groups received a culturally tailored behavioral diabetes prevention program. Strategies to address psychosocial stressors were provided to the enhanced group only. Change in BMI over 12 months was the primary outcome. Secondary outcomes included change in quality of life, and clinical, behavioral, and psychosocial measures at 6 and 12 months. Results The two groups did not significantly differ in BMI change at 12 months. The two groups also did not differ in any secondary outcomes at 6 or 12 months, with the exception of unhealthy food consumption; the standard group reported a larger mean decrease (95% CI) in consumption of unhealthy food compared with the enhanced group (− 4.6 [− 6.8, − 2.5] vs. -0.7 [− 2.9, 1.4], p = 0.01). At 6 months, significant improvements in weight and the physical component of the quality of life measure were observed for both groups compared with their baseline level. Compared with baseline, at 12 months, the standard group showed significant improvement in BMI (mean [95% CI], − 0.5 [− 1.0, − 0.1]) and the enhanced group showed significant improvement in the physical component of the quality of life (2.9 [0.7, 5.2]). Conclusions Adding strategies to address psychosocial barriers to a culturally tailored diabetes prevention program was not successful for improving weight loss among urban Indigenous adults. Trial Registration (if applicable): NCT02266576. Registered October 17, 2014 on clinicaltrials.gov. The trial was prospectively registered. Indigenous people in the United States are at high risk for diabetes. Psychosocial stressors like historical trauma may impede success in diabetes prevention programs. A comparative effectiveness trial compared a culturally tailored diabetes prevention program (standard group) with an enhanced one that addressed psychosocial stressors (enhanced group) in 2015 to 2017. Participants were 207 Indigenous adults with a body mass index (BMI) of [greater than or equai to]30 and one additional criterion of metabolic syndrome, and were randomized to the standard or enhanced group. Both groups received a culturally tailored behavioral diabetes prevention program. Strategies to address psychosocial stressors were provided to the enhanced group only. Change in BMI over 12 months was the primary outcome. Secondary outcomes included change in quality of life, and clinical, behavioral, and psychosocial measures at 6 and 12 months. The two groups did not significantly differ in BMI change at 12 months. The two groups also did not differ in any secondary outcomes at 6 or 12 months, with the exception of unhealthy food consumption; the standard group reported a larger mean decrease (95% CI) in consumption of unhealthy food compared with the enhanced group (- 4.6 [- 6.8, - 2.5] vs. -0.7 [- 2.9, 1.4], p = 0.01). At 6 months, significant improvements in weight and the physical component of the quality of life measure were observed for both groups compared with their baseline level. Compared with baseline, at 12 months, the standard group showed significant improvement in BMI (mean [95% CI], - 0.5 [- 1.0, - 0.1]) and the enhanced group showed significant improvement in the physical component of the quality of life (2.9 [0.7, 5.2]). Adding strategies to address psychosocial barriers to a culturally tailored diabetes prevention program was not successful for improving weight loss among urban Indigenous adults. Abstract Background Indigenous people in the United States are at high risk for diabetes. Psychosocial stressors like historical trauma may impede success in diabetes prevention programs. Methods A comparative effectiveness trial compared a culturally tailored diabetes prevention program (standard group) with an enhanced one that addressed psychosocial stressors (enhanced group) in 2015 to 2017. Participants were 207 Indigenous adults with a body mass index (BMI) of ≥30 and one additional criterion of metabolic syndrome, and were randomized to the standard or enhanced group. Both groups received a culturally tailored behavioral diabetes prevention program. Strategies to address psychosocial stressors were provided to the enhanced group only. Change in BMI over 12 months was the primary outcome. Secondary outcomes included change in quality of life, and clinical, behavioral, and psychosocial measures at 6 and 12 months. Results The two groups did not significantly differ in BMI change at 12 months. The two groups also did not differ in any secondary outcomes at 6 or 12 months, with the exception of unhealthy food consumption; the standard group reported a larger mean decrease (95% CI) in consumption of unhealthy food compared with the enhanced group (− 4.6 [− 6.8, − 2.5] vs. -0.7 [− 2.9, 1.4], p = 0.01). At 6 months, significant improvements in weight and the physical component of the quality of life measure were observed for both groups compared with their baseline level. Compared with baseline, at 12 months, the standard group showed significant improvement in BMI (mean [95% CI], − 0.5 [− 1.0, − 0.1]) and the enhanced group showed significant improvement in the physical component of the quality of life (2.9 [0.7, 5.2]). Conclusions Adding strategies to address psychosocial barriers to a culturally tailored diabetes prevention program was not successful for improving weight loss among urban Indigenous adults. Trial Registration (if applicable): NCT02266576 . Registered October 17, 2014 on clinicaltrials.gov . The trial was prospectively registered. |
| ArticleNumber | 139 |
| Audience | Academic |
| Author | Qin, Fei Fei Kendrick, Adrian Stafford, Randall S Xiao, Lan Hedlin, Haley K Vasquez, Jan J Rosas, Lisa G Lv, Nan Atencio, Dawn |
| Author_xml | – sequence: 1 givenname: Lisa G orcidid: 0000-0003-4053-7972 surname: Rosas fullname: Rosas, Lisa G email: lgrosas@stanford.edu organization: Department of Epidemiology and Population Health, Stanford University, 1701 Page Mill Road, CA, Palo Alto, CA, 94304, USA. lgrosas@stanford.edu – sequence: 2 givenname: Jan J surname: Vasquez fullname: Vasquez, Jan J organization: Office of Community Engagement, Stanford University, Palo Alto, CA, USA – sequence: 3 givenname: Haley K surname: Hedlin fullname: Hedlin, Haley K organization: Department of Medicine, Stanford University, Palo Alto, CA, USA – sequence: 4 givenname: Fei Fei surname: Qin fullname: Qin, Fei Fei organization: Department of Medicine, Stanford University, Palo Alto, CA, USA – sequence: 5 givenname: Nan surname: Lv fullname: Lv, Nan organization: Institute of Health Research and Policy, University of Illinois at Chicago, Chicago, IL, USA – sequence: 6 givenname: Lan surname: Xiao fullname: Xiao, Lan organization: Department of Medicine, Stanford University, Palo Alto, CA, USA – sequence: 7 givenname: Adrian surname: Kendrick fullname: Kendrick, Adrian organization: American Indian Community Action Board, San Jose, CA, USA – sequence: 8 givenname: Dawn surname: Atencio fullname: Atencio, Dawn organization: American Indian Community Action Board, San Jose, CA, USA – sequence: 9 givenname: Randall S surname: Stafford fullname: Stafford, Randall S organization: Department of Medicine, Stanford University, Palo Alto, CA, USA |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/32000738$$D View this record in MEDLINE/PubMed |
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| CitedBy_id | crossref_primary_10_1080_17482631_2021_1990197 crossref_primary_10_1007_s11906_022_01178_5 crossref_primary_10_1080_10410236_2024_2369340 crossref_primary_10_1016_j_ecl_2021_05_003 crossref_primary_10_1371_journal_pone_0302562 |
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| Keywords | Body mass index Diabetes Prevention Program American Indian and Alaskan natives Historical trauma Metabolic syndrome Randomized controlled trial Quality of life |
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| Snippet | Indigenous people in the United States are at high risk for diabetes. Psychosocial stressors like historical trauma may impede success in diabetes prevention... Abstract Background Indigenous people in the United States are at high risk for diabetes. Psychosocial stressors like historical trauma may impede success in... Background Indigenous people in the United States are at high risk for diabetes. Psychosocial stressors like historical trauma may impede success in diabetes... BACKGROUNDIndigenous people in the United States are at high risk for diabetes. Psychosocial stressors like historical trauma may impede success in diabetes... Abstract Background Indigenous people in the United States are at high risk for diabetes. Psychosocial stressors like historical trauma may impede success in... |
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| SubjectTerms | Addictive behaviors Adult Adults Aged American Indian and Alaskan natives Behavior Blood pressure Body mass Body mass index Body size Body weight loss Care and treatment Cholesterol Community Culturally Competent Care Demographic aspects Diabetes Diabetes mellitus Diabetes Mellitus - prevention & control Diabetes Prevention Program Diabetes therapy Disease control Drug abuse Fasting Female Food Food consumption Glucose Health risks Historical trauma Humans Indigenous peoples Intervention Lifestyles Lipoproteins Male Medical screening Metabolic disorders Metabolic syndrome Metabolism Methods Middle Aged Native Americans Native North Americans Obesity Population Groups - psychology Population Groups - statistics & numerical data Prevention Prevention programs Program Evaluation Psychology Quality of life Questionnaires Randomization Randomized controlled trial Risk factors Sex crimes Studies Trauma United States Urban areas Urban environments Urban population Urban Population - statistics & numerical data Weight control Weight loss Womens health |
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| Title | Comparing enhanced versus standard Diabetes Prevention Program among indigenous adults in an urban setting: a randomized controlled trial |
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