Vincent 2007.
Methods |
Parallel randomised controlled clinical trial (RCT) Randomisation ratio: 10:10 Superiority design |
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Participants |
Inclusion criteria:
Exclusion criteria:
Participating population: Mexican Americans diagnosed with type 2 diabetes Diagnostic criteria: none stated |
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Interventions |
Number of study centres: 1 Treatment before study: N/A Intervention: intervention consisted of 8 weekly 2‐hour group sessions, which included didactic content, cooking demonstrations and group support. Didactic content considered essential by the ADA and the National Diabetes Education Program (NDEP 2002) was the foundation of the intervention. Numerous cultural modifications were used, including encouraging participants to bring a support person to sessions, delivering intervention and all materials in Spanish, facilitating the support group by providing a promotora (Mexican American lay educator) and including cultural content such as Mexican American risks and home remedies Control: Control group received usual care and education given at the clinic. This consisted of a 10‐ to 15‐minute encounter with a physician or nurse practitioner 2 to 4 times per year Provider: Group sessions were facilitated by a promotora—a Mexican American lay educator. Does not specify whether anyone else was present at the sessions |
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Outcomes |
Outcomes reported in abstract of publication: Primary outcomes: Secondary outcomes: Assessed at 2 months and at 3 months:
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Study details |
Run‐in period: unclear Study terminated before regular end: no |
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Publication details |
Language of publication: English Funding: grant from University of Arizona Publication status: peer‐reviewed journal |
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Stated aim of study | Quote from publication: "The purpose of this study was to test the feasibility and examine the effects of a culturally tailored intervention for Mexican Americans with type 2 diabetes on outcomes of self‐management" | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote from publication: "were randomly assigned to control or intervention group using a list of random numbers from the Microsoft Excel random‐number generator function" |
Allocation concealment (selection bias) | Unclear risk | Comment: not mentioned |
Blinding of participants and personnel (performance bias) Objective outcomes | High risk | Comment: Because of the nature of the intervention, participants and personnel were not blinded |
Blinding of participants and personnel (performance bias) Subjective outcomes | High risk | Comment: Because of the nature of the intervention, participants and personnel were not blinded |
Blinding of outcome assessment (detection bias) Lab tests: Lipids, HBA1C | Low risk | Comment: not mentioned, but objectives outcomes unlikely to have been affected by any lack of blinding |
Blinding of outcome assessment (detection bias) Subjective outcomes | High risk | Comment: not mentioned whether or not researchers who collected information were blinded. Also, some questionnaire data were collected by researchers reading aloud the questionnaire to participants, although apparently they had been trained to read questionnaires "without leading the participants to a specific answer and to communicate in a nonjudgmental manner regarding diabetes knowledge or health beliefs." However, participants not blinded |
Incomplete outcome data (attrition bias) Objective outcomes | Unclear risk | Comment: small sample, per‐protocol analysis used. 3/20 (15%) participants dropped out. Different reasons for attrition between groups |
Incomplete outcome data (attrition bias) Subjective outcomes | Unclear risk | Comment: small sample, per‐protocol analysis used. 3/20 (15%) participants dropped out |
Selective reporting (reporting bias) | Unclear risk | Comment: protocol not seen |
Other bias | Unclear risk | Comment: none |
A1C: glycosylated haemoglobin A1c; AADE: American Academy of Diabetes Educators; ACEi, angiotensin‐converting enzyme inhibitor; ADA: American Diabetes Association; ARB: angiotensin receptor blocker; BMI: body mass index; BP: blood pressure; CAPS: Cross‐Cultural Activity Participation Study; CDA: Church Diabetes Advisor; CDC: Centers for Disease Control and Prevention; CG: control group; CHC: community health centre; CHD: coronary heart disease; CHW: community health worker; CST: coping skills training; CVD: cardiovascular disease; DCP: Diabetes Care Profile; DEC: Diabetes Education Provider; DES‐SF: Diabetes Empowerment Scale, Short Form; DKQ: Diabetes Knowledge Questionnaire; DM: diabetes mellitus; DQOL: Diabetes Quality of Life Measure; DSEQ: Diabetes Self‐Efficacy Outcomes Expectancies Questionnaire; DSMT: diabetes self‐management training; ER: emergency room; ESRD: end‐stage renal disease; ESRF: end‐stage renal failure; FBG: fasting blood glucose; FFQ: Food Frequency Questionnaire; GP: XXX; HbA1c: glycosylated haemoglobin A1c; HDL: high‐density lipoprotein; HE: health education; HGMT: home glucose monitoring with teletransmission; IAP: intervention action plan; IG: intervention group; IMB: Information‐Behavioural Skills model; ITT: intention‐to‐treat; KDSKA: Kim Depression Scale for Korean Americans; LDL‐C: low‐density lipoprotein cholesterol; MOC: Medical Outcomes Study; MHCCQ: Modified Health Care Climate Questionnaire; N/A: not applicable; NCM: nurse care manager; NCMHD: National Center on Minority Health Disparities; NDEP: National Diabetes Education Program; OGTT: oral glucose tolerance test; OHA: oral hypoglycaemic agent; PA: physical activity; PAID: Problem Areas in Diabetes Survey; PBV: perceived behaviour control; PCP: primary care provider; QALY: quality‐adjusted life‐year; QoL: quality of life; RCT: randomised controlled trial; SD: standard deviation; SDSCA: Summary of Diabetes Self‐Care Activities; SDSMP: Spanish Diabetes Self‐Management Program; SMBG: self monitoring of blood glucose; T2DM: type 2 diabetes mellitus; TPB: theory of planned behaviour; wk: weeks.