Agurs‐Collins 1997.
Methods |
Parallel randomised controlled clinical trial (RCT) Randomisation ratio: 1:1 Superiority design |
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Participants |
Inclusion criteria:
Exclusion criteria: not explicitly stated (but see inclusion criteria) Diagnostic criteria: by medical history |
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Interventions |
Number of study centres: not stated Treatment before study: not stated if previous HE Intervention: weekly nutrition sessions (60 minutes) with exercise training (30 minutes) for 3 months; following 3 months on biweekly problem‐solving (90 minutes) sessions. Also 1 individual counselling session Control: 1 class on glycaemic control at 3 weeks from start; 2 letters with written information on nutrition. Participants were given the results of blood tests Provider: dietician and exercise physiotherapist with experience in working with African Americans |
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Outcomes |
Outcomes reported in abstract of publication: Primary outcomes(s): HbA1c (hypothesis testing) Secondary outcome(s):
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Study details |
Run‐in period: not stated Study terminated before regular end: yes—stopped before target of 40 per treatment arm because of time and funding constraints |
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Publication details |
Language of publication: English Funding: dissertation research grant, partially funded by the National Institute of Aging and the National Institutes of Health Publication status: peer review journal |
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Stated aim of study | Quote from publication: "The objective was to evaluate a weight loss and exercise programme designed to improve diabetes management in older African Americans" | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote from publication: "Randomization was supervised by the study statistician..." Comment: split into groups depending on medication or dietary therapy, and then "assigned randomly with 1:1 ratio within medication strata" |
Allocation concealment (selection bias) | Unclear risk | Comment: no mention |
Blinding of participants and personnel (performance bias) Objective outcomes | High risk | Quote from publication: "One of the authors, a registered dietician experienced in working with older African‐Americans delivered the intervention program..." Comment: participants and staff not blinded because of the nature of the study |
Blinding of participants and personnel (performance bias) Subjective outcomes | High risk | Comment: not blinded |
Blinding of outcome assessment (detection bias) Lab tests: Lipids, HBA1C | Unclear risk | Comment: no mention of whether laboratory staff/outcome assessors for BP were blinded |
Blinding of outcome assessment (detection bias) Subjective outcomes | High risk | Comment: participants completing questionnaires unlikely to have been blinded |
Incomplete outcome data (attrition bias) Objective outcomes | Unclear risk | Comment: unequal loss to follow‐up, no mention of ITT analysis |
Incomplete outcome data (attrition bias) Subjective outcomes | Unclear risk | Comment: as above |
Selective reporting (reporting bias) | Unclear risk | Comment: protocol not available |
Other bias | Unclear risk | Comment: none |