Glasgow 2000.
Methods | Trial design:
2 x 2 randomised factorial design Randomisation procedure: "...Participants were randomly assigned to one of four conditions..." Allocation concealment: Unclear Blinding: Recipients: No Providers of Care: Unclear Outcome Assessors: Unclear Quality Assessment Category: C (one point awarded) ‐ high risk of bias. |
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Participants | Country: USA Setting: Centre for Healthy Living Number: 320 participants randomised across the four arms. 80 in the CG (67 present at 6 month follow‐up) and 80 in the IG (75 present at 6 month follow‐up) Age: CG: 60.6 ± 9.5 years IG: 60.5 ± 8.6 years Sex: CG: 33.7% male, 66.3% female. IG: 52.6% male, 47.4% female. Diagnostic criteria: Welborn criteria for type 2 diabetes Inclusion criteria: 1. Type 2 diabetes 2. Having a telephone 3. Not planning to move out of the area of a year Exclusion criteria: 1. Type 1 diabetes 2. Planning to relocate out of area within one year |
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Interventions | Trial intervention(s): Community Resources Intervention. Comprised of a general pamphlet about low‐fat eating and access to community resources which were a three‐ring binder full of indexed community resources, four newsletters identifying opportunities for participants to obtain support. A food frequency questionnaire was mailed and tailored feedback was sent with advice to decrease dietary fat intake. Comparison intervention(s): A general pamphlet about low fat eating was handed out to the control group participants. |
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Outcomes | Participants in the community resources group decreased their mean weight from 96.2 ± 22.2kg at baseline to a follow‐up value of 95.3 ± 20.9kg at six months.
Participants in the basic care group decreased their mean weight from 90.3 ± 16.3kg at baseline to a follow‐up value of 89.4 ± 16.8kg at six months. In the community resources group concentration of glycated haemoglobin remained stable (7.3 ± 1.5% at baseline to 7.3 ± 1.4% at the six month follow‐up). In the basic care group, the concentration of glycated haemoglobin decreased from 7.6 ± 1.2% at baseline to 7.4 ± 1.2% at the six month follow‐up. 1. HbA1c 2. Weight 3. Dietary patterns 4. Lipids 5. Fat intake 6. Patient satisfaction measures 7. Quality of life were all measured at 6 months. |
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Notes | Source of funding of trial: Supported by grant RO1‐DK 35524‐13 from the National Institutes of Health. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Unclear risk | B ‐ Unclear |