WHT:FSMP 2003.
| Methods | RCT | |
| Participants | Postmenopausal women from diverse ethnic and socioeconomic backgrounds (USA)
CVD risk: low
Control: randomised 883, analysed 649 at 6 mo, 443 at 12 mo, 194 at 18 mo
Intervention: randomised 1325, analysed 1071 at 6 mo, 698 at 12 mo, 285 at 18 mo
Mean years in trial: unclear, follow‐up from 6 to 18 months
% male: 0%
Age: mean control 59.8 (SD 6.6), intervention 60.1 (SD 6.6) Baseline BMI: 28.8 (SD 4.7) for all |
|
| Interventions | Reduced fat vs usual diet Control aims: maintain usual diet Intervention aims: up to 20%E from fat, reduced saturated fat and dietary cholesterol, increased fruit, vegetables and whole grains Control methods: pamphlet on general dietary guidelines provided, no other follow‐up, seen at baseline, then 6, 12 and 18 months for assessment Intervention methods: women allocated to groups of 8 to 15 women with a nutritionist leader, meeting weekly for 6 weeks, bi‐weekly for 9 months then quarterly. Women provided with personal fat gram goals Weight goals: weight and calories not mentioned Total fat intake (at 1 year): intervention 25.4 (SD unclear), control 36.0 (SD unclear) %E Saturated fat intake (at 1 year): intervention 8.7 (SD unclear), control 12.1 (SD unclear) %E Style: diet advice Setting: community |
|
| Outcomes | Stated trial outcomes: dietary intake/feasibility Available outcomes: weight, BMI, blood pressure |
|
| Notes | Weight and BMI data only found for 6 months of intervention | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "randomised" |
| Allocation concealment (selection bias) | Unclear risk | Not discussed |
| Blinding (performance bias and detection bias) All outcomes | High risk | No for participants, though outcome assessors were blinded |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | All those randomised were analysed for weight |
| Selective reporting (reporting bias) | Low risk | For weight |
| Other bias | Low risk | |
| Free of systematic difference in care? | High risk | Greater time and support provided to intervention group |
| Free of dietary differences other than fat? | High risk | Suggestion to intervention group to increase fruit, vegetable and whole grain intakes |