| Methods |
RCT of parallel group design. |
| Participants |
Post‐menopausal women from minority and low socioeconomic class populations consuming at least 35% of energy from fat. Women recruited from clinics in Georgia, Alabama and Florida. Women had no major chronic disease and were not on lipid‐lowering medication. 2208 women randomised (60% to the intervention), mean age 60 years. |
| Interventions |
Intervention to reduce fat intake to 20% energy or less. A nutritionalist assigned fat gram goals to each participant. Group sessions were held weekly for 6 weeks, fortnightly for 6 weeks, and monthly for 9 months and then quarterly. Sessions included nutritional information and behavioural change strategies. Elements of the program were enhanced or added to meet the needs of a diverse population. The comparison group received "dietary guidelines for Americans" but were not counselled. Intervention lasted for 2 years, with follow‐up at 6, 12 and 18 months. Data abstracted for 6 months follow‐up as thereafter follow‐up was poor. |
| Outcomes |
Total dietary fat and saturated fat (% Kcal), fruit servings per day, vegetable servings per day. |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
See Table 1 |
| Allocation concealment (selection bias) |
Unclear risk |
See Table 1 |
| Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
See Table 1 |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
See Table 1 |
| Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
See Table 1 |
