TABLE 2.
Clinical measures at baseline and 12 weeks
| Intervention group | Control group | Effect size | P | |||||
|---|---|---|---|---|---|---|---|---|
| Week 0 | Week 12 | Change | Week 0 | Week 12 | Change | |||
| Dietary intake | ||||||||
| Energy (kcal/d) | 1,564 (1,405-1,724) | 1,332 (1,188 to 1,476) | −232 (−383 to −81)a | 1,597 (1,417 to 1,778) | 1,709 (1,303 to 2,114) | 111 (−241 to 464) | −344 (−723 to 36) | 0.07 |
| Total fat (g/d) | 60.9 (51.7 to 70.1) | 30.8 (26.1 to 35.5) | −30.1 (−39.6 to −20.5)b | 59.7 (50.9 to 68.4) | 61.8 (47.6 to 76.0) | 2.1 (−7.0 to 11.2) | −32.2 (−45.4 to −19.0) | <0.001 |
| Saturated fat (g/d) | 17.3 (13.2 to 21.5) | 5.6 (4.7 to 6.6) | −11.7 (−16.0 to −7.5)b | 14.8 (11.6 to 17.9) | 17.7 (12.6 to 22.7) | 2.9 (−0.8 to 6.7) | −14.6 (−20.4 to −8.9) | <0.001 |
| Carbohydrates (g/d) | 204.4 (179.3 to 229.4) | 223 (194.8 to 251.2) | 18.6 (−4.9 to 42.2) | 222.8 (191.3 to 254.4) | 243.7 (171.2 to 316.3) | 20.9 (−48.7 to 90.5) | −2.3 (−75.1 to 70.6) | 0.95 |
| Protein (g/d) | 60.3 (53.3 to 67.2) | 59.0 (53.3 to 64.8) | −1.2 (−8.2 to 5.8) | 56.0 (48.6 to 63.4) | 57.2 (48.9 to 65.6) | 1.2 (−7.1 to 9.5) | −2.4 (−13.0 to 8.2) | 0.65 |
| Cholesterol (mg/d) | 162.2 (108.7 to 215.7) | 4.6 (1.1 to 8.2) | −157.6 (−210.6 to −104.5)b | 77.2 (38.7 to 115.6) | 101.4 (64.5 to 138.3) | 24.3 (−6.2 to 54.7) | −181.8 (−242.0 to −121.6) | <0.001 |
| Fiber (g/d) | 30.3 (25.5 to 35.2) | 42.1 (37.1 to 47.1) | 11.8 (7.5 to 16.1)b | 33.5 (27.3 to 39.7) | 30.8 (24.9 to 36.7) | −2.7 (−7.1 to 1.7) | 14.5 (8.4 to 20.6) | <0.001 |
| Physical activity (MET-min/wk) | 2,918 (2,037 to 3,798) | 2,842 (2,019 to 3,665) | −76 (−692 to 540) | 2,485 (1,414 to 3,555) | 2,840 (1,411 to 4,270) | 356 (−371 to 1,083) | −432 (−1,357 to 493) | 0.35 |
| Body weight | ||||||||
| Body weight (kg) | 74.8 (69.3 to 80.2) | 71.1 (66.0 to 76.3) | −3.6 (−4.5 to −2.7)b | 73.4 (68.2 to 78.7) | 73.2 (67.9 to 78.5) | −0.24 (−0.9 to 0.4) | −3.4 (−4.5 to −2.3) | <0.001 |
| BMI (kg/m2) | 27.2 (25.0 to 29.3) | 25.8 (23.8 to 27.9) | −1.3 (−1.7 to −1.0)b | 26.6 (24.7 to 28.5) | 26.6 (24.7 to 28.5) | −0.01 (−0.2 to 0.2) | −1.3 (−1.7 to −0.9) | <0.001 |
| Hot flashes app reports | ||||||||
| Hot flashes total | 6.0 (4.9 to 7.2) | 1.4 (0.7 to 2.0) | −4.7 (−6.0 to −3.4)b | 5.7 (4.3 to 7.1) | 3.4 (2.3 to 4.6) | −2.2 (−3.2 to −1.3)b | −2.4 (−4.0 to −0.8) | 0.003 |
| Hot flashes moderate-severe | 5.0 (3.8 to 6.2) | 0.6 (0.3 to 0.8) | −4.4 (−5.6 to −3.2)b | 4.4 (3.2 to 5.7) | 2.9 (1.8 to 4.0) | −1.5 (−2.4 to −0.7)b | −2.9 (−4.3 to −1.4) | <0.001 |
| Daytime hot flashes | 4.5 (3.5 to 5.5) | 1.1 (0.6 to 1.6) | −3.5 (−4.5 to −2.4)b | 3.9 (2.9 to 4.9) | 2.4 (1.5 to 3.2) | −1.6 (−2.2 to −0.9)b | −1.9 (−3.1 to −0.7) | 0.003 |
| Daytime hot flashes moderate-severe | 3.7 (2.7 to 4.6) | 0.4 (0.2 to 0.6) | −3.3 (−4.2 to −2.3)b | 3.1 (2.2 to 3.9) | 1.9 (1.1 to 2.8) | −1.1 (−1.7 to −0.5)b | −2.2 (−3.3 to −1.0) | <0.001 |
| Nighttime hot flashes | 1.5 (1.2 to 1.9) | 0.3 (0.1 to 0.5) | −1.2 (−1.6 to −0.8)b | 1.7 (1.2 to 2.3) | 1.1 (0.7 to 1.4) | −0.7 (−1.1 to −0.3)a | −0.5 (−1.0 to −0.0) | 0.04 |
| MENQOL | ||||||||
| Vasomotor | 5.7 (5.2 to 6.2) | 3.7 (3.0 to 4.5) | −2.0 (−2.7 to −1.2)b | 4.4 (3.8 to 5.1) | 3.7 (3.2 to 4.3) | −0.7 (−1.1 to −0.3)b | −1.2 (−2.1 to −0.4) | 0.004 |
| Psychosocial | 3.3 (2.7 to 4.0) | 2.5 (1.9 to 3.0) | −0.9 (−1.4 to −0.3)a | 2.8 (2.3 to 3.2) | 2.5 (2.0 to 2.9) | −0.3 (−0.6 to −0.0)c | −0.6 (−1.2 to 0.1) | 0.08 |
| Physical | 3.6 (3.1 to 4.0) | 2.6 (2.2 to 3.0) | −0.9 (−1.4 to −0.5)b | 2.9 (2.5 to 3.3) | 2.6 (2.3 to 2.9) | −0.3 (−0.5 to −0.0)c | −0.7 (−1.2 to −0.1) | 0.01 |
| Sexual | 4.1 (3.2 to 5.0) | 2.8 (2.1 to 3.5) | −1.3 (−2.0 to −0.5)a | 2.8 (2.1 to 3.4) | 2.4 (1.8 to 3.1) | −0.4 (−0.7 to −0.0)c | −0.9 (−1.7 to −0.1) | 0.03 |
BMI (kg/m2), body mass index as reported in kilograms of body weight per meter height squared; MENQOL, Menopause-Specific Quality of Life questionnaire; MET, metabolic equivalents.
For within-group P values: aP < 0.01; bP < 0.001; cP < 0.05.