Table 4.
Change from baseline in body fat measures, nutritional intake, and physical activity following lifestyle intervention
| All Participants (n=71)*** | Initially Accepting Lifestyle (n=53) | Lifestyle Following Education (n=18) | |||||
|---|---|---|---|---|---|---|---|
| 12 Weeks | 24 Weeks | 12 Weeks | 24 Weeks | 12 Weeks | 24 Weeks | ||
| Body fat measurements** | |||||||
| Weight, kg ± SD | |||||||
| Intent to treat | −3.5 ± 3.4* (−4.3, −2.7) | −5.2 ± 4.4* (−6.3, −4.2) | −3.5 ± 3.5 (−4.5, −2.5) | −5.3 ± 4.6 (−6.5, −3.9) | −3.6 ± 2.9 (−5.1, −2.2) | −5.0 ± 3.8 (−6.9, −3.2) | |
| Per protocol | −4.1 ± 3.3* (−5.0, −3.3) | −6.0 ± 4.2* (−7.0, −4.9) | −4.1 ± 3.5 (−5.1, −3.0) | −5.9 ± 4.5 (−7.3, −4.6) | −4.3 ± 2.7 (−5.8, −2.9) | −6.0 ± 3.3 (−7.8, −4.2) | |
| BMI, kg/m2 ± SD | |||||||
| Intent to treat | −1.3 ± 1.3* (−1.6, −1.0) | −1.9 ± 1.7* (−2.4, −1.5) | −1.3 ± 1.4 (−1.7, −0.9) | −2.0 ± 1.8 (−2.5, −1.5) | −1.3 ± 1.3 (−2.0, −0.7) | −1.8 ± 1.6 (−2.6, −1.0) | |
| Per protocol | −1.6 ± 1.3* (−1.9, −1.2) | −2.3 ± 1.7* (−2.7, −1.8) | −1.5 ± 1.3 (−1.9, −1.1) | −2.2 ± 1.8 (−2.8, −1.7) | −1.7 ± 1.2 (−2.4, −1.1) | −2.3 ± 1.4 (−3.1, −1.5) | |
| Waist circumference, cm ± SD | |||||||
| Intent to treat | −6.6 ± 7.7* (−8.4, −4.8) | −9.2 ± 7.9* (−11.1, −7.4) | −6.9 ± 7.9 (−9.0, −4.7) | −9.7 ± 8.4 (−12.0, −7.4) | −5.7 ± 7.0 (−9.2, −2.2) | −7.9 ± 6.2 (−11.0, −4.8) | |
| Per protocol | −7.7 ± 7.7* (−9.6, −5.7) | −10.6 ± 7.6* (−12.5, −8.7) | −7.9 ± 8.0 (−10.3, −5.6) | −10.9 ± 8.1 (−13.3, −8.6) | −6.9 ± 7.2 (−10.8, −2.9) | −9.5 ± 5.6 (−12.6, −6.4) | |
| Hip circumference, cm ± SD | |||||||
| Intent to treat | −6.6 ± 7.8* (−8.4, −4.7) | −9.5 ± 8.4* (−11.5, −7.5) | −6.8 ± 8.2 (−9.1, −4.6) | −10.3 ± 8.9 (−12.8, −7.9) | −5.9 ± 6.6 (−9.1, −2.6) | −7.1 ± 6.4 (−10.3, −3.9) | |
| Per protocol | −7.7 ± 7.9* (−9.7, −5.6) | −10.9 ± 8.1* (−13.0, −8.9) | −7.9 ± 8.3 (−10.3, −5.4) | −11.7 ± 8.6 (−14.2, −9.1) | −7.0 ± 6.7 (−10.7, −3.3) | −8.6 ± 6.1 (−11.9, −5.2) | |
| Nutritional Intake** | |||||||
| Proportion achieving caloric intake goal, n (%) | |||||||
| Intent to treat | 24 (33.8) (22.8, 44.8) | 27 (38.0) (26.7, 49.3) | 18 (34.0) (21.2, 46.7) | 22 (41.5) (28.2, 54.8) | 6 (33.3) (11.6, 55.1) | 5 (27.8) (7.1, 48.5) | |
| Change in daily caloric intake, kcal ± SD | |||||||
| Per protocol | −898±1088* (−1179, −617) | −989±1259* (−1311,−617) | −1016±1160 (−1365, 668) | −1109±1342 (−1508,−711) | −542±762 (−964,−120) | −620±899 (−1118,−122) | |
| Proportion achieving fat intake goal, n (%) | |||||||
| Intent to treat | 10 (14.1) (6.0, 22.2) | 10 (14.1) (6.0, 22.2) | 9 (17.0) (6.9, 27.1) | 8 (15.1) (5.5, 24.7) | 1 (5.6) (0, 16.1) | 2 (11.1) (4, 25.6) | |
| Change in daily fat intake, grams ± SD | |||||||
| Per protocol | −48 ± 70* (−66, −30) | −56 ± 80* (−77, −36) | −54±73 (−76,−33) | −62±86 (−88,−37) | −30±57 (−61, 2) | −38±56 (−69, −7) | |
| Proportion achieving saturated fat intake goal, n (%) | |||||||
| Intent to treat | 35 (49.3) (37.7, 60.9) | 33 (46.5) (34.9, 58.1) | 26 (49.1) (35.6, 62.5) | 24 (45.3) (31.9, 58.7) | 9 (50.0) (26.9, 73.1) | 9 (50.0) (26.9, 73.1) | |
| Change in daily saturated fat intake, grams ± SD | |||||||
| Per protocol | −16 ± 29* (−23, −9) | −17 ± 26* (−24, −10) | −18±32 (−27, −8) | −19±29 (−27,−10) | −11±14 (−19, −4) | −12±16 (−21, −3) | |
| Physical Activity | |||||||
| Proportion achieving 150-minute activity goal, n (%) | |||||||
| Intent to treat | 49 (69.0) (58.3, 79.8) | 55 (77.5) (67.7, 87.2) | 39 (73.6) (61.7, 85.5) | 41 (77.4) (66.1, 88.6) | 10 (55.6) (32.6, 78.5) | 14 (77.8) (58.6, 97.0) | |
P-value vs. baseline <0.0001. Only p-values for the entire cohort are presented.
Mean±standard deviation or n (%), (95% confidence interval) are included.
Changes in outcomes due to intervention were tested by the two-tailed paired t-test.
Intent-to-treat calculation included all participants (n=71) where drop-outs were assigned a change of zero; Per protocol calculation included only participants (n=61) who provided the week 24 assessment.
Differences between individuals initially accepting lifestyle intervention and those accepting intervention following the educational program were tested by the Fisher’s exact test (two-tailed) or the two-sample t-test; no differences were noted.