End-of-Study Dietary Intake and Physical Activity Measures for Each Arm by Intention to Treat
| Measurea . | Arm 1 (Low-Normal TSH; n = 46) . | Arm 2 (High-Normal TSH; n = 47) . | Arm 3 (Mildly Elevated TSH; n = 45) . | Arm 2 vs Arm 1b . | Arm 3 vs Arm 1b . | Arm 3 vs Arm 2b . | |||
|---|---|---|---|---|---|---|---|---|---|
| Difference (95% CI) . | P Value . | Difference (95% CI) . | P Value . | Difference (95% CI) . | P Value . | ||||
| Daily energy intake, kcal/kg/d | 26.8 ± 1.3 | 28.6 ± 1.6 | 27.4 ± 1.2 | 1.3 (−2.1 to 4.7) | 0.64 | 1.2 (−2.4 to 4.8) | 0.71 | −0.1 (−3.5 to 3.3) | > 0.99 |
| CHO intake, % | 45.2 ± 1.2 | 46.0 ± 1.2 | 46.9 ± 1.2 | 0.96 (−2.83 to 4.75) | 0.82 | 1.11 (−3.00 to 5.22) | 0.8 | 0.15 (−3.64 to 3.93) | > 0.99 |
| Fat intake, % | 36.1 ± 0.8 | 34.1 ± 1.0 | 34.5 ± 0.9 | −0.46 (−3.21 to 2.29) | 0.92 | −0.14 (−3.07 to 2.78) | > 0.99 | 0.31 (−2.37 to 2.99) | 0.96 |
| Protein intake, % | 16.0 ± 0.5 | 16.4 ± 0.7 | 15.4 ± 0.6 | −0.74 (−2.71 to 1.23) | 0.65 | −0.87 (−2.96 to 1.23) | 0.59 | −0.13 (−2.11 to 1.85) | 0.99 |
| Daily PAEE, kcal/d | |||||||||
| Total | 524 ± 29 | 574 ± 38 | 503 ± 33 | 110 (30 to 191) | 0.004c | 20.2 (−67.0 to 107.5) | 0.85 | −90.0 (−172.2 to −7.9) | 0.03 |
| Per kg of LBM | 11.6 ± 0.7 | 12.6 ± 0.6 | 11.4 ± 0.6 | 2.3 (0.5 to 4.0) | 0.006c | 0.32 (−1.55 to 2.19) | 0.91 | −2.0 (−3.7 to −0.2) | 0.03 |
| Light | 173 ± 7 | 172 ± 8 | 164 ± 9 | 6.4 (−12.5 to 25.2) | 0.70 | 0.32 (−20.17 to 20.8) | > 0.99 | −6.0 (−25.2 to 13.1) | 0.73 |
| Moderate/vigorous | 352 ± 25 | 401 ± 31 | 339 ± 26 | 99.9 (32.0 to 167.7) | 0.002c,d | 20.2 (−53.3 to 93.6) | 0.79 | −79.7 (−149.0 to −10.4) | 0.02 |
| Duration of daily activity, min | |||||||||
| Sedentary | 575 ± 16 | 530 ± 17 | 591 ± 16 | −18.6 (−63.6 to 26.5) | 0.59 | 38.1 (−10.7 to 86.8) | 0.16 | 56.6 (11.4 to 101.8) | 0.01c |
| Light | 200 ± 8 | 207 ± 7 | 196 ± 7 | 12.2 (−9.5 to 33.9) | 0.38 | 3.4 (−20.1 to 27.0) | 0.94 | −8.8 (−30.8 to 13.3) | 0.61 |
| Moderate/vigorous | 114 ± 8 | 135 ± 9 | 109 ± 7 | 32.2 (8.4 to 56.0) | 0.005c | 9.3 (−16.1 to 34.6) | 0.66 | −22.9 (−46.8 to 0.9) | 0.06 |
| Proportion of time spent in daily activity, % | |||||||||
| Sedentary | 64.3 ± 1.5 | 60.5 ± 1.6 | 65.6 ± 1.4 | −3.9 (−7.9 to 0.1) | 0.06 | 1.0 (−3.4 to 5.4) | 0.85 | 4.9 (0.8 to 9.0) | 0.01 |
| Light | 22.8 ± 0.8 | 23.9 ± 0.8 | 22.1 ± 0.8 | 0.14 (−2.13 to 2.40) | 0.99 | −1.0 (−3.5 to 1.4) | 0.57 | −1.2 (−3.5 to 1.1) | 0.44 |
| Moderate/vigorous | 12.9 ± 0.9 | 15.6 ± 1.0 | 12.2 ± 0.8 | 3.5 (1.2 to 5.8) | 0.001c,d | −0.01 (−2.48 to 2.45) | > 0.99 | −3.5 (−5.8 to −1.2) | 0.001c,d |
| Measurea . | Arm 1 (Low-Normal TSH; n = 46) . | Arm 2 (High-Normal TSH; n = 47) . | Arm 3 (Mildly Elevated TSH; n = 45) . | Arm 2 vs Arm 1b . | Arm 3 vs Arm 1b . | Arm 3 vs Arm 2b . | |||
|---|---|---|---|---|---|---|---|---|---|
| Difference (95% CI) . | P Value . | Difference (95% CI) . | P Value . | Difference (95% CI) . | P Value . | ||||
| Daily energy intake, kcal/kg/d | 26.8 ± 1.3 | 28.6 ± 1.6 | 27.4 ± 1.2 | 1.3 (−2.1 to 4.7) | 0.64 | 1.2 (−2.4 to 4.8) | 0.71 | −0.1 (−3.5 to 3.3) | > 0.99 |
| CHO intake, % | 45.2 ± 1.2 | 46.0 ± 1.2 | 46.9 ± 1.2 | 0.96 (−2.83 to 4.75) | 0.82 | 1.11 (−3.00 to 5.22) | 0.8 | 0.15 (−3.64 to 3.93) | > 0.99 |
| Fat intake, % | 36.1 ± 0.8 | 34.1 ± 1.0 | 34.5 ± 0.9 | −0.46 (−3.21 to 2.29) | 0.92 | −0.14 (−3.07 to 2.78) | > 0.99 | 0.31 (−2.37 to 2.99) | 0.96 |
| Protein intake, % | 16.0 ± 0.5 | 16.4 ± 0.7 | 15.4 ± 0.6 | −0.74 (−2.71 to 1.23) | 0.65 | −0.87 (−2.96 to 1.23) | 0.59 | −0.13 (−2.11 to 1.85) | 0.99 |
| Daily PAEE, kcal/d | |||||||||
| Total | 524 ± 29 | 574 ± 38 | 503 ± 33 | 110 (30 to 191) | 0.004c | 20.2 (−67.0 to 107.5) | 0.85 | −90.0 (−172.2 to −7.9) | 0.03 |
| Per kg of LBM | 11.6 ± 0.7 | 12.6 ± 0.6 | 11.4 ± 0.6 | 2.3 (0.5 to 4.0) | 0.006c | 0.32 (−1.55 to 2.19) | 0.91 | −2.0 (−3.7 to −0.2) | 0.03 |
| Light | 173 ± 7 | 172 ± 8 | 164 ± 9 | 6.4 (−12.5 to 25.2) | 0.70 | 0.32 (−20.17 to 20.8) | > 0.99 | −6.0 (−25.2 to 13.1) | 0.73 |
| Moderate/vigorous | 352 ± 25 | 401 ± 31 | 339 ± 26 | 99.9 (32.0 to 167.7) | 0.002c,d | 20.2 (−53.3 to 93.6) | 0.79 | −79.7 (−149.0 to −10.4) | 0.02 |
| Duration of daily activity, min | |||||||||
| Sedentary | 575 ± 16 | 530 ± 17 | 591 ± 16 | −18.6 (−63.6 to 26.5) | 0.59 | 38.1 (−10.7 to 86.8) | 0.16 | 56.6 (11.4 to 101.8) | 0.01c |
| Light | 200 ± 8 | 207 ± 7 | 196 ± 7 | 12.2 (−9.5 to 33.9) | 0.38 | 3.4 (−20.1 to 27.0) | 0.94 | −8.8 (−30.8 to 13.3) | 0.61 |
| Moderate/vigorous | 114 ± 8 | 135 ± 9 | 109 ± 7 | 32.2 (8.4 to 56.0) | 0.005c | 9.3 (−16.1 to 34.6) | 0.66 | −22.9 (−46.8 to 0.9) | 0.06 |
| Proportion of time spent in daily activity, % | |||||||||
| Sedentary | 64.3 ± 1.5 | 60.5 ± 1.6 | 65.6 ± 1.4 | −3.9 (−7.9 to 0.1) | 0.06 | 1.0 (−3.4 to 5.4) | 0.85 | 4.9 (0.8 to 9.0) | 0.01 |
| Light | 22.8 ± 0.8 | 23.9 ± 0.8 | 22.1 ± 0.8 | 0.14 (−2.13 to 2.40) | 0.99 | −1.0 (−3.5 to 1.4) | 0.57 | −1.2 (−3.5 to 1.1) | 0.44 |
| Moderate/vigorous | 12.9 ± 0.9 | 15.6 ± 1.0 | 12.2 ± 0.8 | 3.5 (1.2 to 5.8) | 0.001c,d | −0.01 (−2.48 to 2.45) | > 0.99 | −3.5 (−5.8 to −1.2) | 0.001c,d |
Data presented as unadjusted mean ± SEM.
Abbreviation: CHO, carbohydrate.
Dietary measures were available for all but 1 value in the mildly elevated arm; physical activity measures were available for all subjects but 1 in the low-normal, 1 in the high-normal, and 2 in the mildly elevated arms.
Multiple linear regression models were adjusted for age, estrogen status, baseline TSH (low-normal vs high-normal), SD of TSH values at all but the first visit, baseline LT4 dose, duration of LT4, duration of LT4 dose, and baseline value of outcome; P values were adjusted using Tukey multiple comparison procedure for pairwise comparisons between arms. For each set of related outcome measures (diet, PAEE, and physical activity measures), Bonferroni and FDR multiple testing adjustments were applied to all related individual Tukey-adjusted P values comparing the three arms (data not shown).
P value was still statistically significant at the 0.05 level when applying multiple testing adjustments and grouping outcomes from the same test together for the Bonferroni correction.
P value was still statistically significant at the 0.05 level when applying multiple testing adjustments and grouping outcomes from the same test together for the FDR correction.
End-of-Study Dietary Intake and Physical Activity Measures for Each Arm by Intention to Treat
| Measurea . | Arm 1 (Low-Normal TSH; n = 46) . | Arm 2 (High-Normal TSH; n = 47) . | Arm 3 (Mildly Elevated TSH; n = 45) . | Arm 2 vs Arm 1b . | Arm 3 vs Arm 1b . | Arm 3 vs Arm 2b . | |||
|---|---|---|---|---|---|---|---|---|---|
| Difference (95% CI) . | P Value . | Difference (95% CI) . | P Value . | Difference (95% CI) . | P Value . | ||||
| Daily energy intake, kcal/kg/d | 26.8 ± 1.3 | 28.6 ± 1.6 | 27.4 ± 1.2 | 1.3 (−2.1 to 4.7) | 0.64 | 1.2 (−2.4 to 4.8) | 0.71 | −0.1 (−3.5 to 3.3) | > 0.99 |
| CHO intake, % | 45.2 ± 1.2 | 46.0 ± 1.2 | 46.9 ± 1.2 | 0.96 (−2.83 to 4.75) | 0.82 | 1.11 (−3.00 to 5.22) | 0.8 | 0.15 (−3.64 to 3.93) | > 0.99 |
| Fat intake, % | 36.1 ± 0.8 | 34.1 ± 1.0 | 34.5 ± 0.9 | −0.46 (−3.21 to 2.29) | 0.92 | −0.14 (−3.07 to 2.78) | > 0.99 | 0.31 (−2.37 to 2.99) | 0.96 |
| Protein intake, % | 16.0 ± 0.5 | 16.4 ± 0.7 | 15.4 ± 0.6 | −0.74 (−2.71 to 1.23) | 0.65 | −0.87 (−2.96 to 1.23) | 0.59 | −0.13 (−2.11 to 1.85) | 0.99 |
| Daily PAEE, kcal/d | |||||||||
| Total | 524 ± 29 | 574 ± 38 | 503 ± 33 | 110 (30 to 191) | 0.004c | 20.2 (−67.0 to 107.5) | 0.85 | −90.0 (−172.2 to −7.9) | 0.03 |
| Per kg of LBM | 11.6 ± 0.7 | 12.6 ± 0.6 | 11.4 ± 0.6 | 2.3 (0.5 to 4.0) | 0.006c | 0.32 (−1.55 to 2.19) | 0.91 | −2.0 (−3.7 to −0.2) | 0.03 |
| Light | 173 ± 7 | 172 ± 8 | 164 ± 9 | 6.4 (−12.5 to 25.2) | 0.70 | 0.32 (−20.17 to 20.8) | > 0.99 | −6.0 (−25.2 to 13.1) | 0.73 |
| Moderate/vigorous | 352 ± 25 | 401 ± 31 | 339 ± 26 | 99.9 (32.0 to 167.7) | 0.002c,d | 20.2 (−53.3 to 93.6) | 0.79 | −79.7 (−149.0 to −10.4) | 0.02 |
| Duration of daily activity, min | |||||||||
| Sedentary | 575 ± 16 | 530 ± 17 | 591 ± 16 | −18.6 (−63.6 to 26.5) | 0.59 | 38.1 (−10.7 to 86.8) | 0.16 | 56.6 (11.4 to 101.8) | 0.01c |
| Light | 200 ± 8 | 207 ± 7 | 196 ± 7 | 12.2 (−9.5 to 33.9) | 0.38 | 3.4 (−20.1 to 27.0) | 0.94 | −8.8 (−30.8 to 13.3) | 0.61 |
| Moderate/vigorous | 114 ± 8 | 135 ± 9 | 109 ± 7 | 32.2 (8.4 to 56.0) | 0.005c | 9.3 (−16.1 to 34.6) | 0.66 | −22.9 (−46.8 to 0.9) | 0.06 |
| Proportion of time spent in daily activity, % | |||||||||
| Sedentary | 64.3 ± 1.5 | 60.5 ± 1.6 | 65.6 ± 1.4 | −3.9 (−7.9 to 0.1) | 0.06 | 1.0 (−3.4 to 5.4) | 0.85 | 4.9 (0.8 to 9.0) | 0.01 |
| Light | 22.8 ± 0.8 | 23.9 ± 0.8 | 22.1 ± 0.8 | 0.14 (−2.13 to 2.40) | 0.99 | −1.0 (−3.5 to 1.4) | 0.57 | −1.2 (−3.5 to 1.1) | 0.44 |
| Moderate/vigorous | 12.9 ± 0.9 | 15.6 ± 1.0 | 12.2 ± 0.8 | 3.5 (1.2 to 5.8) | 0.001c,d | −0.01 (−2.48 to 2.45) | > 0.99 | −3.5 (−5.8 to −1.2) | 0.001c,d |
| Measurea . | Arm 1 (Low-Normal TSH; n = 46) . | Arm 2 (High-Normal TSH; n = 47) . | Arm 3 (Mildly Elevated TSH; n = 45) . | Arm 2 vs Arm 1b . | Arm 3 vs Arm 1b . | Arm 3 vs Arm 2b . | |||
|---|---|---|---|---|---|---|---|---|---|
| Difference (95% CI) . | P Value . | Difference (95% CI) . | P Value . | Difference (95% CI) . | P Value . | ||||
| Daily energy intake, kcal/kg/d | 26.8 ± 1.3 | 28.6 ± 1.6 | 27.4 ± 1.2 | 1.3 (−2.1 to 4.7) | 0.64 | 1.2 (−2.4 to 4.8) | 0.71 | −0.1 (−3.5 to 3.3) | > 0.99 |
| CHO intake, % | 45.2 ± 1.2 | 46.0 ± 1.2 | 46.9 ± 1.2 | 0.96 (−2.83 to 4.75) | 0.82 | 1.11 (−3.00 to 5.22) | 0.8 | 0.15 (−3.64 to 3.93) | > 0.99 |
| Fat intake, % | 36.1 ± 0.8 | 34.1 ± 1.0 | 34.5 ± 0.9 | −0.46 (−3.21 to 2.29) | 0.92 | −0.14 (−3.07 to 2.78) | > 0.99 | 0.31 (−2.37 to 2.99) | 0.96 |
| Protein intake, % | 16.0 ± 0.5 | 16.4 ± 0.7 | 15.4 ± 0.6 | −0.74 (−2.71 to 1.23) | 0.65 | −0.87 (−2.96 to 1.23) | 0.59 | −0.13 (−2.11 to 1.85) | 0.99 |
| Daily PAEE, kcal/d | |||||||||
| Total | 524 ± 29 | 574 ± 38 | 503 ± 33 | 110 (30 to 191) | 0.004c | 20.2 (−67.0 to 107.5) | 0.85 | −90.0 (−172.2 to −7.9) | 0.03 |
| Per kg of LBM | 11.6 ± 0.7 | 12.6 ± 0.6 | 11.4 ± 0.6 | 2.3 (0.5 to 4.0) | 0.006c | 0.32 (−1.55 to 2.19) | 0.91 | −2.0 (−3.7 to −0.2) | 0.03 |
| Light | 173 ± 7 | 172 ± 8 | 164 ± 9 | 6.4 (−12.5 to 25.2) | 0.70 | 0.32 (−20.17 to 20.8) | > 0.99 | −6.0 (−25.2 to 13.1) | 0.73 |
| Moderate/vigorous | 352 ± 25 | 401 ± 31 | 339 ± 26 | 99.9 (32.0 to 167.7) | 0.002c,d | 20.2 (−53.3 to 93.6) | 0.79 | −79.7 (−149.0 to −10.4) | 0.02 |
| Duration of daily activity, min | |||||||||
| Sedentary | 575 ± 16 | 530 ± 17 | 591 ± 16 | −18.6 (−63.6 to 26.5) | 0.59 | 38.1 (−10.7 to 86.8) | 0.16 | 56.6 (11.4 to 101.8) | 0.01c |
| Light | 200 ± 8 | 207 ± 7 | 196 ± 7 | 12.2 (−9.5 to 33.9) | 0.38 | 3.4 (−20.1 to 27.0) | 0.94 | −8.8 (−30.8 to 13.3) | 0.61 |
| Moderate/vigorous | 114 ± 8 | 135 ± 9 | 109 ± 7 | 32.2 (8.4 to 56.0) | 0.005c | 9.3 (−16.1 to 34.6) | 0.66 | −22.9 (−46.8 to 0.9) | 0.06 |
| Proportion of time spent in daily activity, % | |||||||||
| Sedentary | 64.3 ± 1.5 | 60.5 ± 1.6 | 65.6 ± 1.4 | −3.9 (−7.9 to 0.1) | 0.06 | 1.0 (−3.4 to 5.4) | 0.85 | 4.9 (0.8 to 9.0) | 0.01 |
| Light | 22.8 ± 0.8 | 23.9 ± 0.8 | 22.1 ± 0.8 | 0.14 (−2.13 to 2.40) | 0.99 | −1.0 (−3.5 to 1.4) | 0.57 | −1.2 (−3.5 to 1.1) | 0.44 |
| Moderate/vigorous | 12.9 ± 0.9 | 15.6 ± 1.0 | 12.2 ± 0.8 | 3.5 (1.2 to 5.8) | 0.001c,d | −0.01 (−2.48 to 2.45) | > 0.99 | −3.5 (−5.8 to −1.2) | 0.001c,d |
Data presented as unadjusted mean ± SEM.
Abbreviation: CHO, carbohydrate.
Dietary measures were available for all but 1 value in the mildly elevated arm; physical activity measures were available for all subjects but 1 in the low-normal, 1 in the high-normal, and 2 in the mildly elevated arms.
Multiple linear regression models were adjusted for age, estrogen status, baseline TSH (low-normal vs high-normal), SD of TSH values at all but the first visit, baseline LT4 dose, duration of LT4, duration of LT4 dose, and baseline value of outcome; P values were adjusted using Tukey multiple comparison procedure for pairwise comparisons between arms. For each set of related outcome measures (diet, PAEE, and physical activity measures), Bonferroni and FDR multiple testing adjustments were applied to all related individual Tukey-adjusted P values comparing the three arms (data not shown).
P value was still statistically significant at the 0.05 level when applying multiple testing adjustments and grouping outcomes from the same test together for the Bonferroni correction.
P value was still statistically significant at the 0.05 level when applying multiple testing adjustments and grouping outcomes from the same test together for the FDR correction.
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