Table 2.
Estimated marginal mean (EMM) changes from baseline to 16 and 32 weeks.a
| Outcomes | Intervention group, EMM (95% CI)b | Control group, EMM (95% CI)c | Difference between groups, EMM (95% CI) | P | |
| HbA1c (%) | |||||
| 16 weeks | –0.9 (–1.1, –0.6) | –0.5 (–0.8, –0.2) | –0.4 (–0.7, –0.1) | .01 | |
| 32 weeks | –0.8 (–1.1, –0.6) | –0.3 (–0.6, 0.0) | –0.5 (–0.8, –0.2) | .002 | |
| Weight (kg) | |||||
| 16 weeks | –8.5 (–11.9, –5.2) | –3.9 (–8.0, 0.2) | –4.6 (–8.8, –0.4) | .03 | |
| 32 weeks | –12.7 (–16.1, –9.2) | –3.0 (–7.3, 1.3) | –9.6 (–14.0, –5.3) | <.001 | |
| Triglycerides (mg/dL) | |||||
| 16 weeks | –35.5 (–65.7, –5.2) | –17.4 (–55.2, 20.4) | –18.1 (–56.1, 19.9) | .35 | |
| 32 weeks | –60.1 (–91.3, –28.9) | –6.2 (–46.0, 33.6) | –53.9 (–93.6, –14.2) | .01 | |
| HDL cholesterol (mg/dL) | |||||
| 16 weeks | 1.4 (–2.7, 5.6) | –0.3 (–5.3, 4.8) | 1.7 (–3.4, 6.8) | .52 | |
| 32 weeks | 4.8 (0.5, 9.1) | 0.6 (–4.7, 5.9) | 4.1 (–1.2, 9.5) | .13 | |
| LDL cholesterol (mg/dL) | |||||
| 16 weeks | –0.8 (–10.9, 9.4) | 1.5 (–11.7, 14.7) | –2.2 (–15.3, 10.8) | .74 | |
| 32 weeks | –0.3 (–10.8, 10.3) | –6.1 (–19.9, 7.7) | 5.9 (–7.8, 19.5) | .40 | |
| Diabetes-related distress | |||||
| 16 weeks | –0.5 (–0.8, –0.1) | –0.3 (–0.7, 0.1) | –0.1 (–0.6, 0.3) | .49 | |
| 32 weeks | –0.4 (–0.8, 0.0) | –0.4 (–0.8, 0.0) | 0.0 (–0.5, 0.5) | .98 | |
| CES-Depression | |||||
| 16 weeks | –3.7 (–7.8, 0.5) | 0.8 (–3.7, 5.4) | –4.5 (–9.3, 0.4) | .07 | |
| 32 weeks | –0.6 (–5.0, 3.7) | –1.0 (–6.0, 4.0) | –0.4 (–4.8, 5.6) | .88 | |
| CESD Positive Affect | |||||
| 16 weeks | 8.4 (–5.3, 22.2) | –4.4 (–19.1, 10.3) | 12.9 (–2.9, 28.7) | .11 | |
| 32 weeks | 0.5 (–13.6, 14.8) | 7.2 (–9.0, 23.4) | –6.6 (–23.5, 10.3) | .45 | |
| DES Negative Affect | |||||
| 16 weeks | –0.7 (1.5, 0.1) | –0.1 (–0.9, 0.8) | –0.6 (–1.5, 0.3) | .19 | |
| 32 weeks | –0.4 (–1.2, 0.4) | –0.7 (–1.6, 0.2) | 0.3 (0.5, –0.6) | .49 | |
| DES Positive Affect | |||||
| 16 weeks | 0.5 (–0.3, 1.4) | –0.2 (–1.1, 0.7) | 0.7 (–0.3, 1.7) | .15 | |
| 32 weeks | 0.4 (–0.5, 1.2) | 0.3 (–0.7, 1.2) | 0.1 (–0.9, 1.1) | .82 | |
| Vitality (SF-36 subscale) | |||||
| 16 weeks | 13.3 (2.5, 24.02) | 2.3 (–9.4, 13.9) | 11.0 (–1.4, 23.4) | .08 | |
| 32 weeks | 9.2 (–1.9, 20.4) | 11.0 (–1.8, 23.8) | –1.8 (–15.1, 11.6) | .80 | |
| Total kilocalories | |||||
| 16 weeks | –362.9 (–634.7, –91.1) | –300.8 (–594.3, –7.4) | –62.1 (–376.0, 251.7) | .65 | |
| 32 weeks | –439.3 (–719.4, –159.3) | –216.6 (–559.2, 125.9) | –222.7 (–569.9, 124.5) | .13 | |
| Total grams of nonfiber carbohydrates | |||||
| 16 weeks | –123.2 (–167.2, –79.2) | –27.03 (–75.4, 21.3) | –19.2 (–147.4, –44.9) | <.001 | |
| 32 weeks | –122.7 (–167.9, –77.5) | –14.8 (–71.0, 41.5) | –107.9 (–164.6, –51.3) | <.001 | |
| Total grams of fat | |||||
| 16 weeks | –7.8 (–36.3, 20.7) | –18.7 (–48.8, 11.4) | 10.9 (–21.7, 43.4). | .42 | |
| 32 weeks | –4.0 (–33.2, 25.3) | –23.7 (–58.5, 11.1) | 19.8 (–15.9, 55.5) | .13 | |
| Total grams of protein | |||||
| 16 weeks | –0.5 (–14.0, 13.0) | –0.2 (–15.3, 14.9) | –0.3 (–16.2, 15.6) | .97 | |
| 32 weeks | –1.6 (–15.5, 12.3) | –0.1 (–17.7, 17.6) | –1.5 (–19.2, 16.1) | .86 | |
| Total grams of sugar | |||||
| 16 weeks | –37.2 (–53.8, –20.5) | –4.4 (–22.9, 14.1) | –32.7 (–52.3, –13.2) | <.001 | |
| 32 weeks | –32.5 (–49.7, –15.4) | –0.3 (–21.9, 21.3) | –32.2 (–53.9, –10.6) | <.001 | |
a Data are estimated marginal means and 95% confidence intervals by linear mixed-effects model analysis.
b Total analyzed in intervention group: n=12 for week 16 and n=11 for week 32.
c Total analyzed in control group: n=9 for week 16 and n=8 for week 32.