Changes in Clinical and Psychological Outcomes Over 15-Month Follow-Up
| Outcome | Group | Baseline | 3 Months–Baseline | 9 Months-Baseline | 15 Months-Baseline |
|---|---|---|---|---|---|
| HbA1c, %, mean (CI) | Intervention | 7.8 (7.2–8.4) | −0.1 (−0.4 to 0.3) P = .72 | 0.0 (−0.4 to 0.4) P >.99 | 0.5 (−0.1 to 1.1) P = .10 |
| Control | 8.0 (7.6–8.5) | −0.3 (−0.7 to 0.0) P = .08 | 0.1 (−0.3 to 0.5) P = .61 | 0.1 (−0.5 to 0.8) P = .71 | |
| Control vs Intervention | −0.2 (−1.0 to 0.5) P = .53 | 0.3 (−0.2 to 0.8) P = .30 | −0.1 (−0.7 to 0.5) P = .71 | 0.4 (−0.5 to 1.3) P = .39 | |
| HbA1c, mmol/mol mean, (CI) | Intervention | 62.0 (55.0–68.0) | −1.1 (−4.4 to 3.3) P = .72 | 0.0 (−4.4 to 4.4) P >.99 | 5.5 (−1.1 to 12.0) P = .10 |
| Control | 64.0 (60.0–69.0) | −3.3 (−7.7 to 0.0) P = .07 | 1.1 (−3.3 to 5.5) P = .61 | 1.1 (−5.5 to 8.7) P = .71 | |
| Control vs Intervention | −2.2 (−10.9 to 5.5) P = .53 | 3.3 (−2.2 to 8.7) P = .30 | −1.1 (−7.7 to 5.5) P = .71 | 4.4 (−5.5 to 14.2) P = .39 | |
| LDL cholesterol, mg/dL, mean (CI) | Intervention | 95.3 (85.8–104.7) | 3.0 (−3.8 to 9.9) P = .39 | 4.6 (−2.6 to 11.8) P = .22 | 1.6 (−7.7 to 10.9) P = .74 |
| Control | 90.1 (81.3–99.0) | 15.5 (8.6–22.3) P <.001 | 16.5 (8.9–24.1) P <.001 | 16.6 (6.8–26.3) P = .002 | |
| Control vs Intervention | 5.1 (−7.6 to 17.9) P = .43 | −12.5 (−22.1 to −2.8) P = .01 | −11.9 (−22.4 to −1.5) P = .03 | −15.0 (−28.5 to −1.5) P = .03 | |
| HDL cholesterol, mg/dL, mean (CI) | Intervention | 46.3 (42.1–50.6) | 5.8 (3.4–8.3) P <.001 | 13.6 (10.3–16.9) P <.001 | 14.1 (9.9–18.2) P <.001 |
| Control | 49.6 (45.3–54.0) | 0.8 (−1.7 to 3.2) P = .54 | 14.3 (10.8–17.8) P <.001 | 13.3 (8.9–17.7) P <.001 | |
| Control vs Intervention | −3.3 (−9.3 to 2.7) P = .28 | 5.1 (1.7–8.5) P = .005 | −0.7 (−5.5 to 4.1) P = .78 | 0.8 (−5.3 to 6.8) P = .81 | |
| Systolic blood pressure, mm Hg, mean (CI) | Intervention | 137.2 (131.8–142.5) | −0.7 (−5.6 to 4.2) P = .78 | −0.6 (−6.0 to 4.8) P = .83 | −2.5 (−7.7 to 2.7) P = .35 |
| Control | 137.8 (132.6–142.9) | 3.6 (−1.3 to 8.6) P = .15 | 4.3 (−1.2 to 9.9) P = .13 | 7.5 (2.0–13.0) P = .008 | |
| Control vs Intervention | −0.6 (−7.9 to 6.7) P = .87 | −4.3 (−11.3 to 2.6) P = .23 | −4.9 (−12.7 to 2.8) P = .22 | −10.0 (−17.6 to −2.4) P = .01 | |
| Diastolic blood pressure, mm Hg, mean (CI) | Intervention | 87.4 (83.8–91.1) | −4.5 (−7.7 to −1.3) P = .007 | −3.3 (−6.7 to 0.1) P = .06 | −6.4 (−9.8 to −3.1) P <.001 |
| Control | 86.4 (82.7–90.2) | 1.9 (−1.3 to 5.1) P = .26 | 1.6 (−2.0 to 5.1) P = .39 | 1.9 (−1.7 to 5.4) P = .31 | |
| Control vs Intervention | 1.0 (−4.1 to 6.1) P = .69 | −6.4 (−10.9 to −1.8) P = .007 | −4.8 (−9.8 to 0.1) P = .06 | −8.3 (−13.2 to −3.4) P = .001 | |
| BMI, kg/m2, mean (CI) | Intervention | 36.2 (34.2–38.3) | −0.4 (−0.9 to 0.1) P P = .12 | −0.7 (−1.2 to −0.1) P = .01 | −1.0 (−1.5 to −0.5) P <.001 |
| Control | 35.4 (33.1–37.8) | −0.2 (−0.7 to 0.3) P = .42 | −0.3 (−0.8 to 0.3) P = .35 | −0.2 (−0.7 to 0.3) P = .49 | |
| Control vs Intervention | 0.8 (−2.2 to 3.9) P = .59 | −0.2 (−0.9 to 0.5) P = .60 | −0.4 (−1.2 to 0.3) P = .29 | −0.8 (−1.6 to −0.1) P = .03 | |
| Waist circumference, inches, mean (CI) | Intervention | 44.8 (43.1–46.6) | −1.0 (−1.8 to −0.2) P = .02 | −1.3 (−2.2 to −0.5) P = .003 | −1.4 (−2.2 to −0.5) P = .003 |
| Control | 45.3 (43.4–47.1) | −0.7 (−1.5 to 0.1) P = .10 | −1.4 (−2.3 to −0.5) P = .003 | −1.3 (−2.2 to −0.4) P = .004 | |
| Control vs Intervention | −0.4 (−2.9 to 2.1) P = .73 | −0.3 (−1.5 to 0.9) P = .61 | 0.0 (−1.2 to 1.3) P = .95 | 0.0 (−1.3 to 1.2) P = .98 | |
| Diabetes support scale, mean (CI) | Intervention | 5.4 (5.0–5.7) | 0.5 (0.1–0.9) P = .02 | 0.2 (−0.2 to 0.6) P = .33 | 0.4 (0.0–0.9) P = .04 |
| Control | 5.3 (4.8–5.7) | 0.4 (0.0–0.8) P = .07 | 0.4 (0.0–0.8) P = .08 | 0.2 (−0.2 to 0.6) P = .31 | |
| Control vs Intervention | 0.1 (−0.5 to 0.7) P = .73 | 0.1 (−0.5 to 0.7) P = .75 | −0.2 (−0.8 to 0.4) P = .53 | 0.2 (−0.4 to 0.8) P = .48 | |
| Little to no diabetes distress,a % (CI) | Intervention | 58.1 (45–71) | 74.4 (59–85) P = .01 | 69.5 (55–81) P = .08 | 64.0 (50–76) P = .30 |
| Control | 63.5 (50–75) | 90.2 (74–97) P = .01 | 85.0 (68–94) P = .04 | 83.7 (67–93) P = .03 | |
| Control vs Intervention | −5.3 (−24 to 13) P = .58 | .−10.5 (−32 to 11) P = .19 | −10.1 (−33 to 12) P = .29 | −14.4 (−37 to 9) P = .13 |
BMI = body mass index; CI = 95% confidence interval.
Note: N = 106: Intervention n = 54, Control n = 52. All longitudinal outcomes except diabetes distress were analyzed using a linear mixed model (LMM). Diabetes distress was analyzed using a generalized estimating equation (GEE). Control-vs-Intervention P values are between-group values; other P values given are for within-group difference from baseline to the specified time.
↵a Diabetes Distress Scale (DDS). DDS <2: little or no distress; 2≤ DDS <3: moderate distress; DDS ≥3: high distress. P values for DDS are for change relative to baseline. Due to sparse cell counts in the “High Diabetes Distress” category at follow-up times, the logistic regression categories were “Little to no Diabetes Distress” vs “Moderate to High Diabetes Distress.” For the method used to determine confidence intervals for diabetes distress scores, see Supplemental Appendix at http://www.annfammed.org/content/13/Suppl_1/S27/suppl/DC1.
b Minimal depression indicated by PHQ (Primary Care Evaluation of Mental Disorders) ≥3.