Peer-Led, Empowerment-Based Approach to Self-Management Efforts in Diabetes (PLEASED): A Randomized Controlled Trial in an African American Community

Tricia S. Tang; Martha M. Funnell; Brandy Sinco; Michael S. Spencer; Michele Heisler

doi:10.1370/afm.1819

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Figure 1
CONSORT 2012 flow diagram: PLEASED Study
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Figure 2
Trajectory of unadjusted mean LDL cholesterol levels over time
Note: At baseline, LDL cholesterol (LDL-C) levels did not differ significantly between groups. All increases within the Control group were significant (P <.05) relative to the Intervention group. Within-group changes from baseline to 3, 9, and 15 months were all significant for the Control group (P = .01).

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Table 1

Baseline Characteristics of Study Participants

Characteristic	Peer-led Group (n = 54)	Control Group (n = 52)	Total (n = 106)	P Value for Between-Group Difference
Age, y, mean (SD)	56.7 (11.5)	55.9 (11.3)	56.3 (11.4)	.71^a
Men, n (%)	17 (31.5%)	18 (34.6%)	35 (33.0%)	.73^b
Race or ethnicity, n (%)				N/A
African American	54 (100%)	52 (100%)	106 (100%)
Education, n (%)				.33^c
Some high school or less	5 (9.6%)	3 (5.8%)	8 (7.7%)
High school graduate or GED	6 (11.5%)	7 (13.5%)	13 (12.5%)
Some college/technical/vocational training	25 (48.1%)	18 (34.6%)	43 (41.3%)
College graduate or higher	16 (30.8%)	24 (46.2%)	40 (38.5%)
Employed, n (%)	20 (38.5%)	25 (48.1%)	45 (43.3%)	.32^b
Have health insurance, n (%)	45 (95.7%)	49 (100.0%)	94 (97.9%)	.24^c
Household income, n (%)				.25^b
<$20,000	9 (17.3%)	14 (26.9%)	23 (22.1%)
$20,000 – $49,999	21 (40.4%)	24 (46.2%)	45 (43.3%)
$50,000 or more	20 (38.5%)	13 (25.0%)	33 (31.7%)
Social support
Married or partnered, n (%)	26 (50.0%)	24 (46.2%)	50 (48.1%)	.69^b
Diabetes social support, mean (SD)	5.4 (1.3)	5.3 (1.5)	5.3 (1.4)	.73^a
Antihyperglycemic medication, n (%)				.97^b
No medications	7 (14.0%)	6 (12.2%)	13 (13.1%)
Only oral diabetes medication	24 (48.0%)	24 (49.0%)	48 (48.5%)
Insulin, with or without medication	19 (38.0%)	19 (38.8%)	38 (38.4%)
Medication adherence, n (%)
Often or very often miss insulin dose/wk	2 (10.0%)	1 (4.8%)	3 (7.3%)	.61^c
Often or very often miss medication dose/wk	0 (0.0%)	1 (2.2%)	1 (1.3%)	>.99^c
General health
Self-rated fair or poor general health, n (%)	17 (32.7%)	19 (36.5%)	36 (34.6%)	.68^b
Minimal depression,^d n (%)	37 (72.5)	29 (55.8)	66 (64.1)	.08^b
Diabetes distress scale^e				.83^b
Little or no distress	30 (57.7)	33 (63.5)	63 (60.6)
Moderate distress	15 (28.8)	13 (25.0)	28 (26.9)
High distress	7 (13.5)	6 (11.5)	13 (12.5)
Physiological measures
Hemoglobin A_1c, %, mean (SD)	7.8 (2.1)	8.0 (1.6)	7.9 (1.9)	.53^a
Hemoglobin A_1c, mmol/mol, mean (SD)	62.0 (23.0)	64.0 (17.5)	63.0 (20.8)	.53^a
Total cholesterol, mg/DL, mean (SD)	155.3 (42.3)	151.8 (40.1)	153.5 (41.1)	.67^a
LDL cholesterol, mg/DL, mean (SD)	95.3 (33.8)	90.1 (31.8)	92.7 (32.8)	.43^a
HDL Cholesterol, mg/DL, mean (SD)	46.4 (15.2)	49.6 (15.6)	48.0 (15.4)	.28^a
Total cholesterol / HDL cholesterol	3.5 (1.0)	3.2 (1.0)	3.4 (1.0)	.12^a
Systolic BP, mm Hg, mean (SD)	137.2 (19.5)	137.8 (18.5)	137.5 (18.9)	.87^a
Diastolic BP, mm Hg, mean (SD)	87.5 (13.2)	86.4 (13.4)	87.0 (13.2)	.69^a
Body mass index, kg/m², mean (SD)	36.2 (7.4)	35.4 (8.5)	35.8 (7.9)	.59^a
Waist circumference, inches, mean (SD)	44.9 (6.3)	45.3 (6.6)	45.1 (6.4)	.73^a
Diabetes duration, years, mean (SD)	8.0 (6.9)	10.5 (9.7)	9.2 (8.5)	.14^f

↵a t-Test.
↵b Pearson χ² test.
↵c Fisher’s exact test.
↵d Minimal depression indicated by PHQ (Primary Care Evaluation of Mental Disorders) ≥3.
↵e Diabetes Distress Scale (DDS); DDS <2: little or no distress; 2≤ DDS <3: moderate distress; DDS ≥3: high distress.
↵f Log-Rank test.

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Table 2

Changes in Clinical and Psychological Outcomes Over 15-Month Follow-Up

Outcome	Group	Baseline	3 Months–Baseline	9 Months-Baseline	15 Months-Baseline
HbA_1c, %, 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
HbA_1c, 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.