The Diabetes Educator

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Community-Based Peer-Led Diabetes Self-management: A Randomized Trial

Kate Lorig, Philip L. Ritter, Frank J. Villa and Jean Armas
The Diabetes Educator 2009; 35; 641 originally published online Apr 30, 2009;
DOI: 10.1177/0145721709335006

The online version of this article can be found at:

http://tde.sagepub.com/cgi/content/abstract/35/4/641

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 Community-Based Diabetes Self-management

641

Community-Based Peer-Led
Diabetes Self-management
A Randomized Trial

Purpose Kate Lorig, DrPH

Philip L. Ritter, PhD
The purpose of this study is to determine the effective-
Frank J. Villa, MPH
ness of a community-based diabetes self-management
program comparing treatment participants to a random- Jean Armas, BA
ized usual-care control group at 6 months. From the Stanford University School of Medicine.

Correspondence to Philip L. Ritter, Suite 204, 1000

Methods Welch Rd, Palo Alto, CA 94304 (philr@stanford.edu).

Acknowledgments: We wish to acknowledge the

A total of 345 adults with type 2 diabetes but no criteria
for high A1C were randomized to a usual-care control
group or 6-week community-based, peer-led diabetes
self-management program (DSMP). Randomized partici-
pants were compared at 6 months. The DSMP interven-
tion participants were followed for an additional 6 months
(12 months total). A1C and body mass index were mea-
sured at baseline, 6 months, and 12 months. All other data
assistance of Mirna Sanchez for data collection and
metabolic testing and Christina Lum for assisting with
metabolic testing. Dr Lorig receives royalties for the
book Living a Healthy Life With Chronic Conditions,
which was used as a resource by participants in the
program. If the program is disseminated, she could
receive additional royalties. Supported by the
California Health Care Foundation. ClinicalTrials.gov ID
NCT00684086.

were collected by self-administered questionnaires. DOI: 10.1177/0145721709335006

© 2009 The Author(s)

Results
At 6 months, DSMP participants did not demonstrate
improvements in A1C as compared with controls. Baseline
A1C was much lower than in similar trials. Participants
did have significant improvements in depression, symp-
toms of hypoglycemia, communication with physicians,
healthy eating, and reading food labels (P < .01). They
also had significant improvements in patient activation
and self-efficacy. At 12 months, DSMP intervention par-
ticipants continued to demonstrate improvements in
depression, communication with physicians, healthy eat-
ing, patient activation, and self-efficacy (P < .01). There
were no significant changes in utilization measures.

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Conclusions
These findings suggest that people with diabetes without
elevated A1C can benefit from a community-based, peer-
led diabetes program. Given the large number of people
with diabetes and lack of low-cost diabetes education,
the DSMP deserves consideration for implementation.
T
ype 2 diabetes affects 9.6% of the population
above the age of 20 and 20.9% of those 60
and above, and its prevalence is increasing.1
While the need for self-management support
is well documented, most diabetes education
programs target those who have a high hemoglobin A1C
(usually 7 or above), are available only in clinical settings,
and are accessed by referral from health professionals. The
Cochrane Collaboration published a review of group-based
training for type 2 diabetes.2 This review found only 11
studies that met the Cochrane criteria. Eight of these were
randomized studies, and 3 were controlled studies. All of
the interventions were taught by health professionals, and
only 1 of the studies took place outside of a clinical setting.
Almost uniformly, the participants had high baseline A1C
levels with means ranging from 7.7 to 12.3. Only 1 study
reported a mean baseline A1C less than 7.
Several studies have documented that people with diabe-
tes have a greater prevalence of depression than the nondia-
betic population, ranging from 10% to 30%.3 In contrast, a
national study found that 6.9% of the general population
was estimated to have major depressive disorder.4 The
authors were unable to find data on the prevalence of sub-
clinical depression for people with diabetes. Depression has
been associated with poor self-management and glycemic
control.5
Taking into consideration these factors, the authors
have undertaken to develop and evaluate a community-
based program for people with type 2 diabetes. In a previ-
ous community-based peer-led pilot study using a pretest/
posttest design, participants demonstrated improvements
(P < .05) in health behaviors (exercise, diet, practice of
relaxation techniques, communication with provider) and
health status (self-reported health, fatigue, physical dis-
comfort, health distress, and role/activity limitations);
A1C was not measured.6 Recently, an intervention very
similar to the one used in this study was evaluated for
Spanish speakers in a larger 6-month randomized trial
followed by an 18-month longitudinal study. That study,
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with a mean baseline A1C of 7.4, found that intervention
participants, when compared with usual-care controls,
experienced an improvement in A1C and quality of life
(P < .05) and that these effects ­persisted for 18 months.7
The present study determines the effectiveness of a
community-based Diabetes Self Management Program
(DSMP) for English speakers comparing treatment
participants with a randomized usual-care control group
at 6 months.
Hypotheses
1. Participants receiving the DSMP, compared with random-
ized controls, would demonstrate improvements at 6 months
in the following:
a. health-status (A1C, weight, depression, fatigue, self-
rated health, frequency of hyperglycemia and hypogly-
cemia symptoms),
b. self-management behaviors (exercise, communication
with physicians, frequency of glucose monitoring,
healthy eating, reading nutrition labels), and
c. self-efficacy for managing diabetes and patient activation.
2. Any benefits of the DSMP would be maintained after
12 months.
Research Design and Methods
In this article, the results of a randomized 6-month
trial of the DSMP with a 12-month longitudinal follow-up
are reported.
Diabetes Self-management Program
The original Spanish-language Diabetes Self-
management Program (SDSMP)7 was developed based on
needs assessments conducted with 4 groups of people with
diabetes and 3 groups of diabetes educators. It was then
reviewed by diabetes nurse educators, nutritionists, and a
diabetologist and modified to be translatable for real-
world practice (low cost, community based, and peer led).
The program protocol and all program material were
originally written in Spanish and then rewritten in English.
The English version (DSMP) is not a direct translation
from Spanish but is very similar except for cultural adapta-
tions such as the changes in the foods discussed and hav-
ing participants work in pairs instead of small groups.
The DSMP is a 6-week program offered 2½ hours
weekly by 2 peer leaders. Programs (a total of 19) were
held in community settings such as churches and senior
centers in 6 San Francisco Bay Area counties. Class sizes
ranged from 10 to 15 including participants’ family and
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643

Table 1

Topics Covered in the Program

Workshop Overview

Week 1 Week 2 Week 3 Week 4 Week 5 Week 6

Overview of self-management and diabetes 

Making an action plan      
Nutrtition/Healty Eating    
Feedback/problem-solving     
Preventing low blood glucose 
Preventing complications 
Fitness/exercise  
Stress management 
Relaxation techniques  
Difficult emotions 
Monitoring blood glucose 
Depression 
Positive thinking 
Communication 
Medications 
Working with your health care professional 
Working with the health care system 
Sick days 
Skin and foot care 
Future plans 

friends. Peer leaders (N = 18) ranged in age from 35 to 70
years and came from the same communities as the par-
ticipants. Most had type 2 diabetes and were not health
professionals. They received 4 days of training in the use
of the detailed DSMP protocol; mastery was assessed
through staff observation of 2 practice teaches. During the
training, each exercise in the DSMP was modeled by staff
trainers, with the leaders acting as program participants.
Following the modeling of activities, each activity was
revisited with explanations of why it is taught in the man-
ner it is taught. In addition, leaders received training in
delivering lecturettes, brainstorming, and conducting
structured discussions. They also received training on
how to handle problem people. Finally, they received
instruction on program logistics. All of the training, like
the DSMP itself, if highly interactive. Included in the
training were 2 opportunities for the leader to do practice
teaches in pairs. These were observed and critiqued by the
other leaders in training and the project staff.
During the actual program sessions, peer-leaders used the
protocol as a minute-by-minute detailed guide. Observations
of sessions confirmed that the peer-leaders were careful in
maintaining fidelity to the structured program.
Program content included all areas of the American
Association of Diabetes Education Standards (AADES78,9),
with 2 exceptions. The actual process of glucose monitoring
is not taught, although monitoring is discussed. Although
there is a general discussion of medications, there is no
discussion of specific medications, nor is insulin injection
taught. Topics covered are shown in Table 1. All participants
also received a copy of the book Living a Healthy Life With
Chronic Conditions,10 which served as a reference. Each
week, specific chapters or pages of the book were suggested
as a source for additional information, but reading was not
required and there were no tests of the material in the book.
The program is highly interactive with emphasis on action
planning and problem solving. It uses skill building, goal
setting, and reinforcement with the goal of enhancing

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­
participants’ self-efficacy. The study was approved by the
Stanford School of Medicine Institutional Review Board.
Participants and Data Collection
This study took place from 2005 to 2007. Participants
were 18 years or older, not pregnant or in care for cancer,
and had type 2 diabetes. There were no other inclusion or
exclusion criteria, and literacy was not a specific require-
ment for inclusion. Unlike most past studies in which
health professionals referred participants, this study was
advertised in the community by word of mouth, announce-
ments in churches, and through clinics and mass media
including talk radio. Participants contacted the study via
a toll-free telephone line, were told about the study, and,
after screening for eligibility, were asked to complete
consent and baseline questionnaires either by phone or
mail. Baseline questionnaires were collected for com-
parison to postintervention questionnaires and were not
analyzed until later in the study. Participants’ physicians
verified their diagnoses. Physicians or clinics referred
only 6% of the participants. One week before the begin-
ning of each program, metabolic data (A1C) and weight
were obtained by project staff at the program sites. These
data were sent to both treatment and control subjects and
their physicians.
After participants had applied to attend at a specific
site and completed baseline questionnaires, randomiza-
tion was performed using random number tables. The
proportion assigned to the treatment group was manip-
ulated so as to ensure at least 10 participants in each
program. This resulted in more subjects being random-
ized to treatment than control status. Usual care ranged
from community clinics to specialist care and was rep-
resentative of care received in urban areas.
Randomized Study
The randomized controlled study compared the DSMP
to the usual-care control group at 6 months. After 6-month
data collection, controls were offered the DSMP.
Longitudinal Follow-up
Treatment participants in the randomized study were
followed for an additional 6 months and completed a
mailed 12-month questionnaire. This follow-up allowed
us to test if any improvements noted at 6 months would
still be evident at 1 year by comparing 1-year outcomes
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to baseline scores. Those who enrolled in the randomized
trial in the last 11 months of the study were not eligible
for the longitudinal follow-up.
Measures
Health status, health behaviors, health care utiliza-
tion, and self-efficacy were measured at each time
point. The specific measures were based on diabetes-
related problems identified in participant focus groups
and on self-efficacy theory.11 A1C was measured using
self-administered BIOSAFE kits. These have an
expected normal range of 3.8 to 5.9 compared with 4 to
6 for National Glycohemoglobin Standardization
Program (NGSP) standards.12 These assays have been
shown to be reliable and valid.13 Symptoms of hyperg-
lycemia and hypoglycemia were measured using scales
developed by Piette.14 Depression was measured by the
PHQ-9.15 Fatigue was measured using a visual numeric
scale.16 Health-related distress was measured by the
health distress scale adopted from the Medical Outcome
Study.17,18 A single item from the National Health
Survey measured self-rated health.19 Health behaviors
were assessed by a physical activities scale measuring
total minutes per week of aerobic exercise18 and by
weekly frequency of glucose monitoring. A 3-item scale
measured communication with physicians.18 It used a
6-point scale (never to always) to measure how often
the participant prepared a list of questions for the physi-
cian, asked questions of the physician regarding things
the participant did not know, and discussed personal
problems with the physician related to the illness. A
3-item scale to measure healthy eating was developed
for this study. It consisted of the frequency of eating
full-fat dairy products, eating fruits and vegetables, and
eating snack foods. The frequencies of the 3 types of
food were measured on a 5-point scale ranging from
never to more than 3 times per day, and the 3 frequen-
cies were averaged. A single item, “How often do you
read nutrition labels?” was measured along 5 points
ranging from never to always. Comprehension of nutri-
tion labels was not evaluated.
We also included the 9-item short form of the Patient
Activation Measure (PAM), which assesses patient self-
reported knowledge, skill, and confidence for self-
management of one’s health or chronic condition.20
Self-efficacy was measured using the diabetes self-
efficacy scale (α = .85) and a test-retest validity of .80.18
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Health care utilization over the prior 6 months was
measured by self-report. In a study evaluating the validity
of self-reported utilization with utilization reported by
chart audit,21 there were no biases toward improved report-
ing over time. Details of the psychometric properties of all
variables except for healthy eating and reading of nutrition
labels may be found on the Internet at http://patienteduca-
tion.stanford.edu/research.
We also created a summary index of the number of
health indicators that improved by at least a 0.3 effect
size (defined as the change score divided by the baseline
standard deviation). The effect size of 0.3 was chosen
because it is likely to be of significance to patients with
chronic conditions.22 With 7 health behaviors, this index
had a possible range of 0 to 7. A similar index was con-
structed for health behaviors, with the possible score
ranging from 0 to 5.
Data Analysis
All subjects randomized at baseline, irrespective of the
number of weeks they participated in the intervention, were
included in the analyses. Using t tests, baseline DSMP
intervention participants were compared with usual-care
control participants. All variables demonstrating significant
differences at baseline as covariates in subsequent multi-
variate analyses of 6-month outcomes were included.
The baseline variables for those who failed to com-
plete the 6-month questionnaire were then compared
with those who had completed questionnaires, again
using t tests.
At 6 months, analyses of covariance models compared
treatment versus control groups. Six-month outcomes
were the dependent variables, and demographic variables
and the outcome variable at baseline were included as
covariates. Least-square means (adjusted for covariates)
were computed to determine if there were significant dif-
ferences between the 2 randomized groups.
For the treatment group, 12-month scores were com-
pared to baseline using paired t tests.
All analyses were done using both actual data col-
lected and intent-to-treat methodology—based on substi-
tuting last acquired data for missing data, and P values
for both methods are reported in the tables. P values are
interpreted within each category of outcome (health indi-
cators, health behaviors, and utilization) in light of mul-
tiple comparisons using Bonferroni corrections. Thus,
with 7 health indicators, a criteria P value of .007 is used.
With 5 health behaviors, .01 is used as the minimal
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Community-Based Diabetes Self-management
645
P value to indicate statistical significance. The 3 health
utilization variables would require a P of .017.
Results
Participants
Randomized 6-month study. Nineteen DSMP work-
shops were held between 2005 and 2007. Of 352 indi-
viduals who completed the consent form and a baseline
questionnaire, 159 were randomized to the usual-care
group and 186 to the DSMP. Treatment participants
attended a mean of 4.9 of 6 sessions.
At 6 months, 133 controls (84%) completed follow-up
questionnaires, as did 161 (87%) intervention participants.
Study participants had a mean age of 66.7, 66% were
female, and the mean years of education was 15.9. The only
demographic variable that approached statistical difference
was age, with the treatment group being slightly older (67.7
vs 65.4, P = .064; Table 2). There were no significant dif-
ferences between treatment group and control group in the
baseline values of any of the outcome variables.
The PHQ scale measures level of depression. The
provisional diagnosis categories23 indicated that 23% of
the participants had depression symptoms: 11% minor to
mild major depression, 6% moderately severe major depres-
sion, and 6% severe major depression.
Longitudinal 12-month follow-up. Among the origi-
nal 186 intervention group participants, 126 were eligible
for 12-month questionnaires, and 102 completed them.
Thus, 81% of those eligible to complete the 12-month
questionnaire did so (Figure 1). Noneligible participants
were those who entered the randomized study too late to
complete 12-month questionnaires.
Noncompleters
Randomized 6-month study. Comparing study partici-
pants who completed 6-month questionnaires (n = 294) to
those who did not (n = 51), the completers were more
likely to be non-Hispanic white (70% vs 48%, P = .002)
and were older (mean age 67.5 vs 61.8 years, P = .001).
They also had a trend toward higher A1C, more health
distress, and more activity limitation (P = .019, .017, and
.040, respectively, but not significant after correcting for
multiple comparisons). When comparing baseline vari-
ables for intervention 6-month noncompleters with usual-
care-control 6-month noncompleters, no demographic
variables were significantly different. One baseline
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Table 2

Baseline Means by Randomizationa

Usual Care DSMP

Variable (n = 159) (n = 186) P
Demographic variables
Age, y (range 24-93) 65.4 (11.4) 67.7 (11.9) .064
Male, % 33.8 37.6 .480
Years of education (range 0-20) 15.7 (3.28) 15.2 (2.96) .167
Married, % 53.8 52.2 .720
Non-Hispanic white, % 70.6 64.0 .205
Baseline weight, kg 88.9 (24.6) 87.0 (24.0) .489
Using insulin, % 17.0 17.7 .835
Health indicators
Hemoglobin A1C ↓ 6.74 (1. 38) 6.70 (1.48) .847
Self-reported global health (0-5) ↓ 3.09 (0.852) 3.05 (0.847) .666
Symptoms of hypoglycemia (0-12) ↓ 1.66 (1.75) 1.45 (1.51) .290
Symptoms of hyperglycemia (0-12) ↓ 2.15 (1.76) 1.95 (1.80) .241
Fatigue (0-10) ↓ 4.79 (2.63) 4.45 (2.48) .234
PHQ depression (0-27) ↓ 6.46 (5.60) 6.35 (5.85) .866
Weight, kg ↓ 89.0 (24.7) 87.0 (23.9) .449
Health behaviors
Aerobic exercise, min/wk ↑ 119 (112) 105 (99.9) .243
Communication with physician (0-5) ↑ 2.95 (1.19) 2.95 (1.29) .990
Healthy eating (0-6) ↑ 4.02 (0.827) 4.02 (0.716) .933
Read food labels (0-4) ↑ 2.99 (1.04) 2.85 (1.14) .263
Self-efficacy (1-10) ↑ 6.93 (1.77) 6.78 (1.86) .451
Patient activation (PAM) (0-100) ↑ 60.4 (14.9) 62.9 (17.8) .165
Health care utilization
Physician visits (past 6 mo) 3.40 (4.26) 3.40 (4.45) .990
Emergency visits (past 6 mo) 0.233 (0.667) 0.274 (.768) .596
Days in hospital (past 6 mo) 0.377 (1.93) 0.651 (3.57) .368
a
 The range and direction are given with each variable, where applicable. An upward arrow indicates a higher value is desirable; a downward arrow indicates that a lower
value is desirable. Standard deviations are included in parentheses following each mean. P values are from t tests comparing the 2 groups.

outcome variable approached being ­different: the control
6-month noncompleters had more symptoms of hypoglce-
mia than the intervention noncompleters P = .036, not
significant after taking into account multiple compari-
sons). The proportion of intervention noncompleters
(14%) compared with that of usual-care control noncom-
pleters (16%) was not statistically significant (P = .539).
Outcomes
Randomized 6-month study. A1C was not signifi-
cantly improved by the intervention. After allowing for
multiple comparisons, the intervention group had statisti-
cally fewer symptoms of hypoglycemia and less depres-
sion than the usual-care control group (P < .007; Table 3).
Fatigue was marginally improved for the intervention
compared with the control group (P = .052). Among
health behaviors, communication with physician, healthy
eating, and reading labels were significantly improved for
the intervention group (P < .01), while aerobic exercise
and glucose testing were marginally improved after tak-
ing multiple comparisons into account (P = .049 and .024,
respectively). Self-efficacy and PAM were significantly
improved for the intervention group compared with

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Recruitment 629 left contact information

Did not meet eligibility

requirements N=29
Refused N=265

Enrollment Returned Baseline

Questionnaire
and were Randomized
N=345

Randomization Randomized to Randomized to

Intervention Usual Care
N= 186 N=159

Followup of N completing=161 (87%) N completing=133 (84%)

Participants
25 did not complete 26 did not complete
6 Months
questionnaire questionnaire
After Baseline

126 eligible for

12 month follow-up

Longitudinal N completing=102
Followup, (81% of eligible)
12 Months
After Baseline

Figure 1.  Participants in the randomized trial and longitudinal follow-up.

­usual-care controls (P = .001 and .017, respectively).
There were no significant differences between random-
ized groups in health care utilization.
Longitudinal 12-month follow-up. At 12 months,
treatment participants continued to show improvements
in depression, communication with physician, healthy
eating, self-efficacy, and patient activation compared
with baseline values (Table 4). They also had a mean
weight reduction of 1.1 kg, which would appear to be
clinically important but was not statistically significant
(P = .052).
Depression. As depression, measured by the PHQ-9
depression scale, was one outcome that was significantly
improved among the intervention participants at 1 year, it
was examined in more detail. The mean change in depres-
sion at 1 year was a 1.4-point reduction (P = .005). When
looking at just those who had depressive symptoms at
baseline (a score of 10 or above on the PHQ), 56% had
minimal or no depressive symptoms at 1 year. In contrast,
only 7% of those with minimal or no depression at base-
line had scores above 10 at 1 year (χ2 P < .001).
For the PHQ, a reduction of 5 is considered a clinically
significant improvement in depression.23 Consequently,
the proportion of participants whose depression was
reduced by at least 5 points was examined. At 6 months,
19.4% of intervention participants and 8.2% of the con-
trol group had had such a 5 or greater reduction (P =
.007). At 1 year, the proportion with improvements in
depression was similar, with 20.6% of intervention par-
ticipants having a 5 or greater reduction (χ2 P < .001).

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Table 3

Six-Month Changes by Randomizationa

6-Month Change Scores

Variable Usual Care (n = 133) DSMP (n = 161) P, Nonmissing Cases P, Intent to Treat
Health indicators
Hemoglobin A1C ↓ –0.173 (0.928) –0.108 (0.998) .803 .604
Self-reported global health (0-5) ↓ 0.023 (0.609) –0.062 (0.730) .331 .243
Symptoms of hypoglycemia (0-12) ↓ 0.030 (1.41) –0.350 (1.43) .003 .002
Symptoms of hyperglycemia (0-12) ↓ 0.105 (1.66) –0.089 (1.79) .242 .138
Fatigue (0-10) ↓ 0.038 (2.05) –0.304 (2.49) .097 .052
PHQ depression (0-27) ↓ 0.541 (4.49) –1.51 (4.33) <.001 <.001
Weight, kg ↓ –0.275 (4.19) –0.212 (3.13) .958 .955
Health behaviors
Aerobic exercise, min/wk ↑ –19.2 (103) 9.70 (115) .097 .049
Communication with physician (0-5) ↑ 0.068 (0.934) 0.310 (0.992) .013 .016
Glucose monitoring, times/wk ↑ –0.511 0.219 <.001 <.001
Healthy eating ↑ –0.082 (0.718) 0.198 (0.750) <.001 <.001
Read food labels ↑ –0.180 (0.824) 0.119 (0.941) .009 .005
Self-efficacy (1-10) ↑ –0.122 (1.709) 0.495 (1.52) .003 .001
Patient activation (PAM) (0-100) ↑ 1.75 (15.3) 4.52 (15.8) .014 .017
Health care utilization
Physician visits (past 6 mo) –0.106 (3.37) 0.219 (3.88) .292 .462
Emergency visits (past 6 mo) 0.113 (0.885) –0.012 (0.742) .455 .273
Days in hospital (past 6 mo) –0.143 (1.75) 0.00 (4.31) .308 .152
a
 The range and direction are given with each variable, where applicable. An upward arrow indicates a higher value is desirable; a downward arrow indicates that a lower
value is desirable. Change score P values compare least-squares means at 6 months after controlling for baseline value of the outcome and demographic variables as
covariates in analyses of covariance models.

Effect size changes. At 6 months, the number of health Conclusions

indicator or health behavior improvements of at least 0.3
effect sizes for the intervention participants versus the
control group was compared. The average of such health
indicator improvements was 2.0 for the intervention group
versus 1.6 for the control group (P = .007). Similarly, the
mean number of health behavior improvements of 0.3
effect sizes or more was 1.4 versus 0.95 for the interven-
tion compared with control groups (P < .001).
At 12 months, the percentage of the intervention popu-
lation who improved by at least 0.3 effect sizes on at least
1 of 7 health indicators was 79% of the participants, and
32% had 3 or more such improvements. Similarly, 78%
had at least one 0.3 effect size improvement in health
behaviors, and 22% had 3 or more. The mean number of
improvements of 0.3 or more was 2.0 health indicators
and 1.5 health behaviors.
Six-Month Randomized Study
The results were somewhat mixed but tend to support
the hypotheses that the DSMP resulted in improved health
status indicators and health behaviors. Both self-efficacy
and PAM were strongly improved by participation in the
DSMP intervention. Improvements in both health indica-
tors or health behaviors of at least 0.3 effect sizes were
significantly greater for intervention participants than for
the control group, strongly suggesting that a large portion
of the participants benefited from the program.
The reduction in A1C that was found with the SDSMP7
did not occur in this study. When comparing participants in
the 2 studies, English-language study participants had lower
A1C levels at baseline than those of the Spanish study par-
ticipants (mean of 6.72 vs 7.41). Thus, it may be that the

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Table 4

Twelve-Month Follow-up, Changes After Intervention, DSMP Participantsa

Variable Change (n = 102), Mean (SD) P, Nonmissing Cases P, Intent to Treat

Health indicators
Hemoglobin A1C ↓ 0.059 (1.04) .574 .533
Self-reported global health (0-5) ↓ –0.109 (0.628) .088 .117
Symptoms of hypoglycemia (0-12) ↓ –0.109 (1.33) .511 .174
Symptoms of hyperglycemia (0-12) ↓ –0.240 (1.50) .101 .292
Fatigue (0-10) ↓ –0.356 (2.15) .099 .050
PHQ depression (0-27) ↓ –1.42 (5.03) .002 .005
Weight, kg ↓ –1.02 (6.31) .105 .084
Health behaviors
Aerobic exercise, min/wk ↑ –7.21 (107) .498 .621
Communication with physician ↑ 0.356 (0.950) <.001 <.001
Glucose monitoring, times/wk ↑ 0.0774 (2.36) .696 .673
Healthy eating ↑ 0.151 (0.694) .030 .003
Read food labels ↑ 0.118 (0.749) .116 .066
Self-efficacy (1-10) ↑ 0.473 (1.51) .002 .002
Patient activation (PAM) (0-100) ↑ 4.30 (14.4) .003 .007
Utilization
Physician visits (past 6 mo) 0.543 (4.24) .194 .362
Emergency visits (past 6 mo) 0.020 (0.675) .770 .891
Days in hospital (past 6 mo) 0.980 (7.00) .161 .492
a
 The range and direction are given with each variable, where applicable. An upward arrow indicates a higher value is desirable; a downward arrow indicates that a
lower value is desirable. Standard deviations are included in parentheses following each mean. P values are from paired t tests comparing baseline with 12-month
scores.

participants in this study had already reached a floor effect,
which did not allow for improvement. They also were more
likely to own a device for monitoring glucose than partici-
pants in the Spanish study (90.5% vs 79.5%). In addition,
English-language study participants largely accessed care
through private insurance and Medicare as opposed to
Spanish speakers, who tended to access care through pro-
viders serving the uninsured or underinsured. Although the
results of initial A1C testing were given to all subjects in
both studies, it may be that English speakers with initially
high blood glucose levels were better able to access care
and initiate attempts to improve their condition than Spanish
speakers. Any 1 or a combination of these differences may
contribute to the English-language DSMP results not being
as strong as the results from the SDSMP.
depression, with trends toward less fatigue and weight
loss. Although not statistically significant, all other
health status indicators change scores were in the direc-
tion of improvement. Participants also had continued
improvements in communication with their physicians,
healthy eating, self-efficacy, and patient activation. The
improvements of 0.3 or greater effect sizes reinforced the
finding that a large portion of the population had at least
some benefit from the program, although without a con-
trol group at 1 year, one cannot be absolutely certain that
the program was responsible for these improvements.
For people with diabetes, health indicators tend to
worsen. Thus, the consistence maintenance or improve-
ment from baseline is encouraging, especially when
considering that this was a community-based sample.

Longitudinal 12-Month Follow-up Limitations

One year after starting the intervention, DSMP par- Because DSMP participants could not be blinded, there
ticipants continued to show significant improvements in is the possibility of an attention effect (improvement merely

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The Diabetes EDUCATOR
650
because they are being paid attention to, or the Hawthorn
effect). However, such an effect would not be expected to
be maintained for 1 year following the intervention. At the
same time, a similar effect would be expected in all studies
of a similar intensity. In addition, all subjects and their
physicians received data on subjects’ A1C level at baseline,
and this may have affected participant or physician behav-
ior for both treatment and control participants. It might be
speculated that if A1C levels had not previously been care-
fully monitored and were found to be high, participants’
physicians may have initiated or encouraged new interven-
tions outside of the DSMP. Questionnaire data (eg, depres-
sion levels) were not analyzed until the completion of the
study and were not shared with physicians.
Surprisingly, when participants are able to self-select
into a diabetes education program, a large percentage
have an A1C level below 7. Nevertheless, these partici-
pants were able to benefit from the intervention. This
points out the desire for diabetes education irrespective
of subjects’ A1C level. While these participants might be
labeled as being “in control,” improvements in depres-
sion and behaviors indicate that benefit occurs. Ideally,
analyses would be redone for only the subgroup with
A1C levels greater than 7. However, with only 33 cases
at baseline with A1C values greater than 7, there was
insufficient power to undertake such analyses.
Because there were few differences in the baseline val-
ues of outcome variables between the 6-month intervention
noncompleters and usual-care control group noncom-
pleters, and the noncompletion rate was similar for both
groups, it is likely that any bias caused by dropouts would
have affected both randomized groups similarly. Thus, it is
not very likely that noncompletion was an important factor
affecting the 6-month randomized study. More caution
must be exercised in considering the 12-month outcomes,
as there was no longer a control group for comparison.
With a largely self-selected pool of possible partici-
pants, we cannot claim that our sample of people with
diabetes is representative of a larger population. However,
because it was community based, rather than selected for
high A1C, it is more likely to be representative of a broader
segment of the diabetic population than many previous
intervention studies that concentrated on only the most ill.
Future Directions
A future trial of the DSMP with larger numbers of par-
ticipants with high A1C levels would be desirable and
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allow evaluation of the program for that population.
Additional research is also needed to answer the important
questions of what parts of the intervention are most likely
to lead to positive outcomes and who is most likely to
benefit from the intervention. Analyses of mediators and
moderators of self-management interventions are part of
an intended future research project but beyond the scope
of this study. The role of peer leaders was not addressed in
this study and should be examined in more detail.
Summary
A community-based, peer-led diabetes self-manage-
ment program can have effects lasting for as long as 1 year.
Although the population study had a relatively low base-
line A1C and there was no significant improvement in
A1C, the population gained other benefits from the inter-
vention, including fewer depressive symptoms.
Implications for Diabetes Educators
To meet the needs of a growing diabetes population,
the reach of evidence-based diabetes education must be
expanded. The use of structured, peer-led programs may
be part of the solution. Such programs need the support
and guidance of diabetes educators to reach their full
potential. The DSMP along with its Spanish counterpart,
Tomando Control de Su Salud, may become new tools
for diabetes education.
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