Abstract
Females, especially older women, historically have been excluded from coronary heart disease (CHD) studies. The
PrimeTime program was a randomized clinical trial designed to study the effects of a comprehensive lifestyle management
program (very low-fat vegetarian diet, smoking cessation, stress-management training, moderate exercise, and group support)
on changes in behavioral risk factors among postmenopausal women with CHD. The study also explored program effects on
four psychosocial clusters: coping with stress, distress, social support, and self-efficacy. The program produced significant
behavioral improvements in 4- and 12-month adherence to diet, physical activity, and stress-management in the PrimeTime
women compared to the Usual Care (UC) group. In addition, the PrimeTime participants demonstrated improvements
relative to UC on psychosocial measures of self-efficacy, perceived social support, and ability to cope with stress. Strengths
and weaknesses of the study, and implications for future research are discussed. 1998 Elsevier Science Ireland Ltd.
Keywords: Coronary heart disease; Women; Psychosocial factors; Lifestyle change; Social support
1. Introduction
Coronary heart disease (CHD) is the leading cause
of death among women in the United States [1]. It
accounts for 33% of all deaths in females and for
about 250 000 deaths annually among postmenopausal females [2]. Unfortunately, exclusion of
females, especially older women, from CHD re-
0738-3991 / 98 / $19.00 1998 Elsevier Science Ireland Ltd. All rights reserved.
PII: S0738-3991( 98 )00074-3
178
2. Methods
179
180
Table 1
Measures
Instrument
[ of Items
Time
Outcome Measured
Dietary Changes
Kristal Food Habits Questionnaire [17]
4-day Food Record [18]
20
NA
3 min
80 min
15
9
2 min
2 min
NA
3
20 min
2 min
5
4
2 min
5 min
14
29
5 min
7 min
20
5
5 min
2 min
66
7 min
20 min
Self-efficacy
Self efficacy for Diet and Exercise [27]
Summary Self Care Questionnaire [22]
Social Support
Friend and Family Support [28]
32
1
5 min
1 min
23
10 min
40
7 min
181
3. Results
182
Fig. 1. Numbers of participants at each stage of recruitment for the PrimeTime Program.
UC), and mean grams of animal protein (covariateadjusted 12-month follow-up scores of 21.4 grams
for PrimeTime vs. 35.7 grams for UC). These
183
Table 2
Characteristics of Participants, Non-completers and Decliners by Intervention Condition
Patient Characteristic
PrimeTime
(N 5 16)
Mean (S.D.)
or %
Usual Care
(N 5 12)
Mean (S.D.)
or %
Sig.
Non-completers
or Decliners
(N 5 8)
10 (9)
12 (10)
0.67
5 (6)
9
1
8
1
4
0
1
0.02
6
56
38
64 (9)
0
17
73
62 (11)
0.57
0
1
2
64 (9)
25
69
38
41
75
50
0.62
0.69
0.33
0
33
13
56
6
25
677
17
17
0.59
0
100
0
69
58
0.51
50
44
13
6
38
0.50
37
0
0
63
0
25
50
25
58
8
8
25
0.12
17
25
50
8
94
6
0
0
0
83
0
8
0
8
0.32
6
63
31
6.3 (1.4)
80 (9)
32 (4)
0.92
145 (21)
78 (11)
236 (39)
152 (34)
39 (13)
233 (110)
8
50
42
6.7 (1.4)
79 (15)
31 (1)
0.91 (0.1)
145 (20)
72 (7)
234 (52)
138 (32)
44 (16)
329 (313)
25
13
0.72
0.49
0.68
0.87
0.778
0.94
0.96
0.90
0.33
0.41
0.27
87
0
0
13
0
0
0
100
8.4 (2.9)
81 (15)
30 (1)
0.92 (0.1)
156 (23)
106 (13)
242 (58)
161 (55)
47 (21)
298 (232)
184
Table 3
Behavioral outcomes
Measure
Baseline
Mean (S.D.)
Diet Measures: Fat Intake
% Calories From Fat
(4-day Food Record)
Kristal Food Habits
Questionnaire
Block Fat Screener
(Questionnaire)
Diet Measures: Animal Product
% Calories Saturated Fat
(4-day Food Reccord)
Dietary Cholesterol (mgs)
(4-day Food Record)
Animal Protein (g)
(4-day Food Record)
Physical Activity Outcomes
[ Days Exercise / Last 7 Days
(Questionnaire)
Stanford 7-Day Recall
(Interview)
Stress-Management Outcomes
Structured Interview
Summary of Self-Care
Questionnaire
Significance of MANCOVAa
Assessments
4 months
Mean (S.D.)
12 months
Mean (S.D.)
Individual
Overall
4 months
12 months
0.000
0.001
0.002
0.010
0.074
0.010
0.000
0.003
0.001
0.001
0.002
0.018
Tx
UC
Tx
UC
Tx
UC
Intake
Tx
UC
Tx
UC
Tx
UC
27.0 (10.6)
29.3 (8.1)
2.9 (0.56)
2.2 (0.34)
46.7 (44.8)
51.4 (41.4)
11.9 (4.1)
25.8 (8.9)
1.4 (0.25)
1.9 (0.51)
6.3 (8.7)
34.7 (43.4)
13.1 (7.0)
26.7 (7.9)
1.5 (0.3)
1.9 (0.6)
12.8 (13.6)
45.2 (45.9)
8.8 (4.2)
9.5 (3.3)
173.9 (115)
198.77 (115)
43.7 (18.9)
38.7 (12.4)
2.9 (1.3)
8.2 (3.0)
26.8 (20.9)
147.7 (98.8)
18.9 (6.2)
32.7 (15.2)
3.6 (2.3)
8.7 (3.3)
34.2 (31.8)
171.3 (81.0)
21.8 (8.9)
35.3 (14.7)
Tx
UC
Tx
UC
3.8 (1.8)
2.4 (1.5)
160 (105)
137 (105)
4.8 (1.0)
2.4 (1.1)
164 (101)
128 (87)
4.5 (1.6)
2.5 (1.8)
198 (99)
138 (76)
0.000
0.030
0.497
0.307
Tx
UC
Tx
UC
3.3
2.8
1.4
1.4
5.7
3.3
4.4
3.1
5.5
1.5
3.7
2.6
0.010
0.000
0.041
0.091
(2.7)
(2.7)
(1.7)
(1.7)
(2.1)
(2.6)
(1.5)
(1.9)
(2.1)
(2.0)
(1.8)
(1.9)
4 months
12 months
0.002
0.04
0.001
0.004
0.001
0.050
0.012
0.001
Significance of one-tailed multivariate analysis of covariance (MANCOVA) comparing treatment and control follow-up scores covarying
out the effect of baseline scores, social desirability, and number of comorbid diseases
for the remainder of the program. This was confirmed by carbon monoxide and saliva cotinine
analyses. The one smoker in the UC group has
continued to smoke.
185
Table 4
Psychosocial outcomes
Measure
Significance of MANCOVAa
Assessments
Baseline
Mean (S.D.)
4 months
Mean (S.D.)
12 months
Mean (S.D.)
Individual
4 months
Overall
12 months
7.0
7.9
7.3
8.2
(2.0)
(2.0)
(3.1)
(2.1)
0.281
5.6
4.9
4.3
3.5
(0.7)
(0.9)
(0.4)
(0.5)
0.034
3.4
2.9
4.3
4.0
(0.8)
(1.0)
(0.5)
(0.4)
15.6
11.8
11.5
11.8
86.0
86.8
(4.7)
(3.8)
(3.6)
(4.2)
(15.4)
(9.7)
4 months
12 months
0.071
0.012
0.002
0.040
0.097
0.012
0.120
0.003
0.020
0.414
0.001
0.011
0.042
0.411
0.097
Significance of one-tailed multivariate analysis of covariance (MANCOVA) comparing treatment and control follow-up scores covarying
out the effect of baseline scores, social desirability, and number of comorbid diseases.
186
4. Discussion
There is a paucity of CHD studies with women
[30]. The result is that researchers and practitioners
do not have a clear picture of the long-term benefits
and risks to women of clinical decisions regarding
drug therapy and surgery, nor of the pathophysiology, clinical presentation, risk factors, and treatment
outcomes in women. Even less is known about the
behavioral and psychosocial issues surrounding
lifestyle change in women, such as the impact of
social support, stress, or coping skills on diet,
exercise, cessation of cigarette smoking, or management of stress. Also lacking are studies of psychosocial variables which may contribute to the poor
adherence to healthy lifestyle behaviors by women.
This study addressed several of these issues,
namely, (a) the extent to which an intensive lifestyle
change program is feasible for women with CHD, (b)
their degree of adherence to a lifestyle change
program, and (c) psychosocial factors related to
lifestyle changes.
The results show that on average the PrimeTime
women came very close (1213% calories from fat)
to the stringent Ornish guidelines for reducing
dietary fat to 10% of calories and eliminating animal
products. These changes are impressive and fairly
well maintained over 12 months. The diet proved to
be one of the most successful components of the
program. While the PrimeTime women significantly
increased physical activity, most of the improvement
came later in the program, at the 12-month assessment. PrimeTime participants engaged in more stressmanagement activities than did the UC group, but
187
5. Practical implications
We believe that the initial week-long retreat
followed by twice-weekly meetings was crucial to
the success of the PrimeTime program. These activities created a sense of camaraderie among the
women that would be difficult to achieve otherwise.
A closely knit staff assisted the participants during
each group session. Intensive, concurrent management of multiple lifestyle behaviors may not seem
feasible given the resources of many health care
systems, but may be warranted in populations at
extremely high risk for further CHD-related diseases.
As care for CHD continues to draw large expenditures from limited health care resources, the utility of
relatively inexpensive comprehensive, healthy
lifestyle practices is becoming increasingly apparent
[32]. While cost-effectiveness data were not collected
in this study, the retreat and twice-weekly meetings
were inexpensive compared to coronary bypass
surgery, which costs approximately $39,175 (range:
$24,290$82,744) each [33]. Several hospitals have
adopted the Ornish program; cost comparisons with
standard, more invasive procedures, such as coronary
bypass surgery, are in progress. To reduce health
care costs without having to create new lifestyle
change programs, hospitals or private medical practices could form liaisons that exploit existing community resources (e.g., mall-walking programs, stressmanagement classes).
Research aimed at understanding complex phenomena such as lifestyle change is most appropriately achieved by investigating the combined
effect of multiple behavioral risk factors. Too often,
in an effort to simplify and to control unwanted
factors, studies have focused on a single risk factor
[34]. Lifestyle practices are affected by a wide array
of determinants, including biological, psychosocial,
relational, and cultural factors. To gain a more
comprehensive understanding of womens health and
well-being, it is not enough to examine individual
psychosocial and behavioral practices in isolation.
Acknowledgements
The work reported here was supported by grant
R29 HL50181 from the National Heart, Lung and
188
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