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Patient Education and Counseling 35 (1998) 177188

Behavioral and psychosocial effects of intensive lifestyle


management for women with coronary heart disease
Deborah J. Toobert*, Russell E. Glasgow, Linda A. Nettekoven, Jane E. Brown
Oregon Research Institute, Chronic Illness Research Group, 1715 Franklin Boulevard, Eugene, OR 97403 -1983, USA
Received 19 August 1997; received in revised form 24 March 1998; accepted 28 April 1998

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-

*Corresponding author. Tel.: 1 1 541 4842123; fax 1 1 541


4841108; e-mail: deborah@ori.org

search has been commonplace [3].There is increasing


discussion in the scientific community of the need to
develop a fuller understanding of the impact of heart
disease on women [4].
Of CHD studies that have examined women, most
have focused on expensive pharmacological treatments [5] or surgical procedures. Strategies to promote healthier lifestyles-rather than invasive surgical
or medical procedures-promise to reduce the use of
medical services, help contain costs, prevent initial
or recurrent heart attacks, and improve quality of life
[6].

0738-3991 / 98 / $19.00 1998 Elsevier Science Ireland Ltd. All rights reserved.
PII: S0738-3991( 98 )00074-3

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D. J. Toobert et al. / Patient Education and Counseling 35 (1998) 177 188

Convincing evidence suggests that improvements


in lifestyle behaviors, including smoking cessation
[7], diet [8], exercise [9], and social support [10], can
reduce further risks from heart disease. Despite the
known contribution of multiple lifestyle risk factors
to prevention and treatment of heart disease, studies
intervening simultaneously on combinations of factors, which produces a synergistic response, are
practically non-existent [11].
Of the few studies testing the effects of a comprehensive lifestyle program on CHD risk [12],
participants experienced a range of improvement,
from slowing the rate of CHD progression to regression of coronary lesions, compared to randomized
controls. Ornish et al. [13] performed a randomized
controlled trial of multiple lifestyle changes vs.
Usual Care (UC) in 41 patients with clinically
manifest coronary disease. The program consisted of
a very low-fat diet (less than 10% of calories from
fat), smoking cessation, stress-management training,
moderate aerobic exercise, and group support.
Stenosis regressed in the treatment group and progressed in the UC group. Five participants in this
study (one in the experimental group and four in the
UC group) were women. The Ornish program appears to yield substantial cardiovascular benefits
among men, but the behavioral and psychosocial
processes through which change occurred are unclear. Its generalizability and applicability to highrisk women is uncertain.
The goal of the PrimeTime project was to deliver
and evaluate an Ornish-type intervention to improve
lifestyle behaviors among post-menopausal CHD
women. The project incorporated the results of our
investigations of behavioral and psychosocial factors
in diabetes self-care [14] to guide measurement of
outcomes.
This report compares PrimeTime and UC participants on adherence to targeted lifestyle behaviors,
including diet, exercise, stress-management, and
smoking cessation. Also documented are group
differences on changes in psychosocial factors, including distress (e.g., stress, depression), styles
of coping with stress, self-efficacy, and perceived
support. Biological effects of the program and
24-month follow-up data will be presented separately.

2. Methods

2.1. Study design and eligibility


A randomized study was conducted to investigate
the effectiveness of a comprehensive lifestyle selfmanagement (PrimeTime) program designed for
post-menopausal women with CHD. Participants
were recruited using a variety of methods, including
presentations, mailings, meetings, flyers, advertisements, and coverage from local newsletters, newspapers, radio, and television. Women interested in
participating telephoned project staff, who briefly
described the program and determined eligibility.
Eligible individuals were invited to an orientation,
where project staff described the study and ascertained each womans willingness to commit to the
program. Women completing baseline assessment
(75% of those expressing interest and eligible) were
stratified and then randomized to either the
PrimeTime program or UC. Stratification was by (a)
presence or absence of diabetes, (b) smoking status,
and (c) total / HDL cholesterol ratios of greater than
vs. less than 6.0. Participants were assessed at
baseline, 4 months, and 12 months. The UC group
received no intervention beyond the usual care of
their physician. All participants volunteered their
time.
Post-menopausal females with documented CHD
were eligible for the program. CHD was identified
using disease endpoints from the Framingham Heart
Study [15], including documented atherosclerosis,
myocardial infarction (MI), percutaneous transluminal coronary angioplasty, and / or coronary bypass
graft surgery. Exclusion criteria employed by Ornish
et al. [13], including having other life-threatening
illnesses, myocardial infarction during the preceding
6 weeks, a history of receiving streptokinase or
alteplase, or being scheduled for bypass surgery,
were used. CHD documentation and permission from
primary care physicians and cardiologists were required.

2.2. Primetime intervention


As in the Ornish Lifestyle Heart Trial [13],
PrimeTime participants completed a 7-day retreat to

D. J. Toobert et al. / Patient Education and Counseling 35 (1998) 177 188

begin the intervention. Each woman was encouraged


to bring her spouse or support partner who had
agreed to assist her with the program. The retreat
was designed to serve several purposes: (a) provide
an opportunity for participants to become emotionally bonded through common experiences and a series
of exercises promoting feelings of support, (b)
maximize compliance with the initial intervention by
housing participants together at a hotel, and (c) help
participants learn and start practising the basic skills
to make the required lifestyle changes. The
PrimeTime program including the retreat, was provided without charge to participants.
The daily schedule included cooking classes
featuring techniques and no- and very low-fat foods
recommended in the Reversal Diet [6]. Retreat meals
were planned by the project dietician to follow these
guidelines (e.g., vegetarian, less than 10% calories
from fat), and were prepared by the hotel cooking
staff under her direction. The dietician briefly discussed the nutritional and low-fat content of each
meal as well as the benefits of a high-fiber diet.
Study participants received instruction in, and had
an opportunity to practice, stress-management techniques twice per day during the retreat, led by a
certified Yoga instructor. The techniques included
Hatha Yoga stretches, progressive deep relaxation,
deep breathing, meditation, and directed or receptive
imagery (i.e., visualizing improvements occurring in
the heart). The purpose was to increase the participants sense of relaxation, concentration, and awareness. Participants were asked to practice these techniques for at least 1 h per day after the retreat, and
were given a 1-h audiocassette tape to assist them.
Daily group physical activity sessions included
warm-up, walking or aerobics, and cool-down led by
an American College of Sports Medicine-certified
exercise physiologist. Participants were individually
prescribed exercise intensity based on treadmill
exercise test performance. Following the retreat, the
intervention exercise program required participants
to engage in 1-h sessions at least 3 days each week.
Retreat evenings ended with small, relatively
unstructured group sessions for sharing feelings.
Participants discussed difficulties with program components and emotional issues as they arose, practised
communication skills, and engaged in exercises to

179

build group support and decrease feelings of social


isolation. Group leaders emphasized unconditional
positive regard, and encouraged participants to share
feelings rather than thoughts and to refrain from
offering advice.

2.2.1. Weekly meetings


Twice-weekly 4-h meetings followed the retreat
for the next 15 months. Participants were encouraged
to have their spouses or partners accompany them to
each meeting. Each meeting followed a sequence
similar to the retreat schedule: (a) supervised exercise training, (b) Yoga and relaxation led by a trained
instructor, (c) one catered dinner or potluck, and (d)
small group discussions.
2.2.2. Diet
PrimeTime participants were instructed to adhere
to the Reversal Diet [6], which contains no animal
products, other than egg whites and nonfat yogurt,
and no added oils or other concentrated fats. The
high-fiber diet contains less than 10% of calories
from fat, 70% to 75% of calories from carbohydrates, 15% to 20% of calories from protein, and 5
milligrams of cholesterol per day.
2.2.3. Smoking cessation
The smoking cessation component of the
PrimeTime program was based on the work of
Lando, McGovern, and Sipfle [16] and the experience of investigators at Oregon Research Institute. The program, designed for the one smoker in
the intervention group, featured an initial personal
consultation and two brief follow-up contacts.
2.2.4. Fading of intervention
The twice-weekly group meetings were reduced to
2-week intervals for 6 months, then reduced to once
per month for the final 3 months.
2.3. Measures
Multiple measures of both adherence / self-care and
psychosocial constructs were used, including, where
feasible, self-monitoring, and interviewer rating measures as well as self-reports. All measures were
administered at baseline, and 4-, and 12-month

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D. J. Toobert et al. / Patient Education and Counseling 35 (1998) 177 188

follow-up. Table 1 summarizes the measures, the


author(s), and respondent time burden. More details
on each instrument are available from the authors.

and average percent calories from fat from the 4-day


food record. The second set, Animal Products,
consisted of three scores from the 4-day food record:
percent calories from saturated fat, milligrams of
dietary cholesterol, and grams of animal protein. The
final dietary set, Fiber, consisted of one dimension
from the FHQ which measures fruit and vegetable
intake, grams of fiber from the 4-day food record,
and the fruit / vegetable / fiber screener summary
score.

2.3.1. Dietary outcomes


To document dietary changes, participants completed the Kristal Food Habits Questionnaire (FHQ)
[17], a 4-day food record [18], and two paper-andpencil screeners-one for dietary fat intake and one
for fiber, fruit, and vegetables [19,20]. Three sets of
multivariate analyses were employed to assess group
differences on these measures. The first set, entitled
Fat Intake, consisted of the summary score from
the FHQ, estimated fat intake from the fat screener,

2.3.2. Exercise outcomes


Two measures were collected of exercise self-care
behaviors: The Stanford 7-Day Recall [21] and the

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

Behaviors associated with eating low fat foods


Average daily calories consumed from fat, saturated fat,
animal protein, dietary cholesterol
Estimated daily grams of fat
Weekly frequency of fruit, fiber and vegetable intake

NA
3

20 min
2 min

Average kilocalories expended per day


Number of days and amount of time engaged in physical
activity in past 7 days

5
4

2 min
5 min

[ of days in past week performed stress-mgmt. activities


Frequency of stress-management practice (Yoga,
relaxation, meditation, visualization)

14
29

5 min
7 min

Perceived lack of control or ability to cope w / life events


Three dimensions: manageability, meaningfulness and
comprehensibility of life
Depression
Depression, anxiety, behavioral-emotional control

NCI Block Fat Screener [19]


Block Fruit / Fiber / Vegetable Screener [20]
Exercise Self-care Behaviors
Stanford 7-Day Recall [21]
Summary of Self Care Q [22]
Stress-management activities
Summary of Self-Care Q [22]
Structured Face-to-Face Interview
Psychosocial process measures
Distress
Perceived Stress [24]
Sense of Coherence
Depression (CES-D)
MOS-36 Mental Health
Coping
Ways of Coping [25]

20
5

5 min
2 min

66

7 min

Problem Solving [26]

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

Interpersonal Support Evaluation [29]

40

7 min

Total Assessment Time: Approximately 3 h

Coping styles employed in stress encounters:


active and passive coping
Overall problem solving skill and number of different
solutions proposed
Confidence in performing exercise and diet behaviors
Confidence in decreasing fat in next month
Perceived social support specific to health-related eating
and exercise behaviors
Perception that others will provide assistance and
emotional support when needed

D. J. Toobert et al. / Patient Education and Counseling 35 (1998) 177 188

composite score from our Summary of Self-Care


Activities Questionnaire [22]. Stress-management
activities were assessed using a structured interview
and a composite of five questions from the Summary
of Self-Care Activities Questionnaire [22]. Smoking
cessation was measured by self-report, confirmed by
carbon monoxide and saliva cotinine analysis.

2.3.3. Psychosocial process measures


The psychosocial process measures are grouped
into four categories: distress (e.g., stress, depression,
sense of coherence), styles of coping with stress,
self-efficacy, and perceived support. To account for
the potential impact of socially desirable response
bias on all self-report measures, outcome scores were
adjusted using the Balanced Inventory of Desirable
Responding [23] as a covariate. Stress was measured
with the Perceive Stress Scale [24], and coping was
measured using the revised Ways of Coping [25] and
a problem-solving interview [26]. Self-efficacy was
assessed using the Self-Efficacy for Diet and Exercise Behaviors [27] and one item from a revision of
the Summary of Diabetes Self-Care Activities Questionnaire [22]. Three measures were used as indices
of social support: two measures developed by Sallis
et al. [28]-the Friend Support for Eating and Exercise
Scale (FRSE) and the Family Support for Eating and
Exercise Scale (FAMSE)-and, for general social
support, the Interpersonal Support Evaluation List
(ISEL) [29].
2.4. Statistical analyses
A series of one-way analyses of variance
(ANOVA) were conducted to evaluate baseline
equivalence of conditions and subject attrition. Given
the small sample size and large number of measures,
multivariate analyses of covariance (MANCOVA)
were used to control experiment-wide error rate in
evaluating intervention effects on the three behavioral components and four psychosocial outcomes. Where the overall MANCOVA was significant, follow-up analyses of covariance (ANCOVAs)
were conducted to identify specific variables accounting for the differential change. In all analyses,
baseline scores on the dependent variable, the socially desirable responding scale [23], and number of
other chronic diseases served as covariates. The

181

MANCOVAs were repeated using data collected at 4


and 12 months.

3. Results

3.1. Participation and sample characteristics


Of 98 women who responded to recruitment
notices and were screened for eligibility, 28 were
randomized into the study (see Fig. 1).
No significant group differences were found on
any demographic and medical history variables
except number of co-morbidities (see Table 2). Most
patients had lived with their heart disease for a
number of years, and 97% of the baseline sample
had other chronic diseases, most commonly arthritis
and hypertension (both affecting 68% of subjects).
The UC group had an average of 4.1 other chronic
illnesses and the PrimeTime group had an average of
2.6 [F(1, 26) 5 5.1, P , 0.02]. Table 2 includes the
limited information available from eligible women
who declined to participate or dropped out of the
study.

3.2. Behavioral outcomes


Attendance at the twice-weekly meetings was
good, with PrimeTime women attending 81% of the
118 sessions (range 5 55% to 97%) and PrimeTime
support partners attending 70% of the sessions
(range 5 54% to 88%).
As shown in Table 3, the PrimeTime group
showed significantly greater 4- and 12-month improvement in fat and animal product intake than did
the UC group in overall MANCOVAs. There were
no significant differences in fiber intake. Data from
4-day food records indicated that the intervention
produced large, significant, and consistent improvements in mean percent calories from fat (covariateadjusted 12-month follow-up values of 14% for
PrimeTime vs. 26% for UC), mean percent calories
from saturated fat (covariate-adjusted 12-month follow-up levels of 3.8% for PrimeTime vs. 8.5% for
UC), mean milligrams of dietary cholesterol
(covariate-adjusted 12-month follow-up scores of 41
milligrams for PrimeTime vs. 164 milligrams for

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D. J. Toobert et al. / Patient Education and Counseling 35 (1998) 177 188

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

changes occurred even though both groups were


slightly below 30% calories from fat at baseline, a
relatively low level of fat intake compared to nation-

D. J. Toobert et al. / Patient Education and Counseling 35 (1998) 177 188

183

Table 2
Characteristics of Participants, Non-completers and Decliners by Intervention Condition
Patient Characteristic

Years Diagnosed with CHD


Clinical Cardiac Events
Nonfatal MI** or CABG**
Primary PTCA**
Angiographically Determined
Atherosclerosis
Co-morbidity
%With No Other Disease
% With 1-2 Other Disease(s)
% With $ 3 Other Diseases
Age
Medications
% Taking Lipid-lowering
% Taking Blood Pressure-lowering
% Taking Estrogen Replacement Therapy
Marital Status
% Married
% Divorced / Single
% Widowed
Having a Partner With Whom to Attend
Program (%)
Present Living Arrangement
% With Spouse
% With Spouse and Children
% With Children
% Alone
Level of Education Achieved
% 7th to 11th Grade
% High School Graduate
% Some College
% College / Univ. Graduate
Ethnic, Racial Background
% Caucasian
% Native American, Alaskan
% Hispanic
% African American
% Other
Current Smoking Status
% Current Smoker
% Ex-Smoker
% Non-Smokers
Glycosylated Hemoglobin (%)
Weight (kg)
Body Mass Index
Waist / Hip Ratio
SBP (mm Hg)
DBP (mm Hg)
Total Cholesterol (mg / dl)
LDL Cholesterol (mg / dl)
HDL Cholesterol (mg / dl)
Plasma Triglycerides (mg / dl)

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)

For comparison of the Usual Care vs. the PrimeTime participants.


** MI indicates myocardial infarction; CABG, coronary artery bypass graft surgery, and PTCA, percutaneous transluminal coronary
angioplasty.

184

D. J. Toobert et al. / Patient Education and Counseling 35 (1998) 177 188

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

al averages. Improvements were more substantial at


4 months.
Follow-up ANCOVAs revealed significantly greater improvements for the PrimeTime group on the
summary score from the FHQ at 4 and 12 months.
The overall fat intake summary score from the Block
fat screener also showed substantial improvements
for the PrimeTime group at 4 and 12 months
compared to UC, but reached significance at 12
months only. Despite impressive dietary improvements, the PrimeTime group did not meet the
recommended Ornish guidelines of consuming 10%
or fewer calories from fat and of having 10 milligrams or less of dietary cholesterol per day.
Physical activity results parallel the dietary selfcare outcomes. Significant overall effects were found
on the MANCOVAs for physical activity outcomes at
both 4 and 12 months. Follow-up univariate AN-

COVAs revealed that this was due to substantial


increases in the number of daily exercise sessions
and minutes spent engaged in physical activity for
PrimeTime participants compared to the UC group,
as measured by the Summary of Self-Care Questionnaire.
In terms of stress management, results indicated
the PrimeTime group significantly increased the
number of times per week they engaged in stressmanagement activities compared to the UC condition. These increases were detected by both the
Structured Interview and the Summary of Self-Care
Questionnaire at 4 and 12 months. The PrimeTime
participants showed a slight, non-significant decrease
in practice of stress-management techniques at the
12-month follow-up.
The one smoker in the PrimeTime group successfully quit during the retreat and remained abstinent

D. J. Toobert et al. / Patient Education and Counseling 35 (1998) 177 188

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

strategies employed in carrying out the lifestyle


activities and (b) the interviewer-rated quality of the
strategies employed.
Significant overall effects were found in the
MANCOVAs for self-efficacy at both 4 and 12
months. Follow-up univariate ANCOVAs revealed
that PrimeTime participants significantly increased
scores reflecting Self-efficacy for Lowering Fat
Intake while scores in the UC group decreased at 4
months. These results were not maintained at 12
months: The PrimeTime group remained elevated
from baseline but dropped slightly from 4 months.
Both groups decreased scores measuring Self-Efficacy for Diet and Exercise Behaviors [27] over time,
but the UC group decreased significantly more than
the PrimeTime group at 4 and 12 months.
The overall 12-month follow-up MANCOVA result on social support was significant (P 5 0.012)

3.3. Psychosocial outcomes


The overall MANCOVAs examining the six distress summary scores were nonsignificant at 4 and 12
months. The overall MANCOVA results across the
five coping with stress summary scores were nonsignificant (P 5 0.07) at the 4-month assessment. However, a significant overall effect (P 5 0.012) was
found at 12 months. Follow-up univariate analyses,
shown in Table 4, indicated that the effect was due
primarily to significantly larger improvements among
the PrimeTime participants in (a) the number of

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

Coping with Stress


Questionnaire:
Ways of Coping
Tx
6.9 (2.0)
7.3 (1.9)
Active
UC
7.5 (3.3)
7.4 (1.9)
Ways of Coping
Tx
7.0 (2.5)
7.8 (3.0)
Passive
UC
9.1 (3.3)
7.9 (2.1)
Interview:
Problem Solving
Tx
5.3 (1.0)
5.2 (1.0)
Int. [ Strategies
UC
4.6 (0.8)
5.4 (1.1)
Problem Solving
Tx
3.4 (0.5)
3.9 (0.5)
Int. Global Rating
UC
3.5 (0.5)
3.6 (0.5)
Self-Efficacy (Paper and Pencil Questionnaires)
Decreasing Fat
Tx
3.2 (0.7)
3.7 (0.5)
Intake
UC
3.1 (0.5)
2.8 (1.0)
Diet and Exercise
Tx
4.4 (0.4)
4.3 (0.4)
UC
4.3 (0.4)
3.9 (0.5)
Perceived Support (Both are Paper and Pencil Questionnaires)
Sallis Total
Tx
13.7 (4.5)
15.2 (4.1)
Positive Score
UC 11.5 (3.6)
12.1 (3.2)
Sallis Total
Tx
13.9 (6.0)
12.6 (5.7)
Negative Score
UC 12.1 (5.4)
12.6 (3.9)
Interpersonal
Tx
60.1 (5.4)
62.8 (7.3)
Support Eval.
UC 63.3 (7.3)
63.3 (4.9)
a

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

D. J. Toobert et al. / Patient Education and Counseling 35 (1998) 177 188

whereas the 4-month follow-up MANCOVA result


was not (P 5 0.097). The 12-month follow-up analysis revealed that PrimeTime participants increased
their perception of positive social support on the
Friend and Family Support for Eating and Exercise
Scale compared to the UC group. Although participants in PrimeTime, compared to the control condition, perceived decreases in non-supportive behaviors by friends and family at both 4 and 12
months, these differences did not achieve statistical
significance.

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

PrimeTime participants had difficulty in regularly


practising stress-reduction techniques for a variety of
reasons, including structural problems with their
bodies, other chronic diseases, and lack of time.
One of the strongest psychosocial findings, statistically and anecdotally, was the greater ability of the
PrimeTime women to generate multiple, high-quality
strategies for coping with stress. For example, during
their
twice-weekly
stress-reduction
sessions,
PrimeTime women learned to breathe deeply. Many
women reported that the breathing techniques gave
them a portable tool to use in stressful situations.
The PrimeTime women also generated good strategies for overcoming barriers to following the exercise and dietary guidelines. For instance, the women
found a variety of ways to maintain a low-fat
vegetarian diet while eating meals away from home.
They brought their own food (e.g., non-fat dressings
to restaurants, brown bag lunches with friends and
relatives), discovered eateries serving healthful
foods, informed friends and relatives about their
program, and in many cases successfully persuaded
their children and grandchildren to join them in
eating healthier. Group differences were not significant on the Coping with Stress MANCOVA at 4
months but the PrimeTime participants continued to
improve their skills, and differences reached statistical significance by the 12-month follow-up.
The self-efficacy results indicate that during the
first 4 months of the program, the PrimeTime women
felt more capable of decreasing their fat intake. As
the reality of maintaining this low level over the long
haul became evident, their confidence slipped, along
with a slight but non-significant increase in their fat
intake. Self-efficacy levels for the UC women, who
were not asked to make dietary changes, also declined slightly over the 12-month program.
While there is strong research linking social
support and physical health for men, there are few
studies for women, especially women with CHD.
Several aspects of social support are pertinent to
understanding lifestyle change in women. These
include: (a) the measurement of social support as a
multi-faceted concept, (b) the link between social
support (in its many guises) and the ability to
successfully engage in healthy lifestyle practices, and
(c) the link between social support and CHD risk
factors and mortality.

D. J. Toobert et al. / Patient Education and Counseling 35 (1998) 177 188

The PrimeTime study provides important clues


about the different aspects of social support, which
may help guide future research. PrimeTime participants increased self-perceptions of both positive (supportive) and negative (non-supportive) behaviors
directed towards them by family members (or close
friends), specific to health-related eating and exercise
behaviors. Anecdotally, we know our measures
failed to tap the increased social network that
accrued to the PrimeTime women, which may be
equally or even more important. After meeting for
nearly 2 years, participants developed friendships
with a large cadre of other women who shared an
intimate understanding of their health efforts. More
research is needed to assess this aspect of social
support.
It is unclear whether varying levels of family
support had varying effects on the study participants.
One-third of the PrimeTime women had fully supportive husbands (e.g., came to the meetings, ate the
same food, engaged in physical activity and stressmanagement practices with them), another third had
partially supportive husbands who participated in at
least one of the program components (e.g., came to
the meetings but refused to eat the same food), and
the remaining women were either single or their
husbands refused to attend. The sample size is not
large enough to permit statistical analyses of outcomes across these subgroups, but we believe the
performance of lifestyle components of the program
was unrelated to the level of support PrimeTime
women received from their husbands or partners.
An important limitation of this study is the small
sample size of highly motivated women. A larger
sample (at least 200, including adequate numbers of
minority participants) would permit the use of structural equation modeling to help evaluate complex
and potentially reciprocal relationships among the
variables, provide an analysis of program components, and demonstrate the feasibility of implementing comprehensive lifestyle changes with larger,
more diverse, and possibly less-motivated populations. Even with a small sample, the findings of
relatively consistent behavioral effects, which were
maintained over time, are impressive. Further, the
selection procedures did not differ radically from
several larger scale trials with predominantly male
study participants [8,31].

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

D. J. Toobert et al. / Patient Education and Counseling 35 (1998) 177 188

Blood Institute of the National Institutes of Health,


Bethesda, Maryland.

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