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Reduction of global cardiovascular risk with nutritional versus nutritional plus

physical activity intervention in Colombian adults

Article  in  European Journal of Cardiovascular Prevention and Rehabilitation · January 2007

DOI: 10.1097/01.hjr.0000219114.48285.7a · Source: PubMed

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 Original Scientific Paper

Reduction of global cardiovascular risk with nutritional

versus nutritional plus physical activity intervention in
Colombian adults
Carlos Olimpo Mendivila, Edgar Cortésb, Iván Darı́o Sierraa, Andrea Ramı́rezb,
Luz Milena Molanoc, Luz Everlyn Tovarb, Carolina Vargasc, Nancy Granadosb
and Clara Eugenia Péreza

a
Lipids and Diabetes Division, Physiological Sciences Department, bHuman Movement Department
and cNutrition Department, Faculty of Medicine, National University of Colombia, Bogotá,
Colombia.
Received 20 October 2005 Accepted 14 March 2006

Background Cardiovascular disease is a major cause of morbidity/mortality in non-developed countries. Reports of the
effects of non-pharmacological interventions on global cardiovascular risk in Latin American adults, however, are scarce.
Objective To compare the change in global cardiovascular risk induced by a tailored, Adult Treatment Panel-III compliant
nutrition program versus the same program with addition of supervised, regular physical activity in Colombian adults.
Design The study was a randomized, controlled trial.
Methods Seventy-five Colombian patients aged 40–70 years and with Framingham-estimated global cardiovascular risk of
1% or higher were randomly assigned to a nutritional intervention program or a combined nutritional intervention–physical
exercise program for 16 weeks. Patients underwent medical and anthropometric evaluation, bioelectrical impedance, lipid
profile and Framingham global cardiovascular risk determination at baseline and at the end of follow-up.
Results The groups were comparable at baseline; 21 persons in the nutritional intervention program group and 27 in the
nutritional intervention–physical exercise program group completed the follow-up. Global cardiovascular risk modification
(mean ± SE) was – 2.04 ± 1.1 absolute percentage points (relative reduction 19.6%) in the nutritional intervention–physical
exercise program group, compared with 0.23 ± 0.9 (relative increase 2.8%) in the nutritional intervention program group.
Mean difference in global cardiovascular risk modification between groups reached borderline statistical significance in
ANCOVA (P = 0.054). Reductions in systolic and diastolic blood pressure, waist circumference and low-density lipoprotein
cholesterol were similar, but the nutritional intervention–physical exercise program group achieved significantly greater
improvements in body weight, body mass index, percentage body fat and high-density lipoprotein cholesterol.
Conclusions Our data suggest that a structured nutritional intervention–physical exercise program is more efficacious than
a nutritional intervention program in the reduction of global cardiovascular risk and cardiovascular risk factors, in only
16 weeks. Eur J Cardiovasc Prev Rehabil 13:947–955
c 2006 The European Society of Cardiology

European Journal of Cardiovascular Prevention and Rehabilitation 2006, 13:947–955

Keywords: lifestyle, risk reduction, hyperlipidemia, atherosclerosis, exercise, diet therapy, nutrition
Sponsorship: The only source of all support for this study was the National University of Colombia.

Part of this work was previously presented at the Colombian Congress of Cardiology in November, 2003; in an oral presentation. No part of this work has been previously
published.

Correspondence and requests for reprints to Dr Carlos Olimpo Mendivil Anaya,

Introduction
División de Lı́pidos y Diabetes, Laboratorio 418, Facultad de Medicina, Ciudad Cardiovascular atherosclerotic diseases are a leading
Universitaria, Universidad Nacional de Colombia, Bogotá, 01, Colombia.
Tel: + 57 1 3165000; fax: + 57 1 3165000;
cause of death and disability all around the world,
e-mail: comendivila@unal.edu.co even in the poorly developed countries, which are
1741-8267

c 2006 The European Society of Cardiology

Copyright © European Society of Cardiology. Unauthorized reproduction of this article is prohibited.

 948 European Journal of Cardiovascular Prevention and Rehabilitation 2006, Vol 13 No 6
facing a rise in the incidence of conditions
once considered to be exclusive to industrialized
societies [1].
Interventions aimed at lowering the burden of cardiovas-
cular risk factors have consistently shown that reductions
in serum low-density lipoprotein (LDL) cholesterol and
blood pressure, as well as increases in high-density
lipoprotein (HDL) cholesterol produce significant
reductions in the risk of developing cardiovascular events
in the long term [2]. There is a greater abundance of
studies evaluating pharmacological interventions, how-
ever, than those evaluating lifestyle interventions. A
prominent exception is the Lyon Heart Study [3], which
demonstrated a huge impact of a Mediterranean-style
diet in the prevention of cardiovascular outcomes in just
46 months.
In Colombia, cardiovascular diseases account for 27% of
total deaths [4], and despite the lack of a general
population risk factor survey, a small epidemiologic study
[5] showed an alarming risk factor profile in the
population: The prevalence of overweight was more than
40%, about 10% of the population was obese, and 66.7% of
the people were out of their Framingham risk category-
defined lipid goals.
Given the relevance of the problem, and the limited
resources that healthcare systems have for cardiovascular
prevention in developing countries, it is important to
establish the efficacy of non-pharmacological interven-
tions (i.e. diet and exercise) in the modification of
cardiovascular risk factors in adult persons.
We performed a randomized, controlled clinical trial
focused on the changes induced by an Adult Treatment
Panel (ATP) III-compliant nutrition intervention pro-
gram (NIP) versus a program including the same
nutritional intervention plus physical exercise (nutrition
and physical exercise program; NPEP), in Colombian
adults with a Framingham-estimated global cardiovascular
risk (GCVR) of over 1%.
Methods
Patients
Eligible patients comprised all adults between 40 and
70 years old affiliated to the health insurance company of
the National University of Colombia (UNISALUD).
Employing data from a screening campaign performed
on UNISALUD affiliates, we obtained a list of adults
in the desired age range and with a 10-year Framin-
gham-estimated cardiovascular risk equal to or greater
than 1%.
Sample size was determined according to the
formula published by Wittes [6] for use in randomized
Copyright © European Society of Cardiology. Unauthorized reproduction of this article is prohibited.
clinical trials:

 2
2 Z1ða=2Þ þ Z1b
n ¼ 2s ð1Þ
DA
For an expected variability (s) in the main outcome
measure (change in GCVR) of one absolute percent
point, a probability of type I error (a) of 5%, and a power
of 90% (b = 10%) to demonstrate at least a difference
(DA) of one absolute percent point in GCVR between the
intervention groups. The required sample size was a
minimum of 21 individuals in each group, but to keep
statistical power despite an expected withdrawal rate of
40%, a total of 80 patients from the above-mentioned
UNISALUD database were intended to be recruited by
voluntary participation.
Exclusion criteria included diabetes mellitus, body mass
index (BMI) under 18.5 kg/m2, chronic renal failure,
physical disability preventing appropriate adherence to
exercise, serious disease of the gastrointestinal tract,
secondary or malignant hypertension, documented recent
myocardial infarction (less than 3 months ago), unstable
angina, or severe tooth loss.
Design
A total of 80 apparently eligible patients were contacted
by telephone and invited to an informative lecture where
the objective, duration, interventions and logistic details
of the study were explained. Those patients who fulfilled
inclusion and exclusion criteria underwent an initial
evaluation consisting of medical interview emphasizing
smoking status and previous medical conditions, physical
exam including weight, height, waist circumference,
blood pressure, bioelectrical impedance (Tanita 2001
T-WF bioelectrical impedance meter; Tanita Corporation,
Arlington Heights, Illinois, USA), skin folds (triceps,
abdominal, iliac crest, subscapular, thigh and calf);
physiokinetic assessment of strength and flexibility of
main body segments, subjective perception of exercise
intensity by Borg’s scale, and serum lipid profile. Baseline
GCVR according to the Framingham equation [7] and
percentage body fat according to the Yuhasz equation [8]
were calculated from these data. Only biolectrical
impedance-estimated percentage body fat analysis, how-
ever, are reported in this paper.
Data on habitual food consumption were also obtained,
and approximated daily intake of major nutrients was
determined employing the United States Department of
Agriculture tables of food composition [9]. After the
baseline evaluation, all patients were randomly assigned
to group A (NIP) or group B (NPEP) by a computer
random number generator. The design of the whole study
is summarized in Fig. 1.
 Nutritional plus activity intervention Mendivil et al. 949

Fig. 1

Patients affiliated to UNISALUD aged 40 to 70

years and with GCVR ≥ 1%

GCVR:
Sample selection (80 individuals) - Sex
- Age
- Total cholesterol
75 patients fulfillng inclusion/exclusion criteria - HDL cholesterol
- Systolic blood
pressure/treatment
- Smoking status
Initial evaluation
LDL cholesterol
Triglycerides

Weight/Height/BMI

% Body fat
(skinfolds and bioelectrical
impedance)

Physiokinetic evaluation
Randomization

37 patients received a tailored, ATP-III 38 patients received the same nutrition program plus a
compliant nutrition program (NIP group) supervised, regular physical activity program (NPEP group)

16 weeks 16 weeks

21 individuals completed follow-up 28 individuals completed follow-up

in the NIP group in the NPEP group

GCVR/Lipid profile/Blood pressure/BMI GCVR/Lipid profile/Blood pressure/BMI

% Body fat/Physiokinetic evaluation % Body fat/Physiokinetic evaluation

Comparison and analysis

Summary of the study design. UNISALUD, health insurance company of the National University of Colombia; GCVR, global cardiovascular risk;
BMI, body mass index; HDL, high-density lipoprotein; LDL, low-density lipoprotein.

At the end of the study, all completers underwent the
medical, anthropometric, biochemical and physiokinetic
evaluations again.
Interventions
The daily caloric intake (DCI) requirement was calcu-
lated as the product of the ideal body weight (IBW)
(determined by the Metropolitan Life Insurance Com-
pany ideal weight tables [10]) and the activity-associated
caloric expenditure (ACE):
DCI = IBW  ACE
The ACE was estimated according to three categories,
depending on the usual activities of participants: low
ACE (25–30 cal/kg per day), individuals who spend most
of the time seated, and work indoors; medium ACE
(30–35 cal/kg per day), individuals who spend most of the
time stood, but seldom move weights, and work primarily
indoors; high ACE (35–40 cal/kg per day), individuals who
work moving weights, or work most of the time outdoors.
If the patient had a BMI greater than 25 kg/m2, a deficit
of 400 calories was imposed on calculated daily caloric
intake, and after this correction was made the daily
caloric intake of all participants was approximated to the
closest 200 calories (i.e. a patient with a calculated daily
caloric intake of 1762 calories was prescribed a 1800
calorie diet), to make elaboration of diets more practical.
The distribution of calories was made according to

Copyright © European Society of Cardiology. Unauthorized reproduction of this article is prohibited.

 950 European Journal of Cardiovascular Prevention and Rehabilitation 2006, Vol 13 No 6
Table 1 Outline of the physical activity program applied in the nutritional intervention and physical activity group
Phase Week Warm-up
Phase I, conditioning and adaptation 1–5 15
(8 weeks) 6–8 10
Phase II, modification of risk factors 9–20 10
(12 weeks)
Phase III, maintenance of achieved 21–24 10
modifications (4 weeks)
Frequency of exercise sessions 1–8
9–16
%MHR, percentage of maximum heart rate.
current National Cholesterol Education Program NCEP-
ATP III recommendations (50% carbohydrates, 30% fat,
20% protein, saturated fat less than 7%, polyunsaturated
fat up to 10%, monounsaturated fat up to 20%,
cholesterol 200 mg or less and fiber 30 g or more per
day) [11]. The diets were adjusted to local eating habits
and preferences, and were elaborated and explained by
two registered dietitians.
The physical activity in the NPEP group was structured
in a progressive, 16-weeks program, consisting of three
consecutive phases as follows: phase I, conditioning and
adaptation; phase II, modification of risk factors, and
phase III, maintenance of achieved modifications. In each
phase the exercise frequency, time devoted to warm-up,
duration of the session, preferred activities and percent of
maximum heart rate achieved was different. The exercise
program is outlined in Table 1.
Activities that comprised the exercise program were
aerobic dancing, soccer, basketball, recreational kick-
boxing and a few resistance activities to strengthen
localized muscular groups. Heart rate during exercise was
monitored using POLAR heart rate monitors (Polar
Electro Oy, Kempele, Finland). Blood pressure was
measured before and at the end of every exercise session.
All sessions were directed and supervised by three trained
physical therapists.
Follow-up
Study participants were evaluated every 2 weeks in
compliance evaluations at the division, through the
16 weeks of follow-up (weeks 2, 4, 6, 8, 10, 12 and 14).
In every compliance evaluation, a food habits question-
naire was applied inquiring about daily consumption of
fruits/vegetables, use of recommended oil for salad
dressing (olive, canola), use of low fat dairy products,
use of recommended sweetener (non-caloric), and
number of carbohydrate servings per day. All patients
participated in an initial educational session about general
dietary guidelines (focusing on the relevance of saturated
fat reduction), and had personal instruction on nutrition,
cardiovascular risk, and importance of adherence; admin-
Copyright © European Society of Cardiology. Unauthorized reproduction of this article is prohibited.
Duration (min) Intensity
Aerobic exercise Cool-down Total time %MHR
20 10 45 50–55
30 5 45
30 5 45 60–70
45 5 60
3 times a week
5 times a week
istered by a registered dietitian in compliance evaluations
(follow-up evaluations lasted 30 min and were individual).
In the same evaluations, body weight, bioelectrical
impedance, percentage body fat and waist circumference
measurements were performed. A home visit was made in
17 patients selected randomly and irrespective of
intervention group, to ascertain the use of recommended
foods and verify stocks of those foods.
In the NPEP group, an attendance list was kept in order
to document adherence to exercise sessions. Blood
pressure and heart rate were measured before and after
each exercise session.
Statistical analysis
Initial differences in continuous variables between
intervention groups were analyzed using an unpaired
t test. Initial differences in categorical variables between
intervention groups were analyzed by a w2 test. The
primary efficacy variable was change in GCVR. Secondary
efficacy measures included change in body weight, BMI,
estimated percentage body fat, waist circumference,
blood lipids and blood pressure. The effects of the
interventions on GCVR, lipid profile, anthropometric
measurements and blood pressure were compared by
analysis of covariance (ANCOVA), using the randomiza-
tion group as factor, and initial value of the continuous
variable as covariable. Differences in risk factor modifica-
tion in subjects with or without excess weight were
compared by a two-way analysis of variance (ANOVA),
with intervention group and BMI category as factors; the
finding of a significant interaction term was considered
proof that overweight influenced the effect of the
intervention on a given outcome. All statistical tests
were two-tailed and had a significance level of 5%
(a = 0.05). All efficacy analyses were performed for the
completing population. Statistical analyses were executed
in SPSS for Windows, Version 11.0 (SPSS, Chicago,
Illinois, USA).
Ethical aspects
After receiving complete information about the study
purpose, mechanism and possible risks, all patients gave
written informed consent.
 Nutritional plus activity intervention Mendivil et al. 951

Table 2 Baseline characteristics of the 75 adults randomized to a nutritional intervention program or a nutrition plus physical intervention
program
Variable Global NIP NPEP P

Age (years) 51.35 (49–53.6) 53.04 (49–56) 50.03 (47–53) 0.189

Women (%) 50.0 42.9 55.6 0.281
Framingham 10-year global cardiovascular risk (%) 10.4 (8.2–12.6) 10.4 (6.7–14.1) 10.4 (7.5–13.2) 0.981
Family history of HT (%) 60.4 47.6 70.4 0.097
Family history of DM (%) 37.5 28.6 44.4 0.205
Family history of CD (%) 41.7 33.3 48.1 0.231
Smokers (%) 22.9 28.6 18.5 0.316
Body weight (kg) 68.5 (65.4–71.5) 68 (63.7–72.2) 68.8 (64.2–73.4) 0.776
BMI (kg/m2) 26.9 (25.6–28.1) 27.5 (25.8–29.3) 26.3 (24.6–28.1) 0.332
Prevalence of BMI Z 25 kg/m2 (%) 64.6 71.4 51.3 0.382
Bioelectrical impedance body fat (%) 27.7 (25.2–30.2) 29.3 (25.6–33.06) 26.5 (22.9–30.1) 0.277
Waist circumference (cm) 87.7 (84.6–90.7) 89.3 (85.01–93.6) 86.4 (81.9–90.9) 0.356
Systolic BP (mmHg) 122.2 (118.4–126.1) 121.6 (116.2–127.1) 122.7 (117.0–128.4) 0.777
Diastolic BP (mmHg) 83.1 (79.1–87.1) 80.4 (77.1–83.8) 85.1 (78.4–91.8) 0.242
Borg (subjective units) 10.5 (9.8–11.2) 10.5 (9.7–11.2) 10.6 (9.5–11.7) 0.880
Resting heart rate 82.4 (78.6–86.1) 79.2 (73.6–84.7) 84.8 (79.7–90.03) 0.132
Total cholesterol (mmol/l) 5.83 (5.3–6.2) 5.51 (4.8–6.2) 6.08 (5.4–6.6) 0.216
HDL cholesterol (mmol/l) 1.01 (0.98–1.03) 1.01 (0.96–1.04) 1.01 (0.97–1.04) 0.868
LDL cholesterol (mmol/l) 4.02 (3.5–4.4) 3.65 (2.9–4.3) 4.30 (3.6–4.9) 0.163
VLDL cholesterol (mmol/l) 0.80 (0.70–0.90) 0.85 (0.69–0.99) 0.77 (0.64–0.90) 0.454
Tryglicerides (mmol/l) 1.75 (1.54–1.98) 1.85 (1.52–2.17) 1.68 (1.39–1.96) 0.454
Carbohydrates intake (%DCI) 52.6 (50.1–55.1) 54.8 (50.9–58.8) 50.8 (47.5–54.1) 0.11
Fat intake (%DCI) 28.5 (26.5–30.6) 27.2 (23.8–30.5) 29.6 (26.9–32.3) 0.246
Protein intake (%DCI) 18.7 (17.4–20.1) 17.9 (16.4–19.3) 19.4 (17.3–21.6) 0.247
Saturated fat intake (%DCI) 9.1 (8.4–9.9) 9.07 (7.9–10.2) 9.2 (8.1–10.3) 0.817
Monounsaturated fat intake (%DCI) 9.5 (8.6–10.5) 9.2 (7.8–10.7) 9.7 (8.3–11.11) 0.65
Polyunsaturated fat intake (%DCI) 9.3 (8.3–10.4) 9.0 (7.2–10.8) 9.6 (8.1–11.07) 0.617
DCI (cal/kg per day) 23.4 (20.7–26.6) 23.9 (18.9–28.8) 23.03 (19.9–26.1) 0.748
Fiber intake (g/day) 15.15 (12.6–17.6) 14.2 (10.4–18.0) 15.87 (12.3–19.3) 0.516
Sodium intake (mg/day) 899.05 (746.2–1051.8) 852.6 (552.9–1152.3) 935.1 (775–1095.2) 0.595
Alcohol intake (g/week) 25.98 (11.9–39.9) 21.84 ( – 0.23–43) 29.2 (9.9–48.4) 0.65

Data are mean and 95% confidence interval unless indicated. NIP, nutritional intervention program; NPEP, nutritional intervention and physical activity program;
HT, hypertension; DM, diabetes mellitus; CD, coronary disease; BMI, body mass index; BP, blood pressure; Borg, punctuation in Borg’s exercise intensity perception
scale; HDL, high-density lipoprotein; LDL, low-density lipoprotein; VLDL, very-low-density lipoprotein; DCI, daily caloric intake.

Results Anthropometric parameters changes

Seventy-five of the 80 patients initially selected fulfilled
inclusion and exclusion criteria and were enrolled in the
study. Table 2 shows the baseline characteristics of the 75
adults that were randomized to NIP or NPEP. There were
no statistically significant differences in demographic,
anthropometric, medical or self-reported nutrient intake
baseline characteristics between groups.
There were 27 subjects who withdrew during the study,
16 in the NIP group and 11 in the NPEP group; so that
the final study population comprised 48 participants,
21 from the NIP group, and 27 from the NPEP group.
The reason for withdrawal was loss of follow-up in all
cases of both groups. No participant in either group
withdrew because of an adverse event.
Global cardiovascular risk change
Mean initial GCVR was 10.4% in both intervention
groups. Compared with week 0, participants in the NPEP
group had a mean reduction in GCVR of 2.04 ± 1.1
absolute percentage points, and those in the NIP group
had a mean increase of 0.23 ± 0.9 absolute percentage
points. The ANCOVA-estimated mean difference
between groups was 2.3 absolute percentage points
(P = 0.054).
Mean body weight was reduced by 0.79 ± 0.3 kg in the
NIP group, and by 1.91 ± 0.4 kg in the NPEP group
(P = 0.046). The NPEP group also achieved significantly
greater reductions than the NIP group in BMI (0.92 ± 0.2
versus 0.45 ± 0.2 kg/m2; P = 0.042) and bioelectrical
impedance-estimated percentage body fat (1.93 ± 0.6
versus 0.29 ± 0.3%; P = 0.008). Both groups reduced
their mean waist circumference (3.26 ± 0.6 cm for NPEP,
2.96 ± 0.7 cm for NIP), but the difference in favor of the
NPEP group did not reach statistical significance
(P = 0.525).
Blood lipids changes
The effect on HDL cholesterol positive modification was
significantly better for the NPEP (0.03 ± 0.05 mmol/l
elevation for NPEP versus 0.12 ± 0.4 mmol/l reduction
for NIP; P = 0.026). None of the differences in the
remaining lipid parameters was significant, despite a
larger decrease in total cholesterol (TC) in the NPEP
group, and a larger decrease in LDL cholesterol in the
NIP group. Interestingly, both groups increased their mean
blood triglyceride concentration; 0.45 ± 0.22 mmol/l in the
NIP group, and 0.26 ± 0.17 in the NPEP group. The rise
in serum triglycerides was not statistically different
between groups (P = 0.41).

Copyright © European Society of Cardiology. Unauthorized reproduction of this article is prohibited.

 952 European Journal of Cardiovascular Prevention and Rehabilitation 2006, Vol 13 No 6

Table 3 Effect of the nutrition intervention program, and the nutrition and physical exercise program on outcome variables
Parameter NIP NPEP P in ANCOVA

Week 0 Week 16 Change Week 0 Week 16 Change

GCVR (%) 10.47 (1.8) 10.71 (1.5) 0.23 (0.9) 10.42 (1.4) 8.38 (1.1) – 2.04 (1.1) 0.054
Body weight (kg) 68.00 (2.0) 67.21 (2.0) – 0.79 (0.3) 68.89 (2.2) 66.96 (2.3) – 1.91 (0.42) 0.046
BMI (kg/m2) 27.59 (0.9) 27.15 (0.8) – 0.45 (0.2) 26.39 (0.9) 25.47 (0.8) – 0.92 (0.2) 0.042
Percentage body fat 29.33 (1.8) 29.05 (1.7) – 0.29 (0.3) 26.56 (1.7) 24.63 (1.6) – 1.93 (0.6) 0.008
Waist circumference 89.33 (2.1) 86.38 (1.9) – 2.96 (0.7) 86.44 (2.2) 83.19 (2.1) – 3.26 (0.6) 0.525
Total cholesterol (mmol/l) 5.51 (0.35) 5.14 (0.20) – 0.36 (0.33) 6.08 (0.31) 5.63 (0.20) – 0.46 (0.29) 0.219
Tryglicerides (mmol/l) 1.85 (0.18) 2.30 (0.26) 0.45 (0.22) 1.68 (0.13) 1.95 (0.19) 0.26 (0.17) 0.41
HDL cholesterol (mmol/l) 1.01 (0.02) 0.89 (0.04) – 0.12 (0.4) 1.01 (0.02) 1.04 (0.05) 0.03 (0.05) 0.026
LDL cholesterol (mmol/l) 3.65 (0.35) 3.20 (0.17) – 0.45 (0.35) 4.30 (0.30) 3.69 (0.21) – 0.61 (0.31) 0.185
VLDL cholesterol (mmol/l) 0.85 (0.08) 1.06 (0.12) 0.21 (0.10) 0.77 (0.06) 0.89 (0.09) 0.12 (0.08) 0.396
Systolic blood pressure (mmHg) 121.67 (2.6) 116.19 (2.5) – 5.48 (2.6) 124.63 (2.5) 113.52 (2.5) – 11.11 (1.8) 0.28
Diastolic blood pressure (mmHg) 80.48 (1.6) 73.33 (1.5) – 7.14 (1.6) 80.74 (1.9) 72.04 (1.3) – 8.33 (1.4) 0.405

Data are mean (standard error). NIP, nutritional intervention program; NPEP, nutritional intervention and physical activity program; ANCOVA, analysis of covariance;
GCVR, Framingham-estimated 10-year global cardiovascular risk; BMI, body nass index; HDL, high-density lipoprotein; LDL, low-density lipoprotein; VLDL, very-low-
density lipoprotein. The covariable in ANCOVA was in all cases the initial value of the variable.

Blood pressure changes Discussion

Both groups notably reduced their mean systolic blood
pressure, but a difference was evident between treatment
groups, with a more marked drop in the NPEP
group (11.1 ± 1.8 mmHg) than in the NIP group
(5.48 ± 2.6 mmHg). This difference, however, was not
significant (P = 0.28). There was also an important
reduction in diastolic blood pressure, without a significant
difference between groups. The effect of interventions
on anthropometric and lipid parameters and blood
pressure is summarized in Table 3.
Influence of overweight on risk profile modification
We did not detect any significant interaction between
the intervention group and BMI category (overweight
versus normal weight), probably because of insufficient
statistical power (Fig. 2). Striking findings, however,
were that the greatest reduction in GCVR was
achieved in participants with normal weight rando-
mized to the NPEP, and that the same group had the
largest improvements in all cardiovascular risk
factors with the exception of anthropometric measure-
ments.
Relationship between adherence and global cardiovas-
cular risk modification
We tested the differences in GCVR according to self-
reported average number of daily servings of fruit, average
number of daily servings of vegetables, use of recom-
mended oil, use of recommended dairy products, and use
of recommended edulcorant. No significant relationship
was found between any of the adherence variables and
change in GCVR when each variable was considered with
intervention group in a two-way ANOVA, nor in a
multiple linear regression analysis including all adherence
variables and intervention group simultaneously (P > 0.05
for all coefficients except intervention group).
In this short-term study, the addition of a supervised,
structured regular physical activity program to a caloric-
appropriate, NCEP-ATP III compliant nutrition inter-
vention program induced a considerable reduction in
GCVR, that was not found with the NIP alone. The
unexpected finding of the lack of effect of the NIP on
GCVR may be explained by the consistent reductions in
HDL cholesterol that took place in that group. Previous
studies have found a negative effect of diet alone, and
specially of strict saturated fat restriction, on serum HDL
cholesterol [12–14].
Despite the borderline statistical significance
(P = 0.054), this study found a clear tendency towards a
superior effect of the addition of exercise over that of diet
alone in the modification of cardiovascular risk and
cardiovascular risk factors.
The fact that the NPEP had a more profound impact on
body weight, BMI and percentage body fat emphasizes
the role of exercise in therapeutic lifestyle changes, given
that intentional weight loss has been associated with
reduced mortality and coronary risk in epidemiological
studies [15–17]. It has also been shown that exercise
influences percentage body fat and insulin sensitivity
more than diet [18,19] and the risk of chronic illnesses is
lower in physically trained individuals, even if they have
not reached a normal weight [20].
In contrast with other studies [18], we did not identify a
significantly greater effect of exercise on abdominal
obesity, as measured by the waist circumference, in spite
of a small difference in favor of the NPEP group.
It is important to note that exercise prevented
the reduction in HDL cholesterol induced by diet alone,

Copyright © European Society of Cardiology. Unauthorized reproduction of this article is prohibited.

 Nutritional plus activity intervention Mendivil et al. 953

Fig. 2

2.00 0.00 0.00

−0.20
−0.50
0.00

Change in BMI (kg/m3)

Change in GCVR (%)

Change in weight (kg)

−0.40
−1.00
−2.00 −0.60
−1.50
−0.80
−4.00
−2.00
−1.00

−6.00 P = 0.837 −2.50 P = 0.623 −1.20 P = 0.339

NIP NPEP NIP NPEP NIP NPEP

0.00 0.60 P = 0.830

0.00
0.50
−1.00

Change in TG (mmol/l)
Change in % body fat

Change in WC (cm)

−1.00 0.40

−2.00
0.30
−2.00
0.20
−3.00

−3.00 0.10
P = 0.128 −4.00 P = 0.753
0.00
NIP NPEP NIP NPEP NIP NPEP

0.20 P = 0.598 0.00 0.00

−0.20 −2.50
0.10
Change in SBP (mmHg)
Change in HDLc (mmol/l)

Change in LDLc (mmol/l)

−0.40 −5.00
0.00
−0.60 −7.50

−0.10
−0.80 −10.00

−0.20 −1.00 P = 0.549 −12.50 P = 0.398

NIP NPEP NIP NPEP NIP NPEP

Influence of overweight on global cardiovascular risk (GCVR) and cardiovascular risk factor modification. White bars represent means for
participants with body mass index (BMI) under 25 kg/m2. Gray bars represent means for participants with BMI equal to or greater than 25 kg/m2.
Reported P values correspond to those associated to interaction terms (BMI category * intervention group) in two-way ANOVA. Note how response
in anthropometric measurements tended to be better in overweight individuals, whereas response in GCVR, lipid profile and blood pressure was
better in normal weight individuals. NIP, nutritional intervention program; NPEP, nutritional intervention and physical activity program; WC, waist
circumference; TG, tryglicerides; HDLc, HDL cholesterol; LDLc, LDL cholesterol; SBP, systolic blood pressure.

Copyright © European Society of Cardiology. Unauthorized reproduction of this article is prohibited.

 954 European Journal of Cardiovascular Prevention and Rehabilitation 2006, Vol 13 No 6
and that HDL cholesterol is one of the stron-
gest predictors of coronary risk, as reflected by its
influence in GCVR estimation by the Framingham
equation [7].
The fact that LDL cholesterol and TC reductions were
similar between groups confirms that LDL cholesterol is
one of the lipid factors in which physical activity has a low
potential to work. The potential confounding effect of
differences in statin use may be dismissed, since statin
use did not differ significantly between groups (22.2% in
NIP group versus 19.2% in NPEP group; Fisher’s exact
test P = 0.54).
The unexpected rise in serum triglycerides found in both
groups might be explained by a compensatory increase in
carbohydrate consumption by the patients, since the ATP
III dietary approach focuses mainly on fat, cholesterol
and fiber.
We examined the self-reported average number of
carbohydrate servings per day against change in triglycer-
ides, finding no clear association; but it is not possible to
discard patient under-reporting of intake as a cause for a
masked relationship. One previous study in adult women
[21] found a significant increase in triglycerides and a
significant reduction in HDL cholesterol with the
substitution of calories from carbohydrates for calories
from fat, suggesting that dietary plans that focus mainly
on fat may worsen the triglyceride–HDL axis.
Although the statistical test for comparison of group means
did not show a significant difference in systolic blood
pressure reduction, it is possible that the greater effect of
the NPEP on systolic pressure was a major contributor to
the fall in GCVR observed in that group, and thus blood
pressure modification is one of the key effects of exercise
on GCVR reduction.
Some studies, most of them performed in overweight
women [22–24] did not find an additional effect of
exercise in risk factors in the short term. A possible reason
for the discordance between those and our data is the
amount of caloric restriction, which in our study was
400 cal/day for overweight participants, and in other
studies has been as high as 1000 cal/day [22]. Never-
theless, we consider that a caloric restriction of 400 cal/
day is much more feasible in real-life conditions and thus
our results are more likely to be found in clinical and
community settings. Another possible source for the
discordance is different patient characteristics (we
studied both men and women, and both normal weight
and overweight people).
Although the greater improvement in cardiovascular risk
profile in patients with normal weight suggests that these
Copyright © European Society of Cardiology. Unauthorized reproduction of this article is prohibited.
patients had a better compliance to intervention in both
groups, we found no significant difference in self-
reported intakes of fruits, vegetables, carbohydrates or
use of recommended oil, edulcorant and dairy products
between participants who were or were not overweight.
This is probably a consequence of lower self-reported
intake accuracy among overweight people.
Limitations
The physical activity program we implemented had a
high frequency of exercising and thus required a great
deal of self-compromise from the participants, which may
limit its application in some settings. We did not perform
an exercise stress test at the beginning and at the end
of the intervention period. We did find, however, a
significantly higher decrease in mean Borg’s scale of
perceived intensity of exercise in the NPEP group
(21.8% reduction in NPEP versus 12.28% reduction in
NIP; P = 0.0001).
Conclusion
In the short term, an NPEP provided significantly greater
benefits than an NIP in Colombian adults.
Acknowledgements
We wish to thank the Human Movement and Nutrition
Departments, for their valuable help in allowing us to
make use of their facilities.
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