Table 1

Summary of characteristics of included primary prevention interventions of CVD in premenopausal women

Study, countryStudy yearPopulation characteristicsStudy designStudy settingInterventionControlTreatment durationPrimary outcomesSecondary outcomes
Diet
Tuekpe et al,19 Japan*March–April 2005Normotensive, free-living Japanese women aged 18–38 years living in Okinawa
Mean age:
Intervention: 24.4 (3.8)
Control: 25.7 (4.8)
Randomised-controlled trial
N=56
Home-based settingHome delivery of an average weight of 371.4 g/day combination of vegetables delivered twice weekly through an express home delivery service for a period of 14 days: Goya (Momordica cha- rantia), green papaya (Carica papaya), Handama (Gynura bicolor), Karashina (Brassica juncea), Njana (Crepidiastrum lanceolatum), Fuchiba (Artemisia vulgaris) and Fudanso (Beta vulgaris)
(n=27)
Asked to avoid vegetables included in the intervention
(n=29)
14 daysUrinary potassium excretionOther urine electrolytes and serum folic acid, triglycerides and high-density lipoproteina (HDL), cholesterol, low-density lipoprotein (LDL) cholesterol and total cholesterols
Moore et al,35 UKNROverweight men and women (BMI between 25 and 40 kg/m2); aged 35–60 years; not consuming regular oil supplements, NSAIDs, aspirin, steroids, immunosuppressants, or lipid-lowering drugs; not diagnosed with diabetes, hypertension, hyperlipidaemia, asthma or chronic inflammatory diseases; female subjects are not pregnant or planning pregnancy mean age: 50 (9)
BMI: 30.3 (3.9)
Double-blinded, randomised-controlled dietary intervention trial
n=157
Home-based settingWhitefish/rapeseed
(n=29)
Whitefish/sunflower
(n=30)
Oily fish/rapeseed
(n=32)
Oily fish/rapeseed
(n=32)
No intervention
(n=34)
24 weeksFatty acid intake; fatty acid status; anthropometry and body composition; CVD risk factors; insulin sensitivity; inflammatory status
Vitamin E
Lee et al,28 USAWomen’s Health Study conducted between
1992 and 2004
Apparently healthy US women aged at least 45 years
Mean age (SD): 54.6 (7.0)
45–54: 24 025 (60.3%)
BMI: mean (SD): 26.04 (5.06)
<25: 19 849 (50.8%)
25–29: 12 081 (30.9%)
>29: 7126 (18.2%)
Premenopause: 10 973 (27.6%)
Randomised, double-blind, placebo controlled 2×2 factorial trial
n=39 876
Individual settingVitamin E (600 IU of α-tocopherol) every other day (n=19 937)Placebo (n=19 939)10 years (women received calendar packs each year)Composite end point of first major cardiovascular event (nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death)Total invasive cancer
Hercberg et al,34 FranceMarch to July 1994Women aged 35–60 years or men aged 45–60 years; absence of disease likely to affect active participation or may be a threat for 5 years survival; acceptance of the chance of receiving a placebo and acceptance of constraints of participation; lack of history of regular supplementation with any of the vitamins or minerals in the supplement provided; and absence of extreme beliefs or behaviour regarding diet
Women mean age: 46.6 (6.6)
BMI: 22.9 (3.0)
Postmenopausal: 26.9%
Randomised, double-blind, placebo-controlled primary prevention trial
n=7713
Individual settingSingle daily capsule of combination of antioxidants: 120 mg of ascorbic acid, 30 mg of vitamin E, 6 mg of beta carotene, 100 µg of selenium, and 20 mg of zinc
(n=3869)
Placebo (n=3844)8 years cohort study (as per trial protocol) patients received 52 weekly packs of 7 capsulesMajor fatal and nonfatal ischaemic cardiovascular eventsAll-cause mortality
Liu et al,29 USAWomen’s Health Study conducted between
1992 and 2004
Apparently healthy US women aged at least 45 years
Mean age (SD): 54.6 (7.0)
45–54: 23 473 (60.6%)
BMI: mean (SD): 25.9 (4.96)
<25: 19 655 (51.8%)
25–29: 11 713 (30.9%)
>29: 6563 (17.3%)
Premenopause: 10 757 (27.9%)
Randomised, double-blind, placebo controlled 2×2 factorial trial
n=38 716
Individual settingVitamin E (600 IU of α-tocopherol) every other day (n=19 347)Placebo (n=19 369)10 years (women received calendar packs each year)Incidence of diabetes mellitus type 2
Lifestyle modification interventions
Koniak-Griffin et al,27 USAData were collected between January 2010 and August 201235–64 years, self-identified Latina/Hispanic overweight Women
Mean age (SD): 44.6 (7.9)
Mean BMI:
Intervention: 32.37 (5.00)
Control: 32.86 (6.29)
Single blinded, randomised using web-based programme with 1:1 intervention to control ratio using block randomisation procedure
n=223
Group based setting6 months Lifestyle Behaviour Intervention comprised of group education (eight weekly classes in the first 2 months) plus Individual teaching and learning (over 4 months). (n=111)6 months safety/disaster preparedness educational programme (eight classes) plus individual teaching and learning (eight classes) (n=112)6 months interventions with data collected at baseline, 6 months and 9 months follow-upDietary habits, physical activity and clinical measures including BMI, weight, waist circumference, blood pressure, lipids and blood glucose
Hardcastle et al,25 UKNR18 to 65 years old with at least 1 CHD risk factor; BMI (28 or more), hypertension (at least 150/90 mm Hg), and hypercholesterolaemia (at least 5.2 mmol/L)
Mean age: 51.10 (0.58)
Females: 240 (67%)
BMI: 33.99 (0.33)
Stratified, randomised controlled trial with 7:5 intervention to control ratio
n=334
Individual settingCounselling delivered by a Physical activity specialist and a registered dietitian
(n=203)
Standard information only
(n=131)
6 months treatment durationBlood pressure and resting blood sample (cholesterol, triglycerides, HDL, LDL)Self-reported physical activity, fat intake, fruit, and vegetable consumption
Stuart et al,33 AustraliaAugust to November 2010Adults aged 30–56 years with BMI greater or equal 26.0 and less or equal 40.0 kg/m2, waist circumference >0.102 cm for men and >0.88 cm for women mean age: 48 (5.88)
Females: 30 (61%)
BMI: 33.13 (5.39)
Randomised trial (parallel, with block and stratified sampling)
n=49
Individual settingTelephone-supported comprehensive lifestyle intervention programme
(n=26)
Usual care - written general lifestyle advice
(n=23)
12 week intervention (outcomes measured at week 0 and then at week 12)Fasting plasma lipids, blood pressure, weight, height, and waist circumference; physical activity and motivation
Pazoki et al,31 IranNRWomen ages 25–65 years
Mean age: 39.4
Multistage stratified cluster random sampling
N=335
Community based setting8 weeks lifestyle modification programme for increasing physical activity based on a revised form of Choose to Move programme, an American Heart Association Physical Activity Programme for Women. Audio-taped activity instructions with music and practical usage of education package. Weekly home-visits
(n=170)
No intervention
(n=165)
8 week lifestyle modification programme with follow-up at week 0 and end of week 8Physical activityBMI, blood pressure, total cholesterol, triglycerides, fasting blood sugar, knowledge score
Low et al,30 USA2011–2012Female employees aged 40–65 years with one or more risk (overweight, high stress level, lack of physical activity or smoking). Hypertensive (systolic ≥200 mm Hg, diastolic ≥110 mm Hg), blood glucose (≥300 mg/dL) requires physician approval.
Mean age: 52 (6.3)
Intervention: 51 (6.5)
Control: 53 (6)
Unblinded randomised controlled trial with 1-year follow-up after the programme
N=57
Individual settingWeekly communication (phone or email) integrating goal setting and overcoming obstacles in addition to what the control group is provided
(n=28)
Risk reduction classes on weight loss/nutrition, stress management, exercise training, and smoking cessation, access to an on-site gymnasium, and organised walks
(n=29)
6 months programme durationCardiovascular risk factors (weight, stress, physical activity)
Kandula et al,26 USAJune 2012–November 2013South Asian Immigrants (mainly Indian and Pakistani); aged between 30 and 59; with at least one atherosclerotic cardiovascular disease risk factor (obesity, hypertension, hyperlipidemia, pre-diabetes and diabetes)
Female: 63% mean age: 50 (8)
BMI: 30 (5)
Single blinded, randomised controlled trial
N=63
Group based setting6 interactive group classes focused on increasing physical activity, healthful diet, weight, and stress management with telephone follow-up
(n=31)
Translated print education materials about ASCVD and healthy behaviours
(n=32)
16 weeks lifestyle intervention with additional 10 weeks telephone support (6 months intervention duration)Change in moderate/vigorous physical activity and dietary saturated fat intake at 3 and 6 monthsClinical and psychosocial outcomes
Cappuccio et al24 Africa2001–2002Adults aged 40–75 years
Mean age: 54.7 (11.3)
Females: 628 (62%)
Community-based cluster randomised trial incorporating health promotion
N=1013
Community based settingIntensive health education programme with additional advice not to limit salty food intake, or add salt to food and cooking
(n=522)
Intensive health education programme
(n=491)
6 months24 hours urine and blood pressure
Aspirin
Pradhan et al.32 USAWomen’s Health Study conducted between
1992 and 2004
Healthy women aged >45 years and free of clinical diabetes
Mean age: NR
% age:
45–54 years: 60.6 %
Double-blinded trial
N=38 716
Individual setting100 mg aspirin on alternate days
N=19 326
Placebo
N=19 390
10 years (women received calendar packs each year)Incidence of clinical type 2 diabetes
Ridker et al.17 USAWomen’s Health Study conducted between
1992 and 2004
Healthy Women
Mean age: 54.6±7.0
Mean BMI: 26.0±5.1
Premenopausal (%): 27.6
Mean age:
Intervention: 54.6±7.0
Control: 54.6±7.0
Mean BMI:
Intervention: 26.1±5.1
Control: 26.0±5.0
Double-blinded trial
N=39 876
Individual setting100 mg aspirin on alternate days
N=19 934
Placebo
N=19 942
10 years (women received calendar packs each year)A combination of major cardiovascular events, including nonfatal myocardial infarction, non-fatal stroke, and death from cardiovascular causesIndividual end points of fatal or nonfatal myocardial infarction, fatal or nonfatal stroke, ischaemic stroke, haemorrhagic stroke, and death from cardiovascular causes.
  • *Vegetables include: Goya (Momordica cha-rantia), green papaya (Carica papaya), Handama (Gynura bicolor), Karashina (Brassica juncea), Njana (Crepidiastrum lanceolatum), Fuchiba (Artemisia vulgaris) and Fudanso (Beta vulgaris); level of blood pressure is negatively correlated with the urine excretion of potassium.

  • ASCVD, atherosclerotic cardiovascular disease; BMI, body mass index;CHD, coronary heart disease; CVD, cardiovascular disease; NSAID, Nonsteroidal anti-inflammatory drug.