AHA 2008: FIT HEART: Novel Family-Based Intervention a Good Idea, But Better Methods Needed

November 12, 2008

November 12, 2008 (New Orleans, Louisiana) — A new study in which the family members of patients hospitalized for cardiovascular disease (CVD) were given CVD risk screening with immediate feedback and provided with lifestyle advice has shown that it is useful to take advantage of such "motivational moments. [1]" Dr Lori Mosca (Columbia University Medical Center, New York) reported the findings of FIT HEART at the late-breaking clinical-trials session here today, and it was published online simultaneously November 12, 2008 in Circulation: Cardiovascular Quality and Outcomes.

"The root cause of CVD in this country is lifestyle, and I believe it's going to be lifestyle that is going to be the ultimate solution. We need to stress the importance of preserving a low-risk state," Mosca told a press briefing.

But overall, the FIT HEART study was negative--those randomized to the intervention fared no better than those randomized to the control group in terms of the primary end point, change in low-density-lipoprotein (LDL) levels--although the active group did significantly improve their diet score compared with the controls, by 13% (p=0.04). Blood pressure and adiposity worsened in both groups, however.

Discussant for the trial, Dr Noel Bairey-Merz (Cedars Sinai Medical Center, Los Angeles, CA), commended Mosca et al for performing this novel family-based intervention, adding that it "validates that teachable moment and is a wonderful opportunity to target a family member when another family member is hospitalized." But the fact that the trial was negative indicates "that we need to get better methods, sharpen the sword," Bairey-Merz told the media. "Despite individual coaching, people were unable to make significant changes in a toxic environment," she pointed out.

Screening Process Identified Many Who Were Unaware of Risk

Despite individual coaching, people were unable to make significant changes in a toxic environment.

In FIT HEART, 501 healthy adult family members of patients hospitalized with CVD were recruited to a special intervention, with personalized risk-factor screening, therapeutic lifestyle change counseling, and progress reports to physicians on adherence to primary-prevention goals, vs a control intervention in which people were simply told not to smoke and to eat well and exercise. Of the participants, 66% were female and 36% were from an ethnic minority. The mean age was 48 years.

"Staff went to the bedside and the waiting room" or included packs in the discharge papers of the hospitalized patients, Mosca explained. Of the participants, 70% were blood relatives of the hospitalized person and more than 50% were the adult children of that person.

The primary end point was difference in mean percentage change in LDL in the two groups at one year, and secondary outcomes included change in diet, lifestyle, and standard CVD risk factors over the same period.

There was no difference in the primary end point between the groups: although LDL declined significantly from baseline in the special-intervention group, it also dropped in the control arm (-4.4 mg/dL and -4.5 mg/dL, respectively), and there was no difference in the percentage of subjects at LDL goals in the two groups at one year.

There were some improvements in the special-intervention group, however. As well as their diet score improving significantly, they were more likely to exercise more than three days per week than the control arm. And the "good" cholesterol, HDL, was significantly lower in the control arm, but not in the special-intervention arm (-3.2% vs +0.1%; p=0.01).

Unfortunately, however, despite both groups having significant improvements in saturated-fat intake and dietary cholesterol, as well as mean number of days of physicalactivity per week, adiposity and blood pressure worsened in both groups.

The unique finding of this study is that this screening process identified many family members of patients with CVD who were unaware of their own risk factors.

Of interest, said Mosca, was the fact that among subjects with LDL of >130 mg/dL, 39% were not aware of their cholesterol problem. Similarly, among those with blood pressure of >140/90, 39% reported no history or awareness of hypertension.

"Thus, the unique finding of this study is that this screening process identified many family members of patients with CVD who were unaware of their own risk factors," she pointed out.

Physicians should routinely ask about recent family cardiac events and consider screening family members during this "motivational moment," she concluded.

Make the Right Choice Easy and the Wrong Choice Hard

Bairey-Merz commended Mosca et al for the high number of women enrolled, noting that females now account for more CVD deaths annually in the US than men. But, she noted, "We've had four decades of heart-disease research, but we continue to fail to employ strategies that work.

"This was overall a negative trial. We need to constantly strive to make the right choice easy and the wrong choices hard and figure out how we can employ [better] methods at a community level," she added.

It's very clear from this that restricting saturated fat in the diet is not sufficient.

"It's very clear from this that restricting saturated fat in the diet is not sufficient," she stressed, "because patients' HDL still goes down, and they increase weight and blood pressure in our toxic environment. We need to adopt the Mediterranean diet," she said, following the example of the Europeans and implementing "more clinical translational nutritional approaches."

Mosca has served as a consultant to Anthera, Astra-Zeneca, Merck, and Pfizer and has received honoraria from Daiichi-Sankyo, Merck/Schering-Plough, and Takeda.

  1. Mosca L, Mochari H, Liao M, et al. A novel, family-based intervention trial to improve heart health: FIT HEART. Results of a randomized controlled trial. Circ Cardiovasc Qual Outcomes 2008; DOI:10.1161/CIRCOUTCOMES.108.825786. Available at: https://circoutcomes.ahajournals.org.

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