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Prevention in the “Real World”: One-year Results of the GOAL Implementation Trial

A lifestyle implementation trial was designed for the primary care setting. The goal was to determine whether findings from the Finnish Diabetes Prevention Study (DPS),[1] which demonstrated a 58% reduction in diabetes with lifestyle intervention, could be replicated in a real-world clinical setting.

The content of the GOAL intervention was based on the 5 DPS objectives (< 30% energy intake from fat, < 10% from saturated fat, 15 g of fiber/1000 kcal, ≥ 4 hours/week moderate exercise, > 5% weight reduction). Study nurses at 16 healthcare centers in the Päijät-Häme Province in Finland identified 462 high-risk patients (ie, with risk factors including hypertension, obesity, elevated blood glucose, or elevated lipids) age 50-65 years. Public health nurses delivered a program of 6 group sessions that included dietary information, group discussions, self-monitoring behavior, goal setting, and planning to 352 study participants. Using food diaries, self-reported exercise levels, and anthropometric measurements, key lifestyle measures were taken at baseline and at 12 months. The investigators compared the success in achieving the lifestyle objectives with those reported by the DPS. They also assessed change in clinical risk factors, and whether attainment of goals was associated with follow-up glucose tolerance.

Compared with the DPS, the success rate in the GOAL study was significantly lower for the physical activity objective (66% vs 86%, P < .001) and weight loss objective (12% vs 43%, P < .001). However, attainment of 4 or more objectives, which the DPS showed was sufficient to prevent type 2 diabetes, did not differ (20% vs 18%, ns). Furthermore, 83% of those who attained 4 or more objectives had normal glucose tolerance at follow-up, compared with 73% of those who attained < 4 objectives (P < .05). The GOAL program also achieved favorable outcomes for several clinical risk factors, including body mass index and waist circumference.

Efficacy trials have proven that lifestyle modification reduces the incidence of type 2 diabetes among high-risk individuals.[1-3] However, the interventions were intensive, lasted several years, and were conducted in healthy volunteers. Whether the trial results can be replicated in typical clinical settings is a vitally important question. The GOAL study yielded cautiously promising results. The poorer attainment of the physical activity and weight loss goals relative to the DPS was somewhat disappointing, because these 2 goals proved to be more important than the dietary goals in preventing diabetes in the DPS data. Thus, the relative low intensity of group-based lifestyle counseling may not be sufficient to achieve the weight loss needed to prevent diabetes. Nevertheless, subjects in the GOAL study were just as likely as DPS subjects to attain 4 or more objectives. Because this is the point at which diabetes is prevented, the ultimate goal of diabetes prevention is indeed possible.

Sources:

  1. Tuomilehto J, Eriksson JG, Valle TT, et al. Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance. N Engl J Med. 2001;344:1343-1350. Abstract
  2. Knowler WC, Barrett-Connor E, Fowler SE, et al. Reduction in the incidence of type 2 diabetes with life-style intervention or metformin. N Engl J Med. 2002;346:393-403. Abstract
  3. Pan XR, Li GW, Hu YH et al. Effects of diet and exercise in preventing NIDDM in people with impaired glucose tolerance. The Da Qing IGT and Diabetes Study. Diabetes Care. 1997;20:537-544. Abstract

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FACT:
Childhood Obesity Epidemic to Send CHD Rates Soaring, Even in Young Adults: Deaths in teenagers, due to CHD will be higher, up as much as 19% when today’s teenagers reach age 35 to 50.  The study is the largest of its kind and the first to convincingly demonstrate that excess childhood BMI increases the risk of heart disease in adulthood. As childhood BMI increased, so did the risk of heart disease in adulthood, the authors note. By way of example, they estimated that a 13-year-old boy who weighs 11.2 kg more than average would increase his probability of having a CHD event before age 60 by 33%. CHD risk associated with BMI also increased with age.. Whereas increased BMI was associated with a moderate risk of developing heart disease in adulthood, by age 13, that risk was even higher. "Taken together, these results suggest that even in this short period of childhood, interventions aimed at helping children attain and maintain an appropriate weight can protect them from future adverse health consequences.

December 6, 2007 issue of the New England Journal of Medicine