Obesity Clinical Trial
Official title:
A Randomized Trial of Lifestyle Intervention in Primary Health Care for the Modification of Cardiovascular Risk Factors - the Björknäs Study
The purpose of this study is to determine whether a short group intervention programe aiming at lifestyle changes at a local health centre can improve risk factors for cardiovascular disease
Successfully transferring the findings of expensive and tightly controlled lifestyle
intervention programmes to the primary care setting is necessary if such knowledge is to be
used for disease prevention at the population level. Therefore, our objective was to
evaluate the efficacy of a lifestyle intervention programe in the primary health care
setting, targeted at patients with moderate- to high-risk of cardiovascular disease
according to cardiovascular risk factor levels, physical activity and quality of life
ratings.
Randomised controlled trial with follow-up at 3, 12, 24 and 36 months, carried out in a
primary health care centre in Northern Sweden. A total of 151 middle-aged men and women,
with hypertension, dyslipidemia, type 2 diabetes or obesity were enrolled. The subjects were
randomised to an intervention (n = 75) or control group (n = 76). 120 subjects completed the
three-year follow-up. The intervention was based on the protocols used in the Finnish
Diabetes Prevention study (DPS) and the U.S Diabetes Prevention Program
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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