Hypertension Clinical Trial
To quantify the association between multiple intentional weight losses (i.e., weight fluctuations) and the development of hypertension and diabetes mellitus among 50,790 female nurses participating in the ongoing Nurses' Health Study II. In addition to assessing the consequences of weight fluctuations, their correlates and course were identified.
BACKGROUND:
In the United States, approximately one third of adult women are trying to lose weight. Most
weight losses are not sustained and in fact may be followed by gains of at least as much
weight as was intentionally lost. It is unclear whether there are adverse outcomes
associated with multiple intentional weight losses.
DESIGN NARRATIVE:
The prospective study addressed the impact of weight fluctuation on development of
hypertension (HPT) and diabetes (DM) by following women who significantly fluctuated in
weight compared to those who generally maintained a stable weight. The subject source was
all participants between 1989 and 1993 in the Nurses Health Study II (NHS) who did not
experience a full term pregnancy between 1989 and 1993 and who were free of HPT, DM and
cancer in 1993. A random sample of each of two weight fluctuation classifications, >20 lbs.
(3 or more times) and 10-19 lbs. (3 or more times) was identified. A control group of
non-fluctuators was matched by age and body mass index strata. Baseline data consisted of
information obtained from the 1993 NHS II follow-up along with supplemental questionnaires
sent to study participants to elicit specific information on past and present weight
gain/loss and intentionality of weight fluctuation. Prospective data came from follow-up
questionnaires in 1995, 1997, and 1999. Hypertension and DM ascertainment were obtained from
self-report in the questionnaire. This ascertainment method appeared quite adequate based on
validity studies carried out on subsamples of this cohort.
The study completion date listed in this record was obtained from the "End Date" entered in
the Protocol Registration and Results System (PRS) record.
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