Obesity Clinical Trial
To study weight maintenance behaviors, weight trends, and behavioral differences between healthy, normal weight and mildly obese adults.
BACKGROUND:
The treatment of obesity has met with limited success and clinically significant weight
losses have been difficult to achieve and maintain. Screening to determine which patient
will benefit most from treatment, emphasis on maintenance of weight loss and understanding
individual weight trends and goals, all have demonstrated significant impact on long-term
treatment outcome. Stunkard established a new classification of obesity according to
severity and predicted outcome to treatment, distinguishing mild and moderate overweight
from severe forms of obesity. Those who were classified as mildly obese were those who were
most likely to be successful in traditional forms of treatment. A comprehensive study of
this mildly obese population and normal weight maintenance behaviors provided important
information on which to build future treatment interventions and/or effective strategies.
This would be of particular importance in the prevention of obesity and progressive
escalation of the obese state.
DESIGN NARRATIVE:
Subjects were studied retrospectively by history and prospectively in their natural setting
for five years. A 2 x 2 x 5 multifactorial design was used where sex (males versus females)
and weight (obese versus normal) were crossed with five different age groups according to
decades (20-29, 30-39, 40-49, 50-59 and 60 or more years) respectively. A total of 50 (25
normal and 25 obese) were recruited for each age/sex group. Dependent variables included:
weight, weight trends, fluctuation, body composition; diet; activity or exercise; weight
maintenance behaviors and adaptive responses; general well-being, emotional states,
psychopathology; routine blood and urinalyses; cardiovascular disease risk profile including
lipids, blood pressure, sodium, potassium, calcium and phosphorus levels, diet, smoking,
alcohol and caffeine use, onset of menopause and changes in medical status or medication
use. Comprehensive assessment was done yearly.
The study was renewed in 1992 to extend follow-up and evaluation of the RENO Diet Heart
Study and to complete and extend testing of the primary hypotheses. The three major
hypotheses tested included: 1) weight fluctuations affected cardiovascular disease (CVD)
risk factors over and above weight change alone; 2) weight changes, fluctuations and
patterns interacted with nutritional, behavioral, psychological and medical factors, but
these factors also affected CVD risk independent of weight; and 3) retrospective,
self-reported weights, fluctuations and patterns were predictive of prospective weights and
weight fluctuations.
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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