Obesity Prevention Clinical Trial
Official title:
A Randomized Clinical Trial of Home-based Exercise Combined With a Slight Caloric Restriction on Obesity Prevention Among Women
The study investigated the effectiveness of home-based exercise combined with a slight
caloric restriction on weight change during 12 months in non-obese women. In addition the
investigators evaluate the effects of baseline insulin resistance on modulation of weight
change.
A randomized clinical trial with a factorial design was conducted from 2003 to 2005. Two
hundred three middle-aged women (Rio de Janeiro/Brazil), 25-45 years, were randomly assigned
to one of two groups: control (CG) and home-based exercise (HB). The HB group received a
booklet on aerobic exercise that could be practiced at home (3 times/week - 40 min/session),
in low-moderate intensity, during 12 months. Both groups received dietary counseling aimed
at a slight energy restriction of 100-300 calories per day.
The HB experienced a greater weight loss in the first 6 months (-1.4 vs. -0.8 kg; p=0.04),
but after 12 months there was no differences between groups (-1.1 vs. -1.0; p=0.20). Of the
serum biochemical markers, HDL-cholesterol showed major change, with an increase at month 12
of 18.3 mg/dl in the HB compared to 9.5 in the CG (p<0.01). At baseline the non-IR group
(n=121) compared to IR (n=64) had similar values of BMI (26.7 vs. 26.3 p=0.21), but
statistically significant lower values of waist, glucose, insulin and HOMA-IR, as expected.
When the group non-IR and IR were further stratified by GI diet, there were no differences
according to diet in both groups. Women classified as IR at baseline had greater weight loss
after 12 months of follow-up (-1.62 kg vs. -1.08 kg; p=0.01), and HB exercise helped to
reduce weight only among NIR women (-1.51 vs. -0.68; p=0.04); no differences were observed
between intervention groups for IR women (-1.54 vs. -1.66; p=0.24). There were no
differences between IR and NIR groups for lipid profile after adjustment for weight changes.
During follow-up, changes were more pronounced among those women in the high GI diet. These
differences were statistically significant for weight and BMI and were greater among the IR
compared to the non-IR. Changes in HOMA-IR after 3 months of follow-up were different
comparing non-IR with IR at baseline. The IR had a reduction in the HOMA-IR, whereas in the
non-IR this value increased (-0.73 vs. +0.37; p=<0.001). Also this reduction was greater
among high compared to low GI diet (p=0.04).
Status | Completed |
Enrollment | 203 |
Est. completion date | October 2005 |
Est. primary completion date | October 2005 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 25 Years to 45 Years |
Eligibility |
Inclusion Criteria: Non-obese women aged 25-45 years Exclusion Criteria: Physician-diagnosed thyroid disease or diabetes or who were menopausal or any other disease that could be influenced by intervention |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Rio de Janeiro State University |
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