A Randomized Clinical Trial of Home-based Exercise Combined With a Slight Caloric Restriction on Obesity Prevention Among Women
NCT ID: NCT01206413
Last Updated: 2010-09-21
Study Results
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Basic Information
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COMPLETED
PHASE4
203 participants
INTERVENTIONAL
2003-10-31
2005-10-31
Brief Summary
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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).
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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LGI
Low glycemic index
Low glycemic index diet
HGI
High glycemic index
High glycemic index diet
HB
Home-based exercise
Home-based exercise intervention
CONTROL
Non-exercisers
Non-exercisers
Interventions
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Low glycemic index diet
High glycemic index diet
Home-based exercise intervention
Non-exercisers
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
25 Years
45 Years
FEMALE
Yes
Sponsors
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Rio de Janeiro State University
OTHER
Responsible Party
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State University of Rio de Janeiro
References
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Mediano MF, Neves FA, Cunha AC, Souza EP, Moura AS, Sichieri R. Changes in body weight, C-reactive protein, and total adiponectin in non-obese women after 12 months of a small-volume, home-based exercise program. Clinics (Sao Paulo). 2013;68(8):1121-7. doi: 10.6061/clinics/2013(08)10.
Other Identifiers
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CNPQ500404/2003-8
Identifier Type: -
Identifier Source: org_study_id