A Randomized Clinical Trial of Home-based Exercise Combined With a Slight Caloric Restriction on Obesity Prevention Among Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01206413
Recruitment Status : Completed
First Posted : September 21, 2010
Last Update Posted : September 21, 2010
Information provided by:
Rio de Janeiro State University

Brief Summary:

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).

Condition or disease Intervention/treatment Phase
Obesity Prevention Dietary Supplement: Low glycemic index diet Dietary Supplement: High glycemic index diet Other: Home-based exercise intervention Other: Non-exercisers Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 203 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: A Randomized Clinical Trial of Home-based Exercise Combined With a Slight Caloric Restriction on Obesity Prevention Among Women
Study Start Date : October 2003
Actual Primary Completion Date : October 2005
Actual Study Completion Date : October 2005

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: LGI
Low glycemic index
Dietary Supplement: Low glycemic index diet
Active Comparator: HGI
High glycemic index
Dietary Supplement: High glycemic index diet
Experimental: HB
Home-based exercise
Other: Home-based exercise intervention
Active Comparator: CONTROL
Other: Non-exercisers

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Mauro Felippe Felix Mediano, State University of Rio de Janeiro Identifier: NCT01206413     History of Changes
Other Study ID Numbers: CNPQ500404/2003-8
First Posted: September 21, 2010    Key Record Dates
Last Update Posted: September 21, 2010
Last Verified: September 2010

Keywords provided by Rio de Janeiro State University:
overweight; treatment; women

Additional relevant MeSH terms:
Nutrition Disorders
Body Weight
Signs and Symptoms