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

This study has been completed.
Sponsor:
Information provided by:
Rio de Janeiro State University
ClinicalTrials.gov Identifier:
NCT01206413
First received: September 20, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted
  Purpose

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 Intervention 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
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: A Randomized Clinical Trial of Home-based Exercise Combined With a Slight Caloric Restriction on Obesity Prevention Among Women

Resource links provided by NLM:


Further study details as provided by Rio de Janeiro State University:

Enrollment: 203
Study Start Date: October 2003
Study Completion Date: October 2005
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Non-exercisers
Other: Non-exercisers

  Eligibility

Ages Eligible for Study:   25 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided by Rio de Janeiro State University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mauro Felippe Felix Mediano, State University of Rio de Janeiro
ClinicalTrials.gov Identifier: NCT01206413     History of Changes
Other Study ID Numbers: CNPQ500404/2003-8
Study First Received: September 20, 2010
Last Updated: September 20, 2010
Health Authority: Brazil: National Committee of Ethics in Research

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

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

ClinicalTrials.gov processed this record on July 20, 2014