Effect of Different Physical Programs on the Body Composition of Adult Men and Women With an Initial Body Fat >25% and >30%, Respectively.
Primary Purpose
Overweight, Obesity
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
education and modifying diet
education, modifying diet and physical activity prescription
Sponsored by
About this trial
This is an interventional other trial for Overweight focused on measuring obesity, Physical Activity, fat mass, fat free mass
Eligibility Criteria
Inclusion Criteria:
- Having a body fat percentage >30
- Having a BMI >25
- Being sedentary and
- Have not been submitted to a restrictive diet in the 6 months preceding this study.
Exclusion Criteria:
- Suffered from type 2 diabetes or renal conditions
- Being pregnancy or attempt at pregnancy,
- Being in a maternal lactation period,
- Being underage
- Undergoing antidepressant pharmacological treatment
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Control Group (CON)
Moderate physical activity Group (PAM)
Intensity physical activity Group (PAI)
Arm Description
education and modifying diet
education, modifying diet and physical activity prescription
education, modifying diet and physical activity prescription
Outcomes
Primary Outcome Measures
Changes from baseline BMI.
Baseline mean BMI values will be measured and compared at 3, 6, 12 and 24 months. BMI will be assessed on a monthly basis during nutritional consultation through a Bioelectrical Impedance Analysis method using a Tanita BC-418 Segmental Body Composition Analyser/Scale.
Changes from baseline Fatty mass.
Baseline mean Fatty mass values will be measured and compared at 3, 6, 12 and 24 months. Fatty mass will be assessed on a monthly basis during nutritional consultation through a Bioelectrical Impedance Analysis method using a Tanita BC-418 Segmental Body Composition Analyser/Scale. Fatty mass is measured as a percentage.
Changes from baseline Free-fatty mass.
Baseline mean Free-fatty mass values will be measured and compared at 3, 6, 12 and 24 months. Free-fatty mass will be assessed on a monthly basis during nutritional consultation through a Bioelectrical Impedance Analysis method using a Tanita BC-418 Segmental Body Composition Analyser/Scale. Fatty mass is measured as a percentage.
Changes from baseline Muscular Mass.
Baseline mean Muscular Mass values will be measured and compared at 3, 6, 12 and 24 months. Muscular Mass will be assessed on a monthly basis during nutritional consultation through a Bioelectrical Impedance Analysis method using a Tanita BC-418 Segmental Body Composition Analyser/Scale. Fatty mass is measured as a Kg.
Changes from baseline Corporal Water .
Baseline mean Corporal Water values will be measured and compared at 3, 6, 12 and 24 months. Corporal Water will be assessed on a monthly basis during nutritional consultation through a Bioelectrical Impedance Analysis method using a Tanita BC-418 Segmental Body Composition Analyser/Scale. Fatty mass is measured as a Kg.
Adherence to dietary pattern will be also measured through personal interview
Participants will be subjected for an intervention based on nutritional (control group) and physical education (two intervention arms) during 24 months. Partial measures will be also taken every week. In the end of the trial, changes in dietary patterns will be measured comparing means differences between baselines, 3, 6, 12 and 24 months.
Adherence to physical activity patterns will be also measured through IPAQ (International Physical Activity Questionnaire).
Participants will be subjected for an intervention based on nutritional (control group) and physical education (two intervention arms) during 24 months. Partial measures will be also taken every week. In the end of the trial, changes in physical activity will be measured comparing means differences between baselines, 3, 6, 12 and 24 months.
Secondary Outcome Measures
Full Information
NCT ID
NCT03833791
First Posted
February 1, 2019
Last Updated
January 20, 2021
Sponsor
Universidad de Córdoba
1. Study Identification
Unique Protocol Identification Number
NCT03833791
Brief Title
Effect of Different Physical Programs on the Body Composition of Adult Men and Women With an Initial Body Fat >25% and >30%, Respectively.
Official Title
Effect of the Prescription of Physical Activity on the Fat, Muscle Mass, and Body Weight of Overweight or Adult Men and Women: Randomized Clinical Trial of 6 Month Duration.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
December 15, 2018 (Actual)
Study Completion Date
June 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Córdoba
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Compare the Effect of Different Physical Programs on the Body Composition of Adult Women and Men With a Total Body Fat Percentage ≥ 30 % at the Beginning of the Test or BMI ≥25
Detailed Description
Weight loss by exercise can be frequently deceptive. The focus continues to be centred around total body weight and body mass index (BMI), despite the fact that body fat and fat-free mass are the indicators that represent the greatest risk in the comorbidity associated with obesity. Body weight per se cannot be considered to be reliable; however, its quality can be justified, when measured together with the loss in body fat and the maintenance or increase in fat-free mass.
The purpose of the study is compare the effect of different physical programs (FA) on the body composition (BC) of adult women with a total body fat percentage ≥ 30 % and adult men with a BMI ≥25 at the beginning of the test.
Participants (n=220, women = 110, men = 110) will be recruited through outpatient from private clinics in Cádiz, Andalucía, Spain, as well as through community presentations. Overweight or obese and sedentary women and men will be randomly assigned into three groups according to different levels of AF. 21 of the participants will be assigned to the sedentary control group (METs <2.9), 20 in a group of moderate AF (METs 3-5.9), and 19 will be assigned to the group of intense AF (METs >6).
For 6 months, all of the women shall follow the same diet with an identical distribution of macronutrients. There will be a weekly check up of weight, fat, body water and muscle mass for all of them.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
Keywords
obesity, Physical Activity, fat mass, fat free mass
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
220 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Group (CON)
Arm Type
Active Comparator
Arm Description
education and modifying diet
Arm Title
Moderate physical activity Group (PAM)
Arm Type
Experimental
Arm Description
education, modifying diet and physical activity prescription
Arm Title
Intensity physical activity Group (PAI)
Arm Type
Experimental
Arm Description
education, modifying diet and physical activity prescription
Intervention Type
Behavioral
Intervention Name(s)
education and modifying diet
Intervention Description
The control group maintains a sedentary lifestyle and is only subjected to follow a hypocaloric diet
Intervention Type
Behavioral
Intervention Name(s)
education, modifying diet and physical activity prescription
Intervention Description
One group, in addition to fulfilling a hypocaloric diet identical to the control group, is subjected to prescribe moderate physical activity.
Other group, in addition to fulfilling a hypocaloric diet identical to the control and moderate group, is subjected to prescribe intense activity.
Primary Outcome Measure Information:
Title
Changes from baseline BMI.
Description
Baseline mean BMI values will be measured and compared at 3, 6, 12 and 24 months. BMI will be assessed on a monthly basis during nutritional consultation through a Bioelectrical Impedance Analysis method using a Tanita BC-418 Segmental Body Composition Analyser/Scale.
Time Frame
At baseline (0 years) and followed for 2 years
Title
Changes from baseline Fatty mass.
Description
Baseline mean Fatty mass values will be measured and compared at 3, 6, 12 and 24 months. Fatty mass will be assessed on a monthly basis during nutritional consultation through a Bioelectrical Impedance Analysis method using a Tanita BC-418 Segmental Body Composition Analyser/Scale. Fatty mass is measured as a percentage.
Time Frame
At baseline (0 years) and followed for 2 years
Title
Changes from baseline Free-fatty mass.
Description
Baseline mean Free-fatty mass values will be measured and compared at 3, 6, 12 and 24 months. Free-fatty mass will be assessed on a monthly basis during nutritional consultation through a Bioelectrical Impedance Analysis method using a Tanita BC-418 Segmental Body Composition Analyser/Scale. Fatty mass is measured as a percentage.
Time Frame
At baseline (0 years) and followed for 2 years
Title
Changes from baseline Muscular Mass.
Description
Baseline mean Muscular Mass values will be measured and compared at 3, 6, 12 and 24 months. Muscular Mass will be assessed on a monthly basis during nutritional consultation through a Bioelectrical Impedance Analysis method using a Tanita BC-418 Segmental Body Composition Analyser/Scale. Fatty mass is measured as a Kg.
Time Frame
At baseline (0 years) and followed for 2 years
Title
Changes from baseline Corporal Water .
Description
Baseline mean Corporal Water values will be measured and compared at 3, 6, 12 and 24 months. Corporal Water will be assessed on a monthly basis during nutritional consultation through a Bioelectrical Impedance Analysis method using a Tanita BC-418 Segmental Body Composition Analyser/Scale. Fatty mass is measured as a Kg.
Time Frame
At baseline (0 years) and followed for 2 years
Title
Adherence to dietary pattern will be also measured through personal interview
Description
Participants will be subjected for an intervention based on nutritional (control group) and physical education (two intervention arms) during 24 months. Partial measures will be also taken every week. In the end of the trial, changes in dietary patterns will be measured comparing means differences between baselines, 3, 6, 12 and 24 months.
Time Frame
At baseline (0 years) and followed for 2 years
Title
Adherence to physical activity patterns will be also measured through IPAQ (International Physical Activity Questionnaire).
Description
Participants will be subjected for an intervention based on nutritional (control group) and physical education (two intervention arms) during 24 months. Partial measures will be also taken every week. In the end of the trial, changes in physical activity will be measured comparing means differences between baselines, 3, 6, 12 and 24 months.
Time Frame
At baseline (0 years) and followed for 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Having a body fat percentage >30
Having a BMI >25
Being sedentary and
Have not been submitted to a restrictive diet in the 6 months preceding this study.
Exclusion Criteria:
Suffered from type 2 diabetes or renal conditions
Being pregnancy or attempt at pregnancy,
Being in a maternal lactation period,
Being underage
Undergoing antidepressant pharmacological treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alberto Hernández-Reyes
Organizational Affiliation
Universidad de Córdoba
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31882009
Citation
Hernandez-Reyes A, Camara-Martos F, Molina-Luque R, Romero-Saldana M, Molina-Recio G, Moreno-Rojas R. Changes in body composition with a hypocaloric diet combined with sedentary, moderate and high-intense physical activity: a randomized controlled trial. BMC Womens Health. 2019 Dec 27;19(1):167. doi: 10.1186/s12905-019-0864-5.
Results Reference
derived
Learn more about this trial
Effect of Different Physical Programs on the Body Composition of Adult Men and Women With an Initial Body Fat >25% and >30%, Respectively.
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