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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
Universidad de Córdoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Overweight focused on measuring obesity, Physical Activity, fat mass, fat free mass

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    February 1, 2019
    Last Updated
    January 20, 2021
    Sponsor
    Universidad de Córdoba
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    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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