Effect of Different Physical Programs on the Body Composition of Adult Men and Women With an Initial Body Fat >25% and >30%, Respectively.

NCT ID: NCT03833791

Last Updated: 2021-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-01
• Study Completion Date: 2019-06-01

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.

Conditions

Overweight; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Control Group (CON)

education and modifying diet

Group Type: ACTIVE_COMPARATOR

education and modifying diet

Intervention Type: BEHAVIORAL

The control group maintains a sedentary lifestyle and is only subjected to follow a hypocaloric diet

Moderate physical activity Group (PAM)

education, modifying diet and physical activity prescription

Group Type: EXPERIMENTAL

education, modifying diet and physical activity prescription

Intervention Type: BEHAVIORAL

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.

Intensity physical activity Group (PAI)

education, modifying diet and physical activity prescription

Group Type: EXPERIMENTAL

education, modifying diet and physical activity prescription

Intervention Type: BEHAVIORAL

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.

Interventions

education and modifying diet

The control group maintains a sedentary lifestyle and is only subjected to follow a hypocaloric diet

Intervention Type: BEHAVIORAL

education, modifying diet and physical activity prescription

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidad de Córdoba

OTHER

Sponsor Role: lead

Responsible Party

Alberto Hernández de los Reyes

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alberto Hernández-Reyes

Role: PRINCIPAL_INVESTIGATOR

Universidad de Córdoba

References

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.

Reference Type: DERIVED

PMID: 31882009 (View on PubMed)

Other Identifiers

TESIS-OBESITICS-2018

Identifier Type: -

Identifier Source: org_study_id