Clinical trial NCT03833791: 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
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
Keywords: obesity
Physical Activity
fat mass
fat free mass
Lead sponsor: Universidad de Córdoba
Sponsor class: OTHER
First posted: 2019-02-07
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Changes from baseline BMI.
timeFrame: At baseline (0 years) and followed for 2 years
measure: Changes from baseline Fatty mass.
timeFrame: At baseline (0 years) and followed for 2 years
measure: Changes from baseline Free-fatty mass.
timeFrame: At baseline (0 years) and followed for 2 years
measure: Changes from baseline Muscular Mass.
timeFrame: At baseline (0 years) and followed for 2 years
measure: Changes from baseline Corporal Water .
timeFrame: At baseline (0 years) and followed for 2 years
measure: Adherence to dietary pattern will be also measured through personal interview
timeFrame: At baseline (0 years) and followed for 2 years
measure: Adherence to physical activity patterns will be also measured through IPAQ (International Physical Activity Questionnaire).
timeFrame: At baseline (0 years) and followed for 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Universidad de Córdoba
name: Alberto Hernández-Reyes
role: PRINCIPAL_INVESTIGATOR
References:
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.