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OverweightNCT03833791

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

A study testing education and modifying diet and education, modifying diet and physical activity prescription in people with Overweight and Obesity, run by Universidad de Córdoba.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Overweight, Obesity
What is being tested?
education and modifying diet and education, modifying diet and physical activity prescription
Could I receive a placebo?
No, everyone receives an active treatment
How many people
220 participants
Where
No sites listed yet
Study dates
1 Jan 2016to 1 Jun 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

About this study

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.

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

Read the 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
Being tested
education and modifying diet, education, modifying diet and physical activity prescription
Keywords
obesity, Physical Activity, fat mass, fat free mass
Medical subject headings
Overweight, Obesity, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • education and modifying dietBehavioural

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

  • education, modifying diet and physical activity prescriptionBehavioural

    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.

Study groups in NCT03833791
Study groupRoleWhat they receive
Control Group (CON)Active comparatoreducation and modifying diet
Receives: Behavioral: education and modifying diet
Moderate physical activity Group (PAM)Experimentaleducation, modifying diet and physical activity prescription
Receives: Behavioral: education, modifying diet and physical activity prescription
Intensity physical activity Group (PAI)Experimentaleducation, modifying diet and physical activity prescription
Receives: Behavioral: education, modifying diet and physical activity prescription

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: At baseline (0 years) and followed for 2 years

  2. 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.

    Measured: At baseline (0 years) and followed for 2 years

  3. 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.

    Measured: At baseline (0 years) and followed for 2 years

  4. 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.

    Measured: At baseline (0 years) and followed for 2 years

  5. 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.

    Measured: At baseline (0 years) and followed for 2 years

  6. 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.

    Measured: At baseline (0 years) and followed for 2 years

  7. 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.

    Measured: At baseline (0 years) and followed for 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2019
  2. Study start1 Jan 2016
  3. Primary completion15 Dec 2018
  4. Study completion1 Jun 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
220 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03833791
Sponsor's protocol ID
TESIS-OBESITICS-2018
Status last verified
Jan 2021
First submitted
1 Feb 2019
Last updated
25 Jan 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 31882009

Questions about this trial

What is this clinical trial studying?

A study testing education and modifying diet and education, modifying diet and physical activity prescription in people with Overweight and Obesity, run by Universidad de Córdoba.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes from baseline BMI. (time frame: At baseline (0 years) and followed for 2 years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03833791, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2021.

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