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ObesityOBEFYSANCT05713461

Physical Exercise in Obesity for Health and Quality of Life.

A study testing exercise training program and Feeding training in people with Obesity and Overweight and Obesity, run by Universidad Pablo de Olavide at 1 site in Spain.

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

This project aims to develop an intervention on healthy habits based on physical exercise and nutritional education in people with obesity. It is accepted that exercise and nutrition are keys to controlling body weight. People with obesity frequently present with metabolic syndrome and a low-grade inflammatory state. Read more about this study

Who is it for?
Ages 35 to 65 years, women onlyHealthy volunteers can take part
What is being tested?
exercise training program and Feeding training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteSpain
Study dates
26 Oct 2022to 30 Jun 2023
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 35 to 65 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • The recruitment of participants would be carried out through advertising in the press, social networks, and electronic media.
  • Main inclusion criteria
  • Sex: Female
  • Caucasian
  • Age. women from 35 years to 65 years.
  • BMI: >29
Show all 27Show fewer
  • Abdominal perimeter: >90 cm women
  • No known Diabetes
  • No known cancer
  • No Known lung disease
  • No known cardiovascular disease
  • No known thyroid disease
  • No known liver disease
  • No known autoimmune disease
  • No other endocrine disorder causes obesity
  • No current treatment with anti-obesity medication
  • No current treatment with anti-inflammatory medication
  • No weight loss of > 5kg within the last 6 months
  • No diagnosis of depression or treatment with anti-depressive medication, ongoing or within the last three months before enrolment
  • No diagnosis of psychiatric disorder or treatment with antipsychotic medication
  • No history of suicidal behavior or ideations within the last three months before enrolment
  • No previous surgical treatment for obesity
  • Not pregnant/considering pregnancy
  • No functional impairments that prevent the performance of intensive exercise
  • Declare a sedentary lifestyle ((< 1,5 hours of structured physical activity per week at moderate intensity)
  • No participation in other research intervention studies
  • Signed informed consent.

Who cannot join

  • Diagnosis of pathology that involves an inflammatory process in the last year.
  • Objective findings that contraindicate participation in intensive exercise
  • The language barrier, mental incapacity, unwillingness or inability to understand the instruction of the study
  • Not completing 75% of the training sessions

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • CIRFD Universidad Pablo de Olavide

    Seville, 41013

Other trials in Spain

About this study

Official title: Effects of a Physical Exercise Program Adapted to People With Obesity on Health Indicators and Quality of Life.

This project aims to develop an intervention on healthy habits based on physical exercise and nutritional education in people with obesity.

It is accepted that exercise and nutrition are keys to controlling body weight. People with obesity frequently present with metabolic syndrome and a low-grade inflammatory state.

Read more

It is not known what should be the most effective training load/dose (duration, intensity, type of exercise) to improve health indicators related to metabolic syndrome and lipo-inflammation, and body composition in people with obesity.

A large-scale randomized controlled trial (RCT) will be essential to better understand the type and characteristics of training load/dose most effective in counteracting the detrimental effects of obesity.

The aim of this trial in 50 obese women was to answer the following questions:

  • Does the training program improve physical fitness?
  • Does the training program improve body composition?
  • Does the training program improve the state of chronic low-grade inflammation?
  • Does the training program improve the quality of life and perceived health?
  • Do people with obesity and metabolic syndrome respond in the same way to training?
  • what is the effect of four weeks of detraining?
Read the detailed description

A female single group, 2-armed ( people with obesity and metabolic syndrome vs people with obesity without metabolic syndrome), investigator-blinded, trial.

The study will last 17 weeks. Week 1 (testing 1: pretest); weeks 2-11 (Intervention: interval training program); week 12 (testing 3: postest); weeks 13-16 (detraining period); week 17 (testing 3: detraining test)

Participants will be allocated (1:1) regarding metabolic syndrome Behavioural: exercise training program Adapted Interval Training Intervention, three days a week, 10 weeks.

Warm-up ≃ 10': Joint mobility and cardiovascular activation.

Main part ≃ 45 min.:

Resistance training circuit for strengthening the main muscle groups.

  • Shoulder muscles
  • Pectoral muscles
  • Knee Flexor-extensor muscles
  • hip flexor extensor muscles Between 50-70% 1 RM (estimated). Repetitions 1-2 RIR (Repetition in Reserve). Load Intensity was controlled through RPE (OMNI-RES Scale) between 7-8 out of 10.

The training load will increase while maintaining the same intensity.

Cool down ≃ 5' Flexibility and CORE

Behavioural: Feeding training Two workshops on healthy eating habits (Week 1 and week 5). Food Frequency Questionnaires (weekly). Feedback weekly Mediterranean Diet Adherence Screener (MEDAS) The dietary intervention will be based on the nutritional recommendations based on the Mediterranean diet, according to the evidence from the PREDIMED trial.

Being tested
exercise training program, Feeding training
Keywords
lipoinflammation, metabolic syndrome, training, overweight, sedentary lifestyle
Medical subject headings
Obesity, Overweight, Metabolic Syndrome, Sedentary Behavior

What participants receive

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

  • exercise training programBehavioural

    Also called interval training program

    Adapted Interval Training Intervention, three days a week, 10 weeks.

    Warm-up 10': Joint mobility and cardiovascular activation

    Main part:

    Resistance training circuit for strengthening the main muscle groups.

    Cool down Flexibility and CORE

  • Feeding trainingBehavioural

    Two workshops on healthy eating habits (Week 1 and week 5). Food Frequency Questionnaires (weekly). Feedback weekly. Mediterranean Diet Adherence Screener (MEDAS). The dietary intervention will be based on the nutritional recommendations based on the Mediterranean diet, according to the evidence from the PREDIMED trial.

Study groups in NCT05713461
Study groupRoleWhat they receive
obese women without metabolic syndromeExperimentalWomen with obesity and without metabolic syndrome
Receives: Behavioral: exercise training program; Behavioral: Feeding training
obese women with metabolic syndromeExperimentalWomen with obesity and with metabolic syndrome
Receives: Behavioral: exercise training program; Behavioral: Feeding training

What is being measured

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

  1. Change in low-grade chronic inflammation

    Plasma levels of inflammatory and lipoinflammatory markers

    Multiplex Quantitative measurement of 40 human adipokines in plasma (cytokine antibody arrays (pg/ml) :

    1. Adiponectin
    2. Adipsin
    3. AgRP
    4. ANGPTL4
    5. BDNF
    6. Chemerin
    7. CRP
    8. GH
    9. IFNg
    10. IGFBP-1
    11. IGFBP-2
    12. IGF-I
    13. IL-10
    14. IL-12p40
    15. IL-12p70
    16. IL-1b
    17. IL-1ra
    18. IL-6
    19. IL-8
    20. Insulin
    21. Leptin
    22. Lipocalin-2
    23. MSPa
    24. OPG
    25. PAI-1
    26. PDGF-BB
    27. Pepsinogen 1
    28. Pepsinogen 2
    29. Procalcitonin
    30. Prolactin
    31. RANTES
    32. RBP4
    33. Resistin
    34. SAA
    35. TGFb1
    36. TSP-1
    37. TNF RI
    38. TNF RII
    39. TNFa
    40. VEGF

    Measured: from baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle)

  2. Change in body composition

    Body composition by DEXA. Main body composition components:

    • Body Fat Mass (g)
    • Body Lean Mass (g)
    • Body Bone mineral content (g)
    • Body Total mass (g)
    • Estimated Visceral Adipose Tissue (g)
    • BMI: kg/m^2

    Measured: from baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle)

  3. Change in physical fitness (resistance; muscular strength)

    • Maximum dynamic strength of the upper body (bench press; kg)
    • Lower body maximal dynamic strength (leg press; kg)
    • Grip maximal isometric strength (handgrip: kg)

    Measured: from baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle)

  4. Change in physical fitness (aerobic power; VO2max)

    Aerobic power. VO2 max. (estimated from the 6-minute walk test; ml/kg/min)

    Measured: From baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle)

  5. Change in physical fitness (Coordination; balance)

    Balance test one leg (seconds)

    Measured: From baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle)

  6. Change in perceived health and perceived quality of life

    perceived health by questionnaire (SF-12). The SF-12 response options are Likert-type scales that assess intensity or frequency.

    The number of response options ranges from three to six, depending on the item, and each question receives a value that is later transformed into a scale from 0 to 100.

    Measured: from baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle)

  7. Change in healthy eating habits

    Mediterranean Diet Adherence Screener (MEDAS). MEDAS consists of 12 questions on food consumption frequency and 2 questions on food intake habits considered characteristic of the Spanish Mediterranean diet. Each question was scored 0 or 1.

    Measured: from baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle)

Secondary outcomes (5)

  1. Change eating habits

    Food Frequency Questionnaires (weekly). Recording the frequency of food consumption per week

    Measured: Every week, from baseline (0 weeks) to follow-up (10 weeks)

  2. Change in Biochemistry Determinations In Plasma (lipidic profile)

    LIPIDIC PROFILE Total Cholesterol (mg/dl) HDL Cholesterol (mg/dl) LDL Cholesterol (mg/dl) Triglycerides (mg/dl)

    Measured: From baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle)

  3. Change in Biochemistry Determinations In Plasma (glucose metabolism)

    Glycosylated Hemoglobin A1c (%) Insulin (uU/ml) Glucose (mg/dl) Insulin Resistance. HOMA-IR = (fasting insulin (uU/ml) * fasting glucose (mg/dl)) / 405

    Measured: From baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle)

  4. Change in Biochemistry Determinations In Plasma (Enzymes of fatigue or muscular damage)

    ENZYMES (Fatigue or muscular damage) Creatine Kinase (UI/L) Transaminases (GOT/AST, GPT/ALT, GGT; UI/L ) C-Reactive Protein (mg/l)

    Measured: From baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle)

  5. Change in Biochemistry Determinations In Plasma (protein metabolism)

    PROTEIN METABOLISM Uric Acid (mg/dl) Urea (mg/dl) Creatinine (mg/dl) Bilirubin (mg/dl)

    Measured: From baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle)

Timeline

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

  1. First posted6 Feb 2023
  2. Study start26 Oct 2022
  3. Primary completion31 May 2023
  4. Study completion30 Jun 2023

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
Treatment
Allocation
Non-randomised
Intervention model
Factorial
Model description
To compare the effects of an interval training program in obese women with metabolic syndrom vs obese women without metabolic syndrom
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05713461
Sponsor's protocol ID
UPO-1381609
Acronym
OBEFYSA
Status last verified
Oct 2023
First submitted
7 Jan 2023
Last updated
16 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing exercise training program and Feeding training in people with Obesity and Overweight and Obesity, run by Universidad Pablo de Olavide at 1 site in Spain.

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 27 inclusion and 4 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 16 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Change in low-grade chronic inflammation (time frame: from baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle)). 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 NCT05713461.

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 16 Oct 2023.

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