OBEFYSA: Physical Exercise in Obesity for Health and Quality of Life.

Sponsor

Universidad Pablo de Olavide (Other)

Overall Status

Recruiting

CT.gov ID

NCT05713461

Collaborator

University of Seville (Other)

Enrollment

Location

Arms

6.3

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

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?

Condition or Disease	Intervention/Treatment	Phase
Obesity Overweight and Obesity Overweight or Obesity	Behavioral: exercise training program Behavioral: Feeding training	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Non-Randomized

Intervention Model:

Factorial Assignment

Intervention Model Description:

To compare the effects of an interval training program in obese women with metabolic syndrom vs obese women without metabolic syndromTo compare the effects of an interval training program in obese women with metabolic syndrom vs obese women without metabolic syndrom

Masking:

Double (Participant, Investigator)

Masking Description:

Participants do not know if they have metabolic syndrom Physical training supervisors do not know if participants have metabolic syndrom

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 26, 2022

Anticipated Primary Completion Date :

Mar 31, 2023

Anticipated Study Completion Date :

May 5, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: obese women without metabolic syndrome Women with obesity and without metabolic syndrome	Behavioral: exercise 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 Other Names: interval training program Behavioral: 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.
Experimental: obese women with metabolic syndrome Women with obesity and with metabolic syndrome	Behavioral: exercise 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 Other Names: interval training program Behavioral: 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.

Arm

Intervention/Treatment

Experimental: obese women without metabolic syndrome

Women with obesity and without metabolic syndrome

Behavioral: exercise 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

Other Names:

interval training program

Behavioral: 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.

Experimental: obese women with metabolic syndrome

Women with obesity and with metabolic syndrome

Behavioral: exercise training program

Other Names:

interval training program

Behavioral: Feeding training

Outcome Measures

Primary Outcome Measures

Change in low-grade chronic inflammation [from baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle)]
Plasma levels of inflammatory and lipoinflammatory markers Multiplex Quantitative measurement of 40 human adipokines in plasma (cytokine antibody arrays (pg/ml) : Adiponectin Adipsin AgRP ANGPTL4 BDNF Chemerin CRP GH IFNg IGFBP-1 IGFBP-2 IGF-I IL-10 IL-12p40 IL-12p70 IL-1b IL-1ra IL-6 IL-8 Insulin Leptin Lipocalin-2 MSPa OPG PAI-1 PDGF-BB Pepsinogen 1 Pepsinogen 2 Procalcitonin Prolactin RANTES RBP4 Resistin SAA TGFb1 TSP-1 TNF RI TNF RII TNFa VEGF
Change in body composition [from baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle)]
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
Change in physical fitness (resistance; muscular strength) [from baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle)]
Maximum dynamic strength of the upper body (bench press; kg) Lower body maximal dynamic strength (leg press; kg) Grip maximal isometric strength (handgrip: kg)
Change in physical fitness (aerobic power; VO2max) [From baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle)]
Aerobic power. VO2 max. (estimated from the 6-minute walk test; ml/kg/min)
Change in physical fitness (Coordination; balance) [From baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle)]
Balance test one leg (seconds)
Change in perceived health and perceived quality of life [from baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle)]
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.
Change in healthy eating habits [from baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle)]
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.

Secondary Outcome Measures

Change eating habits [Every week, from baseline (0 weeks) to follow-up (10 weeks)]
Food Frequency Questionnaires (weekly). Recording the frequency of food consumption per week
Change in Biochemistry Determinations In Plasma (lipidic profile) [From baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle)]
LIPIDIC PROFILE Total Cholesterol (mg/dl) HDL Cholesterol (mg/dl) LDL Cholesterol (mg/dl) Triglycerides (mg/dl)
Change in Biochemistry Determinations In Plasma (glucose metabolism) [From baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle)]
Glycosylated Hemoglobin A1c (%) Insulin (uU/ml) Glucose (mg/dl) Insulin Resistance. HOMA-IR = (fasting insulin (uU/ml) * fasting glucose (mg/dl)) / 405
Change in Biochemistry Determinations In Plasma (Enzymes of fatigue or muscular damage) [From baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle)]
ENZYMES (Fatigue or muscular damage) Creatine Kinase (UI/L) Transaminases (GOT/AST, GPT/ALT, GGT; UI/L ) C-Reactive Protein (mg/l)
Change in Biochemistry Determinations In Plasma (protein metabolism) [From baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle)]
PROTEIN METABOLISM Uric Acid (mg/dl) Urea (mg/dl) Creatinine (mg/dl) Bilirubin (mg/dl)

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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
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.

Exclusion Criteria:

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