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

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.

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?

Study Overview

• Status: Completed
• Conditions: Obesity; Overweight and Obesity; Overweight or Obesity
• Intervention / Treatment: Behavioral: exercise training program; Behavioral: Feeding training

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Sevilla, Spain, 41013
    • CIRFD Universidad Pablo de Olavide

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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) : 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	from baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle)
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	from baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle)
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)	from baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle)
Change in physical fitness (aerobic power; VO2max)	Aerobic power. VO2 max. (estimated from the 6-minute walk test; ml/kg/min)	From baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle)
Change in physical fitness (Coordination; balance)	Balance test one leg (seconds)	From baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle)
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.	from baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle)
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.	from baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change eating habits	Food Frequency Questionnaires (weekly). Recording the frequency of food consumption per week	Every week, from baseline (0 weeks) to follow-up (10 weeks)
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)	From baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle)
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	From baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle)
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)	From baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle)
Change in Biochemistry Determinations In Plasma (protein metabolism)	PROTEIN METABOLISM Uric Acid (mg/dl) Urea (mg/dl) Creatinine (mg/dl) Bilirubin (mg/dl)	From baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle)

Collaborators and Investigators

• Sponsor: Universidad Pablo de Olavide
• Collaborators: University of Seville
• Investigators: Principal Investigator: Jose A Gonzalez-Jurado, PhD, Universidad Pablo de Olavide de Sevilla

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2022
• Primary Completion (Actual): May 31, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: January 7, 2023
• First Submitted That Met QC Criteria: January 26, 2023
• First Posted (Actual): February 6, 2023

Study Record Updates

• Last Update Posted (Actual): October 16, 2023
• Last Update Submitted That Met QC Criteria: October 13, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: overweight; training; metabolic syndrome; sedentary lifestyle; lipoinflammation
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Obesity; Overweight
• Other Study ID Numbers: UPO-1381609

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No