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

Primary Purpose

Obesity, Overweight and Obesity, Overweight or Obesity

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
exercise training program
Feeding training
Sponsored by
Universidad Pablo de Olavide
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring lipoinflammation, metabolic syndrome, training, overweight, sedentary lifestyle

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • CIRFD Universidad Pablo de Olavide

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

obese women without metabolic syndrome

obese women with metabolic syndrome

Arm Description

Women with obesity and without metabolic syndrome

Women with obesity and with metabolic syndrome

Outcomes

Primary Outcome Measures

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
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
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)
Change in physical fitness (aerobic power; VO2max)
Aerobic power. VO2 max. (estimated from the 6-minute walk test; ml/kg/min)
Change in physical fitness (Coordination; balance)
Balance test one leg (seconds)
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.
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.

Secondary Outcome Measures

Change eating habits
Food Frequency Questionnaires (weekly). Recording the frequency of food consumption per week
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)
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
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)
Change in Biochemistry Determinations In Plasma (protein metabolism)
PROTEIN METABOLISM Uric Acid (mg/dl) Urea (mg/dl) Creatinine (mg/dl) Bilirubin (mg/dl)

Full Information

First Posted
January 7, 2023
Last Updated
October 13, 2023
Sponsor
Universidad Pablo de Olavide
Collaborators
University of Seville
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1. Study Identification

Unique Protocol Identification Number
NCT05713461
Brief Title
Physical Exercise in Obesity for Health and Quality of Life.
Acronym
OBEFYSA
Official Title
Effects of a Physical Exercise Program Adapted to People With Obesity on Health Indicators and Quality of Life.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
October 26, 2022 (Actual)
Primary Completion Date
May 31, 2023 (Actual)
Study Completion Date
June 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Pablo de Olavide
Collaborators
University of Seville

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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?
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight and Obesity, Overweight or Obesity
Keywords
lipoinflammation, metabolic syndrome, training, overweight, sedentary lifestyle

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
To compare the effects of an interval training program in obese women with metabolic syndrom vs obese women without metabolic syndrom
Masking
ParticipantInvestigator
Masking Description
Participants do not know if they have metabolic syndrom Physical training supervisors do not know if participants have metabolic syndrom
Allocation
Non-Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
obese women without metabolic syndrome
Arm Type
Experimental
Arm Description
Women with obesity and without metabolic syndrome
Arm Title
obese women with metabolic syndrome
Arm Type
Experimental
Arm Description
Women with obesity and with metabolic syndrome
Intervention Type
Behavioral
Intervention Name(s)
exercise training program
Other Intervention Name(s)
interval training program
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Feeding training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in low-grade chronic inflammation
Description
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
Time Frame
from baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle)
Title
Change in body composition
Description
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
Time Frame
from baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle)
Title
Change in physical fitness (resistance; muscular strength)
Description
Maximum dynamic strength of the upper body (bench press; kg) Lower body maximal dynamic strength (leg press; kg) Grip maximal isometric strength (handgrip: kg)
Time Frame
from baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle)
Title
Change in physical fitness (aerobic power; VO2max)
Description
Aerobic power. VO2 max. (estimated from the 6-minute walk test; ml/kg/min)
Time Frame
From baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle)
Title
Change in physical fitness (Coordination; balance)
Description
Balance test one leg (seconds)
Time Frame
From baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle)
Title
Change in perceived health and perceived quality of life
Description
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.
Time Frame
from baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle)
Title
Change in healthy eating habits
Description
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.
Time Frame
from baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle)
Secondary Outcome Measure Information:
Title
Change eating habits
Description
Food Frequency Questionnaires (weekly). Recording the frequency of food consumption per week
Time Frame
Every week, from baseline (0 weeks) to follow-up (10 weeks)
Title
Change in Biochemistry Determinations In Plasma (lipidic profile)
Description
LIPIDIC PROFILE Total Cholesterol (mg/dl) HDL Cholesterol (mg/dl) LDL Cholesterol (mg/dl) Triglycerides (mg/dl)
Time Frame
From baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle)
Title
Change in Biochemistry Determinations In Plasma (glucose metabolism)
Description
Glycosylated Hemoglobin A1c (%) Insulin (uU/ml) Glucose (mg/dl) Insulin Resistance. HOMA-IR = (fasting insulin (uU/ml) * fasting glucose (mg/dl)) / 405
Time Frame
From baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle)
Title
Change in Biochemistry Determinations In Plasma (Enzymes of fatigue or muscular damage)
Description
ENZYMES (Fatigue or muscular damage) Creatine Kinase (UI/L) Transaminases (GOT/AST, GPT/ALT, GGT; UI/L ) C-Reactive Protein (mg/l)
Time Frame
From baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle)
Title
Change in Biochemistry Determinations In Plasma (protein metabolism)
Description
PROTEIN METABOLISM Uric Acid (mg/dl) Urea (mg/dl) Creatinine (mg/dl) Bilirubin (mg/dl)
Time Frame
From baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose A Gonzalez-Jurado, PhD
Organizational Affiliation
Universidad Pablo de Olavide de Sevilla
Official's Role
Principal Investigator
Facility Information:
Facility Name
CIRFD Universidad Pablo de Olavide
City
Sevilla
ZIP/Postal Code
41013
Country
Spain

12. IPD Sharing Statement

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Physical Exercise in Obesity for Health and Quality of Life.

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