Physical Exercise in Obesity for Health and Quality of Life.

NCT ID: NCT05713461

Last Updated: 2023-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-26
• Study Completion Date: 2023-06-30

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.

Conditions

Obesity; Overweight and Obesity; Overweight or Obesity

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

obese women without metabolic syndrome

Women with obesity and without metabolic syndrome

Group Type: EXPERIMENTAL

exercise training program

Intervention Type: BEHAVIORAL

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 training

Intervention Type: BEHAVIORAL

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.

obese women with metabolic syndrome

Women with obesity and with metabolic syndrome

Group Type: EXPERIMENTAL

exercise training program

Intervention Type: BEHAVIORAL

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 training

Intervention Type: BEHAVIORAL

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.

Interventions

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

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

interval training program

Eligibility Criteria

Inclusion Criteria

• The recruitment of participants would be carried out through advertising in the press, social networks, and electronic media.

• 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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Seville

OTHER

Sponsor Role: collaborator

Universidad Pablo de Olavide

OTHER

Sponsor Role: lead

Responsible Party

José Antonio González Jurado

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jose A Gonzalez-Jurado, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad Pablo de Olavide de Sevilla

Locations

CIRFD Universidad Pablo de Olavide

Seville, , Spain

Countries

Spain

Other Identifiers

UPO-1381609

Identifier Type: -

Identifier Source: org_study_id