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| Name | Class |
|---|---|
| University of Seville | OTHER |
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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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| obese women without metabolic syndrome | Experimental | Women with obesity and without metabolic syndrome |
|
| obese women with metabolic syndrome | Experimental | Women with obesity and with metabolic syndrome |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| exercise training program | 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 |
| 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) :
| 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:
| from baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle) |
| Change in physical fitness (resistance; muscular strength) |
| 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) |
| 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) |
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Inclusion Criteria:
Main inclusion criteria
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jose A Gonzalez-Jurado, PhD | Universidad Pablo de Olavide de Sevilla | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CIRFD Universidad Pablo de Olavide | Seville | 41013 | Spain |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D024821 | Metabolic Syndrome |
| D057185 | Sedentary Behavior |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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To compare the effects of an interval training program in obese women with metabolic syndrom vs obese women without metabolic syndrom
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Participants do not know if they have metabolic syndrom Physical training supervisors do not know if participants have metabolic syndrom
|
|
| Feeding training | 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. |
|
| 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) |
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) |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D001519 | Behavior |