Effects of lifestyle changes in an obese metabolically healthy elderly population

Obese metabolically healthy elderly population: -omic studies (epigenetics, metabolomics, metagenomics) and its relationship with environmental pollutants

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN11769612

Enrollment

150

Registered

2021-11-29

Start date

2018-11-01

Completion date

Unknown

Last updated

2024-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lifestyle intervention in metabolically healthy obese older adults Nutritional, Metabolic, Endocrine

Interventions

Participants will be encouraged to follow a Mediterranean diet advised by a nutritionist based on the Trichopoulou index and practice regular adapted physical activity for 24 months. The recommended c

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged >65 years 2. BMI =30-<40 kg/m² 3. One or none of the following four cardiometabolic disorders: 3.1 Systolic blood pressure =140 mmHg and/or diastolic blood pressure =90 mmHg 3.2 Triglycerides =150 mg/dl 3.3 HDL-C <40 mg/dl in men and <50mg/dl women 3.4 Fasting blood glucose =100 mg/dl, following the WHO criterion of MHO

Exclusion criteria

Exclusion criteria: 1. Diabetes 2. Hypertension 3. Previous cardiovascular disease (coronary, cerebrovascular or peripheral; aortic aneurysm, heart failure) 4. Severe associated disease (advanced organ failure, dementia, cancer) 5. Immobilized or terminally ill individuals 6. Alcoholism or drug addiction 7. Severe psychiatric illness 8. Weight loss =5 kg in the last 6 months of unknown cause.

Design outcomes

Primary

Measure	Time frame
The primary outcome is a composite outcome where the researchers will analyze the effectiveness of a multidisciplinary and multicomponent intervention carried out in the community setting, aimed at modifying the lifestyle (use of a Mediterranean diet and promotion of physical activity) to prevent the incidence of cardiometabolic alterations in elderly healthy metabolically obese subjects. This has been quantified as an improvement in Mediterranean diet adherence through food frequency questionnaires (baseline and 4, 12 and 24 months) and improvement in physical activity intensities, measured by accelerometry (minutes/day). 1. Nutritional assessment and monitoring: food intake analyzed using questionnaires at baseline and at 4, 12 and 24 months: 1.1. A non-consecutive, 3-day dietary record (two workdays and one weekend day), containing detailed information about food composition and cooking recipes over 72 hours 1.2. A food frequency questionnaire (number of times/day, number of days/week, number of days/14 days, number of days/month, rarely, or never) 1.3. Adherence to Mediterranean diet assessed by a validated 14-item food consumption frequency questionnaire 2. Physical activity monitored using a GENEActiv Actigraph GT3X+ accelerometer at baseline and at 4, 12 and 24 months. The accelerometer should be worn under the chest with a tight elastic belt to ensure close contact with the body. Recordings are made every day for at least 7 days (weekdays and the weekend) to take their hours of physical activity and sleep, except during water activities. Physical activity is also evaluated using the Rapid Assessment of Physical Activity (RAPA) questionnaire, a validated 7-item questionnaire at baseline and at 4, 12 and 24 months	—

Measure

Time frame

The primary outcome is a composite outcome where the researchers will analyze the effectiveness of a multidisciplinary and multicomponent intervention carried out in the community setting, aimed at modifying the lifestyle (use of a Mediterranean diet and promotion of physical activity) to prevent the incidence of cardiometabolic alterations in elderly healthy metabolically obese subjects. This has been quantified as an improvement in Mediterranean diet adherence through food frequency questionnaires (baseline and 4, 12 and 24 months) and improvement in physical activity intensities, measured by accelerometry (minutes/day). 1. Nutritional assessment and monitoring: food intake analyzed using questionnaires at baseline and at 4, 12 and 24 months: 1.1. A non-consecutive, 3-day dietary record (two workdays and one weekend day), containing detailed information about food composition and cooking recipes over 72 hours 1.2. A food frequency questionnaire (number of times/day, number of days/week, number of days/14 days, number of days/month, rarely, or never) 1.3. Adherence to Mediterranean diet assessed by a validated 14-item food consumption frequency questionnaire 2. Physical activity monitored using a GENEActiv Actigraph GT3X+ accelerometer at baseline and at 4, 12 and 24 months. The accelerometer should be worn under the chest with a tight elastic belt to ensure close contact with the body. Recordings are made every day for at least 7 days (weekdays and the weekend) to take their hours of physical activity and sleep, except during water activities. Physical activity is also evaluated using the Rapid Assessment of Physical Activity (RAPA) questionnaire, a validated 7-item questionnaire at baseline and at 4, 12 and 24 months

—

Secondary

Measure	Time frame
1. Anthropometric variables measured by trained personnel at baseline and at 4, 12 and 24 months: 1.1. Weight measured using an electronic scale: TANITA Body Composition Analyzer. Type TBF-300 MA. (TANITA Corporation; 1-14-2 Maeno-cho, Itabashi-ku. Tokio, Japan) 1.2. Height measured with no shoes using a wall stadiometer (Stadiometer Barys Electra Model. 511-300-A0A. ASIMED) 1.3. BMI calculated by dividing weight (kg) by height squared (m²) 1.4. The waist/hip index (WHI) calculated as the ratio of abdominal circumference (at the level of the mid-point between the anterosuperior iliac crest and the last costal arch, parallel to the ground and upon exhalation) and hip, both in cm 1.5. Blood pressure measured with a validated automated electronic sphygmomanometer (OMRON M7 (HEM-780-E, OMRON Healthcare Co. Ltd, Kyoto, Japan) after 5 minutes of rest while the participant is in a seated position 2. Serum adipokine and inflammatory biomarkers levels (IL-6 and TNFa) measured using an enzyme-linked immunosorbent assay (ELISA) (R&D Systems, Inc., Minneapolis, MN, USA) on blood samples collected after an overnight fast at baseline and at 4, 12 and 24 months 3. High-sensitivity CRP levels measured using ELISA (DRG Instruments GmbH, Germany) on blood samples collected after an overnight fast at baseline and at 4, 12 and 24 months	—

Measure

Time frame

1. Anthropometric variables measured by trained personnel at baseline and at 4, 12 and 24 months: 1.1. Weight measured using an electronic scale: TANITA Body Composition Analyzer. Type TBF-300 MA. (TANITA Corporation; 1-14-2 Maeno-cho, Itabashi-ku. Tokio, Japan) 1.2. Height measured with no shoes using a wall stadiometer (Stadiometer Barys Electra Model. 511-300-A0A. ASIMED) 1.3. BMI calculated by dividing weight (kg) by height squared (m²) 1.4. The waist/hip index (WHI) calculated as the ratio of abdominal circumference (at the level of the mid-point between the anterosuperior iliac crest and the last costal arch, parallel to the ground and upon exhalation) and hip, both in cm 1.5. Blood pressure measured with a validated automated electronic sphygmomanometer (OMRON M7 (HEM-780-E, OMRON Healthcare Co. Ltd, Kyoto, Japan) after 5 minutes of rest while the participant is in a seated position 2. Serum adipokine and inflammatory biomarkers levels (IL-6 and TNFa) measured using an enzyme-linked immunosorbent assay (ELISA) (R&D Systems, Inc., Minneapolis, MN, USA) on blood samples collected after an overnight fast at baseline and at 4, 12 and 24 months 3. High-sensitivity CRP levels measured using ELISA (DRG Instruments GmbH, Germany) on blood samples collected after an overnight fast at baseline and at 4, 12 and 24 months

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Countries

Spain

Contacts

Public ContactM Rosa Bernal-López

robelopajiju@yahoo.es+34 951290346

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026