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| Name | Class |
|---|---|
| Fundación FES | OTHER |
| Fundación Cardiovascular de Colombia | OTHER |
| Instituto Nacional de Salud | UNKNOWN |
| University College, London |
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At the moment, most of efforts to prevent non-transmissible chronic diseases at population level have been centered in promoting healthful behaviors like physical activity, consumption of fruits and vegetables, and discouraging from the consumption of tobacco and alcohol in adult population, but the results have been little hopeful. In the last years, manifold studies have indicated the relation between metabolic alterations and of the fetal growth with the development of non-transmissible chronic diseases in adult age. More recently, it has been proposed that maternal factors (endothelial function, oxidative stress and alterations in adipokines) and placental ones (mitochondrial dysfunction) are the precursory mechanisms of fetal metabolic alterations and of the later development of non-transmissible chronic diseases. Also, it has been suggested that possibly supplementation with micronutrients and the physical exercise during the gestation can regulate these maternal and placental factors. For the reasons just mentioned, it is necessary to clarify if these proposed factors are related to fetal metabolic alterations and if the supplementation during the gestation with micronutrients and/or the physical exercise can regulate them, which would be an early and novel alternative to fortify the prevention of non-transmissible chronic diseases in the population.
Purpose
Hypothesis:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Other | Regular aerobic physical exercise + placebo |
|
| 2 | Other | Activities of daily living + Micronutrients |
|
| 3 | Other | Regular aerobic exercise + micronutrients |
|
| 4 | Placebo Comparator | Activities of daily living + placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regular aerobic physical exercise | Behavioral | Walking (10 minutes), aerobic exercise (30 minutes), stretching (10 minutes) and relaxation exercise (10 minutes). Exercise will be performed at three sessions per week. All sessions will be supervised by a physical therapist and a physical educator. |
| Measure | Description | Time Frame |
|---|---|---|
| Endothelium-dependent flow mediated dilation | Baseline / week 32-36 of gestation |
| Measure | Description | Time Frame |
|---|---|---|
| Biomarkers of endothelial function in blood from umbilical vein and maternal blood | Baseline / 32-36 weeks gestation and delivery | |
| Markers of mitochondrial function | Baseline / 32-36 weeks gestation and delivery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ana C Plata, MSc | Universidad del Valle, Colombia | Study Chair |
| Julio Cesar Mateus, MD, MEpi | Fundación FES, División de Salud. Colombia | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ana C Plata, MSc | Cali | Valle del Cauca Department | Colombia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22341377 | Derived | Robledo-Colonia AF, Sandoval-Restrepo N, Mosquera-Valderrama YF, Escobar-Hurtado C, Ramirez-Velez R. Aerobic exercise training during pregnancy reduces depressive symptoms in nulliparous women: a randomised trial. J Physiother. 2012;58(1):9-15. doi: 10.1016/S1836-9553(12)70067-X. | |
| 21356082 | Derived | Ramirez-Velez R, Romero M, Echeverri I, Ortega JG, Mosquera M, Salazar B, Giron SL, Saldarriaga W, Aguilar de Plata AC, Mateus JC. A factorial randomized controlled trial to evaluate the effect of micronutrients supplementation and regular aerobic exercise on maternal endothelium-dependent vasodilatation and oxidative stress of the newborn. Trials. 2011 Feb 28;12:60. doi: 10.1186/1745-6215-12-60. |
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| OTHER |
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|
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| Micronutrients | Dietary Supplement | Zinc 30mg, Magnesium 400mg, Beta-carotene 9 mg, Tocopherol 30mg, vitamin C 200mg y Niacin 100mg. |
|
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| Activities of daily living + placebo | Other | Basic activities of daily living (bathing, dressing, eating, walking) without counseling by a physical therapist and prenatal care. Placebo Comparator: Equivalent to placebo (maltodextrin). |
|
| Neonatal and maternal anthropometric indicators | Baseline / 32-36 weeks gestation and delivery |
| Quality of life SF-12 | Baseline / 32-36 weeks gestation and delivery |
| Functional capacity (VO2max) | Baseline / 32-36 weeks gestation and delivery |
| ID | Term |
|---|---|
| D011225 | Pre-Eclampsia |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D018977 | Micronutrients |
| D008722 | Methods |
| D000203 | Activities of Daily Living |
| ID | Term |
|---|---|
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000078622 | Nutrients |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D008919 | Investigative Techniques |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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