Physical Activity, Dietary Intake and Bone Status in 6-12 Years Children

Study Overview
=================
Brief Summary
-----------------
Peak bone mass acquisition through childhood and adolescence has been associated with lower risk of osteopenia and osteoporosis in the elderly. The main factors that influence bone mass are the non-modifiable, such as genetics, ethnicity and sex, and the modifiable ones which are nutrition and physical activity or exercise. In the literature are references that demonstrates positive effects of high physical activity, adequate intakes of macro- and micronutrients on bone mass both in adults and in children. Bone mineralization is more adaptive in childrens' growing bones and this is an opportunity for stronger effects by mechanical stimuli during physical activity. The presence of a diet complete of nutrient intakes seems to strengthen the effects of mechanical loads on bone growth and mineralization. The present trial aimed to evaluate the effects of physical activity and nutrition intakes on bone mass in pre-pubertal children.

Detailed Description
-----------------
The sample of this study was healthy pre-pubertal boys and girls (N=210) who had training age 0-1 years. Data collection included anthropometric measurements, blood sampling, body composition, bone measurements and physical performance measurements. Nutritional intake was recorded for seven consecutive days in order to evaluate nutrient intakes using an appropriate software and habitual physical activity was measured for the same days using accelerometers. Pubertal stage determined by Tanner scale. All measurements were made only once at the beginning of school year.

Official Title
-----------------
Effect of Nutrition and Physical Activity on Bone Status in 6-12 Years Children

Conditions
-----------------
Bone Status

Intervention / Treatment
-----------------
* Behavioral: physical activity level
* Behavioral: Dietary Intake


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: were 6-12 years and pre-pubertal were healthy and had no prior bone fractures or related surgical operation their body fat was <30%, e) had no history of growth irregularities were not receiving agents or drugs that affect bone tissue (e.g. Gonadotropin-Releasing Hormone (GnRH) agonists, antiresorptive, bisphosphonates, etc.) Exclusion Criteria: had prior bone fractures or related surgical operation their body fat was >30% had history of growth irregularities were receiving agents or drugs that affect bone tissue (e.g. GnRH agonists, antiresorptive, bisphosphonates, etc.)

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| physical activity level<br>Children categorized either in the group with moderate to vigorous physical activity or in the group with low physical activity according the accelerometer's measures | Behavioral: physical activity level<br> <br> |
| dietary intake<br>Childrens' 24th dietary recalls for 7 days analyzed for protein, calcium, vitamin D and phosphorus intake and they categorized according the RDAs above or below them. | Behavioral: Dietary Intake<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Whole body bone mineral density | Measured by Dual-X-ray Absoroptiometry | 1 day (Once) | 
| Lumbar spine bone mineral density | Measured by Dual-X-ray Absoroptiometry | 1 day (Once) | 
| Hips bone mineral density | Measured by Dual-X-ray Absoroptiometry | 1 day (Once) | 
| Whole body mineral content | Measured by Dual-X-ray Absoroptiometry | 1 day (Once) | 
| Lumbar spine bone mineral content | Measured by Dual-X-ray Absoroptiometry | 1 day (Once) | 
| Hips bone mineral content | Measured by Dual-X-ray Absoroptiometry | 1 day (Once) | 
| Body composition | Measured by Dual-X-ray Absoroptiometry and skinfolds | 1 day (Once) | 
| Muscular strength | Handgrip strength | 1 day (Once) | 
| Cardiovascular endurance | 20m shuttle run test | 1 day (Once) | 
| Flexibility | Sit and reach test | 1 day (Once) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sclerostin | Measured in blood samples with an appropriate kit | 1 day (Once) | 
| Serum vitamin D | Measured in blood smaples | 1 day (Once) | 
| Serum calcium | Measured in blood smaples | 1 day (Once) | 
| Pubertal Stage | Evaluated with Tanner Stage protocol | 1 day (Once) |