Study of Parental Ratings of Quality of Life and Body Composition in 5-19 Year Olds While Participating in the Good NEWS 4 Kids Program

Study Overview
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Brief Summary
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This study will compare changes in body composition (lean mass, fat, and bone)and parent ratings of quality of life in 5-19 Year Olds as a function of participation in one of four versions of the Good NEWS 4 Kids Program (GN4K).

Detailed Description
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Purpose: The objectives of this study are to: Compare the relative efficacy of four variations of the GN4K program in facilitating positive changes in body composition and parental ratings of quality of life. Compare parental ratings of children's behavior to DXA-measured changes in body composition; Compare measurements of scale weight, height, waist/hip ratios and BMI with DXA-measured changes in body composition; Develop a logarithm formula with the use of anthropometric measurements and parental ratings to predict body composition changes

Official Title
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A Comparative Effectiveness Research Study Comparing Changes in Body Composition and Parent Ratings of Quality of Life in 5-19 Year Olds as a Function of Participation in One of Four Versions of the Good NEWS 4 Kids Program (GN4K)

Conditions
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Quality of Life, Body Mass Index

Intervention / Treatment
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* Dietary Supplement: MannaBears
* Dietary Supplement: AlgaeCal Calcium
* Dietary Supplement: Calcium carbonate
* Dietary Supplement: Vitamin D3


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must ensure with medical provider that there are not medical conditions that would preclude participation Must be between the ages of 5 and 19 Exclusion Criteria: males and females below the age of 5 and above the age of 19 pregnant or breast feeding

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MannaBears<br>Subjects will take 4 MannaBears daily | Dietary Supplement: MannaBears<br>* Subjects will be administered 4 MannaBears daily<br>|
| Active Comparator: MannaBears, AlgaeCal Calcium, Vitamin D3<br>Subjects will take 4 MannaBears daily and 3 Calcium/Vit D capsules (2 with breakfast and 1 with dinner or vice-versa) daily | Dietary Supplement: MannaBears<br>* Subjects will be administered 4 MannaBears daily<br>Dietary Supplement: AlgaeCal Calcium<br>* Subjects will be administered 750 mg AlgaeCal Calcium<br>Dietary Supplement: Vitamin D3<br>* Subjects will be administered 800 IU vitamin D3<br>|
| Active Comparator: MannaBears, Calcium Carbonate, Vitamin D3<br>Subjects will take 4 MannaBears daily and 3 Calcium/Vit D capsules (2 with breakfast and 1 with dinner or vice-versa) daily | Dietary Supplement: MannaBears<br>* Subjects will be administered 4 MannaBears daily<br>Dietary Supplement: Calcium carbonate<br>* Subjects will be administered 1000 mg calcium carbonate<br>Dietary Supplement: Vitamin D3<br>* Subjects will be administered 800 IU vitamin D3<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in parental ratings of participating child's quality of life | Parent(s) will complete questionnaires on a monthly basis to assess the improvements made or improvements that have been made in various areas of their child's behavior and activities. Change from baseline to end of study will be reported. | 0 and 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in body composition as a measurement of Dual Energy Absorptiometry | Body composition (fat, fat-free mass, and bone mineral density) as measured by Dual Energy Absorptiometry (DXA) | 0 and 90 days | 
| Changes in hip to waist ratios | Parent(s) will be provided with a tape measure with which they will measure their child's hip and waist. | 0 and 90 days | 
| Changes in blood pressure | Blood pressure will be measured at the time the DXA measurement is completed. | 0 and 90 days | 
| Changes in gender and age adjusted BMI |  | 0 and 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Quality of Life, Body Weight and Measures, Malnutrition, Adolescent Nutrition Sciences, Sleep Initiation and Maintenance Disorder, Motor Activity, Drinking