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
- Conditions
- Quality of LifeBody Mass Index
- Interventions
- Dietary Supplement: MannaBearsDietary Supplement: AlgaeCal CalciumDietary Supplement: Calcium carbonateDietary Supplement: Vitamin D3
- Registration Number
- NCT01855009
- Lead Sponsor
- Integrative Health Technologies, Inc.
- Brief Summary
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
Purpose: The objectives of this study are to:
1. 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.
2. Compare parental ratings of children's behavior to DXA-measured changes in body composition;
3. Compare measurements of scale weight, height, waist/hip ratios and BMI with DXA-measured changes in body composition;
4. Develop a logarithm formula with the use of anthropometric measurements and parental ratings to predict body composition changes
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
- Must ensure with medical provider that there are not medical conditions that would preclude participation
- Must be between the ages of 5 and 19
- males and females below the age of 5 and above the age of 19
- pregnant or breast feeding
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MannaBears MannaBears Subjects will take 4 MannaBears daily MannaBears, AlgaeCal Calcium, Vitamin D3 MannaBears Subjects will take 4 MannaBears daily and 3 Calcium/Vit D capsules (2 with breakfast and 1 with dinner or vice-versa) daily MannaBears, AlgaeCal Calcium, Vitamin D3 AlgaeCal Calcium Subjects will take 4 MannaBears daily and 3 Calcium/Vit D capsules (2 with breakfast and 1 with dinner or vice-versa) daily MannaBears, AlgaeCal Calcium, Vitamin D3 Vitamin D3 Subjects will take 4 MannaBears daily and 3 Calcium/Vit D capsules (2 with breakfast and 1 with dinner or vice-versa) daily MannaBears, Calcium Carbonate, Vitamin D3 MannaBears Subjects will take 4 MannaBears daily and 3 Calcium/Vit D capsules (2 with breakfast and 1 with dinner or vice-versa) daily MannaBears, Calcium Carbonate, Vitamin D3 Calcium carbonate Subjects will take 4 MannaBears daily and 3 Calcium/Vit D capsules (2 with breakfast and 1 with dinner or vice-versa) daily MannaBears, Calcium Carbonate, Vitamin D3 Vitamin D3 Subjects will take 4 MannaBears daily and 3 Calcium/Vit D capsules (2 with breakfast and 1 with dinner or vice-versa) daily
- Primary Outcome Measures
Name Time Method Change from baseline in parental ratings of participating child's quality of life 0 and 90 days 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.
- Secondary Outcome Measures
Name Time Method Changes in gender and age adjusted BMI 0 and 90 days Changes in blood pressure 0 and 90 days Blood pressure will be measured at the time the DXA measurement is completed.
Changes in body composition as a measurement of Dual Energy Absorptiometry 0 and 90 days Body composition (fat, fat-free mass, and bone mineral density) as measured by Dual Energy Absorptiometry (DXA)
Changes in hip to waist ratios 0 and 90 days Parent(s) will be provided with a tape measure with which they will measure their child's hip and waist.
Trial Locations
- Locations (1)
Integrative Health Technologies
🇺🇸San Antonio, Texas, United States