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)
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change from baseline in parental ratings of participating child's quality of life
研究概览
简要总结
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).
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 5 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must ensure with medical provider that there are not medical conditions that would preclude participation
- •Must be between the ages of 5 and 19
排除标准
- •males and females below the age of 5 and above the age of 19
- •pregnant or breast feeding
研究组 & 干预措施
MannaBears
Subjects will take 4 MannaBears daily
干预措施: MannaBears (Dietary Supplement)
MannaBears, AlgaeCal Calcium, 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
干预措施: MannaBears (Dietary Supplement)
MannaBears, AlgaeCal Calcium, 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
干预措施: AlgaeCal Calcium (Dietary Supplement)
MannaBears, Calcium Carbonate, 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
干预措施: MannaBears (Dietary Supplement)
MannaBears, Calcium Carbonate, 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
干预措施: Vitamin D3 (Dietary Supplement)
MannaBears, Calcium Carbonate, 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
干预措施: Calcium carbonate (Dietary Supplement)
MannaBears, AlgaeCal Calcium, 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
干预措施: Vitamin D3 (Dietary Supplement)
结局指标
主要结局
Change from baseline in parental ratings of participating child's quality of life
时间窗: 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.
次要结局
- Changes in gender and age adjusted BMI(0 and 90 days)
- Changes in blood pressure(0 and 90 days)
- Changes in body composition as a measurement of Dual Energy Absorptiometry(0 and 90 days)
- Changes in hip to waist ratios(0 and 90 days)
研究者
Gilbert R Kaats
Dr. Gilbert R. Kaats, PhD
Integrative Health Technologies, Inc.