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
NCT ID: NCT01855009
Last Updated: 2013-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
200 participants
INTERVENTIONAL
2013-05-31
2014-03-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TRIPLE
Study Groups
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MannaBears
Subjects will take 4 MannaBears daily
MannaBears
Subjects will be administered 4 MannaBears daily
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
MannaBears
Subjects will be administered 4 MannaBears daily
AlgaeCal Calcium
Subjects will be administered 750 mg AlgaeCal Calcium
Vitamin D3
Subjects will be administered 800 IU vitamin D3
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
MannaBears
Subjects will be administered 4 MannaBears daily
Calcium carbonate
Subjects will be administered 1000 mg calcium carbonate
Vitamin D3
Subjects will be administered 800 IU vitamin D3
Interventions
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MannaBears
Subjects will be administered 4 MannaBears daily
AlgaeCal Calcium
Subjects will be administered 750 mg AlgaeCal Calcium
Calcium carbonate
Subjects will be administered 1000 mg calcium carbonate
Vitamin D3
Subjects will be administered 800 IU vitamin D3
Eligibility Criteria
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Inclusion Criteria
* Must be between the ages of 5 and 19
Exclusion Criteria
* pregnant or breast feeding
5 Years
19 Years
ALL
Yes
Sponsors
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MannaRelief Ministries
UNKNOWN
Integrative Health Technologies, Inc.
NETWORK
Responsible Party
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Gilbert R Kaats
Dr. Gilbert R. Kaats, PhD
Principal Investigators
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Gilbert R Kaats, PhD FACN
Role: PRINCIPAL_INVESTIGATOR
Integrative Health Technologies, Inc.
Harry G Preuss, MD MACN
Role: STUDY_CHAIR
Georgetown University Medical Center, Dept of Biochemistry, Medicine and Pathology
Locations
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Integrative Health Technologies
San Antonio, Texas, United States
Countries
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Central Contacts
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Other Identifiers
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066
Identifier Type: -
Identifier Source: org_study_id
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