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

Sponsor

Integrative Health Technologies, Inc. (Other)

Overall Status

Unknown status

CT.gov ID

NCT01855009

Collaborator

MannaRelief Ministries (Other)

200

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Quality of Life Body Mass Index	Dietary Supplement: MannaBears Dietary Supplement: AlgaeCal Calcium Dietary Supplement: Calcium carbonate Dietary Supplement: Vitamin D3	N/A

Detailed Description

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Official Title:

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)

Study Start Date :

May 1, 2013

Anticipated Primary Completion Date :

Dec 1, 2013

Anticipated Study Completion Date :

Mar 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: MannaBears Subjects will take 4 MannaBears daily	Dietary Supplement: MannaBears Subjects will be administered 4 MannaBears daily
Active Comparator: 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	Dietary Supplement: MannaBears Subjects will be administered 4 MannaBears daily Dietary Supplement: AlgaeCal Calcium Subjects will be administered 750 mg AlgaeCal Calcium Dietary Supplement: Vitamin D3 Subjects will be administered 800 IU vitamin D3
Active Comparator: 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	Dietary Supplement: MannaBears Subjects will be administered 4 MannaBears daily Dietary Supplement: Calcium carbonate Subjects will be administered 1000 mg calcium carbonate Dietary Supplement: Vitamin D3 Subjects will be administered 800 IU vitamin D3

Arm

Intervention/Treatment

Active Comparator: MannaBears

Subjects will take 4 MannaBears daily

Dietary Supplement: MannaBears

Subjects will be administered 4 MannaBears daily

Active Comparator: 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

Dietary Supplement: MannaBears

Subjects will be administered 4 MannaBears daily

Dietary Supplement: AlgaeCal Calcium

Subjects will be administered 750 mg AlgaeCal Calcium

Dietary Supplement: Vitamin D3

Subjects will be administered 800 IU vitamin D3

Active Comparator: 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

Dietary Supplement: MannaBears

Subjects will be administered 4 MannaBears daily

Dietary Supplement: Calcium carbonate

Subjects will be administered 1000 mg calcium carbonate

Dietary Supplement: Vitamin D3

Subjects will be administered 800 IU vitamin D3

Outcome Measures

Primary Outcome Measures

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

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.
Changes in blood pressure [0 and 90 days]
Blood pressure will be measured at the time the DXA measurement is completed.
Changes in gender and age adjusted BMI [0 and 90 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 19 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Integrative Health Technologies	San Antonio	Texas	United States	78209

Sponsors and Collaborators

Integrative Health Technologies, Inc.
MannaRelief Ministries

Investigators

Principal Investigator: Gilbert R Kaats, PhD FACN, Integrative Health Technologies, Inc.
Study Chair: Harry G Preuss, MD MACN, Georgetown University Medical Center, Dept of Biochemistry, Medicine and Pathology