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

June 21, 2013 updated by: Gilbert R Kaats, Integrative Health Technologies, Inc.

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)

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78209
        • Recruiting
        • Integrative Health Technologies
        • Sub-Investigator:
          • Patricia L Keith, BBA
        • Sub-Investigator:
          • Samuel C Keith, BBA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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: Vitamin D3
Subjects will be administered 800 IU vitamin D3
Dietary supplement: Calcium carbonate
Subjects will be administered 1000 mg calcium carbonate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in parental ratings of participating child's quality of life
Time Frame: 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.
0 and 90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in body composition as a measurement of Dual Energy Absorptiometry
Time Frame: 0 and 90 days
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
Time Frame: 0 and 90 days
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
Time Frame: 0 and 90 days
Blood pressure will be measured at the time the DXA measurement is completed.
0 and 90 days
Changes in gender and age adjusted BMI
Time Frame: 0 and 90 days
0 and 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Integrative Health Technologies, Inc.

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Anticipated)

December 1, 2013

Study Completion (Anticipated)

March 1, 2014

Study Registration Dates

First Submitted

May 8, 2013

First Submitted That Met QC Criteria

May 15, 2013

First Posted (Estimate)

May 16, 2013

Study Record Updates

Last Update Posted (Estimate)

June 24, 2013

Last Update Submitted That Met QC Criteria

June 21, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 066

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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