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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Integrative Health Technologies, Inc.
Sponsor:
Collaborator:
MannaRelief Ministries
Information provided by (Responsible Party):
Gilbert R Kaats, Integrative Health Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT01855009
First received: May 8, 2013
Last updated: June 21, 2013
Last verified: June 2013
  Purpose

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 Intervention
Quality of Life
Body Mass Index
Dietary Supplement: MannaBears
Dietary Supplement: AlgaeCal Calcium
Dietary Supplement: Calcium carbonate
Dietary Supplement: Vitamin D3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:


Further study details as provided by Integrative Health Technologies, Inc.:

Primary Outcome Measures:
  • Change from baseline in parental ratings of participating child's quality of life [ Time Frame: 0 and 90 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: 0 and 90 days ] [ Designated as safety issue: No ]
    Body composition (fat, fat-free mass, and bone mineral density) as measured by Dual Energy Absorptiometry (DXA)

  • Changes in hip to waist ratios [ Time Frame: 0 and 90 days ] [ Designated as safety issue: No ]
    Parent(s) will be provided with a tape measure with which they will measure their child's hip and waist.

  • Changes in blood pressure [ Time Frame: 0 and 90 days ] [ Designated as safety issue: No ]
    Blood pressure will be measured at the time the DXA measurement is completed.

  • Changes in gender and age adjusted BMI [ Time Frame: 0 and 90 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: May 2013
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
  Eligibility

Ages Eligible for Study:   5 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01855009

Contacts
Contact: Patricia L Keith, BBA 210-824-4200 hmrcenterstudy@gmail.com

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

No publications provided

Responsible Party: Gilbert R Kaats, Dr. Gilbert R. Kaats, PhD, Integrative Health Technologies, Inc.
ClinicalTrials.gov Identifier: NCT01855009     History of Changes
Other Study ID Numbers: 066
Study First Received: May 8, 2013
Last Updated: June 21, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Integrative Health Technologies, Inc.:
Quality of Life
Body Weight and Measures
Malnutrition
Adolescent Nutrition Sciences
Sleep Initiation and Maintenance Disorder
Motor Activity
Drinking

Additional relevant MeSH terms:
Calcium, Dietary
Calcium Carbonate
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Antacids
Molecular Mechanisms of Pharmacological Action
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on July 20, 2014