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

Quality of Life Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01855009
• Other study ID #: 066
• Status: Recruiting
• Phase: N/A
• First received: May 8, 2013
• Last updated: June 21, 2013
• Start date: May 2013
• Est. completion date: March 2014

Study information

• Verified date: June 2013
• Source: Integrative Health Technologies, Inc.
• Contact: Patricia L Keith, BBA
• Phone: 210-824-4200
• Email: hmrcenterstudy[@]gmail.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 5 Years to 19 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Body Mass Index
• Quality of Life

Intervention

Dietary Supplement:
• 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

Locations

Country	Name	City	State
United States	Integrative Health Technologies	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Integrative Health Technologies, Inc.	MannaRelief Ministries

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in parental ratings of participating child's quality of life	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	No
Secondary	Changes in body composition as a measurement of Dual Energy Absorptiometry	Body composition (fat, fat-free mass, and bone mineral density) as measured by Dual Energy Absorptiometry (DXA)	0 and 90 days	No
Secondary	Changes in hip to waist ratios	Parent(s) will be provided with a tape measure with which they will measure their child's hip and waist.	0 and 90 days	No
Secondary	Changes in blood pressure	Blood pressure will be measured at the time the DXA measurement is completed.	0 and 90 days	No
Secondary	Changes in gender and age adjusted BMI		0 and 90 days	No