NCT01855009

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

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)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Integrative Health Technologies, Inc. · Network
• Sex: All
• Age: 5 Years – 19 Years
• Healthy volunteers: Accepted

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).

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

Conditions

• Quality of Life
• Body Mass Index

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	MannaBears	Subjects will be administered 4 MannaBears daily
DIETARY_SUPPLEMENT	AlgaeCal Calcium	Subjects will be administered 750 mg AlgaeCal Calcium
DIETARY_SUPPLEMENT	Calcium carbonate	Subjects will be administered 1000 mg calcium carbonate
DIETARY_SUPPLEMENT	Vitamin D3	Subjects will be administered 800 IU vitamin D3

Timeline

• Start date: 2013-05-01
• Primary completion: 2013-12-01
• Completion: 2014-03-01
• First posted: 2013-05-16
• Last updated: 2013-06-24

Locations

1 site across 1 country: United States