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

Integrative Health Technologies

Status: Unknown

Conditions: Quality of Life; Body Mass Index

Treatments: Dietary Supplement: Calcium carbonate; Dietary Supplement: AlgaeCal Calcium; Dietary Supplement: MannaBears; Dietary Supplement: Vitamin D3

Study type: Interventional

Funder types: NETWORK; Other

Identifiers

NCT01855009

066

Details and patient eligibility

About

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).

Full 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

Enrollment: 200 estimated patients

Sex: All

Ages: 5 to 19 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

200 participants in 3 patient groups

MannaBears

Active Comparator group

Description:

Subjects will take 4 MannaBears daily

Treatment:

Dietary Supplement: MannaBears

MannaBears, AlgaeCal Calcium, Vitamin D3

Active Comparator group

Description:

Subjects will take 4 MannaBears daily and 3 Calcium/Vit D capsules (2 with breakfast and 1 with dinner or vice-versa) daily

Treatment:

Dietary Supplement: AlgaeCal Calcium

Dietary Supplement: MannaBears

Dietary Supplement: Vitamin D3

MannaBears, Calcium Carbonate, Vitamin D3

Active Comparator group

Description:

Subjects will take 4 MannaBears daily and 3 Calcium/Vit D capsules (2 with breakfast and 1 with dinner or vice-versa) daily

Treatment:

Dietary Supplement: Calcium carbonate

Dietary Supplement: MannaBears

Dietary Supplement: Vitamin D3