Body Mass Index, Quality of Life
Conditions
Keywords
Quality of Life, Body Weight and Measures, Malnutrition, Adolescent Nutrition Sciences, Sleep Initiation and Maintenance Disorder, Motor Activity, Drinking
Brief 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
Interventions
DIETARY_SUPPLEMENTMannaBears
Subjects will be administered 4 MannaBears daily
DIETARY_SUPPLEMENTAlgaeCal Calcium
Subjects will be administered 750 mg AlgaeCal Calcium
DIETARY_SUPPLEMENTCalcium carbonate
Subjects will be administered 1000 mg calcium carbonate
DIETARY_SUPPLEMENTVitamin D3
Subjects will be administered 800 IU vitamin D3
Sponsors
MannaRelief Ministries
Integrative Health Technologies, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
5 Years to 19 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in parental ratings of participating child's quality of life | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in body composition as a measurement of Dual Energy Absorptiometry | 0 and 90 days | Body composition (fat, fat-free mass, and bone mineral density) as measured by Dual Energy Absorptiometry (DXA) |
| Changes in hip to waist ratios | 0 and 90 days | Parent(s) will be provided with a tape measure with which they will measure their child's hip and waist. |
| Changes in blood pressure | 0 and 90 days | Blood pressure will be measured at the time the DXA measurement is completed. |
| Changes in gender and age adjusted BMI | 0 and 90 days | — |
Countries
United States
Contacts
Primary ContactPatricia L Keith, BBA
Outcome results
None listed