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

NCT ID: NCT01855009

Last Updated: 2013-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2014-03-31

Brief Summary

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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

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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

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Quality of Life Body Mass Index

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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MannaBears

Subjects will take 4 MannaBears daily

Group Type ACTIVE_COMPARATOR

MannaBears

Intervention Type DIETARY_SUPPLEMENT

Subjects will be administered 4 MannaBears daily

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

Group Type ACTIVE_COMPARATOR

MannaBears

Intervention Type DIETARY_SUPPLEMENT

Subjects will be administered 4 MannaBears daily

AlgaeCal Calcium

Intervention Type DIETARY_SUPPLEMENT

Subjects will be administered 750 mg AlgaeCal Calcium

Vitamin D3

Intervention Type DIETARY_SUPPLEMENT

Subjects will be administered 800 IU vitamin D3

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

Group Type ACTIVE_COMPARATOR

MannaBears

Intervention Type DIETARY_SUPPLEMENT

Subjects will be administered 4 MannaBears daily

Calcium carbonate

Intervention Type DIETARY_SUPPLEMENT

Subjects will be administered 1000 mg calcium carbonate

Vitamin D3

Intervention Type DIETARY_SUPPLEMENT

Subjects will be administered 800 IU vitamin D3

Interventions

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MannaBears

Subjects will be administered 4 MannaBears daily

Intervention Type DIETARY_SUPPLEMENT

AlgaeCal Calcium

Subjects will be administered 750 mg AlgaeCal Calcium

Intervention Type DIETARY_SUPPLEMENT

Calcium carbonate

Subjects will be administered 1000 mg calcium carbonate

Intervention Type DIETARY_SUPPLEMENT

Vitamin D3

Subjects will be administered 800 IU vitamin D3

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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MannaRelief Ministries

UNKNOWN

Sponsor Role collaborator

Integrative Health Technologies, Inc.

NETWORK

Sponsor Role lead

Responsible Party

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Gilbert R Kaats

Dr. Gilbert R. Kaats, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gilbert R Kaats, PhD FACN

Role: PRINCIPAL_INVESTIGATOR

Integrative Health Technologies, Inc.

Harry G Preuss, MD MACN

Role: STUDY_CHAIR

Georgetown University Medical Center, Dept of Biochemistry, Medicine and Pathology

Locations

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Integrative Health Technologies

San Antonio, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Patricia L Keith, BBA

Role: CONTACT

210-824-4200

Other Identifiers

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066

Identifier Type: -

Identifier Source: org_study_id

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