Quality of LifeNCT01855009
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 study testing MannaBears, AlgaeCal Calcium and Calcium carbonate in people with Quality of Life and Body Mass Index, run by Integrative Health Technologies, Inc. at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 5 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Quality of Life, Body Mass Index
- What is being tested?
- MannaBears, AlgaeCal Calcium and Calcium carbonate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Mar 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Must ensure with medical provider that there are not medical conditions that would preclude participation
- Must be between the ages of 5 and 19
Who cannot join
- males and females below the age of 5 and above the age of 19
- pregnant or breast feeding
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Integrative Health Technologies
San Antonio, Texas, 78209
Patricia L Keith, BBA
Samuel C Keith, BBA
About this study
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)
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).
Read the detailed description
Purpose: The objectives of this study are to:
- 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.
- Compare parental ratings of children's behavior to DXA-measured changes in body composition;
- Compare measurements of scale weight, height, waist/hip ratios and BMI with DXA-measured changes in body composition;
- 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
- Being tested
- MannaBears, AlgaeCal Calcium, Calcium carbonate, Vitamin D3
- Keywords
- Quality of Life, Body Weight and Measures, Malnutrition, Adolescent Nutrition Sciences, Sleep Initiation and Maintenance Disorder, Motor Activity, Drinking
- Medical subject headings
- Body Weight, Malnutrition, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MannaBearsDietary supplement
Subjects will be administered 4 MannaBears daily
AlgaeCal CalciumDietary supplement
Subjects will be administered 750 mg AlgaeCal Calcium
Calcium carbonateDietary supplement
Subjects will be administered 1000 mg calcium carbonate
Vitamin D3Dietary supplement
Subjects will be administered 800 IU vitamin D3
| Study group | Role | What they receive |
|---|---|---|
| MannaBears | Active comparator | Subjects will take 4 MannaBears daily Receives: Dietary Supplement: MannaBears |
| MannaBears, AlgaeCal Calcium, Vitamin D3 | Active comparator | Subjects will take 4 MannaBears daily and 3 Calcium/Vit D capsules (2 with breakfast and 1 with dinner or vice-versa) daily Receives: Dietary Supplement: MannaBears; Dietary Supplement: AlgaeCal Calcium; Dietary Supplement: Vitamin D3 |
| MannaBears, Calcium Carbonate, Vitamin D3 | Active comparator | Subjects will take 4 MannaBears daily and 3 Calcium/Vit D capsules (2 with breakfast and 1 with dinner or vice-versa) daily Receives: Dietary Supplement: MannaBears; Dietary Supplement: Calcium carbonate; Dietary Supplement: Vitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0 and 90 days
Secondary outcomes (4)
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)
Measured: 0 and 90 days
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.
Measured: 0 and 90 days
Changes in blood pressure
Blood pressure will be measured at the time the DXA measurement is completed.
Measured: 0 and 90 days
Changes in gender and age adjusted BMI
Measured: 0 and 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2013 (estimated)
- Study startMay 2013
- Primary completionDec 2013 (estimated)
- Study completionMar 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Integrative Health Technologies, Inc.
- Sponsor type
- Research network
- Collaborators
- MannaRelief Ministries
- Responsible party
- Principal investigator, Gilbert R Kaats, Integrative Health Technologies, Inc.
- Investigators
- Gilbert R Kaats, PhD FACN, Principal investigator, Integrative Health Technologies, Inc.Harry G Preuss, MD MACN, Study chair, Georgetown University Medical Center, Dept of Biochemistry, Medicine and Pathology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01855009
- Sponsor's protocol ID
- 066
- Status last verified
- Jun 2013
- First submitted
- 8 May 2013
- Last updated
- 24 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01855009
- Acronym / sponsor ID
- 066
- Conditions
- Quality of Life, Body Mass Index
- Keywords
- Quality of Life, Body Weight and Measures, Malnutrition, Adolescent Nutrition Sciences, Sleep Initiation and Maintenance Disorder, Motor Activity, Drinking
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Integrative Health Technologies, Inc.Research network
- Collaborators
- MannaRelief Ministries
- Study start
- May 2013
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Mar 2014 (estimated)
- First posted
- 16 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- Compare parental ratings of children's behavior to DXA-measured changes in body composition;
- Compare measurements of scale weight, height, waist/hip ratios and BMI with DXA-measured changes in body composition;
- Develop a logarithm formula with the use of anthropometric measurements and parental ratings to predict body composition changes
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MannaBears | Active comparator | Dietary Supplement: MannaBearsSubjects will take 4 MannaBears daily |
| MannaBears, AlgaeCal Calcium, Vitamin D3 | Active comparator | Dietary Supplement: MannaBears, Dietary Supplement: AlgaeCal Calcium, Dietary Supplement: Vitamin D3Subjects will take 4 MannaBears daily and 3 Calcium/Vit D capsules (2 with breakfast and 1 with dinner or vice-versa) daily |
| MannaBears, Calcium Carbonate, Vitamin D3 | Active comparator | Dietary Supplement: MannaBears, Dietary Supplement: Calcium carbonate, Dietary Supplement: Vitamin D3Subjects will take 4 MannaBears daily and 3 Calcium/Vit D capsules (2 with breakfast and 1 with dinner or vice-versa) daily |
Who may qualify
- Ages
- 5 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Must ensure with medical provider that there are not medical conditions that would preclude participation
- Must be between the ages of 5 and 19
Key exclusion criteria (2 listed)
- males and females below the age of 5 and above the age of 19
- pregnant or breast feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MannaBearsSubjects will be administered 4 MannaBears daily | Dietary supplement | MannaBears, MannaBears, AlgaeCal Calcium, Vitamin D3, MannaBears, Calcium Carbonate, Vitamin D3 |
| AlgaeCal CalciumSubjects will be administered 750 mg AlgaeCal Calcium | Dietary supplement | MannaBears, AlgaeCal Calcium, Vitamin D3 |
| Calcium carbonateSubjects will be administered 1000 mg calcium carbonate | Dietary supplement | MannaBears, Calcium Carbonate, Vitamin D3 |
| Vitamin D3Subjects will be administered 800 IU vitamin D3 | Dietary supplement | MannaBears, AlgaeCal Calcium, Vitamin D3, MannaBears, Calcium Carbonate, Vitamin D3 |
Primary outcome
Change from baseline in parental ratings of participating child's quality of life
Time frame: 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.
4 secondary outcomes
Changes in body composition as a measurement of Dual Energy Absorptiometry
Time frame: 0 and 90 days
Changes in hip to waist ratios
Time frame: 0 and 90 days
Changes in blood pressure
Time frame: 0 and 90 days
Changes in gender and age adjusted BMI
Time frame: 0 and 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilbert R Kaats, PhD FACN principal investigator
Integrative Health Technologies, Inc.
Harry G Preuss, MD MACN study chair
Georgetown University Medical Center, Dept of Biochemistry, Medicine and Pathology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MannaBears, AlgaeCal Calcium and Calcium carbonate in people with Quality of Life and Body Mass Index, run by Integrative Health Technologies, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patricia L Keith, BBA (210-824-4200, hmrcenterstudy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in parental ratings of participating child's quality of life (time frame: 0 and 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2013.