Childhood ObesityNCT00630617
Childhood Obesity Prevention
A study testing Diet, Physical activity, Physical inactivity in people with Childhood Obesity and Diabetes, run by Western Michigan University at 1 site in Northern Mariana Islands.
Trial summary
To develop and evaluate a culturally appropriate childhood obesity prevention program targeting primary care-givers of third grade students. The cognitive-behavioral lifestyle intervention consisted of eight, 90-minute sessions at the elementary schools. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity, Diabetes
- What is being tested?
- Diet, Physical activity, Physical inactivity
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 900 participants
- Where
- 1 siteNorthern Mariana Islands
- Study dates
- Jul 2004to Jul 2007
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Currently having a third grader attending public school
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Northern Mariana Islands1 site
Commonwealth of the Northern Mariana Islands Public School System
Saipan, 96950
About this study
Official title: Project FAMILIA Giya Marianas: Childhood Obesity Prevention Program
To develop and evaluate a culturally appropriate childhood obesity prevention program targeting primary care-givers of third grade students. The cognitive-behavioral lifestyle intervention consisted of eight, 90-minute sessions at the elementary schools.
Primary outcome: body mass index of third graders and their primary care-givers Primary objective: To engage primary care-givers of third grand children in identifying and creating health promoting culturally appropriate environments for young children.
Read the detailed description
The sessions include information about energy balance, portion control, appropriate amounts and types of physical activity, physical inactivity, nutrition and self-esteem. The influence of the primary care-giver on the children's physical activity and nutritional behaviors may lead to greater or lesser rates of obesity in childhood and eventually lead to adult obesity. Therefore, the intention of this intervention is to educate primary care-givers so as to effect change (in a positive way) in the children they care for. Assessment on steps taken, BMI, percent body fat, diet, self reported physical activity and diet will be used to evaluate the impact of the sessions.
- Conditions
- Childhood Obesity, Diabetes
- Being tested
- Diet, Physical activity, Physical inactivity
- Keywords
- Obesity, Prevention, Childhood, Children, Primary care-giver
- Medical subject headings
- Pediatric Obesity, Diabetes Mellitus, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet, Physical activity, Physical inactivityBehavioural
Community based participatory research design
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index
Measured: 3 years
Secondary outcomes (7)
steps
Measured: 3 years
Percent body fat
Measured: 3 years
Basal metabolic rate
Measured: 3 years
Diet information (child and primary care-giver)
Measured: 3 years
Physical Activity and Inactivity information (child and primary care-giver)
Measured: 3 years
Self esteem measures
Measured: 3 years
Knowledge and attitudes
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2008 (estimated)
- Study startJul 2004
- Primary completionJul 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood ObesityStudies 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
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 900 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western Michigan University
- Sponsor type
- University, hospital or other
- Collaborators
- Hillblom Foundation, Commonwealth of the Northern Marianna Islands Public School System
- Investigators
- Mozhdeh B Bruss, PhD, Principal investigator, Western Michigan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00630617
- Sponsor's protocol ID
- 04-06-14
- Status last verified
- Dec 2023
- First submitted
- 28 Feb 2008
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project FAMILIA Giya Marianas: Childhood Obesity Prevention Program
- ClinicalTrials.gov ID
- NCT00630617
- Acronym / sponsor ID
- 04-06-14
- Conditions
- Childhood Obesity, Diabetes
- Keywords
- Obesity, Prevention, Childhood, Children, Primary care-giver
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 900 participants (actual)
- Lead sponsor
- Western Michigan UniversityUniversity, hospital or other
- Collaborators
- Hillblom Foundation, Commonwealth of the Northern Marianna Islands Public School System
- Study start
- Jul 2004
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 7 Mar 2008 (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.
To develop and evaluate a culturally appropriate childhood obesity prevention program targeting primary care-givers of third grade students. The cognitive-behavioral lifestyle intervention consisted of eight, 90-minute sessions at the elementary schools.
Primary outcome: body mass index of third graders and their primary care-givers Primary objective: To engage primary care-givers of third grand children in identifying and creating health promoting culturally appropriate environments for young children.
Detailed description
The sessions include information about energy balance, portion control, appropriate amounts and types of physical activity, physical inactivity, nutrition and self-esteem. The influence of the primary care-giver on the children's physical activity and nutritional behaviors may lead to greater or lesser rates of obesity in childhood and eventually lead to adult obesity. Therefore, the intention of this intervention is to educate primary care-givers so as to effect change (in a positive way) in the children they care for. Assessment on steps taken, BMI, percent body fat, diet, self reported physical activity and diet will be used to evaluate the impact of the sessions.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Currently having a third grader attending public school
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Diet, Physical activity, Physical inactivityCommunity based participatory research design | Behavioural | – |
Primary outcome
Body Mass Index
Time frame: 3 years
7 secondary outcomes
steps
Time frame: 3 years
Percent body fat
Time frame: 3 years
Basal metabolic rate
Time frame: 3 years
Diet information (child and primary care-giver)
Time frame: 3 years
Physical Activity and Inactivity information (child and primary care-giver)
Time frame: 3 years
Self esteem measures
Time frame: 3 years
Knowledge and attitudes
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
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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.
Mozhdeh B Bruss, PhD principal investigator
Western Michigan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet, Physical activity, Physical inactivity in people with Childhood Obesity and Diabetes, run by Western Michigan University at 1 site in Northern Mariana Islands.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 6 Dec 2023. 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 Northern Mariana Islands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Mass Index (time frame: 3 years). 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 6 Dec 2023.