Cardiovascular DiseasesNCT00046579
Psychosocial Determinants of Nutrient Intake in Girls
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To better understand the determinants of nutrient intake in black and white adolescent girls and to examine the effects of nutrient intake and eating behaviors on obesity, a significant risk factor for CVD. Read more about this study
- Who is it for?
- Ages 9 to 23 years, women only
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Obesity
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Aug 2002to Jul 2007
- Phase
- Observational
- 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 9 to 23 years
- Women only
- No healthy volunteers
- Child, Adult
No eligibility criteria
About this study
To better understand the determinants of nutrient intake in black and white adolescent girls and to examine the effects of nutrient intake and eating behaviors on obesity, a significant risk factor for CVD.
Read the detailed description
BACKGROUND:
Studies have documented the importance of eating behavior as a modifiable risk factor for the development of obesity and cardiovascular disease (CVD). The burden of obesity and CVD is not equally distributed in the population; women from ethnic minority populations are particularly likely to be obese and to have higher rates of CVD and stroke than white women.
DESIGN NARRATIVE:
The study determines the extent to which psychological and familial factors contribute to nutrient intake in black and white girls, beyond the well-established effects of ethnicity and socioeconomic factors. Specifically, the aims of the project are the following: 1) to provide a detailed developmental description of eating behaviors and nutrient intake in black and white girls and to examine the "clustering" of certain eating behaviors (e.g., skipping meals and snacking) into eating patterns; 2) to determine the clinical significance of eating behaviors and eating patterns by examining their contribution to nutrient intake and the development of obesity; 3) to examine the role of psychological and familial factors as determinants of eating behaviors, eating patterns, nutrient intake, and obesity in black and white girls. Capitalizing upon the availability of extensive data collected prospectively among an exceptionally well-maintained cohort of 2,379 black and white females over a 12-year period (from ages 9-10 to ages 21-23), the study applies innovative analytic procedures to further the scientific understanding of the determinants of nutrient intake and eating behaviors in adolescent girls. Participants were assessed annually for ten years as part of the National Heart, Lung and Blood Institute Growth and Health Study (NGHS) with measurements of anthropometry, food intake, eating and weight related attitudes and behaviors and family cohesion. Parents also provided information about weight, eating, and family environment at two assessments. In a subsequent study with the same sample, structured clinical interviews were conducted to determine history of psychiatric disorders and risk factors for eating disorders. Adult weight was also measured.
- Conditions
- Cardiovascular Diseases, Heart Diseases, Obesity
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Obesity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2002 (estimated)
- Study startAug 2002
- 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 Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- 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
- Observational
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Ruth Striegel-Moore, Wesleyan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00046579
- Sponsor's protocol ID
- 1184
- Other IDs
- R01HL071122
- Status last verified
- Jan 2008
- First submitted
- 30 Sep 2002
- Last updated
- 29 Jul 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychosocial Determinants of Nutrient Intake in Girls
- ClinicalTrials.gov ID
- NCT00046579
- Acronym / sponsor ID
- 1184
- Conditions
- Cardiovascular Diseases, Heart Diseases, Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Aug 2002
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 1 Oct 2002 (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 better understand the determinants of nutrient intake in black and white adolescent girls and to examine the effects of nutrient intake and eating behaviors on obesity, a significant risk factor for CVD.
Detailed description
BACKGROUND:
Studies have documented the importance of eating behavior as a modifiable risk factor for the development of obesity and cardiovascular disease (CVD). The burden of obesity and CVD is not equally distributed in the population; women from ethnic minority populations are particularly likely to be obese and to have higher rates of CVD and stroke than white women.
DESIGN NARRATIVE:
The study determines the extent to which psychological and familial factors contribute to nutrient intake in black and white girls, beyond the well-established effects of ethnicity and socioeconomic factors. Specifically, the aims of the project are the following: 1) to provide a detailed developmental description of eating behaviors and nutrient intake in black and white girls and to examine the "clustering" of certain eating behaviors (e.g., skipping meals and snacking) into eating patterns; 2) to determine the clinical significance of eating behaviors and eating patterns by examining their contribution to nutrient intake and the development of obesity; 3) to examine the role of psychological and familial factors as determinants of eating behaviors, eating patterns, nutrient intake, and obesity in black and white girls. Capitalizing upon the availability of extensive data collected prospectively among an exceptionally well-maintained cohort of 2,379 black and white females over a 12-year period (from ages 9-10 to ages 21-23), the study applies innovative analytic procedures to further the scientific understanding of the determinants of nutrient intake and eating behaviors in adolescent girls. Participants were assessed annually for ten years as part of the National Heart, Lung and Blood Institute Growth and Health Study (NGHS) with measurements of anthropometry, food intake, eating and weight related attitudes and behaviors and family cohesion. Parents also provided information about weight, eating, and family environment at two assessments. In a subsequent study with the same sample, structured clinical interviews were conducted to determine history of psychiatric disorders and risk factors for eating disorders. Adult weight was also measured.
Study design
Who may qualify
- Ages
- 9 to 23 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 29 Jul 2016.
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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.
Ruth Striegel-Moore
Wesleyan University
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 29 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
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 29 Jul 2016.