Eating BehaviorNCT03342430
Early Dieting in Girls: a Longitudinal Cohort Study
An observational study of Eating Behavior and Dietary Habits, run by Penn State University.
Trial summary
This longitudinal observational cohort followed the growth and development of non-Hispanic white girls from age 5 to 15 years, with a focus on the development of the controls of food intake. Read more about this study
- Who is it for?
- Ages 5 to 6 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Eating Behavior, Dietary Habits, Weight, Body
- How many people
- 197 participants
- Where
- No sites listed yet
- Study dates
- Jun 1996to Aug 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 5 to 6 years
- Women only
- Healthy volunteers accepted
- Child
Study population: Families in central Pennsylvania with a 5-6 year old daughter.
Who may be able to join
- Living with both biological parents
Who cannot join
- Severe food allergies
- Chronic medical conditions affecting food intake
About this study
Official title: Early Dieting in Girls
This longitudinal observational cohort followed the growth and development of non-Hispanic white girls from age 5 to 15 years, with a focus on the development of the controls of food intake.
Read the detailed description
This longitudinal observational cohort followed the growth and development of non-Hispanic white girls from age 5 to 15 years, with a focus on the development of the controls of food intake. Data was collected biennially from girls and their mothers and fathers. Measures included anthropometrics, questionnaires and laboratory measures of eating behavior, dietary recalls, psychosocial characteristics, and parenting measures.
- Conditions
- Eating Behavior, Dietary Habits, Weight, Body
- Medical subject headings
- Feeding Behavior, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Early Dieting in Girls cohort | A cohort of 197 non-Hispanic white girls, observed from age 5 to age 15 years |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dieting practices
Derived from questionnaire by French et al.
Measured: Pattern of development from age 5 to 15 years
Dietary restraint
Dutch Eating Behavior Questionnaire
Measured: Pattern of development from age 5 to 15 years
Disinhibition
Dutch Eating Behavior Questionnaire
Measured: Pattern of development from age 5 to 15 years
Disordered eating
Children's Eating Attitudes Test/Eating Attitudes Test
Measured: Pattern of development from age 5 to 15 years
Secondary outcomes (3)
Body mass index
Weight in kg/height in meters squared, converted to z-scores using CDC growth charts
Measured: Age 5, 7, 9, 11, 13, and 15 years
Total body bone mineral content
Dual energy x-ray absorptiometry
Measured: Age 9, 11, 13, and 15 years
Dietary intake
3-24 hour dietary recalls
Measured: Age 5, 7, 9, 11, 13, and 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study startJun 1996
- Primary completionAug 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Eating BehaviorStudies of the same condition, open and under way.
- More trials run by Penn State UniversityThe 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Savage Williams, Penn State University
- Investigators
- Leann L Birch, PhD, Principal investigator, Penn State University (at time study was conducted)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03342430
- Sponsor's protocol ID
- HD32973
- Status last verified
- Nov 2017
- First submitted
- 6 Nov 2017
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hohman EE, Balantekin KN, Birch LL, Savage JS. Dieting is associated with reduced bone mineral accrual in a longitudinal cohort of girls. BMC Public Health. 2018 Nov 22;18(1):1285. doi: 10.1186/s12889-018-6206-y.
PubMed 30466435
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Dieting in Girls
- ClinicalTrials.gov ID
- NCT03342430
- Acronym / sponsor ID
- HD32973
- Conditions
- Eating Behavior, Dietary Habits, Weight, Body
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Study start
- Jun 1996 (actual)
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 17 Nov 2017 (actual)
- 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 longitudinal observational cohort followed the growth and development of non-Hispanic white girls from age 5 to 15 years, with a focus on the development of the controls of food intake.
Detailed description
This longitudinal observational cohort followed the growth and development of non-Hispanic white girls from age 5 to 15 years, with a focus on the development of the controls of food intake. Data was collected biennially from girls and their mothers and fathers. Measures included anthropometrics, questionnaires and laboratory measures of eating behavior, dietary recalls, psychosocial characteristics, and parenting measures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Early Dieting in Girls cohort | – | –A cohort of 197 non-Hispanic white girls, observed from age 5 to age 15 years |
Who may qualify
- Ages
- 5 to 6 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Families in central Pennsylvania with a 5-6 year old daughter.
Key inclusion criteria (1 listed)
- Living with both biological parents
Key exclusion criteria (2 listed)
- Severe food allergies
- Chronic medical conditions affecting food intake
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
Dieting practices
Time frame: Pattern of development from age 5 to 15 years
Derived from questionnaire by French et al.
Dietary restraint
Time frame: Pattern of development from age 5 to 15 years
Dutch Eating Behavior Questionnaire
Disinhibition
Time frame: Pattern of development from age 5 to 15 years
Dutch Eating Behavior Questionnaire
Disordered eating
Time frame: Pattern of development from age 5 to 15 years
Children's Eating Attitudes Test/Eating Attitudes Test
3 secondary outcomes
Body mass index
Time frame: Age 5, 7, 9, 11, 13, and 15 years
Total body bone mineral content
Time frame: Age 9, 11, 13, and 15 years
Dietary intake
Time frame: Age 5, 7, 9, 11, 13, and 15 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 17 Nov 2017.
- Derived from this study: PubMed 30466435Hohman EE, Balantekin KN, Birch LL, Savage JS. Dieting is associated with reduced bone mineral accrual in a longitudinal cohort of girls. BMC Public Health. 2018 Nov 22;18(1):1285. doi: 10.1186/s12889-018-6206-y.
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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.
Leann L Birch, PhD principal investigator
Penn State University (at time study was conducted)
Questions about this trial
What is this clinical trial studying?
An observational study of Eating Behavior and Dietary Habits, run by Penn State University.
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 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: finished, as of the sponsor's last update on 17 Nov 2017. 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.
What does the primary outcome measure?
Dieting practices (time frame: Pattern of development from age 5 to 15 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03342430, which also lists 1 linked publication.
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 17 Nov 2017.