Pregnancy Eating Attributes Study
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - 44 |
| Updated: | 4/2/2016 |
| Start Date: | October 2014 |
| Contact: | Karen Dorman, RN, MS |
| Email: | kdorman@med.unc.edu |
| Phone: | 919-966-2550 |
Diet, Obesity, and Weight Change in Pregnancy
The primary purpose of this observational cohort study is to examine the role of "food
reward" in maternal diet and weight change during pregnancy and postpartum. The study will
further examine the importance of food reward in the context of behavioral control and other
related aspects of eating behavior, as well as weight-related biomedical, psychosocial and
behavioral factors including genetics, physical activity, stress, sleep and depression. Four
hundred and fifty women of varying baseline weight status will be enrolled early in
pregnancy (before 12 weeks postpartum) and followed until 1 year postpartum. Assessments
will occur at baseline (<12 weeks postpartum), during pregnancy at 13-18 weeks gestation,
16-22 weeks, and 28-32 weeks, and postpartum at 4-6 weeks, 6 months, 9 months and 12 months.
Measures will include assessments of food reward and related constructs, dietary intake,
other health behaviors, and anthropometrics. Clinical data and biological specimens will be
obtained. Infant anthropometrics and feeding practices will also be assessed. Primary
exposures include aspects of food reward and behavioral control, which will be assessed in
multiple ways to maximize information and utility. Primary outcomes include gestational
weight gain, postpartum weight retention and dietary quality.
reward" in maternal diet and weight change during pregnancy and postpartum. The study will
further examine the importance of food reward in the context of behavioral control and other
related aspects of eating behavior, as well as weight-related biomedical, psychosocial and
behavioral factors including genetics, physical activity, stress, sleep and depression. Four
hundred and fifty women of varying baseline weight status will be enrolled early in
pregnancy (before 12 weeks postpartum) and followed until 1 year postpartum. Assessments
will occur at baseline (<12 weeks postpartum), during pregnancy at 13-18 weeks gestation,
16-22 weeks, and 28-32 weeks, and postpartum at 4-6 weeks, 6 months, 9 months and 12 months.
Measures will include assessments of food reward and related constructs, dietary intake,
other health behaviors, and anthropometrics. Clinical data and biological specimens will be
obtained. Infant anthropometrics and feeding practices will also be assessed. Primary
exposures include aspects of food reward and behavioral control, which will be assessed in
multiple ways to maximize information and utility. Primary outcomes include gestational
weight gain, postpartum weight retention and dietary quality.
Inclusion Criteria:
- Female confirmed pregnant <12 weeks at screening
- Uncomplicated singleton pregnancy anticipated
- Age >=18 and <45 at screening
- Willingness to undergo study procedures and provide informed consent for her
participation and assent for the baby's participation
- BMI >=18.5 (to qualify as normal: 18.5-24.9; overweight 25-29.9; or obese : >=30)
- Able to complete self-reported assessments in English
- Access to Internet with email to complete self-reported assessments
- Plan to deliver at UNC Hospital
- Plan to remain in the area for 1 year following delivery
Exclusion Criteria:
- Pre-existing diabetes (type 1 or type 2)
- Multiple pregnancy
- Participant-reported eating disorder
- Any fetal anomaly requiring surgery with hospital admission following delivery (e.g.
NTDs, gastroschisis, cardiac defects, Trisomy 21)
- Any medical condition contraindicating participation in the study such as chronic
illnesses or use of medication that could affect diet or weight e.g. cancer, HIV,
active renal disease, MI in the last 6 months, chronic steroid use, thyroid disease
requiring medication, or autoimmune disease (rheumatoid arthritis, lupus,
antiphospholipid antibody syndrome, scleroderma)
- Psychosocial condition contraindicating participation in the study such as bipolar,
schizophrenia, major affective disorder, substance abuse.
We found this trial at
1
site
Chapel Hill, North Carolina 27514
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