Early Tracking of Childhood Health Determinants (ETCHED) Study
Early Tracking of Childhood Health Determinants (ETCHED) Study
Background:

 Children s weight has increased sharply in recent years. This may put them at higher risk for
 health problems. High blood glucose in a pregnant mother and too much weight gain during
 pregnancy also may have long-term effects on the child s health. Children who become
 overweight or obese during childhood tend to remain so as adults. Researchers want to study
 many risk factors during and after pregnancy, and how these affect a child s development.
 They will also follow the mother s health and well-being after pregnancy.

 Objectives:

 To learn how a pregnant mother s environment, lifestyle, and health conditions may affect her
 child s growth and development from birth until adulthood.

 Eligibility:

 Women 18 and older who are getting prenatal care at Phoenix Indian Medical Center

 Mothers and children who were in the LIFE-Moms Phoenix study

 Design:

 Mothers will have 3 visits during pregnancy.

 In the child s first year, mothers will have 2 visits and their child will have 4.

 Children will have 2 visits in their second year and 1 each year until they turn 18.

 Mothers will have a visit 2 years after birth and 4-5 years later.

 Both the mother and child s medical records will be reviewed. They will have physical exams
 and give blood and stool samples.

 Mothers may give cord blood and placenta samples. They will give breastmilk and urine
 samples. They will fill out questionnaires.

 Children s hair and toenail clippings (and baby teeth that fall out, if possible) will be
 collected. They will have an ultrasound. They may get an activity monitor.

 Mother and child will be followed until the child s 18th birthday.

 ...
The prevalence of childhood obesity (defined by body mass index, BMI greater than or equal to
 95th age-sex specific percentile, CDC, 2000) in the United States has plateaued in the last
 decade, but the prevalence of more severe degrees of obesity continues to increase,
 especially among some minority groups including American Indians and Alaskan Natives. The
 purpose of this protocol is to examine the role of adverse prenatal and early-life risk
 exposures, both biological and environmental, that contribute to the development of
 overweight and obesity in children and increase the risk for associated complications such as
 type 2 diabetes and cardiovascular disease. This longitudinal observational study will enroll
 primarily American Indian/Alaskan Native pregnant women and their offspring, a population
 with a high prevalence of obesity and diabetes. Pregnant mothers 18 years or older and
 receiving prenatal care at the Phoenix Indian Medical Center (PIMC) will be eligible if they
 agree to the study procedures and plan to follow up for at least 3 years postpartum for
 themselves and their offspring. Women, who are unable to consent, are incarcerated, have
 non-viable fetuses, or planned pregnancy termination will be excluded. Enrolled participants
 will be followed through pregnancy, delivery, and 6 years postpartum, and their offspring
 will be followed until their 18th birthday. The primary objective of the study is to explore
 the associations of maternal risk measures including prepregnant BMI, gestational weight
 gain, and glycaemia with body size, body composition, biochemical measures, and
 neuro-cognitive development in the offspring. Family and environmental risk variables that
 contribute to obesity and associated metabolic risk will also be assessed. The primary
 outcomes include body size and adiposity measures in the offspring: birth weight, age-sex
 adjusted weight for length up to 24 months of age, age-sex adjusted BMI at 2-18 years, and
 infant body composition (fat mass and fat free mass). During pregnancy, mothers will have 3
 visits, and following delivery, they will have 4 visits under the current protocol at 6-12
 weeks postpartum, 1 year, 2 years, and 4-5 years postpartum. These visits will include
 maternal medical history, dietary history, physical activity and sleep patterns, and
 screening questionnaires for perceived stress and depression. We will assess gestational
 weight gain and post-pregnancy weight retention. Biochemical tests include periodic measures
 of glycemia (fasting plasma glucose, oral glucose tolerance test (OGTT), glycated
 hemoglobin), lipids, renal function, and epigenetics. Mothers will be encouraged to breast
 feed and follow other recommended post-partum practices. The offspring will be examined at
 birth and will have 4 additional visits within the first year of life at 6-12 weeks, 4
 months, 6 months and 12 months, then at 18 and 24 months, and at 3 years. Thereafter they
 will be scheduled for comprehensive research visits (major visits) at 4-5 years, 6-9 years,
 10-13 years and 14-17 years. The major visits include detailed medical history,
 anthropometry, developmental assessment, laboratory tests, and ultrasound examination for
 subcutaneous and visceral fat. Medical records will be reviewed to assess other health
 problems, inter-current illnesses, hospitalizations, and immunizations.
-  INCLUSION CRITERIA:

 -  Pregnant women aged 18 years or older [pregnancy confirmed by urine or serum pregnancy
 test, initial gestational age estimation will be based on date of last menstrual
 period (LMP).

 -  Plan to receive prenatal care at PIMC

 -  Agree to continue with research study participation (both mother and their offspring),
 for at least 3 years after delivery

 We plan to recruit eligible pregnant women as early as possible, preferably during their
 first prenatal visit, but will enroll them any time during pregnancy. These mothers are
 expected to be primarily of AI/AN heritage or have infants that are AI/AN. There are
 approximately 700 deliveries conducted at PIMC annually. Most pregnant women receive all
 their prenatal care and deliver at PIMC, but some deliver elsewhere for reasons such as
 proximity at the time of delivery or availability of hospital beds. We anticipate that most
 of these pregnant women will meet our recruitment criteria annually; however, there are no
 pre-determined limits to the number of participants we can recruit for this study. If the
 mother has participated in the ETCHED study during a prior pregnancy, she will still be
 eligible for participation in all successive pregnancies, unless incarcerated or unable to
 consent or unwilling or is unable to plan for at least 3-years of follow-up of her and her
 off-spring after delivery.

 STUDY EXCLUSION CRITERIA:

 -  Maternal age of less than 18 years

 -  Women who are incarcerated or are unable to consent.

 -  Unwillingness/inability to plan for at least 3 years of follow-up of mother and her
 offspring post-delivery.

 -  Women whose fetus is not alive or are not planning to continue the pregnancy. We
 anticipate that some patients will be lost to follow up for various reasons. However,
 if any such research participants return to the well childcare clinic for resuming
 care, they would be eligible to re-enroll in ETCHED. For mothers with repeat
 pregnancies, her research visit schedule will be based on the delivery of her most
 recent offspring. Each child will then have his/her own visit schedule independent of
 the mother.

 INCLUSION of MOTHER/CHILD DYADS FROM LIFE-MOMS STUDY:

 -Mothers and offspring from the Lifestyle Interventions for Expectant Moms (LIFE-Moms)
 Phoenix study (Protocol Number 13-DK-N055) will be eligible for participation in the ETCHED
 study. There are 39 maternal/child dyads from the Life-Moms study, born between 10/2013 and
 11/2014, who will be eligible for participation in ETCHED. The mothers and children will be
 followed postpartum as per the ETCHED protocol and data collected during enrollment in the
 Life-Moms protocol will be used in ETCHED study data analysis. The mothers in this cohort
 will be seen for their initial visit at first

 contact. The data collection for each visit will correspond as detailed in Table 2. After
 the initial visit, data collection visits will be scheduled as close to the preferred
 windows as possible and will correspond with the child s visit according to the data
 collected and the preference of the mother.

 RECRUITMENT of STAFF MEMBERS (NIH, and IHS):

 The study is open to NIH or IHS employees who meet study inclusion and exclusion criteria
 except those involved directly with study participants such as data collectors. We will
 provide the NIH Information Sheet on Staff Research Participation to NIH employees who are
 considering participation in our protocol prior to obtaining consent. In addition, we will
 discuss the following applicable safeguards to NIH and IHS staff as a vulnerable class of
 subjects:

 -  Unbiased participation for protocol integrity and participant risk assessment.

 -  Ensure there is no perceived workplace pressure or expectation on either participation
 or deciding not to participate in the protocol in regard to a benefit or adverse
 effect on their NIH or HIS employment or staff position.

 -  Protection of privacy and confidentiality will be maintained, but also with
 acknowledgement of the limits due to sensitive information that may be in their NIH or
 IHS file.

 -  Discussion of time commitments of the study and compensation in accordance with NIH
 policy 2300-630-3, Leave Policy for NIH Employees Participating in NIH Medical
 Research Studies.