Determinants of Gestational Weight Gain in Obese Pregnant Women

Conditions

Energy Expenditure, Energy Intake

Keywords

Pregnancy, Postpartum

Brief summary

The purpose of this study is to measure energy intake and energy expenditure during and after pregnancy. The investigators hypothesize that obese pregnant women with weight gain above the Institute of Medicine (IOM) guidelines, 'High Gainers', will have increased energy intake but no evidence for changes in energy expenditure after adjustment for the weight gained when compared to women with appropriate gestational weight gain, 'Normal Gainers'. Additionally, the investigators will measure the babies born to the pregnant women enrolled in MomEE at one time point before 10 days of life.

Jasper Most, Marshall St. Amant, Daniel S. Hsia, Abby D. Altazan, Diana M. Thomas et al. (10 authors)

Journal of Clinical Investigation2019-08-0153 citations

10.1172/jci130341

Propensity for adverse pregnancy outcomes in African-American women may be explained by low energy expenditure in early pregnancy.

Most J, Gilmore LA, Altazan AD, St Amant M, Beyl RA, Ravussin E, Redman LM.

2018-06-018 citations

10.1093/ajcn/nqy053

Food Photography Is Not an Accurate Measure of Energy Intake in Obese, Pregnant Women.

Most J, Vallo PM, Altazan AD, Gilmore LA, Sutton EF, Cain LE, Burton JH, Martin CK, Redman LM.

2018-04-0119 citations

10.1093/jn/nxy009

Strategies for Successful Recruitment of Pregnant Patients Into Clinical Trials

Elizabeth F. Sutton, Loren E Cain, Porsha M. Vallo, Leanne M. Redman

Obstetrics and Gynecology2017-02-2357 citations

10.1097/aog.0000000000001900

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

Healthy volunteers

Yes

Inclusion criteria

* Are pregnant * Have a body mass index (BMI) greater than or equal to 30kg/m2 * Are 18-40 years old * Medically cleared for participation by primary care obstetrician * Medically cleared for participant by Medical Investigator * Willingness to allow the study access to information in the participant's medical record * Willingness to be notified of incidental findings from study procedures

Exclusion criteria

Clinical * Hypertension (i.e. systolic blood pressure (SBP) \>160 mmHg & diastolic blood pressure (DBP) \>110 mmHg)\* * Diagnosis of diabetes prior to pregnancy * Hb A1c ≥6.5 %\* * Implanted metal objects that render MRI unsafe * HIV or AIDS (self-reported) * Severe anemia (hemoglobin \<8g/dL and/or hematocrit \<24%)\*\* Psychological * History or current psychotic disorder or diagnosis of a current major depressive episode or bipolar disorder * Past history of anorexia or bulimia by medical history or patient report (binge eating disorder is not an exclusion) or current eating disorder * Actively suicidal defined as a value ≥2 on the Beck Depression Index (BDI-II) question 9\* Medications * Current use of one or more of the following medications: metformin, systemic steroids, antipsychotic agents (e.g., Abilify, Haldol, Risperdal, Seroquel, Zyprexa), anti-seizure medications or mood stabilizers that would be expected to have a significant impact on body weight (e.g., Depakote, Lamictal, Lithium, Neurontin, Tegretol, Topamax, Keppra), medications for attention-deficit/hyperactivity disorder (ADHD) including amphetamines and methylphenidate * Continued use of weight loss medication including over the counter (OTC) and dietary supplements for weight loss (e.g., Adipex, Suprenza, Tenuate, Xenical, Alli, conjugated linoleic acid, Hoodia, Green tea extract, Guar gum, HydroxyCut, Sensa, Corti-slim, Chromium, chitosan, Bitter orange) Other

Design outcomes

Primary

Measure	Time frame	Description
Energy Intake	Approximately 6 months (from 13-16 weeks gestation to 35-37 weeks gestation)	Energy intake is determined using the energy intake-balance method. Energy intake was calculated as the sum of energy expenditure by doubly labeled water and energy deposition of fat and fat-free tissues by 3 compartment model using plethysmography and isotope dilution.

Secondary

Measure	Time frame	Description
Physical Activity	Approximately 7 days within 13-16 weeks gestation	Physical activity is determined using daily mean amplitude deviation in milligrams by wrist worn accelerometer over a period of approximately 7 days within early pregnancy (13-16 weeks gestation). Mean amplitude deviation describes the mean distance of data points from the mean, and higher values denote higher levels of physical activity.
Energy Expenditure During Sleep	1 day within 13-16 weeks gestation	Energy expenditure during sleep is determined by 1 overnight stay in a whole body calorimeter within early pregnancy (13-16 weeks gestation).
Percentage of Protein of Energy Intake	Approximately 7 days within 13-16 weeks gestation	Percentage of protein of energy intake is determined by remote food photography method within early pregnancy (13-16 weeks gestation).
Percentage of Fat of Energy Intake	Approximately 7 days within 13-16 weeks gestation	Percentage of fat of energy intake is determined by remote food photography method within early pregnancy (13-16 weeks gestation).
Percentage of Carbohydrate of Energy Intake	Approximately 7 days within 13-16 weeks gestation	Percentage of carbohydrate of energy intake is determined by remote food photography method within early pregnancy (13-16 weeks gestation).

Countries

United States

Participant flow

Participants by arm

Arm	Count
Pregnant Women With Excess Gestational Weight Gain Pregnant women with weight gain above the Institutes of Medicine gestational weight gain guidelines	36
Pregnant Women With Recommended Gestational Weight Gain Pregnant women with weight gain within the Institutes of Medicine gestational weight gain guidelines	8
Pregnant Women With Inadequate Gestational Weight Gain Pregnant women with weight gain below the Institutes of Medicine gestational weight gain guidelines	10
Pregnant Women Not Included in Analysis Pregnant women who enrolled in the study but were not included in data analysis for various reasons.	18
Total	72

Withdrawals & dropouts

Period	Reason	FG003
Overall Study	Lost to Follow-up	5
Overall Study	Miscarriage	3
Overall Study	Missing data from 13-16week study visit	1
Overall Study	Pre-eclampsia	4
Overall Study	Preterm delivery	3
Overall Study	Unreliable Data	2

Baseline characteristics

Characteristic	Total	Pregnant Women With Excess Gestational Weight Gain	Pregnant Women With Recommended Gestational Weight Gain	Pregnant Women With Inadequate Gestational Weight Gain	Pregnant Women Not Included in Analysis
Age, Continuous	27.7 years STANDARD_DEVIATION 5	27.7 years STANDARD_DEVIATION 4.8	25 years STANDARD_DEVIATION 4.8	29.2 years STANDARD_DEVIATION 4.1	28.2 years STANDARD_DEVIATION 6.1
Body Mass Index	37.1 kg/m^2 STANDARD_DEVIATION 5.7	34.8 kg/m^2 STANDARD_DEVIATION 3	34.6 kg/m^2 STANDARD_DEVIATION 4.5	40.6 kg/m^2 STANDARD_DEVIATION 7.9	41.0 kg/m^2 STANDARD_DEVIATION 6.3
Highest Education 1-3 years college	31 Participants	11 Participants	3 Participants	4 Participants	13 Participants
Highest Education College degree	18 Participants	10 Participants	4 Participants	2 Participants	2 Participants
Highest Education High school	9 Participants	6 Participants	1 Participants	1 Participants	1 Participants
Highest Education Less than high school	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Highest Education Postgraduate work	13 Participants	9 Participants	0 Participants	3 Participants	1 Participants
Parity 0 viable pregnancies	34 Participants	16 Participants	4 Participants	3 Participants	11 Participants
Parity 1 viable pregnancies	22 Participants	14 Participants	2 Participants	3 Participants	3 Participants
Parity 2 viable pregnancies	10 Participants	4 Participants	1 Participants	3 Participants	2 Participants
Parity ≥3 viable pregnancies	6 Participants	2 Participants	1 Participants	1 Participants	2 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	34 Participants	12 Participants	4 Participants	6 Participants	12 Participants
Race (NIH/OMB) More than one race	4 Participants	1 Participants	1 Participants	1 Participants	1 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Race (NIH/OMB) White	32 Participants	22 Participants	3 Participants	3 Participants	4 Participants
Sex: Female, Male Female	72 Participants	36 Participants	8 Participants	10 Participants	18 Participants
Sex: Female, Male Male	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	0 / 36	0 / 8	0 / 10	0 / 18
other Total, other adverse events	36 / 36	7 / 8	9 / 10	15 / 18
serious Total, serious adverse events	3 / 36	1 / 8	0 / 10	4 / 18

Outcome results

Primary

Energy Intake

Energy intake is determined using the energy intake-balance method. Energy intake was calculated as the sum of energy expenditure by doubly labeled water and energy deposition of fat and fat-free tissues by 3 compartment model using plethysmography and isotope dilution.

Time frame: Approximately 6 months (from 13-16 weeks gestation to 35-37 weeks gestation)

Population: Analysis could not be completed for the Arm (Pregnant Women Not Included in Analysis). Reasons include the following: missing necessary data from either the 13-16 weeks gestation or 35-37 weeks gestation visit, pre-eclampsia, or unreliable data.

Arm	Measure	Value (MEAN)	Dispersion
Pregnant Women With Excess Gestational Weight Gain	Energy Intake	2908 kilocalories per day	Standard Deviation 384
Pregnant Women With Recommended Gestational Weight Gain	Energy Intake	2698 kilocalories per day	Standard Deviation 280
Pregnant Women With Inadequate Gestational Weight Gain	Energy Intake	2581 kilocalories per day	Standard Deviation 417

Secondary

Energy Expenditure During Sleep

Energy expenditure during sleep is determined by 1 overnight stay in a whole body calorimeter within early pregnancy (13-16 weeks gestation).

Time frame: 1 day within 13-16 weeks gestation

Population: Analysis could not be completed for the Arm (Pregnant Women Not Included in Analysis). Reasons include the following: missing necessary data from either the 13-16 weeks gestation or 35-37 weeks gestation visit, pre-eclampsia, or unreliable data.

Arm	Measure	Value (MEAN)	Dispersion
Pregnant Women With Excess Gestational Weight Gain	Energy Expenditure During Sleep	1648 kilocalories per day	Standard Deviation 198
Pregnant Women With Recommended Gestational Weight Gain	Energy Expenditure During Sleep	1688 kilocalories per day	Standard Deviation 218
Pregnant Women With Inadequate Gestational Weight Gain	Energy Expenditure During Sleep	1907 kilocalories per day	Standard Deviation 329

Secondary

Energy Expenditure During Sleep

Energy expenditure during sleep is determined by 1 overnight stay in a whole body calorimeter within late pregnancy (35-37 weeks gestation).

Time frame: 1 day within 35-37 weeks gestation

Population: Analysis could not be completed for the Arm (Pregnant Women Not Included in Analysis). Reasons include the following: missing necessary data from either the 13-16 weeks gestation or 35-37 weeks gestation visit, pre-eclampsia, or unreliable data.

Arm	Measure	Value (MEAN)	Dispersion
Pregnant Women With Excess Gestational Weight Gain	Energy Expenditure During Sleep	1975 kilocalories per day	Standard Deviation 216
Pregnant Women With Recommended Gestational Weight Gain	Energy Expenditure During Sleep	2081 kilocalories per day	Standard Deviation 288
Pregnant Women With Inadequate Gestational Weight Gain	Energy Expenditure During Sleep	2125 kilocalories per day	Standard Deviation 278

Secondary

Percentage of Carbohydrate of Energy Intake

Percentage of carbohydrate of energy intake is determined by remote food photography method within late pregnancy (35-37 weeks gestation).

Time frame: Approximately 7 days within 35-37 weeks gestation