Determinants of Gestational Weight Gain in Obese Pregnant Women (MomEE)

MomEE: Determinants of Gestational Weight Gain in Obese Pregnant Women

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.

Study Overview

• Status: Completed
• Conditions: Energy Expenditure; Energy Intake

• Study Type: Observational
• Enrollment (Actual): 72

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Pennington Biomedical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

75 obese, pregnant women

Description

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 Exclusion Criteria
• Recent history of or currently smoking, drinking alcohol or abusing drugs (prescription or recreational)
• Plans to move out of the study area within the next 2 years or plans to be out of the study area for more than 4 weeks in the next 12 months
• Planned termination of pregnancy
• Unwillingness to avoid pregnancy for 12 months following delivery
• Claustrophobia
• Prior or planned (within 1 year of expected delivery) bariatric surgery
• Participant's unwillingness or inability to commit to a 1 year follow-up

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Pregnant; Obese pregnant women

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Approximately 6 months (from 13-16 weeks gestation to 35-37 weeks gestation)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical Activity	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.	Approximately 7 days within 13-16 weeks gestation
Physical Activity	Physical activity is determined using daily mean amplitude deviation in milligrams by wrist worn accelerometer over a period of approximately 7 days within late pregnancy (35-37 weeks gestation). Mean amplitude deviation describes the mean distance of data points from the mean, and higher values denote higher levels of physical activity.	Approximately 7 days within 35-37 weeks gestation
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).	1 day within 13-16 weeks gestation
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).	1 day within 35-37 weeks gestation
Percentage of Protein of Energy Intake	Percentage of protein of energy intake is determined by remote food photography method within early pregnancy (13-16 weeks gestation).	Approximately 7 days within 13-16 weeks gestation
Percentage of Protein of Energy Intake	Percentage of protein of energy intake is determined by remote food photography method within late pregnancy (35-37 weeks gestation).	Approximately 7 days within 35-37 weeks gestation
Percentage of Fat of Energy Intake	Percentage of fat of energy intake is determined by remote food photography method within early pregnancy (13-16 weeks gestation).	Approximately 7 days within 13-16 weeks gestation
Percentage of Fat of Energy Intake	Percentage of fat of energy intake is determined by remote food photography method within late pregnancy (35-37 weeks gestation).	Approximately 7 days within 35-37 weeks gestation
Percentage of Carbohydrate of Energy Intake	Percentage of carbohydrate of energy intake is determined by remote food photography method within early pregnancy (13-16 weeks gestation).	Approximately 7 days within 13-16 weeks gestation
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).	Approximately 7 days within 35-37 weeks gestation

Collaborators and Investigators

• Sponsor: Pennington Biomedical Research Center
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Leanne M Redman, PhD, Pennington Biomedical Research

Publications and helpful links

General Publications

• Sutton EF, Cain LE, Vallo PM, Redman LM. Strategies for Successful Recruitment of Pregnant Patients Into Clinical Trials. Obstet Gynecol. 2017 Mar;129(3):554-559. doi: 10.1097/AOG.0000000000001900.
• Lindsay KL, Most J, Buehler K, Kebbe M, Altazan AD, Redman LM. Maternal mindful eating as a target for improving metabolic outcomes in pregnant women with obesity. Front Biosci (Landmark Ed). 2021 Dec 30;26(12):1548-1558. doi: 10.52586/5048.
• Most J, Altazan AD, St Amant M, Beyl RA, Ravussin E, Redman LM. Increased Energy Intake After Pregnancy Determines Postpartum Weight Retention in Women With Obesity. J Clin Endocrinol Metab. 2020 Apr 1;105(4):e1601-11. doi: 10.1210/clinem/dgz330.
• Most J, Amant MS, Hsia DS, Altazan AD, Thomas DM, Gilmore LA, Vallo PM, Beyl RA, Ravussin E, Redman LM. Evidence-based recommendations for energy intake in pregnant women with obesity. J Clin Invest. 2019 Aug 1;129(11):4682-4690. doi: 10.1172/JCI130341.
• Most J, Redman LM. Energy expenditure predictions in postpartum women require adjustment for race. Am J Clin Nutr. 2019 Aug 1;110(2):522-524. doi: 10.1093/ajcn/nqz087. No abstract available.
• Most J, Vallo PM, Gilmore LA, St Amant M, Hsia DS, Altazan AD, Beyl RA, Ravussin E, Redman LM. Energy Expenditure in Pregnant Women with Obesity Does Not Support Energy Intake Recommendations. Obesity (Silver Spring). 2018 Jun;26(6):992-999. doi: 10.1002/oby.22194.
• Most J, Gilmore LA, Altazan AD, St Amant M, Beyl RA, Ravussin E, Redman LM. Propensity for adverse pregnancy outcomes in African-American women may be explained by low energy expenditure in early pregnancy. Am J Clin Nutr. 2018 Jun 1;107(6):957-964. doi: 10.1093/ajcn/nqy053.
• Most J, Vallo PM, Altazan AD, Gilmore LA, Sutton EF, Cain LE, Burton JH, Martin CK, Redman LM. Food Photography Is Not an Accurate Measure of Energy Intake in Obese, Pregnant Women. J Nutr. 2018 Apr 1;148(4):658-663. doi: 10.1093/jn/nxy009.

Helpful Links

• Reproductive Endocrinology & Women's Health Laboratory- Our Research

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2014
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): August 1, 2018

Study Registration Dates

• First Submitted: September 26, 2013
• First Submitted That Met QC Criteria: September 26, 2013
• First Posted (Estimate): October 1, 2013

Study Record Updates

• Last Update Posted (Actual): September 16, 2021
• Last Update Submitted That Met QC Criteria: August 23, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Pregnancy; Postpartum
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Gain; Gestational Weight Gain
• Other Study ID Numbers: PBRC 13020; 1R01DK099175 (U.S. NIH Grant/Contract)