Determinants of Gestational Weight Gain in Obese Pregnant Women

Energy Expenditure Clinical Trial

— MomEE  

Official title:

MomEE: Determinants of Gestational Weight Gain in Obese Pregnant Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01954342
• Other study ID #: PBRC 13020
• Secondary ID: 1R01DK099175
• Status: Completed
• Start date: December 2014
• Est. completion date: August 2018

Study information

• Verified date: August 2021
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: August 2018
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Energy Expenditure
• Energy Intake
• Gestational Weight Gain
• Weight Gain

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Approximately 6 months (from 13-16 weeks gestation to 35-37 weeks gestation)
Secondary	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
Secondary	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
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).	1 day within 13-16 weeks gestation
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).	1 day within 35-37 weeks gestation
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
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).	Approximately 7 days within 35-37 weeks gestation

External Links

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