Clinical trial NCT01954342: Determinants of Gestational Weight Gain in Obese Pregnant Women
Official title: MomEE: Determinants of Gestational Weight Gain in Obese Pregnant Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Energy Intake
Energy Expenditure
Keywords: Pregnancy
Postpartum
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2013-10-01
Enrollment: 72
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 75 obese, pregnant women

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.


Eligibility criteria: 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

Primary outcomes:
measure: Energy Intake
timeFrame: Approximately 6 months (from 13-16 weeks gestation to 35-37 weeks gestation)
Secondary outcomes:
measure: Physical Activity
timeFrame: Approximately 7 days within 13-16 weeks gestation
measure: Physical Activity
timeFrame: Approximately 7 days within 35-37 weeks gestation
measure: Energy Expenditure During Sleep
timeFrame: 1 day within 13-16 weeks gestation
measure: Energy Expenditure During Sleep
timeFrame: 1 day within 35-37 weeks gestation
measure: Percentage of Protein of Energy Intake
timeFrame: Approximately 7 days within 13-16 weeks gestation
measure: Percentage of Protein of Energy Intake
timeFrame: Approximately 7 days within 35-37 weeks gestation
measure: Percentage of Fat of Energy Intake
timeFrame: Approximately 7 days within 13-16 weeks gestation
measure: Percentage of Fat of Energy Intake
timeFrame: Approximately 7 days within 35-37 weeks gestation
measure: Percentage of Carbohydrate of Energy Intake
timeFrame: Approximately 7 days within 13-16 weeks gestation
measure: Percentage of Carbohydrate of Energy Intake
timeFrame: Approximately 7 days within 35-37 weeks gestation
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research
name: Leanne M Redman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.