Determinants of Gestational Weight Gain in Obese Pregnant Women

NCT01954342 | Completed Results

• 2 other identifiers: PBRC 130201R01DK099175
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Energy Intake; Energy Expenditure

Keywords

Pregnancy; Postpartum

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Physical Activity

  Approximately 7 days within 13-16 weeks gestation

• Physical Activity

  Approximately 7 days within 35-37 weeks gestation

• Energy Expenditure During Sleep

  1 day within 13-16 weeks gestation

• Energy Expenditure During Sleep

  1 day within 35-37 weeks gestation

• Percentage of Protein of Energy Intake

  Approximately 7 days within 13-16 weeks gestation

Study Arms (1)

Pregnant

Obese pregnant women

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

75 obese, pregnant women

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Related Publications (8)

• 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.

  PMID: 34994169 DERIVED

• 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.

  PMID: 31905403 DERIVED

• 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.

  PMID: 31369400 DERIVED

• 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.

  PMID: 31367759 DERIVED

• 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.

  PMID: 29797559 DERIVED

• 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.

  PMID: 29767680 DERIVED

• 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.

  PMID: 29659958 DERIVED

• 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.

  PMID: 28178062 DERIVED

Related Links

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

Biospecimen

Retention: SAMPLES WITHOUT DNA

Placenta, Cord Blood, fasting Urine, fasting Maternal plasma and serum (during pregnancy and postpartum).

Limitations and Caveats

Eighteen women who enrolled in the study were not included in analysis for various reasons. The reasons included: missing data from 13-16 gestational week visit, miscarriage, lost to follow-up, preterm delivery, pre-eclampsia, unreliable data.

Results Point of Contact

• Title: Dr. Leanne Redman
• Organization: Pennington Biomedical Research Center

Leanne.Redman@pbrc.edu

2257630947

Study Officials

• Leanne M Redman, PhD

  Pennington Biomedical Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 26, 2013
• First Posted: October 1, 2013
• Study Start: December 1, 2014
• Primary Completion: July 1, 2017
• Study Completion: August 1, 2018
• Last Updated: September 16, 2021
• Results First Posted: June 19, 2020

Record last verified: 2021-08

Locations

US (1)