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Lifestyle Intervention in Preparation for Pregnancy (LIPP)

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ClinicalTrials.gov Identifier: NCT03146156
Recruitment Status : Recruiting
First Posted : May 9, 2017
Last Update Posted : October 18, 2019
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Pennington Biomedical Research Center
The Cleveland Clinic
MetroHealth Medical Center
Massachusetts General Hospital
Information provided by (Responsible Party):
Tufts Medical Center

Brief Summary:

Studies evaluating lifestyle intervention in obese women during pregnancy have reported limited success in decreasing excessive gestational weight gain, and have failed to achieve the key outcome of breaking the obesity cycle and reducing neonatal adiposity or birth weight. Although some investigators advocate weight loss during pregnancy in obese women, these recommendations were based on extrapolation of retrospective epidemiological data. Of concern, we reported increased small for gestational age babies and decreased lean body mass in neonates of obese women with weight loss or inadequate gestational weight gain. Based on our research, optimal outcomes from lifestyle interventions are likely to be temporal and therefore must be initiated prior to conception to first improve maternal metabolic function, and subsequently, placental/fetal growth. Several large retrospective cohort studies support our hypothesis. For example, women who lost weight between pregnancies had fewer large for gestational age babies in contrast to women who increased interpregnancy weight. In addition, prospective randomized controlled trials have shown that postpartum weight loss is achievable without adverse maternal or neonatal outcomes, these studies include women who breastfed. Based on these observations, we propose a randomized control trial to determine the effect of lifestyle intervention initiated prior to a planned pregnancy on improving neonatal metabolism and adiposity. Our over-arching hypothesis is that the maternal pre-pregnancy metabolic condition determines the obesogenic in-utero environment, which affects programming of placental mitochondrial function and metabolic pathways, promoting lipid accumulation and neonatal adiposity. Our rationale is based on the need to establish the most effective time to introduce an intervention that will break the obesity cycle in mothers and their children. Understanding how pregravid metabolic conditioning improves maternal physiology, and cellular and molecular function in pregnancy will provide the empirical data to support the intervention. We have a highly successful record of recruiting women who are planning a pregnancy, obtaining compliance in longitudinal studies, and in long-term follow-up of mothers and their offspring. Lifestyle intervention will be initiated prior to conception to decrease maternal body fat, inflammation, insulin resistance, and ?-cell dysfunction. Our transdisciplinary team has the required expertise in lifestyle interventions management of obesity, and in human physiology that is needed to determine the effects of these interventions on maternal metabolism and fetalplacental growth and function. We will recruit 200 women to pursue the following specific aims:

Specific Aim 1: To investigate the physiological significance of lifestyle intervention in preparation for pregnancy (LIPP) on maternal and neonatal metabolism and adiposity.

Specific Aim 2: To determine the molecular effects whereby lifestyle intervention initiated before pregnancy can improve placental mitochondrial lipid oxidation and accumulation.


Condition or disease Intervention/treatment Phase
Obesity Lifestyle-related Condition Macrosomia, Fetal Behavioral: Lifestyle Intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Lifestyle Intervention in Preparation for Pregnancy (LIPP)
Actual Study Start Date : March 21, 2017
Estimated Primary Completion Date : November 29, 2021
Estimated Study Completion Date : July 1, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Lifestyle Intervention
Lifestyle coaches will provide personalized instruction on physical activity, dietary data, and behavioral strategies.
Behavioral: Lifestyle Intervention
The lifestyle intervention is healthy eating (Medeterranian diet) and exercise to decrease weight by 5-7% compared to prepregnancy weight.

No Intervention: Usual Care
The usual care/control groups will be followed by their primary Obstetrical provider. All overweight/obese women will be offered nutrition counseling early in pregnancy by a registered dietician to support GWG within the IOM guidelines.



Primary Outcome Measures :
  1. Neonatal adiposity comparison between intervention and usual care group [ Time Frame: 48 to 72 hours after delivery ]
    Neonatal anthropometry and air densitometry (pea pod)


Secondary Outcome Measures :
  1. Maternal metabolic status [ Time Frame: from baseline to 6 month post-partum and then during pregnancy at 12 to 16 weeks gestation and 34 to 36 weeks gestation. ]
    body composition, insulin sensitivity and insulin response



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   We will recruit a total of 200 overweight/obese subjects (defined as pregravid BMI 25-35 kg/m2) at the time of their first pregnancy, hereafter defined as obese for the purposes of the proposal) determined by review of the electronic medical record (EMR) after delivery of their first child.
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

All subjects will have had by the time of randomization at 3 months postpartum:

  1. Planning another pregnancy within the next 24 months
  2. Planning to deliver at Tufts medical center during their next pregnancy
  3. A previous full-term singleton pregnancy (gestational age > 37 weeks)
  4. 18 to 40 years of age at the time of enrollment into the study
  5. Vaginal or cesarean delivery
  6. Normal glucose tolerance or gestational diabetes (GDM), but without evidence of postpartum diabetes as defined by a 75 g 2-hr oral glucose tolerance test (OGTT)
  7. Normal blood pressure or mild preeclampsia but normal postpartum blood pressure
  8. Bottle or breast feeding
  9. Normal thyroid function (determined by TSH concentration in blood), normal cell blood count and normal kidney and liver functions. Lipid profile with triglyceride levels not higher than 400 mg/dl (fasting) and LDL levels less than 180 mg/dL
  10. No clinical signs or symptoms of cardiovascular disease or any other disease or condition that may contraindicate participation in exercise training (i.e. COPD, severe asthma, orthopedic abnormalities)
  11. Using contraception

Exclusion criteria:

  1. Pre or post-delivery diabetes
  2. Post-delivery hypertension requiring medication
  3. asthma requiring more than occasional use of a sympathomimetic inhaler, but not chronic inhaled steroids
  4. Inflammatory bowel disease
  5. Need for assisted reproductive technologies to become pregnant
  6. Medical or obstetrical contraindication to the defined exercise program or diet
  7. Tobacco, excessive alcohol use (greater than 2 drinks/day) or illicit drug use
  8. Eating disorders such as bulimia
  9. Gastric surgery to lose weight including banding or bypass procedures
  10. Any psychological or psychiatric condition which may impair participation in the lifestyle intervention program
  11. Multiple pregnancy
  12. HIV, or hepatitis B or C
  13. If a LIPP subject becomes pregnant prior to 16 weeks after randomization before the weight- loss phase for the lifestyle intervention is completed or a control subject becomes pregnant before the 3 month postpartum randomization, i.e. no baseline measurement.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03146156


Contacts
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Contact: Patrick M Catalano, MD 617-636-1468 pcatalano@tuftsmedicalcenter.org
Contact: John P Kirwan, PhD John.Kirwan@pbrc.edu

Locations
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United States, Louisiana
Pennington Biomedical Research Center Recruiting
Baton Rouge, Louisiana, United States, 70808
Contact: John P Kirwan, PhD       John.Kirwan@pbrc.edu   
Contact: Chris Axelrod, M.Ed       Christopher.Axelrod@pbrc.edu   
United States, Massachusetts
Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Contact: Patrick Catalano, MD    617-636-1468      
Contact: Kate Russell    617-636-9197      
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02215
Contact: Allison Bryant Mantha, MD    617-724-0138    abryant@partners.org   
United States, Ohio
MetroHealth Medical Center Active, not recruiting
Cleveland, Ohio, United States, 44109
Cleveland Clinic Active, not recruiting
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Tufts Medical Center
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Pennington Biomedical Research Center
The Cleveland Clinic
MetroHealth Medical Center
Massachusetts General Hospital
Investigators
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Study Director: Larraine Presley, MS, RN Metro Health, Michigan
Study Director: Chris Axelrod, MS The Cleveland Clinic

Publications:

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Responsible Party: Tufts Medical Center
ClinicalTrials.gov Identifier: NCT03146156    
Other Study ID Numbers: IRB16-00553
R01HD088061 ( U.S. NIH Grant/Contract )
First Posted: May 9, 2017    Key Record Dates
Last Update Posted: October 18, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The results of the study will be available in a de-identified manner by contacting the Principal Investigator, after the results have been published.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tufts Medical Center:
obesity
overweight
lifestyle intervention
fetal growth/adiposity
Mediterranean diet
Additional relevant MeSH terms:
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Fetal Macrosomia
Body Weight
Signs and Symptoms
Diabetes, Gestational
Pregnancy Complications
Fetal Diseases
Pregnancy in Diabetics
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Birth Weight