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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 : May 3, 2018
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Patrick Catalano, MetroHealth Medical Center

Brief Summary:
The objective of this proposal is to break the vicious cycle of obesity/metabolic dysfunction during pregnancy. Lifestyle interventions in obese women during pregnancy have had limited success in improving maternal or offspring short and long-term metabolic health. We propose that lifestyle interventions need to be initiated prior to conception in overweight and obese women (henceforth referred to as obese) in order to first improve maternal metabolism. Lifestyle interventions will take place in the greater Cleveland recreational facilities. Metabolic evaluations will be conducted in the Clinical Research Units of the Case Western Reserve Clinical Translational Science Center (CTSC). We hypothesize this will result in decreased fetal adiposity and improved metabolic function in the offspring.

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

Detailed Description:

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

We will recruit mothers who delivered their first baby at MHMC. We will conduct the exercise sessions in local Community Recreation Centers. We will provide childcare and we will support the cost so participants may bring their babies to the LIPP sessions.

The LIPP program is designed to promote weight loss that is 5-10% of current body weight. The 3-month weight loss phase consists of aerobic exercise training with diet and behavioral counseling to induce weight loss as was successfully achieved in prior studies. The women will wear heart rate (HR) monitors (Polar Electro, Woodbury, NY) during each exercise session so that they have visual feedback of their personalized target heart rate goal. Our Lifestyle Coaches will enter all foods eaten into our diet database (NDSR, Minneapolis, MN) to facilitate analysis of calorie, and macro/micro nutrient intake. Subjects will generate photos from before and after the meal in order to estimate the amount of food that was eaten. Data will be obtained at baseline, and at 2-week intervals during the initial 12-week supervised weight loss period.

Lifestyle Intervention - Weight Management/Maintenance:

The pre-pregnancy weight management program (Phases 2A, 2B and 2C) is designed to facilitate personalized weight loss goals using lifestyle behaviors that include, exercise, diet and behavioral modification. The intervention includes a "toolbox" concept to help meet weight loss goals. The Lifestyle Coaches will provide personalized instruction on physical activity/exercise. Participants randomized to the Control group will receive information on post-pregnancy diet/weight loss from the nutritionist as distinct from the LIPP nutritionist to decrease cross contamination between groups.

Weight Management during Pregnancy:

All LIPP and usual care/control groups will be followed by their primary Obstetrical provider. The OB/GYN department at MHMC has recently revised its clinical guidelines for the management of the overweight/obese women based on the December 2015 ACOG practice bulletin. All overweight/obese women will be offered nutrition counseling early in pregnancy by a registered dietician from the MHMC Nutrition Department with follow-up visits as needed to support GWG within the IOM guidelines. The Lifestyle Coach will continue to follow-up only with the LIPP subjects as described in the maintenance phase of the research design.

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

We will accomplish the objectives of Specific Aim 2 by measuring changes in placental mitochondrial enzyme activity and lipid metabolism in women enrolled in the Control or LIPP groups described in Specific Aim 1. Placental tissue will be collected at delivery from all study participants.


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 : January 3, 2017
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2021

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
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) after delivery of their first child on the postpartum unit of MetroHealth Medical Center (MHMC).
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Planning another pregnancy within the next 24 months
  • Planning to deliver at MetroHealth Medical Center during their next pregnancy
  • A previous full-term singleton pregnancy (gestational age > 37 weeks)
  • Vaginal or cesarean delivery
  • 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)
  • Normal blood pressure or mild preeclampsia but normal postpartum blood pressure
  • Bottle or breast feeding
  • Vaginal or cesarean delivery
  • 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
  • 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)
  • Using contraception

Exclusion Criteria:

  • Pre- or post-delivery diabetes
  • Post-delivery hypertension requiring medication
  • Asthma requiring more than occasional use of a sympathomimetic inhaler, but not chronic inhaled steroids
  • Inflammatory bowel disease
  • Need for assisted reproductive technologies to become pregnant
  • Medical or obstetrical contraindication to the defined exercise program or diet
  • Tobacco, excessive alcohol use (greater than 2 drinks/day) or illicit drug use
  • Eating disorders such as bulimia
  • Gastric surgery to lose weight including banding or bypass procedures
  • Any psychological or psychiatric condition which may impair participation in the lifestyle intervention program
  • Multiple pregnancy
  • HIV, or hepatitis B or C
  • If a LIPP participant becomes pregnant prior to 16 weeks after randomization before the weight-loss phase for the lifestyle intervention is completed or a control participant 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
Contact: Patrick M Catalano, MD 2167784262 pcatalano@metrohealth.org
Contact: John P Kirwan, PhD 216-444-3412 kirwanj@ccf.org

Locations
United States, Ohio
MetroHealth Medical Center Recruiting
Cleveland, Ohio, United States, 44109
Contact: Patrick Catalano, MD    216-778-8462    pcatalano@metrohealth.org   
Contact: Larraine Presley    2167788927    lpresley@metrohealth.org   
Cleveland Clinic Active, not recruiting
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
MetroHealth Medical Center
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Study Director: Larraine Presley, MS, RN Metro Health, Michigan
Study Director: Chris Axelrod, MS The Cleveland Clinic

Publications:

Responsible Party: Patrick Catalano, Physician, MetroHealth Medical Center
ClinicalTrials.gov Identifier: NCT03146156     History of Changes
Other Study ID Numbers: IRB16-00553
R01HD088061 ( U.S. NIH Grant/Contract )
First Posted: May 9, 2017    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: May 2017
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.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Patrick Catalano, MetroHealth Medical Center:
obesity
overweight
lifestyle intervention
fetal growth/adiposity
Mediterranean diet

Additional relevant MeSH terms:
Fetal Macrosomia
Diabetes, Gestational
Pregnancy Complications
Fetal Diseases
Pregnancy in Diabetics
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Birth Weight
Body Weight
Signs and Symptoms