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
|Condition or disease||Intervention/treatment||Phase|
|Obesity Lifestyle-related Condition Macrosomia, Fetal||Behavioral: Lifestyle Intervention||Not Applicable|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|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|
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.
- Neonatal adiposity comparison between intervention and usual care group [ Time Frame: 48 to 72 hours after delivery ]Neonatal anthropometry and air densitometry (pea pod)
- 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
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
|Contact: Patrick M Catalano, MDemail@example.com|
|Contact: John P Kirwan, PhDfirstname.lastname@example.org|
|United States, Ohio|
|MetroHealth Medical Center||Recruiting|
|Cleveland, Ohio, United States, 44109|
|Contact: Patrick Catalano, MD 216-778-8462 email@example.com|
|Contact: Larraine Presley 2167788927 firstname.lastname@example.org|
|Cleveland Clinic||Active, not recruiting|
|Cleveland, Ohio, United States, 44195|
|Study Director:||Larraine Presley, MS, RN||Metro Health, Michigan|
|Study Director:||Chris Axelrod, MS||The Cleveland Clinic|