Clinical Trial: Lifestyle Intervention in Preparation for Pregnancy (LIPP)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Lifestyle Intervention in Preparation for Pregnancy (LIPP)

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.

Detailed Summary:

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 Con
Sponsor: MetroHealth Medical Center

Current Primary Outcome: Neonatal adiposity comparison between intervention and usual care group [ Time Frame: 48 to 72 hours after delivery ]

Neonatal anthropometry and air densitometry (pea pod)


Original Primary Outcome: Same as current

Current Secondary Outcome: 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


Original Secondary Outcome: Same as current

Information By: MetroHealth Medical Center

Dates:
Date Received: March 22, 2017
Date Started: January 3, 2017
Date Completion: December 1, 2021
Last Updated: May 5, 2017
Last Verified: May 2017