Lifestyle Intervention in Preparation for Pregnancy (LIPP)

NCT03146156 | Completed DMC

• 2 other identifiers: IRB16-00553R01HD088061
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 4

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 overarching 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.

Conditions

Obesity; Lifestyle-related Condition; Macrosomia, Fetal

Keywords

obesity; overweight; lifestyle intervention; fetal growth/adiposity; Mediterranean diet

Outcome Measures

Primary Outcomes (1)

• Neonatal adiposity comparison between intervention and usual care group

  Neonatal anthropometry and air densitometry (pea pod)

  48 to 72 hours after delivery

Secondary Outcomes (1)

• Maternal metabolic status

  from baseline to 6 month post-partum and then during pregnancy at 12 to 16 weeks gestation and 34 to 36 weeks gestation.

Study Arms (2)

Lifestyle Intervention

EXPERIMENTAL

Lifestyle coaches will provide personalized instruction on physical activity, dietary data, and behavioral strategies.

Behavioral: Lifestyle Intervention

Usual Care

NO INTERVENTION

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.

Interventions

Lifestyle Intervention BEHAVIORAL

The lifestyle intervention is healthy eating (Medeterranian diet) and exercise to decrease weight by 5-7% compared to prepregnancy weight.

Lifestyle Intervention

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: 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.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• All subjects will have had by the time of randomization at 3 months postpartum:
• Planning another pregnancy within the next 24 months
• Planning to deliver at Tufts medical center during their next pregnancy
• A previous full-term singleton pregnancy (gestational age \> 37 weeks)
• to 40 years of age at the time of enrollment into the study
• 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
• 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

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Tufts Medical Center: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Pennington Biomedical Research Center: collaborator
• The Cleveland Clinic: collaborator
• MetroHealth Medical Center: collaborator
• Brigham and Women's Hospital: collaborator

Study Sites (4)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Related Publications (94)

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MeSH Terms

Conditions

Obesity; Mental Disorders; Fetal Macrosomia; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes, Gestational; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Fetal Diseases; Pregnancy in Diabetics; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Birth Weight

Study Officials

• Li Yin Cheok, MA

  Tufts Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2017
• First Posted: May 9, 2017
• Study Start: March 21, 2017
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Time Frame: The results of the study will be available in a de-identified manner by contacting the Principal Investigator, after the results have been published.
• Access Criteria: The results of the study will be available in a de-identified manner by contacting the Principal Investigator, after the results have been published.

Locations

US (4)