Pregnancy and EARly Lifestyle Improvement Study

Study Overview
=================
Brief Summary
-----------------
The investigators propose to conduct a randomized controlled trial in 200 overweight/obese pregnant women and their offspring. The prenatal intervention will emphasize improving diet and physical activity. The lifestyle intervention will be delivered within an empowerment theoretical framework through a combination of group sessions, individual counseling, and by monitoring compliance to diet and physical activity to further tailor the intervention. The post-partum intervention sessions will include mothers and their offspring and will focus on breastfeeding, improving physical activity and quality of the diet and feeding practices through the first post-partum year. As part of routine prenatal care, participants in both the control and intervention arms will be given health-related advice. Since the majority of participants are expected to be eligible for the Women, Infants and Children (WIC) program, both groups will also receive assistance through WIC as per their routine policies. Our primary outcome is Gestational Weight Gain (GWG). The major secondary outcome of interest is infant BMI z-score at 12 months of age, and the investigators will also be evaluating several metabolic outcomes in mothers and infants.

Detailed Description
-----------------
Obesity and hyperglycemia in pregnancy are thought to impact fetal growth through over-nutrition and may stress the fetal pancreas because of the increased demand for insulin. Such intrauterine programming events affect birth weight and raise the offspring's risk trajectory for future obesity, type 2 diabetes, cardiovascular disease and premature death. Investigators propose to conduct a randomized controlled trial in 200 overweight or obese pregnant Puerto Rican women (free of diabetes) and their infants, to favorably impact metabolic health in mothers and infants. Women presenting will be randomized to a lifestyle modification intervention or standard care control group before 16 gestational weeks. The intervention will focus on improving: (1) physical activity levels and (2) diet quality and calorie intake. The lifestyle intervention will be delivered within an empowerment theoretical framework through individualized intervention sessions, intensive group sessions, and by phone calls. The intervention will continue through the first postpartum year and will include the infants. A key objective is to evaluate whether the intervention optimizes infant BMI z-score. We will also evaluate whether the intervention increases the number of women who experience appropriate gestational weight gain, and evaluate several additional aims including relating the interventions with improved insulin sensitivity and beta-cell function in the women, and insulin concentrations adjusted for glucose in their infants.This study will also help us to identify and overcome barriers to develop effective ways of intervening during pregnancy to meaningfully improve cardio-metabolic risk trajectories of future generations.

Official Title
-----------------
Pregnancy and EARly Lifestyle Improvement Study

Conditions
-----------------
Obesity, Hyperglycemia

Intervention / Treatment
-----------------
* Behavioral: Lifestyle intervention group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Singleton viable pregnancy. A twin pregnancy reduced to singleton before 14 weeks by project gestational age is acceptable. An ultrasound must be conducted before randomization that shows a fetal heartbeat; there should be no evidence of more than one fetus on the most recent pre-randomization ultrasound.* Gestational age at randomization no earlier than 9 weeks 0 days and no later than 15 weeks 6 days based on an algorithm that compares the last menstrual period (LMP) date and data from the earliest ultrasound.* BMI ≥25 kg/m2 based on first trimester measured weight and on measured height. The earliest weight measurement before randomization, measured specifically for the study will be used. Reported pre-pregnancy weight will not be used to determine eligibility because of the potential for inaccuracy. If the earliest weight measurement is conducted at 140 to 146 weeks or 150 to 156 weeks, 1 lb or 2 lbs will be subtracted from the measured weight respectively, to adjust to a first trimester weight.* Age ≥ 18* Exclusion Criteria: Diagnosis of diabetes prior to pregnancy (reported physician diagnosed diabetes other than GDM in previous pregnancy or taking insulin or medications to treat diabetes), or an HbA1c ≥ 6.5 % or other test result (elevated fasting glucose ≥126 mg/dL/7.0 mmol/L or 2 h glucose ≥200 mg/dL/11.1 mmol/L when OGTT is completed) suggestive of pre-pregnancy diabetes. All potential participants will have HbA1c performed prior to randomization.* Known fetal anomaly * Planned termination of pregnancy* History of three or more consecutive first trimester miscarriages* Past history of anorexia or bulimia by medical history or patient report. Binge eating disorder is not an exclusion* Current eating disorder diagnosed by EDE-Q questions 2-4 and confirmed after discussion with the participant by study staff* Actively suicidal defined as a value ≥ 2 on the BDI-II question 9* Prior or planned (within 1 year of expected delivery) bariatric surgery* Current use of one or more of the following medications: * Metformin Systemic steroids Antipsychotic agents Anti-seizure medications or mood stabilizers that would be expected to have a significant impact on body weight Medications for ADHD including amphetamines and methylphenidate Continued use of weight loss medication including OTC and dietary supplements for weight loss * Contraindications to aerobic exercise in pregnancy specified in the ACOG Committee Opinion #267, 2002 (reaffirmed 2009) * Hemodynamically significant heart disease defined as an AHA class II (short of breath with exercise) or greater Restrictive lung disease (e.g. pulmonary fibrosis) Poorly controlled seizure disorder Poorly controlled hypertension (blood pressure ≥160/110) History of extreme sedentary lifestyle (e.g. bed bound) Orthopedic limitations to aerobic exercise Severe anemia defined as a hemoglobin < 8 g/dl or hematocrit <24 % Participation in another interventional study that influences weight control* Enrollment in this trial in a previous pregnancy* Intention of the participant or of the care provider for the delivery to be outside the LIFE-Moms Consortium hospital* Participant's unwillingness or inability to commit to a 1 year follow-up of herself or her child, including planning to move away* Past or current intravenous drug use (visual check for injection marks, recorded methadone use, self-report) Self-reported HIV infection (confirmed from medical records or baseline test results) Inability to functionally participate in group sessions and other study requirements on a regular basis during the complete duration of the study, including but not limited to the documented use of the accelerometer for the periods required by the study Non Spanish speaking Plan on giving up infant for adoption '*' Core eligibility criterion for the LIFE-Moms Consortium

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Lifestyle and nutrition control group<br>The control arm will receive routine prenatal care in the prenatal clinic. They will receive regular phone calls and mailings, token gifts and some useful information from data collected in the study, such as physical activity, feedback on behavior throughout the study. To additionally promote adherence (since they will have less contact with study staff), we will include 2 pre-partum and 1 post-partum group sessions meant to increase bonding between participants and retention of control participants. These sessions will include general pregnancy information not related to our interventions. | |
| Active Comparator: Lifestyle intervention group<br>The lifestyle intervention will be delivered within an empowerment framework which promotes behavioral changes by facilitating health self-efficacy, utilizing self-praise and using active coping skills to address and manage emotions. A nutrition component primarily focuses on total calories, for which energy requirements will be individually calculated for each pregnant women and on general diet quality with an emphasis on carbohydrate quality. It will also promote an overall healthy diet, emphasizing improvement of fat quality and reducing salt intake. A physical activity component focuses on promoting regular movement and minimizes the duration of bouts of sitting or lying during waking hours as well as non-exercise activity. | Behavioral: Lifestyle intervention group<br>* The lifestyle intervention will be delivered within an empowerment framework which promotes behavioral changes by facilitating health self-efficacy, utilizing self-praise and using active coping skills to address and manage emotions. A nutrition component primarily focuses on total calories, for which energy requirements will be individually calculated for each pregnant women and on general diet quality with an emphasis on carbohydrate quality. It will also promote an overall healthy diet, emphasizing improvement of fat quality and reducing salt intake. A physical activity component focuses on promoting regular movement and minimizes the duration of bouts of sitting or lying during waking hours as well as non-exercise activity.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gestational Weight Gain | To determine if a combined lifestyle intervention of nutrition and physical activity delivered within an empowerment theoretical framework in pregnant women result in a greater percent of women who gain the appropriate amount of gestational weight gain, as defined by the Institute of Medicine, compared to those receiving standard care. | Delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Does the lifestyle intervention (compared with control) affect the infant BMI z-score at 12 months of age (major | To evaluate whether the intervention influences infant BMI by comparison of infants of mothers randomized to either active intervention or control intervention | 12 months post-partum | 
| Estimates of beta-cell function and insulin action in the mother. | Estimation of beta-cell function, insulin resistance, and insulin sensitivity using data obtained from a frequently sampled 75g OGTT. Calculations will be based on established equations that have been validated for use in pregnancy, such as the model-based approach and the oral disposition index. | 35,0-36,6 wks 48,0-56,0 wks pp | 
| Maternal blood pressure during pregnancy |  | 24,0-27,6 wks; 35,0-36,6 wks; Delivery | 
| Maternal blood pressure postpartum. |  | 4,0-6,0 wks pp; 16,0-24,0 wks pp; 48,0-56,0 wks pp | 
| Infant blood pressure |  | < 48 hour pp; 4-6 wks pp; 16-24 wks pp | 
| Post-partum weight retention |  | 4,0-6,0 wks pp; 16,0-24,0 wks pp; 48,0-56,0 wks pp | 
| Body circumferences in mothers |  | 24,0-27,6 wks 35,0-36,6 wks 4,0-6,0 wks pp; 16,0-24,0 wks pp; 48,0-56,0 wks pp | 
| Body circumferences in infants |  | < 48 hour pp 4-6 wks pp 16-24 wks pp 48-56 wks pp | 
| Skinfold measures in infants |  | < 48 hour pp 16-24 wks pp 48-56 wks pp | 
| Sleep quality and duration in the prenatal periods in mothers | Sleep quality and duration will be assessed using an accelerometer in order to assess duration and quality of sleep | 35,0-36,6 wks | 
| Sleep quality and duration in the postpartum periods in mothers and infants | Sleep quality and duration will be assessed using an accelerometer in order to assess duration and quality of sleep | 48,0-56,0 wks pp | 
| Insulin levels adjusted for glucose levels in the infants |  | < 48 hour pp 16-24 wks pp 48-56 wks pp | 
| Developmental measures in infants |  | < 48 hour pp 16-24 wks pp 48-56 wks pp | 
| Anthropometric and growth measures in the infants |  | < 48 hour pp 4-6 wks pp 16-24 wks pp 48-56 wks pp | 
| Psychosocial measures in the mothers |  | 35,0-36,6 wks 48,0-56,0 wks pp | 
| Pregnancy and Delivery complications |  | 35,0-36,6 wks delivery | 
| Fetal and neonatal adverse outcomes |  | Birth and < 48 hour pp | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obesity, Maternal Welfare, Child Welfare, Nutritional Sciences, Clinical Trial, Pregnancy, Physical activity, Fetal Development, Metabolic Diseases, Life style, Behavior and Behavior Mechanisms, LIFE-Moms