Lifestyle Intervention in Overweight and Obese Pregnant Hispanic Women

Study Overview
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Brief Summary
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The overall goal of this randomized controlled trial is to test the efficacy of a culturally and linguistically modified, individually tailored lifestyle intervention to reduce excess gestational weight gain (GWG), increase postpartum weight loss, and improve maternal metabolic status among overweight/obese Hispanic women.

Detailed Description
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The overall goal of this randomized controlled trial is to test the efficacy of a culturally and linguistically modified, individually tailored lifestyle intervention to reduce excess gestational weight gain (GWG), increase postpartum weight loss, and improve maternal metabolic status among overweight/obese Hispanic women. Specific aims are to evaluate the impact of the intervention on 1) GWG and postpartum weight loss, 2) pregnancy and postpartum biomarkers of insulin resistance (i.e., glucose, insulin, HbA1c, HOMA, leptin, adiponectin), 3) postpartum biomarkers of cardiovascular risk (i.e., blood lipids, blood pressure), 4) offspring outcomes (i.e., anthropometric measures and biomarkers of insulin resistance), and 5) to evaluate the cost-effectiveness of the intervention per average incremental improvement in the outcome variables. Overweight/obese Hispanic women will be recruited in early pregnancy (around 10 wks gestation) and randomly assigned to a Lifestyle Intervention (n=150) or a Comparison Health and Wellness (control) Intervention (n=150). The intervention will utilize exercise (R01NR011295) and dietary intervention materials (R18DK067549) culturally adapted for Hispanics and shown to be efficacious in our previous controlled trials in this ethnic group. Multimodal contacts (i.e., in-person, telephone counseling, and mailed print-based materials) will be used to deliver the intervention during pregnancy ( 12 wks gestation to delivery) continuing into postpartum ( 6 wks to 6 mos postpartum); follow-up will continue for one year postpartum. Targets of the intervention are to achieve Institute of Medicine Guidelines for GWG and postpartum weight loss; ACOG guidelines for physical activity through increasing walking and developing a more active lifestyle; and reduction in total calories by following a balanced healthy diet in compliance with American Diabetes Association guidelines. The intervention draws from Social Cognitive Theory and the Transtheoretical Model and includes strategies for partner and/or family support to address the specific social, cultural, and economic challenges faced by underserved Hispanic women. Measures of compliance will include actigraphs and Hispanic food frequency questionnaires. The proposed project builds upon the expertise of the investigative team in conducting randomized controlled trials of exercise interventions among Hispanic pregnant women (R01 DK074876) and dietary interventions among low-income Hispanics with type 2 diabetes (R18 DK0658850) and can readily be translated into clinical practice in underserved and minority populations.

Official Title
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Proyecto Mama: Lifestyle Intervention in Overweight and Obese Pregnant Hispanic Women

Conditions
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Diabetes

Intervention / Treatment
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* Behavioral: Lifestyle Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hispanic women Overweight or obese before pregnancy (BMI >25 kg/m2) 16-45 years old Exclusion Criteria: prepregnancy BMI <25 kg/m2 history of type 2 diabetes, heart disease, or chronic renal disease contraindications to postpartum participation in moderate physical activity or a low-fat/high-fiber diet (e.g., Crohn's disease, ulcerative colitis) inability to read English or Spanish at a 6th grade level >16 wks gestation current medications which adversely influence glucose tolerance not planning to continue to term or deliver at the study site pregnant with twins or triplets

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lifestyle Intervention<br>Stage-matched physical activity and diet intervention materials and health education. | Behavioral: Lifestyle Intervention<br> <br> |
| No Intervention: Health and Wellness<br>HW served as the comparison group and received the same number of in-person sessions, telephone calls, and mailings at the same time points as LI. Content was limited to general information available to the public from the ACOG and the American Academy of Pediatrics and did not mention exercise behavior change. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postpartum weight change | Postpartum weight change will be measured as the difference between weight at 6 or 12 mos postpartum and weight at delivery. Weight will be measured on a digital scale. | 6 weeks postpartum, 6 months postpartum, 12 months postpartum | 
| Percent of participants meeting postpartum weight goals | Postpartum weight goals will be defined as a 5% reduction from prepregnancy weight. Weight will be measured on a digital scale. | 6 weeks postpartum, 6 months postpartum, 12 months postpartum | 
| Fasting Glucose (FG) | Fasting Glucose (FG) will be measured enzymatically on the Roche P Modular system using Roche Diagnostics reagents (Indianapolis, IN)(mg/dL). | 6 weeks postpartum, 6 months postpartum, 12 months postpartum | 
| Fasting Insulin | Fasting Insulin (FI) will be measured by an electrochemiluminescence immunoassay on the Roche E Modular system in uU/mL. | 6 weeks postpartum, 6 months postpartum, 12 months postpartum | 
| Hemoglobin A1c (HbA1c) | The Hemoglobin A1c (HbA1c) determination on the Roche P Modular system will be based on turbidimetric immunoinhibition using packed red cells. | 6 weeks postpartum, 6 months postpartum, 12 months postpartum | 
| Leptin | Leptin will be measured by an ultra-sensitive ELISA assay, an enzymatically amplified two-step sandwich-type immunoassay (R&D Systems, Minneapolis, MN) (pg/mL). | 6 weeks postpartum, 6 months postpartum, 12 months postpartum | 
| Total Adiponectin | Total Adiponectin (Multimeric) will be measured using an ELISA method from ALPCO Diagnostics Inc. (Salem, NH). | 6 weeks postpartum, 6 months postpartum, 12 months postpartum | 
| Lipoprotein Profile | Lipoprotein Profile: will be simultaneously performed on the Roche P Modular system. Total Cholesterol will be measured enzymatically (mg/dL). Triglycerides will be measured enzymatically with correction for endogenous glycerol (mg/dL). The concentration of High Density Lipoprotein Cholesterol will be determined using a direct enzymatic colorimetric assay (mg/dL). Low Density Lipoprotein Cholesterol will be determined by a homogenous direct method (mg/dL). | 6 weeks postpartum, 6 months postpartum, 12 months postpartum | 
| High Sensitivity C-Reactive Protein | The concentration of High Sensitivity C-Reactive Protein (hsCRP) will be determined using an immunoturbidimetric assay on the Roche P Modular system using reagents and calibrators from DiaSorin (Stillwater, MN) (mg/L). | 6 weeks postpartum, 6 months postpartum, 12 months postpartum | 
| Physical activity | Total activity according to intensity will be measured via the Pregnancy Physical Activity Questionnaire (PPAQ) and hip worn accelerometer. (MET-hrs/week). | 6 weeks postpartum, 6 months postpartum, 12 months postpartum | 
| Dietary Intake | Total calories, along with the other nutrients, will be measured via three 24-hr dietary recalls. | 6 weeks postpartum, 6 months postpartum, 12 months postpartum | 
| Gestational weight gain | Gestational weight gain is measured as the difference between weight at delivery and pre-pregnancy weight | delivery | 
| Compliance with IOM weight gain guidelines | Compliance with IOM weight gain guidelines is measured by comparing the observed weight gain with the 2009 IOM Guidelines [ | delivery | 
| Child waist circumference | measuring tape | delivery | 
| Child head circumference | measuring tape | delivery | 
| Child skinfold thicknesses - subcapsular and triceps | calipers | delivery | 
| Fetal growth | birthweight-for-gestational age z-score | delivery | 
| Ponderal index | birth weight (g) x 100/birth length (cm) | delivery | 
| Birthweight | scale | delivery | 
| Child length | measuring tape | delivery |