Lifestyle Intervention in Overweight and Obese Pregnant Hispanic Women

Not Applicable

Completed

Conditions: Diabetes

Interventions: Behavioral: Lifestyle Intervention

Registration Number: NCT01868230

Lead Sponsor: University of Massachusetts, Amherst

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 232

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lifestyle Intervention	Lifestyle Intervention	Stage-matched physical activity and diet intervention materials and health education.

Primary Outcome Measures

Name	Time	Method
High Sensitivity C-Reactive Protein	6 weeks postpartum, 6 months postpartum, 12 months postpartum	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). The analysis involved an intent-to-treat analysis among the entire sample of randomized participants.
Child Waist Circumference	delivery	measuring tape
Child Head Circumference	delivery	measuring tape
Total Leptin	6 weeks postpartum, 6 months postpartum, 12 months postpartum	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). The analysis involved an intent-to-treat analysis among the entire sample of randomized participants.
Child Length	delivery	measuring tape
Gestational Weight Gain	delivery	Gestational weight change will be measured as the difference between weight at delivery and prepregnancy weight as abstracted from the medical record. The analysis involved an intent-to-treat analysis among the entire sample of randomized participants. Missing postpartum weights were imputed in the manner of prior weight loss trials with the use of 10 random multivariate imputations based on observed variables at baseline.
Postpartum Weight Change	6 weeks postpartum, 6 months postpartum, 12 months postpartum	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. The analysis involved an intent-to-treat analysis among the entire sample of randomized participants. Missing postpartum weights were imputed in the manner of prior weight loss trials with the use of 10 random multivariate imputations based on observed variables at baseline.
Fasting Glucose (FG)	6 weeks postpartum, 6 months postpartum, 12 months postpartum	Fasting Glucose (FG) will be measured enzymatically on the Roche P Modular system using Roche Diagnostics reagents (Indianapolis, IN)(mg/dL). The analysis involved an intent-to-treat analysis among the entire sample of randomized participants.
Fasting Insulin	6 weeks postpartum, 6 months postpartum, 12 months postpartum	Fasting Insulin (FI) will be measured by an electrochemiluminescence immunoassay on the Roche E Modular system in uU/mL. The analysis involved an intent-to-treat analysis among the entire sample of randomized participants.
Percent of Participants Meeting Postpartum Weight Goals	6 weeks postpartum, 6 months postpartum, 12 months postpartum	Postpartum weight goals will be defined as a 5% reduction from prepregnancy weight. Weight will be measured on a digital scale. The analysis involved an intent-to-treat analysis among the entire sample of randomized participants. Missing postpartum weights were imputed in the manner of prior weight loss trials with the use of 10 random multivariate imputations based on observed variables at baseline.
Hemoglobin A1c (HbA1c)	6 weeks postpartum, 6 months postpartum, 12 months postpartum	The Hemoglobin A1c (HbA1c) determination on the Roche P Modular system will be based on turbidimetric immunoinhibition using packed red cells. The analysis involved an intent-to-treat analysis among the entire sample of randomized participants.
Adiponectin	6 weeks postpartum, 6 months postpartum, 12 months postpartum	Total Adiponectin (Multimeric) will be measured using an ELISA method from ALPCO Diagnostics Inc. (Salem, NH). The analysis involved an intent-to-treat analysis among the entire sample of randomized participants.
Total Cholesterol	6 weeks postpartum, 6 months postpartum, 12 months postpartum	Lipoprotein Profile: will be simultaneously performed on the Roche P Modular system. Total Cholesterol will be measured enzymatically (mg/dL). The analysis involved an intent-to-treat analysis among the entire sample of randomized participants.
Low Density Lipoprotein Cholesterol	6 weeks postpartum, 6 months postpartum, 12 months postpartum	Low Density Lipoprotein Cholesterol will be determined by a homogenous direct method (mg/dL).The analysis involved an intent-to-treat analysis among the entire sample of randomized participants.
High Density Lipoprotein Cholesterol.	6 weeks postpartum, 6 months postpartum, 12 months postpartum	The concentration of High Density Lipoprotein Cholesterol will be determined using a direct enzymatic colorimetric assay (mg/dL). The analysis involved an intent-to-treat analysis among the entire sample of randomized participants.
Triglycerides	6 weeks postpartum, 6 months postpartum, 12 months postpartum	Triglycerides will be measured enzymatically with correction for endogenous glycerol (mg/dL). The analysis involved an intent-to-treat analysis among the entire sample of randomized participants.
Child Skinfold Thicknesses - Subcapsular and Triceps	delivery	calipers
Compliance With IOM Weight Gain Guidelines for Pregnancy.	delivery	Compliance with IOM weight gain guidelines during pregnancy is measured by comparing the observed gestational weight gain (GWG) with the 2009 IOM Guidelines. The analysis involved an intent-to-treat analysis among the entire sample of randomized participants. Missing weights were imputed in the manner of prior trials with the use of 10 random multivariate imputations based on observed variables at baseline. Total GWG was calculated by subtracting pre-pregnancy weight from weight at delivery and was categorized as "below," "within," or "above" IOM guidelines based on the IOM's 2009 GWG guidelines: specifically, women with an underweight BMI are advised to gain a total of 28-40 lbs, women with a BMI in the normal weight category are advised to gain 25-35 lbs., women with a BMI in the overweight category are advised to gain 15-25 lbs, and women with a BMI in the obese category are advised to gain 11-20 lbs.
Birthweight	delivery	scale
Fetal Growth	delivery	Birthweight-for-gestational age z-scores will be calculated by subtracting the mean and dividing by the standard deviation from a standardization population (specifically, the 2014 Natality data from National Center for Health Statistics using data limited to Hispanic ethnicity). A Z-score of 0 represents the population mean. Z score values \<0 represent scores lower than the population average observed in the standardization population. It remains to be established which z score range (percentile and SD) is associated with optimal short- and long-term offspring health.
Ponderal Index	delivery	The ponderal index is calculated as birth weight (g) x 100/birth length (cm). A lower ponderal index is typically used to identify neonates that were affected by intrauterine growth restriction. For example, ponderal indexes between 2.5 and 3.0 are generally considered normal, between 2.0 and 2.5 marginal, and less than 2.0 low (unhealthy).