Lifestyle Intervention in Overweight and Obese Pregnant Hispanic Women

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01868230
• Other study ID #: 1R01DK097011-01A1
• Secondary ID: 1R01DK097011-01A
• Status: Completed
• Phase: N/A
• Start date: June 2014
• Est. completion date: July 2020

Study information

• Verified date: January 2024
• Source: University of Massachusetts, Amherst
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 232
• Est. completion date: July 2020
• Est. primary completion date: July 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Overweight

Intervention

Behavioral:
• Lifestyle Intervention

Locations

Country	Name	City	State
United States	Baystate Medical Center	Springfield	Massachusetts

Sponsors (5)

Lead Sponsor	Collaborator
University of Massachusetts, Amherst	Baystate Medical Center, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Northeastern University, University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gestational Weight Gain	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.	delivery
Primary	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. 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.	6 weeks postpartum, 6 months postpartum, 12 months postpartum
Primary	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. 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.	6 weeks postpartum, 6 months postpartum, 12 months postpartum
Primary	Fasting Glucose (FG)	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.	6 weeks postpartum, 6 months postpartum, 12 months postpartum
Primary	Fasting Insulin	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.	6 weeks postpartum, 6 months postpartum, 12 months postpartum
Primary	Hemoglobin A1c (HbA1c)	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.	6 weeks postpartum, 6 months postpartum, 12 months postpartum
Primary	Adiponectin	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.	6 weeks postpartum, 6 months postpartum, 12 months postpartum
Primary	Total 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). The analysis involved an intent-to-treat analysis among the entire sample of randomized participants.	6 weeks postpartum, 6 months postpartum, 12 months postpartum
Primary	Total Cholesterol	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.	6 weeks postpartum, 6 months postpartum, 12 months postpartum
Primary	Low Density Lipoprotein Cholesterol	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.	6 weeks postpartum, 6 months postpartum, 12 months postpartum
Primary	High Density Lipoprotein Cholesterol.	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.	6 weeks postpartum, 6 months postpartum, 12 months postpartum
Primary	Triglycerides	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.	6 weeks postpartum, 6 months postpartum, 12 months postpartum
Primary	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). The analysis involved an intent-to-treat analysis among the entire sample of randomized participants.	6 weeks postpartum, 6 months postpartum, 12 months postpartum
Primary	Compliance With IOM Weight Gain Guidelines for Pregnancy.	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.	delivery
Primary	Child Waist Circumference	measuring tape	delivery
Primary	Child Head Circumference	measuring tape	delivery
Primary	Child Skinfold Thicknesses - Subcapsular and Triceps	calipers	delivery
Primary	Fetal Growth	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.	delivery
Primary	Ponderal Index	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).	delivery
Primary	Birthweight	scale	delivery
Primary	Child Length	measuring tape	delivery