Lifestyle Intervention in Overweight and Obese Pregnant Hispanic Women

NCT01868230 | Completed Results DMC

• 1 other identifier: 1R01DK097011-01A1
• Study Type: interventional
• Target: 232
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (21)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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-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

• 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

• Birthweight

  scale

  delivery

• Child Length

  measuring tape

  delivery

Secondary Outcomes (1)

• Physical Activity

  6 weeks postpartum, 6 months postpartum, 12 months postpartum

Study Arms (2)

Lifestyle Intervention

EXPERIMENTAL

Stage-matched physical activity and diet intervention materials and health education.

Behavioral: Lifestyle Intervention

Health and Wellness

NO INTERVENTION

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.

Interventions

Lifestyle Intervention BEHAVIORAL

Lifestyle Intervention

Eligibility Criteria

• Age: 16 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Hispanic women
• Overweight or obese before pregnancy (BMI \>25 kg/m2)
• years old

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Massachusetts, Amherst: lead
• University of California, San Diego: collaborator
• Northeastern University: collaborator
• Baystate Medical Center: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

Location

Related Publications (2)

• Gubrium A, Leckenby D, Harvey MW, Marcus BH, Rosal MC, Chasan-Taber L. Perspectives of health educators and interviewers in a randomized controlled trial of a postpartum diabetes prevention program for Latinas: a qualitative assessment. BMC Health Serv Res. 2019 Jun 6;19(1):357. doi: 10.1186/s12913-019-4207-x.

  PMID: 31170973 DERIVED

• Chasan-Taber L, Marcus BH, Rosal MC, Tucker KL, Hartman SJ, Pekow P, Stanek E 3rd, Braun B, Solomon CG, Manson JE, Goff SL, Markenson G. Proyecto Mama: a lifestyle intervention in overweight and obese Hispanic women: a randomised controlled trial--study protocol. BMC Pregnancy Childbirth. 2015 Jul 30;15:157. doi: 10.1186/s12884-015-0575-3.

  PMID: 26223246 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Dr. Lisa Chasan-Taber, Principal Investigator
• Organization: UMass Amherst

lct@umass.edu

4135451664

Study Officials

• Lisa Chasan-Taber, ScD

  University of Massachusetts, Amherst

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Epidemiology

Study Record Dates

• First Submitted: May 29, 2013
• First Posted: June 4, 2013
• Study Start: June 1, 2014
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: February 24, 2026
• Results First Posted: February 28, 2024

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)