NCT01679210

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 risk factors for type 2 diabetes and cardiovascular disease among postpartum Hispanic women with a history of abnormal glucose tolerance during pregnancy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
263

participants targeted

Target at P75+ for not_applicable diabetes

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2012

Completed
29 days until next milestone

First Posted

Study publicly available on registry

September 5, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

April 29, 2020

Status Verified

April 1, 2020

Enrollment Period

5.4 years

First QC Date

August 7, 2012

Last Update Submit

April 27, 2020

Conditions

Diabetes

Outcome Measures

Primary Outcomes (14)

  • 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 weight change to prepregnancy weight if prepregnancy BMI was normal, or a 5% change towards prepregnancy weight if prepregnancy BMI was overweight/obese. 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 (FI)

    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

  • TNF

    TNF-receptor II is measured by an ELISA assay from R\&D Systems (pg/mL).

    6 weeks postpartum, 6 months postpartum, 12 months postpartum

  • Albumin-to-creatinine ratio (ACR)

    Albumin-to-creatinine ratio (ACR): Albumin will be measured by a colorimetric assay, an automated dye-binding method using the Roche P Modular system and Roche Diagnostics reagents (Indianapolis, IN) (g/dL). Creatinine will be measured by an enzymatic method using the Roche P Modular system and Roche Diagnostics reagents (Indianapolis, IN) (mg/dL).

    6 weeks postpartum, 6 months postpartum, 12 months postpartum

  • Fetuin-A

    Fetuin-A will be measured by an enzyme immunoassay (EIA) (BioVendor - Candler, NC) (ng/mL).

    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

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 InterventionBEHAVIORAL

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

Lifestyle Intervention

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Hispanic women with one or more glucose values during the diagnostic test meeting or exceeding the thresholds defined according to the American Diabetes Association

You may not qualify if:

  • history of type 1 or 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
  • \<18 or \>45 yrs of age
  • women carrying multiples

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

Location

Related Publications (6)

  • Chasan-Taber L, Marcus BH, Rosal MC, Tucker KL, Hartman SJ, Pekow P, Braun B, Moore Simas TA, Solomon CG, Manson JE, Markenson G. Estudio Parto: postpartum diabetes prevention program for hispanic women with abnormal glucose tolerance in pregnancy: a randomised controlled trial - study protocol. BMC Pregnancy Childbirth. 2014 Mar 10;14:100. doi: 10.1186/1471-2393-14-100.

    PMID: 24606590BACKGROUND

  • Wagner KA, St Laurent CW, Pekow P, Marcus B, Rosal MC, Braun B, Manson JE, Whitcomb BW, Sievert LL, Chasan-Taber L. The Impact of a Lifestyle Intervention on Postpartum Cardiometabolic Risk Factors Among Hispanic Women With Abnormal Glucose Tolerance During Pregnancy: Secondary Analysis of a Randomized Trial. J Phys Act Health. 2023 Oct 27;21(1):40-50. doi: 10.1123/jpah.2023-0145. Print 2024 Jan 1.

    PMID: 37890839DERIVED

  • Wilkie G, Leung K, Moore Simas TA, Tucker KL, Chasan-Taber L. The Association Between Acculturation and Diet and Physical Activity Among Pregnant Hispanic Women with Abnormal Glucose Tolerance. J Womens Health (Larchmt). 2022 Dec;31(12):1791-1799. doi: 10.1089/jwh.2022.0017. Epub 2022 Aug 30.

    PMID: 36040352DERIVED

  • Moore Simas TA, Leung K, Nuss E, Marieni M, Marcus B, Rosal MC, Chasan-Taber L. Factors Associated with Risk of Perinatal Depressive Symptoms Among Puerto Rican Women with Hyperglycemia. Matern Child Health J. 2022 Aug;26(8):1741-1751. doi: 10.1007/s10995-022-03429-y. Epub 2022 Apr 6.

    PMID: 35386031DERIVED

  • Hawkins M, Marcus B, Pekow P, Rosal MC, Tucker KL, Spencer RMC, Chasan-Taber L. The Impact of a Randomized Controlled Trial of a Lifestyle Intervention on Sleep Among Latina Postpartum Women. Ann Behav Med. 2021 Aug 23;55(9):892-903. doi: 10.1093/abm/kaaa118.

    PMID: 33580651DERIVED

  • 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: 31170973DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Lisa Chasan-Taber, ScD

    University of Massachusetts, Amherst

    PRINCIPAL INVESTIGATOR

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
Associate Professor of Epidemiology

Study Record Dates

First Submitted

August 7, 2012

First Posted

September 5, 2012

Study Start

January 1, 2013

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

April 29, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)