- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01868230
Lifestyle Intervention in Overweight and Obese Pregnant Hispanic Women
January 31, 2024 updated by: Lisa Chasan-Taber, University of Massachusetts, Amherst
Proyecto Mama: Lifestyle Intervention in Overweight and Obese Pregnant Hispanic Women
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
232
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
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Springfield, Massachusetts, United States, 01199
- Baystate Medical Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 45 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Lifestyle Intervention
Stage-matched physical activity and diet intervention materials and health education.
|
|
No Intervention: Health and Wellness
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?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Birthweight
Time Frame: delivery
|
scale
|
delivery
|
Gestational Weight Gain
Time Frame: 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.
|
delivery
|
Postpartum Weight Change
Time Frame: 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.
|
6 weeks postpartum, 6 months postpartum, 12 months postpartum
|
Percent of Participants Meeting Postpartum Weight Goals
Time Frame: 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.
|
6 weeks postpartum, 6 months postpartum, 12 months postpartum
|
Fasting Glucose (FG)
Time Frame: 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.
|
6 weeks postpartum, 6 months postpartum, 12 months postpartum
|
Fasting Insulin
Time Frame: 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.
|
6 weeks postpartum, 6 months postpartum, 12 months postpartum
|
Hemoglobin A1c (HbA1c)
Time Frame: 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.
|
6 weeks postpartum, 6 months postpartum, 12 months postpartum
|
Adiponectin
Time Frame: 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.
|
6 weeks postpartum, 6 months postpartum, 12 months postpartum
|
Total Leptin
Time Frame: 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.
|
6 weeks postpartum, 6 months postpartum, 12 months postpartum
|
Total Cholesterol
Time Frame: 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.
|
6 weeks postpartum, 6 months postpartum, 12 months postpartum
|
Low Density Lipoprotein Cholesterol
Time Frame: 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.
|
6 weeks postpartum, 6 months postpartum, 12 months postpartum
|
High Density Lipoprotein Cholesterol.
Time Frame: 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.
|
6 weeks postpartum, 6 months postpartum, 12 months postpartum
|
Triglycerides
Time Frame: 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.
|
6 weeks postpartum, 6 months postpartum, 12 months postpartum
|
High Sensitivity C-Reactive Protein
Time Frame: 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.
|
6 weeks postpartum, 6 months postpartum, 12 months postpartum
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Compliance With IOM Weight Gain Guidelines for Pregnancy.
Time Frame: 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.
|
delivery
|
Child Waist Circumference
Time Frame: delivery
|
measuring tape
|
delivery
|
Child Head Circumference
Time Frame: delivery
|
measuring tape
|
delivery
|
Child Skinfold Thicknesses - Subcapsular and Triceps
Time Frame: delivery
|
calipers
|
delivery
|
Fetal Growth
Time Frame: 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.
|
delivery
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Ponderal Index
Time Frame: 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).
|
delivery
|
Child Length
Time Frame: delivery
|
measuring tape
|
delivery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Lisa Chasan-Taber, ScD, University of Massachusetts, Amherst
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2014
Primary Completion (Actual)
July 1, 2020
Study Completion (Actual)
July 1, 2020
Study Registration Dates
First Submitted
May 29, 2013
First Submitted That Met QC Criteria
June 3, 2013
First Posted (Estimated)
June 4, 2013
Study Record Updates
Last Update Posted (Actual)
February 28, 2024
Last Update Submitted That Met QC Criteria
January 31, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R01DK097011-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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