Clinical trial NCT01868230: Lifestyle Intervention in Overweight and Obese Pregnant Hispanic Women
Official title: Proyecto Mama: Lifestyle Intervention in Overweight and Obese Pregnant Hispanic Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: University of Massachusetts, Amherst
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: University of California, San Diego
name: Northeastern University
name: Baystate Medical Center
First posted: 2013-06-04
Enrollment: 232
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Gestational Weight Gain
timeFrame: delivery
measure: Postpartum Weight Change
timeFrame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
measure: Percent of Participants Meeting Postpartum Weight Goals
timeFrame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
measure: Fasting Glucose (FG)
timeFrame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
measure: Fasting Insulin
timeFrame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
measure: Hemoglobin A1c (HbA1c)
timeFrame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
measure: Adiponectin
timeFrame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
measure: Total Leptin
timeFrame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
measure: Total Cholesterol
timeFrame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
measure: Low Density Lipoprotein Cholesterol
timeFrame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
measure: High Density Lipoprotein Cholesterol.
timeFrame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
measure: Triglycerides
timeFrame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
measure: High Sensitivity C-Reactive Protein
timeFrame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
measure: Compliance With IOM Weight Gain Guidelines for Pregnancy.
timeFrame: delivery
measure: Child Waist Circumference
timeFrame: delivery
measure: Child Head Circumference
timeFrame: delivery
measure: Child Skinfold Thicknesses - Subcapsular and Triceps
timeFrame: delivery
measure: Fetal Growth
timeFrame: delivery
measure: Ponderal Index
timeFrame: delivery
measure: Birthweight
timeFrame: delivery
measure: Child Length
timeFrame: delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Springfield
country: United States
facility: Baystate Medical Center
state: Massachusetts
Study officials:
affiliation: University of Massachusetts, Amherst
name: Lisa Chasan-Taber, ScD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.