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. 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.

Inclusion Criteria:

- Hispanic women

- Overweight or obese before pregnancy (BMI >25 kg/m2)

- 16-45 years old

Exclusion Criteria:

- history of type 2 diabetes, heart disease, or chronic renal disease

- contraindications to participation in moderate physical activity or to a
low-fat/high-fiber diet (e.g., Crohn's disease, ulcerative colitis)

- inability to read English or Spanish at a 6th grade level

- >20 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

- preterm birth (<34 wks), a miscarriage, or a still birth after enrollment or a
stillbirth

- women who become pregnant again in the year following delivery will be censored at the
time of their positive pregnancy test