# Healthy Lifestyle Intervention for High-Risk Minority Pregnant Women: A RCT

> **NIH NIH R01** · BOSTON COLLEGE · 2021 · $361,514

## Abstract

Project Summary/Abstract
The overall purpose of this application is to evaluate the efficacy of an intervention designed to decrease
health disparities in pregnant, emotionally distressed minority women. This randomized controlled trial will test
a six session (spaced over 18 weeks) cognitive behavioral skills building (CBSB) prenatal care intervention
(specifically designed and based on prior research for pregnant minority women experiencing emotional
distress) at two sites. To meet the specific aims of this study we will:
Specific Aim 1. Use a RCT to evaluate the short- and more long-term efficacy of the COPE-P program to
improve healthy lifestyle behaviors (nutrition and exercise), psychosocial health, and birth and post-natal
outcomes in pregnant emotionally distressed minority women as compared to an attention control group.
 Hypotheses 1a (primary outcomes). Immediately after the COPE-P program, at 4-6 weeks postpartum
(3 months post intervention), and at 6 months postpartum (8 months post intervention), COPE-P participants
will report higher healthy lifestyle behaviors, and less anxiety, stress and depressive symptoms than will the
attention control participants.
 Hypothesis 1b (secondary outcomes). COPE-P participants will demonstrate more appropriate
pregnancy weight gain, better birth outcomes (mode of delivery, birth weight, and gestational age), more
appropriate postpartum weight loss, and better breastfeeding outcomes than attention control participants.
Specific Aim 2. Examine the role of cognitive beliefs and perceived difficulty in leading a healthy lifestyle in
mediating the effects of the COPE-P program on healthy lifestyle behaviors and psychological symptoms in
minority pregnant women.
 Hypothesis 2 (theory building exploratory). The effects of the COPE-P program on participants' healthy
lifestyle behaviors and levels of anxiety, stress and depressive symptoms will be mediated by beliefs about
their ability to make healthy lifestyles choices and their perceived difficulty in leading a healthy lifestyle.
Exploratory Aim. Explore characteristics that may moderate healthy lifestyle behaviors, psychosocial health,
and birth and post-natal outcomes (e.g., race/ethnicity, income, age, parity, language, level of education,
marital status).
There is an urgent need to develop and evaluate theoretically-driven, culturally appropriate coping interventions
that can be embedded in routine prenatal care and be widely scaled if found to be efficacious.

## Key facts

- **NIH application ID:** 10151480
- **Project number:** 5R01MD012770-05
- **Recipient organization:** BOSTON COLLEGE
- **Principal Investigator:** SUSAN GENNARO
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $361,514
- **Award type:** 5
- **Project period:** 2017-09-26 → 2023-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10151480

## Citation

> US National Institutes of Health, RePORTER application 10151480, Healthy Lifestyle Intervention for High-Risk Minority Pregnant Women: A RCT (5R01MD012770-05). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10151480. Licensed CC0.

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