Promoting Health in Pregnancy and Postpartum

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

228 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2020-11-01

Brief Summary

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The purpose of this study is to examine the impact of a lifestyle intervention on gestational weight gain, postpartum weight loss, and other secondary outcomes relative to a usual care control group.

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Detailed Description

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Our study will address the following specific aims: (1) examine the impact of a lifestyle intervention on gestational weight gain and postpartum weight loss in overweight and obese women, (2) examine the impact of the intervention on physical activity (PA), dietary intake, and quality of life (QOL), (3) examine race differences in total gestational weight gain, PA, dietary intake, and QOL; and (4) examine the impact of the intervention on offspring adiposity.

Conditions

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Obesity Pregnancy Overweight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Lifestyle Intervention

The intervention will focus on women gaining the recommended amount of weight, increasing physical activity to 150 minutes per week, and meeting healthy eating guidelines.

Group Type EXPERIMENTAL

Lifestyle Intervention

Intervention Type BEHAVIORAL

During pregnancy, participants complete one face-to-face counseling session, receive 10 behavioral podcasts, and receive weekly phone calls until delivery. Participants will be asked to attend one group session on breastfeeding. Participants will have the opportunity to participate in a private Facebook group during pregnancy and postpartum. During postpartum, participants complete one face-to-face counseling session, receive 16 behavioral podcasts, receive brief weekly check-in telephone calls for six weeks, and receive up to 8 telephone counseling calls through 6 months after delivery.

Standard Care

Women in the standard care group will attend their regularly scheduled obstetric (OB) visits with their prenatal care providers and will receive monthly mailings and matched number of podcasts.

Group Type OTHER

Standard Care

Intervention Type BEHAVIORAL

Women will receive standard nutrition counseling provided by physicians, nurses, nutritionists, and counselors from the Women, Infants, and Children (WIC) program (if applicable). They will receive a monthly study mailing that is educational in nature as well as podcasts related to a healthy pregnancy. During pregnancy, the mailings will focus on tips for a healthy pregnancy and on fetal development. During postpartum the mailings will focus on infant development and parenting. We will select a matched number of podcasts from Pea in the Podcast, commercially available podcasts. All mailings and podcasts will avoid discussion of weight, PA, or diet (except for foods to avoid in pregnancy for safety reasons).

Interventions

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Lifestyle Intervention

During pregnancy, participants complete one face-to-face counseling session, receive 10 behavioral podcasts, and receive weekly phone calls until delivery. Participants will be asked to attend one group session on breastfeeding. Participants will have the opportunity to participate in a private Facebook group during pregnancy and postpartum. During postpartum, participants complete one face-to-face counseling session, receive 16 behavioral podcasts, receive brief weekly check-in telephone calls for six weeks, and receive up to 8 telephone counseling calls through 6 months after delivery.

Intervention Type BEHAVIORAL

Standard Care

Women will receive standard nutrition counseling provided by physicians, nurses, nutritionists, and counselors from the Women, Infants, and Children (WIC) program (if applicable). They will receive a monthly study mailing that is educational in nature as well as podcasts related to a healthy pregnancy. During pregnancy, the mailings will focus on tips for a healthy pregnancy and on fetal development. During postpartum the mailings will focus on infant development and parenting. We will select a matched number of podcasts from Pea in the Podcast, commercially available podcasts. All mailings and podcasts will avoid discussion of weight, PA, or diet (except for foods to avoid in pregnancy for safety reasons).

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* White or African American woman
* Overweight or obese (prepregnancy BMI: 25-45 kg/m2)
* ≤ 16 wks gestation at screening
* Age 18-44 years
* No plan to move out of the greater Columbia area in next 18 months
* Regular and consistent telephone access
* Availability for telephone calls
* Willing to accept random assignment

Exclusion Criteria

* Uncontrolled hypertension
* Fetal anomaly
* Taking insulin for diabetes
* Uncontrolled or untreated thyroid disease
* Mental health or substance-abuse hospitalization in last 6 months
* Multiple gestation
* Persistent bleeding in the first trimester
* History of more than 3 miscarriages
* History of an eating disorder or current eating disorder
* History of an incompetent cervix
* Physical disability that prevents exercise
* Told by health care provider not to exercise
* Any other medical conditions that might be a contraindication to exercise or dietary change

Minimum Eligible Age

18 Years

Maximum Eligible Age

44 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes