Promoting Health in Pregnancy and Postpartum (HIPP)

University of South Carolina

Status: Completed

Conditions: Overweight; Obesity; Pregnancy

Treatments: Behavioral: Lifestyle Intervention; Behavioral: Standard Care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02260518

R01HD078407 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 228 patients

Sex: Female

Ages: 18 to 44 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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228 participants in 2 patient groups

Lifestyle Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Lifestyle Intervention

Standard Care

Other group

Description:

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.

Treatment:

Behavioral: Standard Care