Lifestyle Intervention Forever: Healthy Weight for Pregnancy and Birth (Pilot Study)

Completed · Not applicable

Conditions studied: Pregnancy, Obesity, Weight Gain, Obstetric Complications

In brief

Gaining too much weight in pregnancy is associated with adverse pregnancy complications and can have a long-term impact on maternal and offspring health, including increased risk for obesity and metabolic disease. Preventing excessive gestational weight gain could reduce adverse pregnancy outcomes and improve long-term health of mothers and offspring. Thirty obese (BMI ≥30) pregnant women will be recruited for this pilot study and randomly assigned to the Lifestyle Intervention ForEver (LIFE) program or routine care (RC). Participants will be enrolled before 18 weeks gestation and will be followed until 12 weeks after delivery. Women in the LIFE program will be given guidance on healthy eating and exercise at their regularly scheduled obstetric visits. To increase adherence to the program, a contingency management (CM) intervention offering incentives will be used to establish and maintain healthy nutrition and physical activity habits, working towards the goal of restricted weight gain (± 10lb) during their pregnancy. Three study testing visits will be scheduled for all participants: at study entry, 34-36 weeks gestation, and 12 weeks after delivering. Primary outcomes include adherence to the LIFE program, weight change in pregnancy and postpartum, and objective measures of maternal and offspring health.

Key facts

Study ID

NCT01693666

Run by

St. Louis University

People needed

30

Starts

2012-09-01

Expected to finish

2015-07-01

Last updated by the study team

2015-10-02

Who can join

Age: 18 and older, up to 40. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Women aged 18-40 years with a confirmed singleton pregnancy of up to 18 weeks gestation
• Pre-pregnancy or early pregnancy BMI greater than or equal to 30 kg/m2

You may not qualify if…

• Aged < 18 years or > 40 years
• BMI < 30 kg/m2 at study screening
• Multiple gestations
• Previously diagnosed with type 1 or type 2 diabetes mellitus
• Subjects will be excluded from the study if they present with any absolute or relative contraindications to exercise in pregnancy (as defined by ACOG); determined by completion of medical questionnaire by supervising physician
• Any evidence of:
• i. Drug or alcohol abuse ii. Presence of any unstable psychiatric disorder iii. Plans to move away from the geographical area within the next nine months iv. Other medical or behavioral factors that, in the judgement of the supervising physician, may interfere with their ability to take part in a lifestyle intervention program during pregnancy.

Where it is running

• Saint Louis University — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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