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

NCT01693666 | Completed

• 2 other identifiers: 220098485
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pregnancy; Obesity; Weight Gain; Obstetric Complications

Keywords

Pregnancy; Obesity; Weight gain; Obstetric complications; Lifestyle intervention

Outcome Measures

Primary Outcomes (1)

• Measurement of Gestational weight gain from study entry to delivery

  Maternal weight (lb) will be measured at program entry and at the time of delivery to determine weight gain during the study period. Pre-pregnancy body weight will be self-reported and used to estimate total gestational weight gain (lb).

  Approx. 20-25 weeks

Secondary Outcomes (15)

• Measure Change from baseline in maternal body composition

  16-21 weeks

• Measure Change from baseline in maternal aerobic capacity

  16-21 weeks

• Measure Maternal hormonal/metabolic changes from baseline

  16-21 weeks

• Number of participants with Obstetric complications

  1-25 weeks

• Change from baseline in maternal dietary intake

  16-21 weeks

Study Arms (2)

Lifestyle intervention group

EXPERIMENTAL

The LIFE program emphasizes improved nutritional quality, moderate physical activity, and weight maintenance (±10 lb) in obese pregnant women using a contingency management (CM) approach to reinforce behavior change. Participants will meet with the study dietitian and exercise physiologist every 2-4 weeks to develop and maintain individualized nutrition and physical activity plans, reinforced by CM. When the subject meets with the interventionists at their regular appointments, they will review the diet and exercise requirements, and provide vouchers earned as reinforcement from the previous study period. Diet requirements include at least 5 days of food logs each week. Exercise requirements include objective verification of up to 5 exercise sessions per week (as prescribed).

Behavioral: Lifestyle intervention

Routine care group

NO INTERVENTION

Participants in the Routine Care (RC) control group will receive no additional intervention beyond standard of care.

Interventions

Lifestyle intervention BEHAVIORAL

1. To establish an effective contingency management behavioral program (LIFE), increasing adherence to nutritional recommendations and exercise guidelines during pregnancy. 2. To examine the impact of the LIFE program on weight gain restriction during pregnancy and postpartum weight loss in obese women in comparison to the RC group. 3. To examine the impact of the LIFE program on short- and long-term maternal and offspring outcomes at study enrollment, 34-36 weeks gestation and 3 months postpartum in obese women in comparison to the RC group.

Lifestyle intervention group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• St. Louis University: lead

Study Sites (1)

Saint Louis University

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Obesity; Weight Gain

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Rosemary Catanzaro

  St. Louis University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Registered Dietician

Study Record Dates

• First Submitted: September 10, 2012
• First Posted: September 26, 2012
• Study Start: September 1, 2012
• Primary Completion: June 1, 2015
• Study Completion: July 1, 2015
• Last Updated: October 2, 2015

Record last verified: 2015-09

Locations

US (1)