Overview

This trial is active, not recruiting.

Conditions overweight, pregnancy
Treatments intensive lifestyle intervention (ili), usual care
Sponsor Columbia University
Collaborator National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Start date October 2012
End date June 2017
Trial size 210 participants
Trial identifier NCT01616147, 1U01DK094463, AAAN8453

Summary

The primary purpose of this study is to determine whether a lifestyle intervention to prevent excessive gestational weight gain in overweight/obese pregnant women has a positive "ripple" effect on the weight and health behaviors of partners in the home. This randomized, controlled trial is proposed to study the effect, in a cohort of racially and ethnically diverse group of overweight and obese pregnant women, of an Intensive Lifestyle Intervention (ILI) compared to Usual Care (UC) on gestational weight gain (GWG), infant fatness, and mothers' post-delivery weight retention. The hypothesis is that the percent body fat at birth will be significantly less in offspring from ILI mothers than UC mothers.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
Women in the ILI arm will receive intensive counseling during pregnancy and group counseling after delivery regarding behavior, nutrition, and physical activity change. Visits to counselors will occur twice monthly with additional weekly telephone and internet contacts.
intensive lifestyle intervention (ili)
Women in the ILI arm will receive intensive counseling during pregnancy and group counseling after delivery regarding behavior, nutrition, and physical activity change. Visits to counselors will occur twice monthly with additional weekly telephone and internet contacts.
(Active Comparator)
Women in the usual care group will be offered group support classes approximately every 2 months during pregnancy and 3 months after pregnancy.
usual care
Women in the usual care group will be offered group support classes approximately every 2 months during pregnancy and 3 months after pregnancy.

Primary Outcomes

Measure
Infant Percent Fat at Birth
time frame: Within 24 hours of birth

Secondary Outcomes

Measure
Mother fat mass gain 35 Weeks
time frame: 35,0-35,6 weeks of pregnancy
Mother fat mass gain one year postpartum
time frame: 48-56 weeks postpartum
Mother's weight one-year postpartum
time frame: 48-56 weeks postpartum
Infant % fat 14 weeks
time frame: 13-15 weeks
Infant % fat 52 weeks
time frame: 48-52 weeks
Infant Weight 14 weeks
time frame: 13-15 weeks
Infant weight 52 weeks
time frame: 48-56 weeks

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - Singleton viable pregnancy - Gestational age between 9,0 and 15,6 - Body Mass Index of 25 and above - Age 18 and over - Ability to contact Exclusion Criteria: - Less than 18 years old - Diagnosis of Diabetes or Hemoglobin A1c (HbA1c)> or = 6.5% - Known fetal anomaly - Planned termination of pregnancy - History of 3 more more consecutive first trimester miscarriages - Current eating disorder - Actively suicidal - Prior or planned bariatric surgery - Current use of metformin, systemic steroids, antipsychotic agents, anti-seizure medications, mood stabilizers, attention deficit hyperactivity disorder medications - Continued use of weight loss medication - Contraindications to aerobic exercise in pregnancy - Participation in another interventional study that influences weight control - Enrollment in this trial in a previous pregnancy - Intention of the participant or of the care provider for the delivery to be outside the Lifestyle Interventions For Expectant (LIFE) Moms consortium hospital - Participant's unwillingness or inability to commit to a 1 year follow-up of herself or her child, including planning to move away - Smoking - History of Drug and/or Alcohol Addiction - Chronic health problems that prohibit regular exercise or known to influence body composition - Other chronic disease as determined by investigators - Claustrophobia (only for participants who elect to have MRI) - Implanted metal objects that render MRI unsafe (only for participants who elect to have MRI) - Lack of support from primary health care provider or family members - Another member of the household is a study participant or staff member - Any other medical, psychiatric, social or behavioral factor that in the judgement of the Principal Investigator (PI) may interfere with study participation or ability to follow the intervention protocol

Additional Information

Official title LIFT: Lifestyle Interventions For Two (Member of the LIFE Moms Consortium)
Principal investigator Dympna Gallagher, EdD
Description Pregnancy is increasingly recognized as a powerful "teachable moment" for promoting healthy eating, physical activity and obesity prevention, and emerging research has shown that lifestyle interventions to reduce excessive weight gain in pregnancy have a lasting positive effect on maternal weight and health. Often overlooked, however, is the role mothers play in shaping the health of others in their home. Mothers remain predominant "nutritional gatekeepers" of the home, impacting up to 72% of food eaten by their spouse and other family members, and creating home environments that can nurture or hamper healthy weight, eating and activity behaviors in their spouse and family members. Hispanic and African-American mothers in particular appear to have an even stronger impact on the eating habits of their spouse and other family members in the home. Mothers may influence others by the foods and activities they make accessible and by their own eating habits, physical activity levels, and sleeping practices. Interestingly, weight loss interventions targeting overweight individuals (particularly women) have been shown to produce positive "ripple" effects on untreated overweight partners in the home. However, no study to date has examined the potential "ripple" effects of prenatal interventions that target mothers' weight gain and health behaviors on weight loss and behavioral outcomes of others in the home. While some research has examined the effects of prenatal interventions on subsequent offspring outcomes, the "ripple" impact of pregnancy weight gain interventions on partner weight outcomes has received little to no attention. This is of particular concern given data that suggest that partners, like pregnant women, experience unhealthy postpartum weight retention (~1.5 kg at 12 months postpartum), although data are notably scant in this area. Our preliminary data suggest that prenatal interventions targeting gestational weight gain may positively impact untreated partner weight outcomes, but no study to date has examined intervention-related maternal and partner weight changes during pregnancy, using measured weights, objective measures of physical activity, and long-term follow-up during the postpartum period.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Columbia University.