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LIFT: Lifestyle Interventions For Two (LIFT)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Dympna Gallagher, Columbia University
ClinicalTrials.gov Identifier:
NCT01616147
First received: June 7, 2012
Last updated: June 1, 2016
Last verified: June 2016
  Purpose
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.

Condition Intervention
Overweight
Pregnancy
Behavioral: Intensive Lifestyle Intervention (ILI)
Behavioral: Usual Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: LIFT: Lifestyle Interventions For Two (Member of the LIFE Moms Consortium)

Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Infant Percent Fat at Birth [ Time Frame: Within 24 hours of birth ] [ Designated as safety issue: No ]
    Infant % fat at birth as a continuous variable. This will be ascertained from PeaPod within 24 hours after birth.


Secondary Outcome Measures:
  • Mother fat mass gain 35 Weeks [ Time Frame: 35,0-35,6 weeks of pregnancy ] [ Designated as safety issue: No ]
    Fat mass gain of mother at 35,0-35,6 weeks of pregnancy as a continuous variable.

  • Mother fat mass gain one year postpartum [ Time Frame: 48-56 weeks postpartum ] [ Designated as safety issue: No ]
    Mother's fat mass at 52 (range 48-56) weeks postpartum

  • Mother's weight one-year postpartum [ Time Frame: 48-56 weeks postpartum ] [ Designated as safety issue: No ]
    Weight of mother at 52 (range 48-56) weeks

  • Infant % fat 14 weeks [ Time Frame: 13-15 weeks ] [ Designated as safety issue: No ]
    Infant %fat at 14 (range 13-15) weeks. This will be ascertained from PeaPod.

  • Infant % fat 52 weeks [ Time Frame: 48-52 weeks ] [ Designated as safety issue: No ]
    Infant %fat 52 (range 48-56) weeks.

  • Infant Weight 14 weeks [ Time Frame: 13-15 weeks ] [ Designated as safety issue: No ]
    Infant weight at 14 (range 13-15) weeks.

  • Infant weight 52 weeks [ Time Frame: 48-56 weeks ] [ Designated as safety issue: No ]
    Infant weight at 52 (range 48-56) weeks.


Enrollment: 210
Study Start Date: October 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Behavioral: 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: 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.
Behavioral: 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.

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01616147

Locations
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Dympna Gallagher, EdD Columbia University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dympna Gallagher, Associate Professor of Nutritional Medicine, Columbia University
ClinicalTrials.gov Identifier: NCT01616147     History of Changes
Other Study ID Numbers: AAAN8453  1U01DK094463 
Study First Received: June 7, 2012
Last Updated: June 1, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Columbia University:
Intensive Lifestyle Intervention

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 29, 2016