N/A
N=54
Personalized Management of Body Weight During Pregnancy
Weight Gain During Pregnancy
Bottom Line
View on ClinicalTrials.gov: NCT01610752 ↗Enrolled (actual)
54
Serious AEs
14.8%
Results posted
Dec 2018
Primary outcome: Primary: Count of Women Who Have Excess Gestational Weight Gain — 10; 11; 11 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SmartMoms (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Pennington Biomedical Research Center
- Primary completion
- Oct 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Count of Women Who Have Excess Gestational Weight Gain |
10; 11; 11 | — |
| SECONDARY Total Gestational Weight Gain |
8.0; 10.0; 12.8 | — |
| SECONDARY Gestational Weight Gain Per Week |
0.31; 0.39; 0.49 | — |
Summary
The purpose of this study is to determine how to help manage weight gain during pregnancy. This study is part of the National Consortium 'LIFE-Moms: Lifestyle interventions in expectant moms'. LIFE-Moms is 7 studies funded to test different lifestyle interventions in overweight and obese pregnant women.
Eligibility Criteria
Inclusion Criteria
- Are pregnant.
- Are between 18 and 40 years old.
- Have a BMI (a number calculated from your height and weight) equal to or above 25kg/m2.
- Establish prenatal care before 12 weeks of your pregnancy.
- Can read, speak and understand English.
Exclusion Criteria
- Do not plan to deliver your baby at Woman's Hospital, Baton Rouge, LA
- Are pregnant with more than one infant.
- Have habitually smoked during the last 6 months.
- Currently abuse or have abused illegal or prescription drugs in the last 6 months.
- Consume more than 2 alcoholic drinks per week.
- Are unwilling to avoid pregnancy for 12 months following delivery.
- Are unwilling to enroll your baby in the 12 month follow-up testing planned in this study.
- Are planning to move out of the area within the next 2 years or plan to be out of the study area for more than 1 month in the next year.
- Are unwilling to be assigned at random to any of the intervention groups.
- Are planning to terminate your pregnancy.
- Are planning to give your baby up for adoption.
- Are pregnant with a baby who has a known fetal anomaly.
- Have a reason that exercising is unsafe (determined by your physician or study staff).
- Have had or plan to have bariatric surgery within 1 year of your expected delivery.
- Currently have or have a history of the following:
- 3 or more first trimester miscarriages
- High blood pressure
- Type 1 diabetes
- Diagnosis of pregnancy related diabetes during screening
- HIV or AIDS
- Psychotic disorder, major depressive episode, bipolar disorder or eating disorder
- Any other pregnancy, blood, heart, lung, hormone, or digestive problem that your doctor considers unsafe for participation in this study
Data sourced from ClinicalTrials.gov (NCT01610752). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.