Personalized Management of Body Weight During Pregnancy
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| First Received Date ICMJE | May 31, 2012 | ||||||||
| Last Updated Date | January 18, 2013 | ||||||||
| Start Date ICMJE | December 2012 | ||||||||
| Estimated Primary Completion Date | June 2016 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Proportion of pregnant women who gain more weight during pregnancy than is recommended by the Institute of Medicine [ Time Frame: Approximately 6 months (from 1st trimester of pregnancy to delivery) ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01610752 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Personalized Management of Body Weight During Pregnancy | ||||||||
| Official Title ICMJE | Expecting Success: Personalized Management of Body Weight During Pregnancy | ||||||||
| Brief 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. |
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| Detailed Description | The study will last 22 months, from screening until study completion. The entire study will include 3 screening visits, receipt of weight management advice, second trimester testing, third trimester testing and three follow up visits during the first year after the baby is born. Participants will randomly be assigned to 1 of 3 programs to help manage their weight during pregnancy:
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 3 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE | Weight Gain During Pregnancy | ||||||||
| Intervention ICMJE | Behavioral: SmartMoms
This intervention will cover many topics to help you learn about weight management during pregnancy. You will be taught how to use different tools provided to help you monitor your weight. We will ask you to record your body weight (using a scale we will provide) as well as your food intake and exercise habits. |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 306 | ||||||||
| Estimated Completion Date | September 2016 | ||||||||
| Estimated Primary Completion Date | June 2016 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | 18 Years to 40 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01610752 | ||||||||
| Other Study ID Numbers ICMJE | PBRC11024 Expecting Success, U01DK094418-01 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Leanne Redman, Pennington Biomedical Research Center | ||||||||
| Study Sponsor ICMJE | Pennington Biomedical Research Center | ||||||||
| Collaborators ICMJE | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | ||||||||
| Investigators ICMJE |
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| Information Provided By | Pennington Biomedical Research Center | ||||||||
| Verification Date | January 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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