Clinical trial NCT01610752: Personalized Management of Body Weight During Pregnancy
Official title: Expecting Success: Personalized Management of Body Weight During Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Gain During Pregnancy
Keywords: Pregnancy
Gestational weight gain
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2012-06-04
Enrollment: 54
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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:

1. Physician Directed group
2. SmartMoms-Clinic group
3. SmartMoms-Phone group

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

Primary outcomes:
measure: Count of Women Who Have Excess Gestational Weight Gain
timeFrame: Approximately 6 months (from 10-13 weeks gestation to 35-36 weeks gestation)
Secondary outcomes:
measure: Total Gestational Weight Gain
timeFrame: Approximately 6 months (from 10-13 weeks gestation to 35-36 weeks gestation)
measure: Gestational Weight Gain Per Week
timeFrame: Approximately 6 months (from 10-13 weeks gestation to 35-36 weeks gestation)
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
city: Baton Rouge
country: United States
facility: Woman's Hospital
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center
name: Leanne M Redman, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Redman LM, Drews KL, Klein S, Horn LV, Wing RR, Pi-Sunyer X, Evans M, Joshipura K, Arteaga SS, Cahill AG, Clifton RG, Couch KA, Franks PW, Gallagher D, Haire-Joshu D, Martin CK, Peaceman AM, Phelan S, Thom EA, Yanovski SZ, Knowler WC; LIFE-Moms Research Group. Attenuated early pregnancy weight gain by prenatal lifestyle interventions does not prevent gestational diabetes in the LIFE-Moms consortium. Diabetes Res Clin Pract. 2021 Jan;171:108549. doi: 10.1016/j.diabres.2020.108549. Epub 2020 Nov 22.
citation: Palmer MJ, Henschke N, Bergman H, Villanueva G, Maayan N, Tamrat T, Mehl GL, Glenton C, Lewin S, Fonhus MS, Free C. Targeted client communication via mobile devices for improving maternal, neonatal, and child health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013679. doi: 10.1002/14651858.CD013679.
citation: Altazan AD, Redman LM, Burton JH, Beyl RA, Cain LE, Sutton EF, Martin CK. Mood and quality of life changes in pregnancy and postpartum and the effect of a behavioral intervention targeting excess gestational weight gain in women with overweight and obesity: a parallel-arm randomized controlled pilot trial. BMC Pregnancy Childbirth. 2019 Jan 29;19(1):50. doi: 10.1186/s12884-019-2196-8.
citation: Peaceman AM, Clifton RG, Phelan S, Gallagher D, Evans M, Redman LM, Knowler WC, Joshipura K, Haire-Joshu D, Yanovski SZ, Couch KA, Drews KL, Franks PW, Klein S, Martin CK, Pi-Sunyer X, Thom EA, Van Horn L, Wing RR, Cahill AG; LIFE-Moms Research Group. Lifestyle Interventions Limit Gestational Weight Gain in Women with Overweight or Obesity: LIFE-Moms Prospective Meta-Analysis. Obesity (Silver Spring). 2018 Sep;26(9):1396-1404. doi: 10.1002/oby.22250. Epub 2018 Sep 6.
citation: Redman LM, Gilmore LA, Breaux J, Thomas DM, Elkind-Hirsch K, Stewart T, Hsia DS, Burton J, Apolzan JW, Cain LE, Altazan AD, Ragusa S, Brady H, Davis A, Tilford JM, Sutton EF, Martin CK. Effectiveness of SmartMoms, a Novel eHealth Intervention for Management of Gestational Weight Gain: Randomized Controlled Pilot Trial. JMIR Mhealth Uhealth. 2017 Sep 13;5(9):e133. doi: 10.2196/mhealth.8228.
citation: Sutton EF, Cain LE, Vallo PM, Redman LM. Strategies for Successful Recruitment of Pregnant Patients Into Clinical Trials. Obstet Gynecol. 2017 Mar;129(3):554-559. doi: 10.1097/AOG.0000000000001900.
citation: Clifton RG, Evans M, Cahill AG, Franks PW, Gallagher D, Phelan S, Pomeroy J, Redman LM, Van Horn L; LIFE-Moms Research Group. Design of lifestyle intervention trials to prevent excessive gestational weight gain in women with overweight or obesity. Obesity (Silver Spring). 2016 Feb;24(2):305-13. doi: 10.1002/oby.21330. Epub 2015 Dec 26.