Personalized Management of Body Weight During Pregnancy

NCT01610752 | Completed Results DMC

• 2 other identifiers: PBRC 11024U01DK094418-01
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 2

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.

Conditions

Weight Gain During Pregnancy

Keywords

Pregnancy; Gestational weight gain

Outcome Measures

Primary Outcomes (1)

• Count of Women Who Have Excess Gestational Weight Gain

  Count of pregnant women who gain more weight during pregnancy than is recommended by the Institute of Medicine Gestational Weight Gain guidelines

  Approximately 6 months (from 10-13 weeks gestation to 35-36 weeks gestation)

Secondary Outcomes (2)

• Total Gestational Weight Gain

  Approximately 6 months (from 10-13 weeks gestation to 35-36 weeks gestation)

• Gestational Weight Gain Per Week

  Approximately 6 months (from 10-13 weeks gestation to 35-36 weeks gestation)

Study Arms (3)

SmartMoms-Clinic

EXPERIMENTAL

If picked for this group, you will attend study meetings with a weight management counselor. During the second trimester study meetings occur 4 times per month. During the third trimester you will attend study meetings 2 times per month. These meetings 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.

Behavioral: SmartMoms

SmartMoms-Phone

EXPERIMENTAL

If picked for this group, you will have two individual sessions with a weight management counselor. At the first session, you will receive a scale and other technology to help manage your weight during pregnancy. Each week you will receive information from a weight management counselor via a Smartphone (you can use your own Smartphone or one will be provided to you). The information will cover topics to help manage your weight during pregnancy. You will be taught how to use different tools provided to help you monitor your weight. We will ask you to measure your body weight (using a scale we will provide) as well as monitor your food intake and exercise habits with the Smartphone.

Behavioral: SmartMoms

Physician Directed

NO INTERVENTION

If picked for this group, you will receive weight management advice from your physician's office.

Interventions

SmartMoms BEHAVIORAL

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.

SmartMoms-Clinic; SmartMoms-Phone

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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:

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (2)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Woman's Hospital

Baton Rouge, Louisiana, 70815, United States

Location

Related Publications (9)

• Cabre HE, Drews KL, Pomeroy J, Keadle SK, Arteaga SS, Franks PW, Haire-Joshu D, Knowler WC, Pi-Sunyer X, Van Horn L, Wing RR, Cahill AG, Clifton RG, Couch KA, Gallager D, Josefson JL, Joshipura K, Klein S, Martin CK, Peaceman AM, Phelan S, Thom EA, Redman LM; LIFE-Moms Research Group. LIFE-Moms: effects of multicomponent lifestyle randomized control trial on physical activity during pregnancy in women with overweight and obesity. Int J Behav Nutr Phys Act. 2025 Sep 30;22(1):119. doi: 10.1186/s12966-025-01805-9.

  PMID: 41029405 DERIVED

• Flanagan EW, Drews KL, Cade WT, Franks PW, Gallagher D, Phelan S, Van Horn L, Redman LM. Metabolic Health and Heterogenous Outcomes of Prenatal Interventions: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2025 Aug 1;8(8):e2528264. doi: 10.1001/jamanetworkopen.2025.28264.

  PMID: 40839263 DERIVED

• 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.

  PMID: 33238176 DERIVED

• 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.

  PMID: 32813276 DERIVED

• 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.

  PMID: 30696408 DERIVED

• 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.

  PMID: 30230252 DERIVED

• 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.

  PMID: 28903892 DERIVED

• 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.

  PMID: 28178062 DERIVED

• 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.

  PMID: 26708836 DERIVED

MeSH Terms

Conditions

Gestational Weight Gain

Condition Hierarchy (Ancestors)

Weight Gain; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Leanne M. Redman
• Organization: Pennington Biomedical Research Center

leanne.redman@pbrc.edu

2257630947

Study Officials

• Leanne M Redman, Ph.D.

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 31, 2012
• First Posted: June 4, 2012
• Study Start: December 1, 2012
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2015
• Last Updated: September 17, 2021
• Results First Posted: December 12, 2018

Record last verified: 2021-08

Locations

US (2)