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Personalized Management of Body Weight During Pregnancy

Primary Purpose

Weight Gain During Pregnancy

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

SmartMoms

About this trial

This is an interventional prevention trial for Weight Gain During Pregnancy focused on measuring Pregnancy, Gestational weight gain

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Pennington Biomedical Research Center
Woman's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Arm Label

SmartMoms-Clinic

SmartMoms-Phone

Physician Directed

Arm Description

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.

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Total Gestational Weight Gain

Gestational Weight Gain Per Week

"per week" is included to adjust for the different length of time between weight measurements

Full Information

NCT ID

NCT01610752

First Posted

May 31, 2012

Last Updated

August 23, 2021

Sponsor

Pennington Biomedical Research Center

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

1. Study Identification

Unique Protocol Identification Number

NCT01610752

Brief Title

Personalized Management of Body Weight During Pregnancy

Official Title

Expecting Success: Personalized Management of Body Weight During Pregnancy

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Completed

Study Start Date

December 2012 (Actual)

Primary Completion Date

October 2014 (Actual)

Study Completion Date

October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Pennington Biomedical Research Center

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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: Physician Directed group SmartMoms-Clinic group SmartMoms-Phone group

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Weight Gain During Pregnancy

Keywords

Pregnancy, Gestational weight gain

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

54 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SmartMoms-Clinic

Arm Type

Experimental

Arm Description

Arm Title

SmartMoms-Phone

Arm Type

Experimental

Arm Description

Arm Title

Physician Directed

Arm Type

No Intervention

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

SmartMoms

Intervention Description

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.

Primary Outcome Measure Information:

Title

Count of Women Who Have Excess Gestational Weight Gain

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

Total Gestational Weight Gain

Time Frame

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

Title

Gestational Weight Gain Per Week

Description

"per week" is included to adjust for the different length of time between weight measurements

Time Frame

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Leanne M Redman, Ph.D.

Organizational Affiliation

Pennington Biomedical Research Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Pennington Biomedical Research Center

City

Baton Rouge

State/Province

Louisiana

ZIP/Postal Code

70808

Country

United States

Facility Name

Woman's Hospital

City

Baton Rouge

State/Province

Louisiana

ZIP/Postal Code

70815

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

33238176

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.

Results Reference

derived

PubMed Identifier

32813276

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.

Results Reference

derived

PubMed Identifier

30696408

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.

Results Reference

derived

PubMed Identifier

30230252

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.

Results Reference

derived

PubMed Identifier

28903892

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.

Results Reference

derived

PubMed Identifier

28178062

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.

Results Reference

derived

PubMed Identifier

26708836

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.

Results Reference

derived

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Personalized Management of Body Weight During Pregnancy

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