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| ID | Type | Description | Link |
|---|---|---|---|
| U01DK094418-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Physician Directed | No Intervention | If picked for this group, you will receive weight management advice from your physician's office. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Total Gestational Weight Gain | Approximately 6 months (from 10-13 weeks gestation to 35-36 weeks gestation) | |
| Gestational Weight Gain Per Week | "per week" is included to adjust for the different length of time between weight measurements |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leanne M Redman, Ph.D. | Pennington Biomedical Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pennington Biomedical Research Center | Baton Rouge | Louisiana | 70808 | United States | ||
| Woman's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41029405 | Derived | 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. | |
| 40839263 |
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| ID | Title | Description |
|---|---|---|
| FG000 | SmartMoms-Clinic | 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. 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. |
| FG001 | SmartMoms-Phone | 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. 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. 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. |
| FG002 | Physician Directed | If picked for this group, you will receive weight management advice from your physician's office. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SmartMoms-Clinic | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Count of Participants | Participants | Approximately 6 months (from 10-13 weeks gestation to 35-36 weeks gestation) |
|
Approximately 6 months (10-13 weeks gestation to delivery)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SmartMoms-Clinic | 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. 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Miscarriage/pregnancy loss | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Leanne M. Redman | Pennington Biomedical Research Center | 2257630947 | leanne.redman@pbrc.edu |
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| ID | Term |
|---|---|
| D000078064 | Gestational Weight Gain |
| ID | Term |
|---|---|
| D015430 | Weight Gain |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
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|
| Approximately 6 months (from 10-13 weeks gestation to 35-36 weeks gestation) |
| Baton Rouge |
| Louisiana |
| 70815 |
| United States |
| 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. |
| 33238176 | 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. |
| 32813276 | 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. |
| 30696408 | 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. |
| 30230252 | 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. |
| 28903892 | 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. |
| 28178062 | 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. |
| 26708836 | 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. |
| BG001 | SmartMoms-Phone | 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. 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. 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. |
| BG002 | Physician Directed | If picked for this group, you will receive weight management advice from your physician's office. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Parity | Parity is the number of pregnancies that have reached viability. Appropriate individual scores are 0, 1, 2, etc. Means and standard deviations include decimal numbers. | Mean | Standard Deviation | viable pregnancies |
|
| Pregravid BMI | Count of Participants | Participants |
|
| Family income per year | Count of Participants | Participants |
|
| Education | Count of Participants | Participants |
|
| OG001 | SmartMoms-Phone | 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. 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. 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. |
| OG002 | Physician Directed | If picked for this group, you will receive weight management advice from your physician's office. |
|
|
| Secondary | Total Gestational Weight Gain | Posted | Least Squares Mean | Standard Error | kilograms | Approximately 6 months (from 10-13 weeks gestation to 35-36 weeks gestation) |
|
|
|
| Secondary | Gestational Weight Gain Per Week | "per week" is included to adjust for the different length of time between weight measurements | Posted | Least Squares Mean | Standard Error | kilograms per week | Approximately 6 months (from 10-13 weeks gestation to 35-36 weeks gestation) |
|
|
|
| Post-Hoc | Intervention Cost for Participant | Costs incurred for travel to and from treatment sessions and time spent with the counselor while accounting for session attendance and intervention adherence. Outcome measure only assessed in SmartMoms-Clinic and SmartMoms-Phone groups because the Physician Directed group did not receive any intervention. | Posted | Mean | Standard Deviation | US dollars | Approximately 6 months (from 1st trimester until delivery) |
|
|
|
| Post-Hoc | Percentage of Days With Intervention Adherence | Adherence to the SmartMoms intervention was defined as the percentage of days participants weighed and recorded step counts in comparison to the expected number of days. Outcome measure only assessed in SmartMoms-Clinic and SmartMoms-Phone groups because the Physician Directed group did not receive any intervention. | Posted | Mean | Standard Deviation | percentage of days | Approximately 6 months (from 1st trimester until delivery) |
|
|
|
| Post-Hoc | Intervention Cost for Clinic | Clinic costs included interventionist time for training, session preparation, participant contacts, routine staff meetings, and scale and pedometer cost. Outcome measure only assessed in SmartMoms-Clinic and SmartMoms-Phone groups because the Physician Directed group did not receive any intervention. The US dollar cost was standard across each participant in each group so there is $0 standard deviation. | Posted | Mean | Standard Deviation | US dollars | Approximately 6 months (from 1st trimester until delivery) |
|
|
|
| 0 |
| 18 |
| 2 |
| 18 |
| 13 |
| 18 |
| EG001 | SmartMoms-Phone | 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. 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. 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. | 0 | 19 | 1 | 19 | 15 | 19 |
| EG002 | Physician Directed | If picked for this group, you will receive weight management advice from your physician's office. | 0 | 17 | 5 | 17 | 12 | 17 |
| Kidney stones requiring hospitalization | Renal and urinary disorders | Systematic Assessment |
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| Dehydration due to Crohn's disease requiring hospitalization | Gastrointestinal disorders | Systematic Assessment |
|
| Pneumonia requiring hospitalization | Infections and infestations | Systematic Assessment |
|
| Severe pre-eclampsia requiring hospitalization | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Cold/sinus congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Dizziness | Vascular disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Heartburn | Gastrointestinal disorders | Systematic Assessment |
|
| Low vitamin D | Blood and lymphatic system disorders | Systematic Assessment |
|
| Nausea/vomiting | Gastrointestinal disorders | Systematic Assessment |
|
Not provided
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| D013568 |
| Pathological Conditions, Signs and Symptoms |