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| Name | Class |
|---|---|
| University of California, Los Angeles | OTHER |
| United States Department of Agriculture (USDA) | FED |
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The purpose of this study is to help women lose the weight they gained during their pregnancy using a SmartPhone app the investigators have developed called E-Moms. The investigators hypothesize that the moms given the app to use during the study will lose more weight than the moms who do not use the app.
The E-Moms Study will last about 4 months. The weight management program is 4 months long and will end about 6 months after the participant's baby is born. All participants will receive Women, Infants and Children (WIC) services.
For the weight management program, participants will be put into one of these groups:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WIC E-Moms | Experimental | If picked for this group, you will receive a personalized diet and exercise plan to help you lose the weight you gained during your pregnancy. All information will be given to you using a SmartPhone, such as an iPhone. You can use your own phone or one can be loaned to you for the study. You will also be loaned a scale so you can weigh yourself at home. You will also get advice and services from your WIC clinic. |
|
| WIC Moms | No Intervention | You will get advice and services for nutrition and weight management after pregnancy from your WIC clinic. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WIC E-Moms | Behavioral | Participants enrolled in the E-Moms group will receive a personalized dietary prescription to promote weight loss and arrive at pregravid weight by 6 months postpartum. Our weight loss intervention will incorporate standard WIC nutritional advice and will encouraged 150 minutes/week of moderate intensity activity, which is about 3,000 - 4,000 steps/day above baseline, as recommended for maintenance of healthy weight. Each participant will be assigned a trained weight management counselor who will provide frequent recommendations and advice and support at least once per week. |
| Measure | Description | Time Frame |
|---|---|---|
| Body Weight Change | The primary outcome measure is weight change after the 16 week intervention. | Baseline and 16 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leanne Redman, M.S., 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 |
Study data available upon request and following appropriate data transfer agreements in place.
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Potential participants will be recruited via Institutional Review Board (IRB) approved posters and flyers displayed in the WIC office and advertisements posted on the PBRC website (http://www.pbrc.edu/clinicaltrials).
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| ID | Title | Description |
|---|---|---|
| FG000 | WIC E-Moms | Participants enrolled in the WIC E-Moms group will receive a personalized dietary prescription to promote weight loss and arrive at pregravid weight by 6 months postpartum. Our weight loss intervention will incorporate standard WIC nutritional advice and will encouraged 150 minutes/week of moderate intensity activity, which is about 3,000 - 4,000 steps/day above baseline, as recommended for maintenance of healthy weight. Each participant will be assigned a trained weight management counselor who will provide frequent recommendations and advice and support at least once per week. |
| FG001 | WIC Moms | Participants in WIC Moms will receive standardized advice and services for postpartum nutrition and weight management through their nominated WIC clinic. Participants in the control group will not receive a dietary prescription or personalized weight management services from the Pennington Biomedical study team. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | WIC E-Moms | Participants enrolled in the E-Moms group will receive a personalized dietary prescription to promote weight loss and arrive at pregravid weight by 6 months postpartum. Our weight loss intervention will incorporate standard WIC nutritional advice and will encouraged 150 minutes/week of moderate intensity activity, which is about 3,000 - 4,000 steps/day above baseline, as recommended for maintenance of healthy weight. Each participant will be assigned a trained weight management counselor who will provide frequent recommendations and advice and support at least once per week. |
| 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 | Body Weight Change | The primary outcome measure is weight change after the 16 week intervention. | Posted | Mean | Standard Error | kg | Baseline and 16 weeks |
|
Adverse event data was collected over a year time span.
Participant's were questioned by study staff at each study visit for any new or outstanding adverse event details.
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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 | WIC E-Moms | Participants enrolled in the E-Moms group will receive a personalized dietary prescription to promote weight loss and arrive at pregravid weight by 6 months postpartum. Our weight loss intervention will incorporate standard WIC nutritional advice and will encouraged 150 minutes/week of moderate intensity activity, which is about 3,000 - 4,000 steps/day above baseline, as recommended for maintenance of healthy weight. Each participant will be assigned a trained weight management counselor who will provide frequent recommendations and advice and support at least once per week. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cold | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Not Study Related |
1) pilot and feasibility study (small sample size), 2) Variable adherence to the intervention, 3) greater lost to follow-up in the control group.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Leanne Redman | Pennington Biomedical Research Center | 2257630947 | leanne.redman@pbrc.edu |
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| ID | Term |
|---|---|
| D000078064 | Gestational Weight Gain |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D015430 | Weight Gain |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
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|
|
| BG001 | WIC Moms | Participants in WIC Moms will receive standardized advice and services for postpartum nutrition and weight management through their nominated WIC clinic. Participants in the control group will not receive a dietary prescription or personalized weight management services from the Pennington Biomedical study team. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Preconception weight | Mean | Standard Deviation | kg |
|
| Gestational weight gain | Mean | Standard Deviation | kg |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
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| Enrollment weight | Mean | Standard Deviation | kg |
|
| Body fat | Mean | Standard Deviation | % |
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| Systolic blood pressure | Mean | Standard Deviation | mmHg |
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| Diastolic blood pressure | Mean | Standard Deviation | mmHg |
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| Parity | Mean | Standard Deviation | pregnancies |
|
| Marital status | Count of Participants | Participants |
|
| Education | Count of Participants | Participants |
|
| Breastfeed ever | Count of Participants | Participants |
|
| Current smoker | Count of Participants | Participants |
|
Participants in WIC Moms will receive standardized advice and services for postpartum nutrition and weight management through their nominated WIC clinic. Participants in the control group will not receive a dietary prescription or personalized weight management services from the Pennington Biomedical study team. |
|
|
| Post-Hoc | Changes in Hip Circumference of WIC Moms, WIC E-Moms Subgroups: High, Medium, and Low Adherers | Changes in hip circumference from baseline (Week 0) stratified by adherence to the E-Moms intervention and usual care (WIC Moms). | All participants stratified by adherence to the E-Moms intervention and usual care (WIC Moms) | Posted | Mean | Standard Error | cm | Baseline and 16 weeks |
|
|
|
| Post-Hoc | Changes in Waist Circumference of WIC Moms, WIC E-Moms Subgroups: High, Medium, and Low Adherers | Changes in waist circumference from baseline (week 0) stratified by adherence to the E-Moms intervention and usual care (WIC Moms) | All participants stratified by adherence to the E-Moms intervention and usual care (WIC Moms) | Posted | Mean | Standard Error | cm | Baseline and 16 weeks |
|
|
|
| Post-Hoc | Changes in % Body Fat in WIC Moms, WIC E-Moms Subgroups: High, Medium, and Low Adherers. | Changes in % body fat from baseline (week 0) stratified by adherence to the E-Moms intervention and usual care (WIC Moms). | All participants stratified by adherence to the E-Moms intervention and usual care (WIC Moms) | Posted | Mean | Standard Error | % body fat | Baseline and 16 weeks |
|
|
|
| 0 |
| 19 |
| 4 |
| 19 |
| EG001 | WIC Moms | Participants in WIC Moms will receive standardized advice and services for postpartum nutrition and weight management through their nominated WIC clinic. Participants in the control group will not receive a dietary prescription or personalized weight management services from the Pennington Biomedical study team. | 0 | 16 | 1 | 16 |
|
| Viral infection | Infections and infestations | Systematic Assessment | Not Study Related |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment | Not Study Related |
|
| Flu | General disorders | Systematic Assessment | Not Study Related |
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| Fatigue | General disorders | Systematic Assessment | Not Study Related |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |