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There are set guidelines for weight gain developed by the Institute of Medicine in pregnancy but about three quarters of women gain an inappropriate weight during pregnancy. Many studies have assessed ways to decrease weight gain in these women who gain excess weight, usually through a combination of diet and exercise. Still, often these interventions are difficult to implement, expensive, or have low acceptability. Wearable Fitbit devices have been on the market for years and slowly becoming more inexpensive and easier to use.
Previous studies on non-pregnant women have shown that using the device can help reduce weight gain. In addition, small studies in pregnant women have shown they are accurate for measuring steps and have high acceptability and retention rates. The ability of the Fitbit to assess metrics of sleep including sleep duration and quality will also be assessed.
This project aims to provide overweight and obese pregnant women at the beginning of their pregnancy with the Fitbit device and with regular follow-up to assess if there is effectiveness in increasing the rate of women who meet weight gain guidelines compared to women without the device along with measuring aspects of sleep.
This is a prospective randomized control trial study. This study aims to assess the relationship between physical activity and sleep metrics in pregnant women as measured using the Fitbit device and the ability to meet Institute of Medicine weight gain guidelines during pregnancy. The hypothesis of the study is that self-realization and monitoring of activity using the Fitbit will encourage the wearer to be increasingly physically active and assist in meeting weight gain guidelines. This study is performed in conjunction with the University of Arizona sensor lab utilizing the MyDataHelps platform which will assist with collection of data from each participant's Fitbit device and subsequent analysis. Mydatahelps is an easily customizable data collection platform that helps researchers collect participant data in a secure HIPAA compliant manner. They are an external company but have no input in the construction of the project This study will have two arms: one with Fitbit wearers and a control arm for routine prenatal care. Compared to control participants who will not have a Fitbit device, we hypothesize that utilization of the Fitbit device will be effective in helping overweight and obese pregnant women meet Institute of Medicine weight gain guidelines.
The primary endpoint is gestational weight gain throughout pregnancy. Weight will be measured pre-pregnancy, at recruitment, 28 weeks, delivery, and 6 weeks postpartum.
Secondary endpoints will also be measured and include:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fitbit monitoring | Experimental | Individuals in this arm will wear a fitbit device consistently throughout the duration of their pregnancy, and monitor fitbit data using a platform that connects to their phone. The remainder of prenatal care will be per standard procedure. |
|
| Routine prenatal care | No Intervention | Individuals in this arm will receive standard prenatal care without the addition of wearing a fitbit device. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fitbit device | Device | Daily use of a fitbit wearable activity tracker device. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gestational weight gain during pregnancy | Weight will be measured pre-pregnancy, at recruitment (ideally initial prenatal visit), 28 weeks gestation, at delivery and 6 weeks postpartum | From pre-pregnancy or initial prenatal visit until 6 weeks postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients reporting adverse events related to device | Tolerability of wearing the device consistently, any adverse effects | Through duration of participation, average of 8-9 months |
| Number of patients lost to follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laura Mroue, MD | University of Arizona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner University Medical Center | Tucson | Arizona | 85750 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29300720 | Background | Deputy NP, Dub B, Sharma AJ. Prevalence and Trends in Prepregnancy Normal Weight - 48 States, New York City, and District of Columbia, 2011-2015. MMWR Morb Mortal Wkly Rep. 2018 Jan 5;66(51-52):1402-1407. doi: 10.15585/mmwr.mm665152a3. | |
| 19809317 | Background | Rasmussen KM, Catalano PM, Yaktine AL. New guidelines for weight gain during pregnancy: what obstetrician/gynecologists should know. Curr Opin Obstet Gynecol. 2009 Dec;21(6):521-6. doi: 10.1097/GCO.0b013e328332d24e. |
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Upon request and approval by the study team, IPD may be shared with other researchers.
Within 6 months of study publication.
Access will be available by contacting the study PI for approval.
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| ID | Term |
|---|---|
| D000078064 | Gestational Weight Gain |
| D050177 | Overweight |
| D009765 | Obesity |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D015430 | Weight Gain |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
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Individuals that discontinue follow-up or study inclusion
| 18 months |
| Incidence of intrauterine growth restriction | Number of pregnancies affected by intrauterine growth restriction | At delivery |
| Incidence of fetal macrosomia | Number of pregnancies affected by fetal macrosomia | At delivery |
| Incidence of gestational hypertension | Number of patients who develop gestational hypertension in pregnancy | At delivery |
| Incidence of gestational diabetes | Number of patients who develop gestational diabetes in pregnancy | At delivery |
| Incidence of preeclampsia | Number of patients who develop preeclampsia in pregnancy | At delivery |
| Incidence of preterm delivery | Number of patients who experience preterm delivery | At delivery |
| Incidence of cesarean delivery | Number of patients who have cesarean delivery | At delivery |
| Neonatal birth weight | Neonatal birth weight in grams | At delivery |
| Incidence of NICU admission | Number of fetuses requiring admission to neonatal ICU care | At delivery |
| Average number of daily steps taken per individual | Average number of daily steps taken per individual as recorded by fitbit device | At delivery |
| Calories burned per individual | Daily calories burned per individual, as measured by fitbit device, in kcal | At delivery |
| Daily sleep duration | Daily and average sleep duration in hours per individual, as measured by fitbit device | At delivery |
| Fitbit derived sleep quality | Fitbit device determined nightly sleep score | At delivery |
| Global Physical Activity Questionnaire (GPAQ) score | Questionnaire data | At initial enrollment, 28 weeks gestation and delivery |
| Cambridge Worry Scale score | Questionnaire data | At initial enrollment, 28 weeks gestation and delivery |
| Pittsburg Sleep Quality Index score | Questionnaire data | At initial enrollment, 28 weeks gestation and delivery |
| 28586887 | Background | Goldstein RF, Abell SK, Ranasinha S, Misso M, Boyle JA, Black MH, Li N, Hu G, Corrado F, Rode L, Kim YJ, Haugen M, Song WO, Kim MH, Bogaerts A, Devlieger R, Chung JH, Teede HJ. Association of Gestational Weight Gain With Maternal and Infant Outcomes: A Systematic Review and Meta-analysis. JAMA. 2017 Jun 6;317(21):2207-2225. doi: 10.1001/jama.2017.3635. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001519 | Behavior |