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This project aims to determine whether a mobile-health (m-health) tool, accessible via smartphone or website, intervention for overweight and obese pregnant women improves physical activity, gestational weight gain, quality of life, stress and depression during pregnancy. This study will examine factors associated with using the m-health tool and the most highly utilized features of the tool, with a goal of understanding how it can be used and improved in future behavior change interventions. The hypothesis is that compared with usual care, an m-health intervention will result in increased minutes of moderate-to-vigorous physical activity and increased knowledge of the IOM GWG guidelines. The study design is a small pilot randomized trial to assess feasibility. This study will recruit and follow 70 overweight and obese pregnant women during the first trimester of pregnancy from Kaiser San Francisco and other facilities. The m-health intervention has the advantage of enabling overweight and obese women to monitor and improve their health behaviors without impacting the work flow of clinical care. Depending on the results of this initial evaluation, the clinical implications may include its implementation at the health system level and/or being evaluated and improved in the future by a larger investigation in a randomized controlled trial. The study team will assess adherence and acceptability of the intervention to inform future studies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lifestyle Intervention | Experimental |
| |
| Usual Care | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention | Behavioral | The goal of the intervention is to help women increase their minutes of moderate-to-vigorous physical activity and to increase their knowledge of the IOM gestational weight gain guidelines. The lifestyle intervention will be delivered through telephone counseling sessions with a study dietician trained in motivational interviewing techniques, as well as through technology-based tools, automated text messages and core lifestyle intervention sessions. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in minutes of moderate physical activity as assessed by the Pregnancy Physical Activity Questionnaire (PPAQ) | The investigators will assess change in moderate to vigorous physical activity between surveys in pregnancy. The sports and exercise domain encompasses 20 PPAQ activities of moderate intensity (ranging 3 MET to 6 MET) and 2 PPAQ activities of vigorous intensity (6.5 MET and 7 MET). The volumes of all activities in the sports and exercise domain will be summed to arrive at an estimate of overall volume of moderate to vigorous intensity sports and exercise activity, expressed in MET hours per week. Higher levels of activity are generally associated with better outcomes. The distributions of all physical activity variables will be assessed for outliers. | Between 12 and 33 weeks of pregnancy |
| Measure | Description | Time Frame |
|---|---|---|
| Increased knowledge of the current IOM gestational weight gain guidelines | Knowledge of the current IOM GWG guidelines (according to a woman's pre-pregnancy BMI) is assessed during two surveys in pregnancy. If the lower and upper bound provided by the patient are equivalent to or fall within the IOM recommendation bounds, then this will be classified as a match. | Between 12 and 33 weeks of pregnancy |
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Inclusion Criteria:
Exclusion Criteria:
This study is only enrolling female participants.
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| Name | Affiliation | Role |
|---|---|---|
| Monique M Hedderson, Ph.D. | Kaiser Permanente | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente Northern California | Oakland | California | 94612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35731565 | Derived | Thomas T, Xu F, Sridhar S, Sedgwick T, Nkemere L, Badon SE, Quesenberry C, Ferrara A, Mandel S, Brown SD, Hedderson M. A Web-Based mHealth Intervention With Telephone Support to Increase Physical Activity Among Pregnant Patients With Overweight or Obesity: Feasibility Randomized Controlled Trial. JMIR Form Res. 2022 Jun 22;6(6):e33929. doi: 10.2196/33929. |
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| ID | Term |
|---|---|
| D000078064 | Gestational Weight Gain |
| D001835 | Body Weight |
| D050177 | Overweight |
| D009765 | Obesity |
| D012816 | Signs and Symptoms |
| D001836 | Body Weight Changes |
| ID | Term |
|---|---|
| D015430 | Weight Gain |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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|
| D009750 | Nutritional and Metabolic Diseases |