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The purpose of this study is to enable the investigator to conduct proof of concept work related to the feasibility, acceptability, initial efficacy and mechanisms of action (focusing on maternal and infant modifiable factors) for a novel self-management intervention for pregnant women.
This proposed study aims to adapt intervention to address excessive gestational weight gain and psychosocial functioning among a socioeconomically and racially diverse sample of pregnant women .Additionally, data on behavioral mechanisms associated with self-regulatory capacity, such as impulsive control and the ability to delay rewards, that may be linked to self-regulation during pregnancy are needed to support future interventions.
In this study, the investigators will develop and adapt an intervention (Self-Management Around the Reproductive Transition; SMART) that addresses maternal weight, stress, and mood, and document the feasibility, acceptability and initial efficacy of the SMART intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SMART Intervention | Experimental | Counseling sessions will be completed with a toolbox approach so that clinicians can work on topics that are of interest and relevant to each participant. SMART will focus on weight, physical activity, eating and psychosocial issues. Intervention goals will emphasize adherence to healthy behaviors rather than absolute weight goals. Specifically, women will receive consultation about nutritional balance, dietary guidelines for pregnant women and advice to maintain an optimal rate of weight gain according to prepregnancy BMI. Women will use self-monitoring forms to identify and modify cues for unhealthy behaviors. Beliefs about body weight and eating during pregnancy will be addressed and effects of physical activity on body weight, health, and mood will be included. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SMART Intervention | Behavioral | Counseling sessions will be conducted by research project staff that has, at least, masters level or equivalent degrees. Sessions will occur up to 10 times at their regularly scheduled obstetric appointments and also weekly by phone and text messages. In person sessions will last approximately 20-30 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of sessions attended among women enrolled in the study | Number of sessions attended will be calculated for each participant | Approximately 9 months |
| Number of self-monitoring forms returned | Number of self-monitoring forms returned will be calculated for each participant | Approximately 9 months |
| Gestational weight gain | Gestational weight gain will be calculated for each participant. Weight in pounds will be measured on a calibrated scale while women are in street clothes without shoes. | Approximately 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Depressive symptoms | The Center for Epidemiological Studies-Depression Scale will be used to assess depressive symptomatology. A total scores is calculated by finding the sum of the 20 items. Total scores range from 0-60, with higher scores reflecting greater depressive symptomatology. | Approximately 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michele Levine, PhD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
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| ID | Term |
|---|---|
| D015430 | Weight Gain |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Each participant will be provided with counseling sessions throughout the course of their pregnancy.
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| Perceived stress symptoms |
The Perceived Stress Scale will be administered to measure symptoms of perceived stress. The Perceived Stress Scale score is obtained by summing the points awarded to the 10 items and it ranges from 0 to 40. Higher scores indicate greater perceived stress. |
| Approximately 12 months |