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This study will investigate the feasibility of an intervention to increase physical activity in pregnant women with diabetes by incorporating a brief in-person counseling session and Fitbit activity trackers into routine clinical care
This is a small, one-armed pilot study testing a physical activity intervention for pregnant patients with diabetes. The intervention will use both counseling and technology (a FitBit physical activity tracker and smartphone app) to create an individualized, interactive program for each patient. The primary aims of the study are to assess the feasibility of recruiting patients and implementing the program in the clinical setting, and the acceptability of the program for patients and clinicians. Participants will receive a counseling session based on the principles of motivational interviewing to help them set physical activity and step goals, then the interventionist will help them personalize the Fitbit app to their goals. Participants are instructed to continue adaptive goal setting and email their goals and activity weekly to their physicians. In addition to assessing feasibility and acceptability, we will also evaluate change in activity to explore potential efficacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physical activity intervention | Experimental | Participants will receive an individual counseling session in the clinic to help them set physical activity and step goals. They will then receive a Fitbit wrist monitor and help personalizing the Fitbit app. They will send weekly emails to their physicians reporting their goals and current activity. They will return at 12 weeks to engage in a semi-structured interview to give their overall impressions of the intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| physical activity counseling & Fitbit | Behavioral | Participants will receive individual counseling & guidance in goal setting, then will receive a Fitbit wrist monitor and guidance in personalizing the Fitbit features |
| Measure | Description | Time Frame |
|---|---|---|
| Retention | Determined by retention (%) | 12 weeks |
| Acceptability | Determined by participant feedback (% indicating satisfaction with intervention) | 12 weeks |
| Feasibility of recruitment | Determined by percent of those screened who enroll in the study | baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Physical activity change | Change in objectively measured physical activity from baseline to follow-up as measured by hip-worn ActiGraph GT3X+ accelerometers, adjusting for baseline | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
This study is for pregnant patients, so all participants will be female
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Diego | La Jolla | California | 92093-0628 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33084584 | Derived | Larsen B, Micucci S, Hartman SJ, Ramos G. Feasibility and Acceptability of a Counseling- and mHealth-Based Physical Activity Intervention for Pregnant Women With Diabetes: The Fit for Two Pilot Study. JMIR Mhealth Uhealth. 2020 Oct 21;8(10):e18915. doi: 10.2196/18915. |
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Individual participant data will not be shared with other researchers
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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As this is a feasibility study, all participants will receive the intervention
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| D009750 |
| Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |