An interventional study of physical activity counseling & Fitbit in Physical Activity and Type 2 Diabetes Mellitus, sponsored by University of California, San Diego. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-11-21.
Sponsored by University of California, San Diego · Not applicable, Interventional, and Prevention
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.
Exclusion Criteria:
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.
Behavioral: physical activity counseling & Fitbit
Participants will receive individual counseling \& guidance in goal setting, then will receive a Fitbit wrist monitor and guidance in personalizing the Fitbit features
Retention
Determined by retention (%)
Time frame: 12 weeks
Acceptability
Determined by participant feedback (% indicating satisfaction with intervention)
Time frame: 12 weeks
Feasibility of recruitment
Determined by percent of those screened who enroll in the study
Time frame: baseline
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
Time frame: 12 weeks
Plan to share: No — Individual participant data will not be shared with other researchers
This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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University of California, San Diego