Physical Activity, Type 2 Diabetes Mellitus
Conditions
Keywords
Feasibility
Brief summary
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
Detailed description
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.
Interventions
BEHAVIORALphysical 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
Sponsors
University of California, San Diego
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
As this is a feasibility study, all participants will receive the intervention
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* diagnosed with type 2 diabetes or gestational diabetes * currently pregnant * in week 5-25 of gestation * under active (\<100 minutes/week of physical activity) * access to a smartphone
Exclusion criteria
* any medical condition that would make unsupervised activity unsafe or unfeasible, as determined by their physician * moving from the area within 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retention | 12 weeks | Determined by retention (%) |
| Acceptability | 12 weeks | Determined by participant feedback (% indicating satisfaction with intervention) |
| Feasibility of recruitment | baseline | Determined by percent of those screened who enroll in the study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical activity change | 12 weeks | Change in objectively measured physical activity from baseline to follow-up as measured by hip-worn ActiGraph GT3X+ accelerometers, adjusting for baseline |
Countries
United States
Outcome results
None listed