Fit for Two: Incorporating Wearable Trackers Into Clinical Care for Pregnant Women With Diabetes (FFT)

NCT03302377 | Completed

• 1 other identifier: CFM281R
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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

Conditions

Physical Activity; Type 2 Diabetes Mellitus

Keywords

Feasibility

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (1)

• Physical activity change

  12 weeks

Study Arms (1)

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.

Behavioral: physical activity counseling & Fitbit

Interventions

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

Physical activity intervention

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: This study is for pregnant patients, so all participants will be female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• any medical condition that would make unsupervised activity unsafe or unfeasible, as determined by their physician
• moving from the area within 3 months

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California, San Diego

La Jolla, California, 92093-0628, United States

Location

Related Publications (1)

• 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.

  PMID: 33084584 DERIVED

MeSH Terms

Conditions

Motor Activity; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Behavior; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: As this is a feasibility study, all participants will receive the intervention

Study Record Dates

• First Submitted: September 29, 2017
• First Posted: October 5, 2017
• Study Start: October 3, 2017
• Primary Completion: October 31, 2019
• Study Completion: October 31, 2019
• Last Updated: November 21, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)