ClinicalTrials.gg
CompletedNCT03302377FFTUpdated Nov 21, 2019

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

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.

Primary conditionDiabetes Mellitus, Type 2Registry: Motor ActivityReclassifiedWhy we changed it
Registry
Motor Activity — the first condition term the registry derived for this study.
ClinicalTrials.gg
Diabetes Mellitus, Type 2
Why
  1. Motor Activity is a broad heading, used only when no more specific condition is named.
  2. The study's listed conditions name Diabetes Mellitus, Type 2.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by University of California, San Diego · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
19
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 15 studies in Diabetes Mellitus, Type 2 by University of California, San Diego — 5 open to participants now, 6 under way, none of them phase 3. Diabetes Mellitus, Type 2 · University of California, San Diego.

Enrollment
11th of 12
19 · median 35
Started
2017
the only one that year
No phase
8 of 15
2 open now
Registered
7th of 15
by date

Among the 15 studies in Diabetes Mellitus, Type 2 by University of California, San Diego, this one is the 11th largest by enrollment of the 12 interventional ones that give a count, is the only one that started in 2017, is one of 8 with no phase, and was the 7th registered.

Diabetes Mellitus, Type 2

10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.

Browse Diabetes Mellitus, Type 2 studies →

Open to participants now

5 of the 15 studies in Diabetes Mellitus, Type 2 by University of California, San Diego are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 5 open studies →

Where they have run

Who these studies take

Of the 883 Diabetes Mellitus, Type 2 studies recruiting now, 373 (42%) set no upper age limit and 384 (43%) stop at 75 or younger; 52 take children under 18; 203 take healthy volunteers.

This study: 18 Years and older · female · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 15 studies in Diabetes Mellitus, Type 2 by University of California, San Diego, or all of them as a file.
02

Study 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

Read the 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.

03

Conditions studied

  • Physical Activity
  • Type 2 Diabetes Mellitus

Browse trials for

Keywords

  • Feasibility
04

In context

Diabetes Mellitus, Type 2 Reclassified

10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.

This study's enrollment of 19 is below the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

University of California, San Diego is the lead sponsor of 980 studies on the registry; 195 are open to participants now.

Of its 113 completed or terminated interventional studies of FDA-regulated products, 71 (63%) have results posted.

Compared within Diabetes Mellitus, Type 2, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Motor Activity. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
06

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
19 participants (actual)

Study arms

  • Experimental
    Physical activity intervention

    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

  • 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

07

What researchers measure

Primary outcomes

  1. Retention

    Determined by retention (%)

    Time frame: 12 weeks

  2. Acceptability

    Determined by participant feedback (% indicating satisfaction with intervention)

    Time frame: 12 weeks

  3. Feasibility of recruitment

    Determined by percent of those screened who enroll in the study

    Time frame: baseline

Secondary outcomes

  1. 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

08

Study locations

1 site
  • University of California, San Diego
    La Jolla, California 92093-0628, United States
09

References and documents

Publications

  • 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. PubMed 33084584 ↗

Individual participant data

Plan to share: No — Individual participant data will not be shared with other researchers

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2017 to primary completion in Oct 2019, 24 months.

Of 2,066 non-industry interventional studies with no phase under Diabetes Mellitus, Type 2, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 40. This study's 24 months is above that.

Counting every sponsor, half of 2,243 studies reached it within 21 months; a quarter within 10 and three quarters within 39.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 29, 2017
First posted
Oct 5, 2017
StartActual
Oct 3, 2017
Primary completionActual
Oct 31, 2019
CompletionActual
Oct 31, 2019
Last update
Nov 21, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 21, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03302377
Responsible party
Britta Larsen (Assistant Professor, University of California, San Diego) — Principal investigator
First posted
Oct 5, 2017
Start date
Oct 3, 2017
Primary completion
Oct 31, 2019
Completion
Oct 31, 2019
Last update
Nov 21, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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