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Trial Outcomes & Findings for Development of a Lifestyle Physical Activity Intervention to Reduce Risk for Perinatal Cannabis Use (NCT NCT05528380)

NCT ID: NCT05528380

Last Updated: 2026-08-13

Results Overview

Number of participants using cannabis at week 12, assessed via the Timeline Follow Back

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

16 participants

Primary outcome timeframe

from week 6 to the end of the intervention at week 12

Results posted on

2026-08-13

Participant Flow

This study used wide-scale community recruitment to reach a number of sites serving perinatal women, including OB/GYN, primary care and behavioral health settings, as well as community based advertising online (e.g. hospital website, social media such as Facebook) and in-person community fliers. All potential participants were screened by phone.

Because this was an Open Trial, all eligible participants were assigned to the lifestyle physical activity intervention. Please note that this study was funded as part of an NIH R34 award that involved 2 different studies. The current project reported here (NCTNCT05528380) was an open pilot trial; in addition, there was a second study funded by the R34, which was a pilot randomized controlled trial (RCT). The pilot RCT study was designated a separate NCT entry (NCT06239701).

Participant milestones

Participant milestones
Measure
Intervention
In the Open Trial all participants received a Fitbit to track activity levels and participate in a 6-session lifestyle physical activity intervention over the course of 12 weeks. The intervention consists of 20-25 minute phone or video-delivered session to: (a) review PA progress and re-evaluate current step-count goals, (b) problem-solve barriers to incorporating PA into their daily lives, (c) address difficulties utilizing the Fitbit, (d) encourage the use of bouts of PA as a coping strategy, and e) engage the participant in brief discussions focused on increasing and maintaining PA.
Overall Study
STARTED
16
Overall Study
Week 3
16
Overall Study
Week 6
16
Overall Study
Week 10 (EOT)
16
Overall Study
COMPLETED
12
Overall Study
NOT COMPLETED
4

Reasons for withdrawal

Reasons for withdrawal
Measure
Intervention
In the Open Trial all participants received a Fitbit to track activity levels and participate in a 6-session lifestyle physical activity intervention over the course of 12 weeks. The intervention consists of 20-25 minute phone or video-delivered session to: (a) review PA progress and re-evaluate current step-count goals, (b) problem-solve barriers to incorporating PA into their daily lives, (c) address difficulties utilizing the Fitbit, (d) encourage the use of bouts of PA as a coping strategy, and e) engage the participant in brief discussions focused on increasing and maintaining PA.
Overall Study
Withdrawal by Subject
1
Overall Study
Lost to Follow-up
3

Baseline Characteristics

Development of a Lifestyle Physical Activity Intervention to Reduce Risk for Perinatal Cannabis Use

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Intervention
n=16 Participants
In the Open Trial all participants received a Fitbit to track activity levels and participate in a 6-session lifestyle physical activity intervention over the course of 12 weeks. The intervention consists of 20-25 minute phone or video-delivered session to: (a) review PA progress and re-evaluate current step-count goals, (b) problem-solve barriers to incorporating PA into their daily lives, (c) address difficulties utilizing the Fitbit, (d) encourage the use of bouts of PA as a coping strategy, and e) engage the participant in brief discussions focused on increasing and maintaining PA.
Age, Continuous
29.88 years
STANDARD_DEVIATION 6.28 • n=1 Participants
Sex: Female, Male
Female
16 Participants
n=1 Participants
Sex: Female, Male
Male
0 Participants
n=1 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=1 Participants
Race (NIH/OMB)
Asian
0 Participants
n=1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=1 Participants
Race (NIH/OMB)
Black or African American
2 Participants
n=1 Participants
Race (NIH/OMB)
White
10 Participants
n=1 Participants
Race (NIH/OMB)
More than one race
3 Participants
n=1 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
n=1 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
4 Participants
n=1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
12 Participants
n=1 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=1 Participants
Number of participants using cannabis at baseline
10 Participants
n=1 Participants
Edinburgh Perinatal Depression Scale (EPDS)
12.91 scores on a scale
STANDARD_DEVIATION 3.30 • n=1 Participants
General Anxiety Disorder -7 (GAD-7)
8.27 scores on a scale
STANDARD_DEVIATION 4.54 • n=1 Participants
Step Counts: average steps per day
5738 steps/day
STANDARD_DEVIATION 1554 • n=1 Participants
International Physical Activity Questionnaire (IPAQ) walked 10+ continuous min/day
6 Participants
n=1 Participants

PRIMARY outcome

Timeframe: from week 6 to the end of the intervention at week 12

Population: Percent of participants reporting use of cannabis at the end of intervention assessment. Twelve of the original 16 completed this assessment.

Number of participants using cannabis at week 12, assessed via the Timeline Follow Back

Outcome measures

Outcome measures
Measure
Intervention
n=12 Participants
In the Open Trial all participants received a Fitbit to track activity levels and participate in a 6-session lifestyle physical activity intervention over the course of 12 weeks. The intervention consists of 20-25 minute phone or video-delivered session to: (a) review PA progress and re-evaluate current step-count goals, (b) problem-solve barriers to incorporating PA into their daily lives, (c) address difficulties utilizing the Fitbit, (d) encourage the use of bouts of PA as a coping strategy, and e) engage the participant in brief discussions focused on increasing and maintaining PA.
Number of Participants Using Cannabis
4 Participants

PRIMARY outcome

Timeframe: Baseline to 12-week endpoint

Population: End of intervention data from a wearable device was obtained from 12 of the 16 participants

objectively-measured via wearable device

Outcome measures

Outcome measures
Measure
Intervention
n=12 Participants
In the Open Trial all participants received a Fitbit to track activity levels and participate in a 6-session lifestyle physical activity intervention over the course of 12 weeks. The intervention consists of 20-25 minute phone or video-delivered session to: (a) review PA progress and re-evaluate current step-count goals, (b) problem-solve barriers to incorporating PA into their daily lives, (c) address difficulties utilizing the Fitbit, (d) encourage the use of bouts of PA as a coping strategy, and e) engage the participant in brief discussions focused on increasing and maintaining PA.
Steps/Day
6562 steps/day
Standard Deviation 2023

PRIMARY outcome

Timeframe: Baseline to 12-week endpoint

Number who reported walking 4 or more days/week for 10 or more continuous minutes per day

Outcome measures

Outcome measures
Measure
Intervention
n=12 Participants
In the Open Trial all participants received a Fitbit to track activity levels and participate in a 6-session lifestyle physical activity intervention over the course of 12 weeks. The intervention consists of 20-25 minute phone or video-delivered session to: (a) review PA progress and re-evaluate current step-count goals, (b) problem-solve barriers to incorporating PA into their daily lives, (c) address difficulties utilizing the Fitbit, (d) encourage the use of bouts of PA as a coping strategy, and e) engage the participant in brief discussions focused on increasing and maintaining PA.
International Physical Activity Questionnaire (IPAQ) Walked 10+ Continuous Min/Day
8 Participants

SECONDARY outcome

Timeframe: past week, assessed at week 12 (end of intervention)

Self-report measure of depression severity; scores range from 0-30, with higher scores indicating more severe depression

Outcome measures

Outcome measures
Measure
Intervention
n=12 Participants
In the Open Trial all participants received a Fitbit to track activity levels and participate in a 6-session lifestyle physical activity intervention over the course of 12 weeks. The intervention consists of 20-25 minute phone or video-delivered session to: (a) review PA progress and re-evaluate current step-count goals, (b) problem-solve barriers to incorporating PA into their daily lives, (c) address difficulties utilizing the Fitbit, (d) encourage the use of bouts of PA as a coping strategy, and e) engage the participant in brief discussions focused on increasing and maintaining PA.
Edinburgh Postnatal Depression Screen
7.91 scores on a scale
Standard Deviation 4.89

SECONDARY outcome

Timeframe: past 2 weeks, assessed at week 12 (end of intervention)

Self-report measure of anxiety severity; scores range from 0-21, with higher scoring indicating more severe anxiety

Outcome measures

Outcome measures
Measure
Intervention
n=12 Participants
In the Open Trial all participants received a Fitbit to track activity levels and participate in a 6-session lifestyle physical activity intervention over the course of 12 weeks. The intervention consists of 20-25 minute phone or video-delivered session to: (a) review PA progress and re-evaluate current step-count goals, (b) problem-solve barriers to incorporating PA into their daily lives, (c) address difficulties utilizing the Fitbit, (d) encourage the use of bouts of PA as a coping strategy, and e) engage the participant in brief discussions focused on increasing and maintaining PA.
Generalized Anxiety Disorder -7
5.18 scores on a scale
Standard Deviation 3.43

SECONDARY outcome

Timeframe: Week 12 End of Treatment (EOT)

The Client Satisfaction Questionnaire is an 8 item survey of participant satisfaction. Scores range from 8-32; higher scores indicate higher satisfaction.

Outcome measures

Outcome measures
Measure
Intervention
n=12 Participants
In the Open Trial all participants received a Fitbit to track activity levels and participate in a 6-session lifestyle physical activity intervention over the course of 12 weeks. The intervention consists of 20-25 minute phone or video-delivered session to: (a) review PA progress and re-evaluate current step-count goals, (b) problem-solve barriers to incorporating PA into their daily lives, (c) address difficulties utilizing the Fitbit, (d) encourage the use of bouts of PA as a coping strategy, and e) engage the participant in brief discussions focused on increasing and maintaining PA.
Client Satisfaction Questionnaire (CSQ-8)
29.1 scores on a scale
Standard Deviation 4.9

Adverse Events

Intervention

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Intervention
n=16 participants at risk
In the Open Trial all participants received a Fitbit to track activity levels and participate in a 6-session lifestyle physical activity intervention over the course of 12 weeks. The intervention consists of 20-25 minute phone or video-delivered session to: (a) review PA progress and re-evaluate current step-count goals, (b) problem-solve barriers to incorporating PA into their daily lives, (c) address difficulties utilizing the Fitbit, (d) encourage the use of bouts of PA as a coping strategy, and e) engage the participant in brief discussions focused on increasing and maintaining PA.
Musculoskeletal and connective tissue disorders
Participant reported twisting her ankle after falling off a stool at an arcade.
6.2%
1/16 • From enrollment until the final assessment at 3 months postpartum, up to 41 weeks total
Musculoskeletal and connective tissue disorders
Participant reported falling on steps while taking out the trash and spraining her ankle.
6.2%
1/16 • From enrollment until the final assessment at 3 months postpartum, up to 41 weeks total

Additional Information

Principal Investigator

Butler Hospital

Phone: 401-455-6303

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place