PregnancyNCT06239701
Development of a Lifestyle Physical Activity Intervention to Reduce Risk for Perinatal Cannabis Use - RCT
A study testing LPA+Fitbit Intervention and Fitbit Only in people with Pregnancy, run by Butler Hospital at 1 site in United States.
Trial summary
The overall goal of this pilot study is to develop and preliminarily evaluate an LPA intervention designed to reduce cannabis use during pregnancy. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- LPA+Fitbit Intervention and Fitbit Only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jan 2024to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- women 18+ years of age
- 12-25 weeks gestation with a healthy singleton pregnancy
- medically-cleared by their prenatal provider for moderate intensity physical activity
- self-report of cannabis use at least once/week in the 3 months prior to the current pregnancy and desire to not engage in prenatal CU
- current psychological distress as defined by Edinburgh Postnatal Depression Scale score >7 and/or Generalized Anxiety Disorder 7 score >5)
- English-speaking
Show all 9Show fewer
- owns a smartphone to enable use of the Fitbit app
- current physical activity level does not meet public health recommendations (less than 150 minutes/week moderate intensity physical activity for the past 3 months)
- expresses interest in reducing or discontinuing CU
Who cannot join
- current DSM-5 diagnosis of moderate/severe substance use disorder other than cannabis use disorder or nicotine use disorder
- use of illicit substances in the last 3 months (other than cannabis)
- acute psychotic symptoms
- current or recent suicidality or homicidality
- current anorexia or bulimia
- current cognitive impairment
Show all 9Show fewer
- physical or medical problems that would not allow safe participation in moderate intensity physical activity
- has plan to relocate away from the geographic area during the study intervention or assessment period
- recently started a new form of mental health or substance use treatment within the past 4 weeks
Trial locations and contacts
1 site in 1 country.
About this study
The overall goal of this pilot study is to develop and preliminarily evaluate an LPA intervention designed to reduce cannabis use during pregnancy.
Read the detailed description
In the pilot RCT, we will recruit 50 women between 12-22 weeks gestation from an established network of prenatal clinics, and randomly assign eligible women to either a: 1) LPA+Fitbit intervention or 2) Fitbit Only control condition. Similar to our prior trials with pregnant women, the intervention period will be 12 weeks in duration during pregnancy, with follow-ups extending to the end of pregnancy and into the postpartum period. Major assessments will occur at baseline, end of treatment (EOT), and 4 weeks postpartum; we will also conduct brief phone surveys at three points in between the larger assessments. Participants will complete a 7-day period of accelerometry and urine toxicology screens following each major assessments. Birth record abstractions to collect information about specific outcomes (pre-term delivery, low birth weight) will be conducted by trained staff at one month post-birth.
- Conditions
- Pregnancy
- Being tested
- LPA+Fitbit Intervention, Fitbit Only
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LPA+Fitbit InterventionBehavioural
Also called Women Out Walking
- In-Person LPA+Fitbit Orientation. During an initial, orientation (45 minutes), a study interventionist will provide information regarding the acute and long-term psychological and physical benefits of increasing PA, including prenatally.
- Telephone PA counseling sessions. A study interventionist will call participants at weeks 2, 4, 6, 8, and 10 of the intervention for a 20-min telephone session.
- Fitbit activity tracker. With participant permission, a Fitbit account (on Fitbit.com) and study-generated password will be created. In doing so, investigators will have access to the participant activity data throughout the intervention. The Fitbit web-based and mobile apps facilitate goal-setting by allowing participants to easily set goals and change these goals at any point. We will customize each participant account to display daily steps and very active minutes, though they will be encouraged to adjust the display according to their preferences.
Fitbit OnlyBehavioural
- In-person Fitbit Orientation. Participants will be given information on the public health guidelines for PA during pregnancy, and as well as how to determine if their PA is moderate-intensity. In addition, interventionists will orient participants to the proper use of the Fitbit tracker and offer tips for self-monitoring step counts with the tracker and on the app.
- Fitbit Activity Tracker. Participants will be given the same Fitbit as in the LPA condition. Participants will not be given any specific step count goals to achieve during the 12-week intervention.
- Brief Telephone Check-ins. As with the LPA+Fitbit participants, those in the Fitbit Only condition will receive phone calls on weeks 2, 4, 6, 8, 10. These calls will last 5 minutes and be focused entirely on answering any problems related to the Fitbit such as syncing issues, charging the battery, and any other technical problems that may arise. No physical activity counseling will be delivered on these calls.
| Study group | Role | What they receive |
|---|---|---|
| LPA and Fitbit | Experimental | The 12-week LPA+Fitbit intervention consists of 3 components:
1. In-Person LPA+Fitbit Orientation
2. Telephone PA counseling sessions.
3. Fitbit activity tracker. Receives: Behavioral: LPA+Fitbit Intervention |
| Only Fitbit | Active comparator | The Fitbit Only condition will include 3 components:
1. In-person Fitbit Orientation.
2. Fitbit Activity Tracker.
3. Brief Telephone Check-ins. Receives: Behavioral: Fitbit Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timeline Follow-back (TLFB)
Interviewer-administered assessment of use of cannabis, alcohol, tobacco, and other drugs
Measured: Baseline to 12-week endpoint
Steps/day
objectively-measured
Measured: Baseline to 12-week endpoint
Activity Minutes/Day
objectively-measured
Measured: Baseline to 12-week endpoint
The Daily Sessions, Frequency & Quantity of Cannabis Use Inventory - Factor 1
Self-reported cannabis use questionnaire -factor 1: daily sessions
Measured: Baseline to 12-week endpoint
The Daily Sessions, Frequency & Quantity of Cannabis Use Inventory - Factor 2
Self-reported cannabis use questionnaire - factor 2: frequency
Measured: Baseline to 12-week endpoint
The Daily Sessions, Frequency & Quantity of Cannabis Use Inventory - Factor 3
Self-reported cannabis use questionnaire - factor 3: age of onset
Measured: Baseline to 12-week endpoint
The Daily Sessions, Frequency & Quantity of Cannabis Use Inventory - Factor 4
Self-reported cannabis use questionnaire - factor 4: Marijuana quantity
Measured: Baseline to 12-week endpoint
The Daily Sessions, Frequency & Quantity of Cannabis Use Inventory - Factor 5
Self-reported cannabis use questionnaire - factor 5: Concentrate quantity
Measured: Baseline to 12-week endpoint
The Daily Sessions, Frequency & Quantity of Cannabis Use Inventory - Factor 6
Self-reported cannabis use questionnaire - factor 6: Edibles quantity
Measured: Baseline to 12-week endpoint
Urine Toxicology Screen
Objective screening for use of cannabis via measurement of THC in urine samples
Measured: Baseline to 12-week endpoint
International Physical Activity Questionnaire
self-report measure of physical activity including minutes/week spent walking, engaging in moderate physical activity, and engaging in vigorous physical activity
Measured: Baseline to 12-week endpoint
Secondary outcomes (4)
Brief COPE
Self-report measure of use of coping strategies; includes 14 2-item scales, each ranging from 2-8. Higher scores indicate increased utilization of a coping strategy.
Measured: Baseline to 12-week endpoint
Marijuana Self-Efficacy Questionnaire
Self-report measure of efficacy for cannabis abstinence; Scores range from 0-100, with higher scores indicating greater use of strategies to reduce marijuana consumption.
Measured: Baseline to 12-week endpoint
Edinburgh Postnatal Depression Screen
Self-report measure of depression severity; scores range from 0-30, with higher scores indicating higher depression
Measured: Baseline to 12-week endpoint
Generalized Anxiety Disorder -7
Self-report measure of anxiety severity; scores range from 0-21, with higher scoring indicating more anxiety
Measured: Baseline to 12-week endpoint
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start22 Jan 2024
- Primary completion31 Mar 2026
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to either a Fitbit Only Condition, or a Fitbit + A Lifestyle Physical Activity Intervention.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Butler Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cynthia Battle, PhD, Principal investigator, Butler Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06239701
- Sponsor's protocol ID
- R34DA055317-02
- Status last verified
- Jul 2026
- First submitted
- 26 Jan 2024
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Lifestyle Physical Activity Intervention to Reduce Risk for Perinatal Cannabis Use - RCT
- ClinicalTrials.gov ID
- NCT06239701
- Acronym / sponsor ID
- R34DA055317-02
- Conditions
- Pregnancy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Butler HospitalUniversity, hospital or other
- Study start
- 22 Jan 2024 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 2 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall goal of this pilot study is to develop and preliminarily evaluate an LPA intervention designed to reduce cannabis use during pregnancy.
Detailed description
In the pilot RCT, we will recruit 50 women between 12-22 weeks gestation from an established network of prenatal clinics, and randomly assign eligible women to either a: 1) LPA+Fitbit intervention or 2) Fitbit Only control condition. Similar to our prior trials with pregnant women, the intervention period will be 12 weeks in duration during pregnancy, with follow-ups extending to the end of pregnancy and into the postpartum period. Major assessments will occur at baseline, end of treatment (EOT), and 4 weeks postpartum; we will also conduct brief phone surveys at three points in between the larger assessments. Participants will complete a 7-day period of accelerometry and urine toxicology screens following each major assessments. Birth record abstractions to collect information about specific outcomes (pre-term delivery, low birth weight) will be conducted by trained staff at one month post-birth.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to either a Fitbit Only Condition, or a Fitbit + A Lifestyle Physical Activity Intervention.
| Arm | Type | Receives |
|---|---|---|
| LPA and Fitbit | Experimental | Behavioral: LPA+Fitbit InterventionThe 12-week LPA+Fitbit intervention consists of 3 components: 1. In-Person LPA+Fitbit Orientation 2. Telephone PA counseling sessions. 3. Fitbit activity tracker. |
| Only Fitbit | Active comparator | Behavioral: Fitbit OnlyThe Fitbit Only condition will include 3 components: 1. In-person Fitbit Orientation. 2. Fitbit Activity Tracker. 3. Brief Telephone Check-ins. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- women 18+ years of age
- 12-25 weeks gestation with a healthy singleton pregnancy
- medically-cleared by their prenatal provider for moderate intensity physical activity
- self-report of cannabis use at least once/week in the 3 months prior to the current pregnancy and desire to not engage in prenatal CU
- current psychological distress as defined by Edinburgh Postnatal Depression Scale score >7 and/or Generalized Anxiety Disorder 7 score >5)
Key exclusion criteria (9 listed)
- current DSM-5 diagnosis of moderate/severe substance use disorder other than cannabis use disorder or nicotine use disorder
- use of illicit substances in the last 3 months (other than cannabis)
- acute psychotic symptoms
- current or recent suicidality or homicidality
- current anorexia or bulimia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LPA+Fitbit InterventionAlso: Women Out Walking1. In-Person LPA+Fitbit Orientation. During an initial, orientation (45 minutes), a study interventionist will provide information regarding the acute and long-term psychological and physical benefits of increasing PA, including prenatally. 2. Telephone PA counseling sessions. A study interventionist will call participants at weeks 2, 4, 6, 8, and 10 of the intervention for a 20-min telephone session. 3. Fitbit activity tracker. With participant permission, a Fitbit account (on Fitbit.com) and study-generated password will be created. In doing so, investigators will have access to the participant activity data throughout the intervention. The Fitbit web-based and mobile apps facilitate goal-setting by allowing participants to easily set goals and change these goals at any point. We will customize each participant account to display daily steps and very active minutes, though they will be encouraged to adjust the display according to their preferences. | Behavioural | LPA and Fitbit |
| Fitbit Only1. In-person Fitbit Orientation. Participants will be given information on the public health guidelines for PA during pregnancy, and as well as how to determine if their PA is moderate-intensity. In addition, interventionists will orient participants to the proper use of the Fitbit tracker and offer tips for self-monitoring step counts with the tracker and on the app. 2. Fitbit Activity Tracker. Participants will be given the same Fitbit as in the LPA condition. Participants will not be given any specific step count goals to achieve during the 12-week intervention. 3. Brief Telephone Check-ins. As with the LPA+Fitbit participants, those in the Fitbit Only condition will receive phone calls on weeks 2, 4, 6, 8, 10. These calls will last 5 minutes and be focused entirely on answering any problems related to the Fitbit such as syncing issues, charging the battery, and any other technical problems that may arise. No physical activity counseling will be delivered on these calls. | Behavioural | Only Fitbit |
Primary outcome
Timeline Follow-back (TLFB)
Time frame: Baseline to 12-week endpoint
Interviewer-administered assessment of use of cannabis, alcohol, tobacco, and other drugs
Steps/day
Time frame: Baseline to 12-week endpoint
objectively-measured
Activity Minutes/Day
Time frame: Baseline to 12-week endpoint
objectively-measured
The Daily Sessions, Frequency & Quantity of Cannabis Use Inventory - Factor 1
Time frame: Baseline to 12-week endpoint
Self-reported cannabis use questionnaire -factor 1: daily sessions
The Daily Sessions, Frequency & Quantity of Cannabis Use Inventory - Factor 2
Time frame: Baseline to 12-week endpoint
Self-reported cannabis use questionnaire - factor 2: frequency
The Daily Sessions, Frequency & Quantity of Cannabis Use Inventory - Factor 3
Time frame: Baseline to 12-week endpoint
Self-reported cannabis use questionnaire - factor 3: age of onset
The Daily Sessions, Frequency & Quantity of Cannabis Use Inventory - Factor 4
Time frame: Baseline to 12-week endpoint
Self-reported cannabis use questionnaire - factor 4: Marijuana quantity
The Daily Sessions, Frequency & Quantity of Cannabis Use Inventory - Factor 5
Time frame: Baseline to 12-week endpoint
Self-reported cannabis use questionnaire - factor 5: Concentrate quantity
The Daily Sessions, Frequency & Quantity of Cannabis Use Inventory - Factor 6
Time frame: Baseline to 12-week endpoint
Self-reported cannabis use questionnaire - factor 6: Edibles quantity
Urine Toxicology Screen
Time frame: Baseline to 12-week endpoint
Objective screening for use of cannabis via measurement of THC in urine samples
International Physical Activity Questionnaire
Time frame: Baseline to 12-week endpoint
self-report measure of physical activity including minutes/week spent walking, engaging in moderate physical activity, and engaging in vigorous physical activity
4 secondary outcomes
Brief COPE
Time frame: Baseline to 12-week endpoint
Marijuana Self-Efficacy Questionnaire
Time frame: Baseline to 12-week endpoint
Edinburgh Postnatal Depression Screen
Time frame: Baseline to 12-week endpoint
Generalized Anxiety Disorder -7
Time frame: Baseline to 12-week endpoint
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cynthia Battle, PhD principal investigator
Butler Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LPA+Fitbit Intervention and Fitbit Only in people with Pregnancy, run by Butler Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timeline Follow-back (TLFB) (time frame: Baseline to 12-week endpoint). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.