Sleep DisturbanceNCT04990206
Improving Sleep Health in Adults With Overweight or Obesity
A study testing TranS-C in people with Sleep Disturbance and Sleep Wake Disorders, run by University of Pittsburgh at 1 site in United States.
Trial summary
This study will examine the feasibility and acceptability of the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) in adults with poor sleep and excess weight. Additionally, the study will explore if TranS-C improves sleep health and cardiovascular outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Disturbance, Sleep Wake Disorders, Sleep Disorder
- What is being tested?
- TranS-C
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Oct 2021to 21 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Currently own and regularly use a smart phone
- Body mass index >27 and ≤ 43
- Poor sleep health on one or more of the sleep health dimensions
Who cannot join
- Presence of an unstable condition requiring physician-supervised diet and exercise
- Physical limitations precluding ability to engage in moderate-intensity physical activity
- Pregnant or intention to become pregnant during study
- Current treatment for a serious mental illness
- Being a current shift worker
- Reported alcohol intake > 4 drinks/day for males and > 3 drinks/day for females
Show all 11Show fewer
- Current participation in a formal weight loss program, loss of ≥ 5% weight in past 6 months, or current use of weight loss medication
- History of bariatric surgery
- Planned extended vacations, absences, or relocation during study
- Another member of household is a participant in the study
- Score > 32 on the Eating Habits Checklist, an eating disorder scale
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh School of Nursing
Pittsburgh, Pennsylvania, 15213
About this study
Official title: A Behavioral Intervention to Improve the Sleep Health of Adults With Obesity: A Feasibility and Acceptability Study
This study will examine the feasibility and acceptability of the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) in adults with poor sleep and excess weight. Additionally, the study will explore if TranS-C improves sleep health and cardiovascular outcomes.
Read the detailed description
Aim 1 (Primary): Examine the feasibility and acceptability of TranS-C among adults with poor sleep health and excess weight.
Aim 2 (Exploratory): Explore the effect of TranS-C on the sleep health of adults with poor sleep and excess weight.
Aim 3 (Exploratory): Explore the effect of TranS-C on the cardiometabolic health of adults with poor sleep and excess weight.
- Conditions
- Sleep Disturbance, Sleep Wake Disorders, Sleep Disorder
- Being tested
- TranS-C
- Medical subject headings
- Parasomnias, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TranS-CBehavioural
TranS-C will be provided in eight weekly, one-on-one 50-minute sessions delivered remotely by two-way video conferencing. Each week will include goal setting and homework assignments which will be reviewed in the following session.
The sessions will include information on sleep and circadian rhythms, behavioral change and motivation, and goal setting. The topics covered in the sessions include establishing regular sleep-wake times, learning a wind-down route, learning a wake-up routine, improving daytime functioning, correcting unhelpful sleep-related beliefs, and maintenance of behavior change.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | TranS-C Receives: Behavioral: TranS-C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Percentage of potential participants screened in order to enroll 10 participants
Measured: 6-months
Attrition rate
Percentage of enrolled participants completing the 8-week intervention
Measured: 6-months
Completeness of questionnaire responses
Percentage of completed responses
Measured: 6-months
Secondary outcomes (10)
Change in composite sleep health score
Change in composite measure of sleep health which is the sum of scores on 6 sleep dimensions. Each dimension will be dichotomized as either 'good (1)' or 'poor (0)' based on clinically and scientifically relevant rationales and added together. Score will range from 0-6 with higher scores representing better sleep health.
Measured: 8-weeks (baseline to post-intervention)
Change in sleep regularity
Change in standard deviation of actigraphic wake time.
Measured: 8-weeks (baseline to post-intervention)
Change in sleep satisfaction
Change in Pittsburgh Sleep Quality Index (PSQI) sleep quality item. Item score ranges from 'very good (0)' to 'very bad (3)'.
Measured: 8-weeks (baseline to post-intervention)
Change in alertness
Change in Epworth Sleepiness Scale (ESS). Total score ranges from 0-24. Scores equal to or greater than 10 represent excessive daytime sleepiness.
Measured: 8-weeks (baseline to post-intervention)
Change in sleep timing
Change in mean actigraphic sleep midpoint.
Measured: 8-weeks (baseline to post-intervention)
Change in sleep efficiency
Change in mean actigraphic sleep efficiency.
Measured: 8-weeks (baseline to post-intervention)
Change in sleep duration
Change in mean actigraphic sleep duration.
Measured: 8-weeks (baseline to post-intervention)
Change in body mass index
Calculated by dividing weight in pounds by height in inches squared and multiplying by a conversion factor of 703. Weight will be measured a with Tanita Scale and Body Fat Analyzer. Height will be measured in with a stadiometer.
Measured: 8-weeks (baseline to post-intervention)
Change in systolic and diastolic blood pressure (BP)
Average of two blood pressure readings at least two minutes apart.
Measured: 8-weeks (baseline to post-intervention)
Change in waist circumference
Measured with a Gulick II measuring tape above the right iliac crest. Will include two measurements to the nearest 0.1 cm. If the two values are within 2 cm of each other, a mean with be calculated; if not, the measurements will be repeated until they are within 2 cm of each other.
Measured: 8-weeks (baseline to post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2021
- Study start7 Oct 2021
- Primary completion21 Sep 2022
- Study completion21 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisturbanceStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Imes, University of Pittsburgh
- Investigators
- Christopher C Imes, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04990206
- Sponsor's protocol ID
- STUDY21050043
- Status last verified
- Sep 2022
- First submitted
- 15 Jul 2021
- Last updated
- 30 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Final data sets from the proposed research may be shared.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Behavioral Intervention to Improve the Sleep Health of Adults With Obesity: A Feasibility and Acceptability Study
- ClinicalTrials.gov ID
- NCT04990206
- Acronym / sponsor ID
- STUDY21050043
- Conditions
- Sleep Disturbance, Sleep Wake Disorders, Sleep Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 7 Oct 2021 (actual)
- Primary completion
- 21 Sep 2022 (actual)
- Study completion
- 21 Sep 2022 (actual)
- First posted
- 4 Aug 2021 (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.
This study will examine the feasibility and acceptability of the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) in adults with poor sleep and excess weight. Additionally, the study will explore if TranS-C improves sleep health and cardiovascular outcomes.
Detailed description
Aim 1 (Primary): Examine the feasibility and acceptability of TranS-C among adults with poor sleep health and excess weight.
Aim 2 (Exploratory): Explore the effect of TranS-C on the sleep health of adults with poor sleep and excess weight.
Aim 3 (Exploratory): Explore the effect of TranS-C on the cardiometabolic health of adults with poor sleep and excess weight.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: TranS-CTranS-C |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Currently own and regularly use a smart phone
- Body mass index >27 and ≤ 43
- Poor sleep health on one or more of the sleep health dimensions
Key exclusion criteria (11 listed)
- Presence of an unstable condition requiring physician-supervised diet and exercise
- Physical limitations precluding ability to engage in moderate-intensity physical activity
- Pregnant or intention to become pregnant during study
- Current treatment for a serious mental illness
- Being a current shift worker
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 |
|---|---|---|
| TranS-CTranS-C will be provided in eight weekly, one-on-one 50-minute sessions delivered remotely by two-way video conferencing. Each week will include goal setting and homework assignments which will be reviewed in the following session. The sessions will include information on sleep and circadian rhythms, behavioral change and motivation, and goal setting. The topics covered in the sessions include establishing regular sleep-wake times, learning a wind-down route, learning a wake-up routine, improving daytime functioning, correcting unhelpful sleep-related beliefs, and maintenance of behavior change. | Behavioural | Intervention |
Primary outcome
Recruitment rate
Time frame: 6-months
Percentage of potential participants screened in order to enroll 10 participants
Attrition rate
Time frame: 6-months
Percentage of enrolled participants completing the 8-week intervention
Completeness of questionnaire responses
Time frame: 6-months
Percentage of completed responses
10 secondary outcomes
Change in composite sleep health score
Time frame: 8-weeks (baseline to post-intervention)
Change in sleep regularity
Time frame: 8-weeks (baseline to post-intervention)
Change in sleep satisfaction
Time frame: 8-weeks (baseline to post-intervention)
Change in alertness
Time frame: 8-weeks (baseline to post-intervention)
Change in sleep timing
Time frame: 8-weeks (baseline to post-intervention)
Change in sleep efficiency
Time frame: 8-weeks (baseline to post-intervention)
Change in sleep duration
Time frame: 8-weeks (baseline to post-intervention)
Change in body mass index
Time frame: 8-weeks (baseline to post-intervention)
Change in systolic and diastolic blood pressure (BP)
Time frame: 8-weeks (baseline to post-intervention)
Change in waist circumference
Time frame: 8-weeks (baseline to post-intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2022.
- Individual participant dataSharing planned: Yes. Final data sets from the proposed research may be shared.
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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.
Christopher C Imes, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TranS-C in people with Sleep Disturbance and Sleep Wake Disorders, run by University of Pittsburgh 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 3 inclusion and 11 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: finished, as of the sponsor's last update on 30 Sep 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Recruitment rate (time frame: 6-months). The study lists 3 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 30 Sep 2022.