ObesityNCT04992637
ClockWork Postpartum Weight Management Study
A study testing ClockWork in people with Obesity and Postpartum Weight Retention, run by University of Pittsburgh at 1 site in United States.
Trial summary
The ClockWork Postpartum Weight Management Pilot Study is an intervention study that will assess the feasibility, acceptability, and initial efficacy of the ClockWork intervention among women with prepregnancy overweight/obesity during the first 4 months postpartum. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Obesity, Postpartum Weight Retention, Weight Gain, Maternal
- What is being tested?
- ClockWork
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jul 2021to 30 Jun 2023
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- Prenatal BMI greater than or equal to 25
- At least 28 weeks gestation
- English speaking
- Singleton pregnancy
Who cannot join
- Preexisting diabetes
- Use of medications known to affect weight (example, second generation antipsychotics)
- Enrolled in current weight management programming
- Recent weight loss surgery (within the past 3 years)
- Women who endorse acute psychiatric symptoms (e.g., suicidality) that warrant immediate treatment will be excluded and referred for care.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
Official title: ClockWork: Harnessing the Circadian Timing System for Postpartum Weight Management & Health
The ClockWork Postpartum Weight Management Pilot Study is an intervention study that will assess the feasibility, acceptability, and initial efficacy of the ClockWork intervention among women with prepregnancy overweight/obesity during the first 4 months postpartum.
Read the detailed description
Overview of Procedures. The investigators developed a prototype mobile app to monitor ClockWork target behaviors, and now aim to gain stakeholder input to refine the interface and improve usability via feedback from postpartum women who began pregnancy with obesity. In this pilot trial, women will complete baseline assessments in the first month postpartum and be randomized to either usual care or ClockWork for 4 months, then complete assessments.
Participants \& Recruitment. Given that the investigators want to initiate treatment quickly after delivery, women will be recruited at the end of pregnancy through Magee-Womens Hospital. Women will be randomized to receive either the ClockWork intervention or Usual Care. ClockWork is a behavioral weight loss intervention comprised of coaching sessions as well as digital monitoring and feedback tools. It addresses 4 key behaviors related to the circadian timing system (CTS), weight, and health and their Amount, Regularity \& Timing-the ART of ClockWork. Women will receive 12 tailored coaching sessions to review digital monitoring of each key behavior, learn intervention content, and set goals, which are delivered in-person, by phone, or web to fit women's needs postpartum. Coaches (Dr. Kolko Conlon or study interventionist) will use women's baseline responses to tailor sessions around the key behaviors. The investigators will protocolize real-time monitoring to increase engagement and adherence, and to facilitate just-in-time adaptive reminders, recommendations, and coaching sessions. Usual Care does not involve any additional intervention.
- Conditions
- Obesity, Postpartum Weight Retention, Weight Gain, Maternal
- Being tested
- ClockWork, Usual Care
- Medical subject headings
- Obesity, Gestational Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClockWorkBehavioural
ClockWork is a behavioral weight loss intervention comprised of coaching sessions as well as digital monitoring and feedback tools. It addresses 4 key behaviors related to the CTS, weight, and health and their Amount, Regularity \& Timing-the ART of ClockWork. Women will receive 12 tailored coaching sessions to review their digital monitoring of each key behavior, learn intervention content, and set goals, which are delivered in-person, by phone, or web to fit women's needs postpartum. Coaches will use women's baseline responses to tailor sessions around the key behaviors. The investigators will protocolize real-time monitoring to increase engagement and adherence, and to facilitate just-in-time adaptive reminders, recommendations, and coaching sessions.
Usual CareOther
Usual Care consists of the standard care that postpartum women receive without any additional intervention components.
| Study group | Role | What they receive |
|---|---|---|
| ClockWork | Experimental | Participants who are randomized to treatment will receive the ClockWork intervention Receives: Behavioral: ClockWork |
| Usual Care | Active comparator | Participants will receive usual care during the postpartum period. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of sessions attended among women randomized to receive the ClockWork Intervention
Number of sessions attended will be calculated for each participant
Measured: First 4 months postpartum
The percentage of days with completed monitoring among women randomized to receive the ClockWork Intervention
Women will be asked to monitor daily
Measured: First 4 months postpartum
Participant liking of ClockWork (sessions, content, digital monitoring interface)
Participant liking will be assessed using a Program Evaluation measure designed for this study. The measure uses a 10-point Likert Scale ranging from "not at all" (1) to "a lot" (10). Higher scores on this measure indicate greater satisfaction with ClockWork program components.
Measured: First 4 months postpartum
Perceived utility ratings of ClockWork (sessions, content, digital monitoring interface)
Perceived utility will be assessed using a Program Evaluation measure designed for this study. The measure uses a 10-point Likert Scale ranging from "not helpful at all" (1) to "extremely helpful" (10). Higher scores on this measure indicate greater satisfaction with ClockWork program components.
Measured: First 4 months postpartum
Changes in the "ART" (amount, regularity, and timing of targeted intervention behaviors) from baseline to 4 months postpartum
A composite score will be calculated to assess changes in the "ART" of behaviors. Participants will record the "ART" of targeted intervention behaviors using self-monitoring forms designed for the study.
Measured: First 4 months postpartum
Weight change from delivery to 4 months postpartum
Weight in lbs.
Measured: First 4 months postpartum
Weight change from prepregnancy to 4 months postpartum
Weight in lbs.
Measured: Pre-pregnancy through 4 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2021
- Study start30 Jul 2021
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Women will be randomized to receive either the ClockWork intervention or Usual Care.
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- The Obesity Society, WW International Inc
- Responsible party
- Principal investigator, Rachel Kolko, University of Pittsburgh
- Investigators
- Rachel Kolko, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04992637
- Sponsor's protocol ID
- STUDY19120236
- Status last verified
- Nov 2023
- First submitted
- 28 Jul 2021
- Last updated
- 3 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 3 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ClockWork: Harnessing the Circadian Timing System for Postpartum Weight Management & Health
- ClinicalTrials.gov ID
- NCT04992637
- Acronym / sponsor ID
- STUDY19120236
- Conditions
- Obesity, Postpartum Weight Retention, Weight Gain, Maternal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- The Obesity Society, WW International Inc
- Study start
- 30 Jul 2021 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 5 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.
The ClockWork Postpartum Weight Management Pilot Study is an intervention study that will assess the feasibility, acceptability, and initial efficacy of the ClockWork intervention among women with prepregnancy overweight/obesity during the first 4 months postpartum.
Detailed description
Overview of Procedures. The investigators developed a prototype mobile app to monitor ClockWork target behaviors, and now aim to gain stakeholder input to refine the interface and improve usability via feedback from postpartum women who began pregnancy with obesity. In this pilot trial, women will complete baseline assessments in the first month postpartum and be randomized to either usual care or ClockWork for 4 months, then complete assessments.
Participants \& Recruitment. Given that the investigators want to initiate treatment quickly after delivery, women will be recruited at the end of pregnancy through Magee-Womens Hospital. Women will be randomized to receive either the ClockWork intervention or Usual Care. ClockWork is a behavioral weight loss intervention comprised of coaching sessions as well as digital monitoring and feedback tools. It addresses 4 key behaviors related to the circadian timing system (CTS), weight, and health and their Amount, Regularity \& Timing-the ART of ClockWork. Women will receive 12 tailored coaching sessions to review digital monitoring of each key behavior, learn intervention content, and set goals, which are delivered in-person, by phone, or web to fit women's needs postpartum. Coaches (Dr. Kolko Conlon or study interventionist) will use women's baseline responses to tailor sessions around the key behaviors. The investigators will protocolize real-time monitoring to increase engagement and adherence, and to facilitate just-in-time adaptive reminders, recommendations, and coaching sessions. Usual Care does not involve any additional intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Women will be randomized to receive either the ClockWork intervention or Usual Care.
| Arm | Type | Receives |
|---|---|---|
| ClockWork | Experimental | Behavioral: ClockWorkParticipants who are randomized to treatment will receive the ClockWork intervention |
| Usual Care | Active comparator | Other: Usual CareParticipants will receive usual care during the postpartum period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- At least 18 years of age
- Prenatal BMI greater than or equal to 25
- At least 28 weeks gestation
- English speaking
- Singleton pregnancy
Key exclusion criteria (5 listed)
- Preexisting diabetes
- Use of medications known to affect weight (example, second generation antipsychotics)
- Enrolled in current weight management programming
- Recent weight loss surgery (within the past 3 years)
- Women who endorse acute psychiatric symptoms (e.g., suicidality) that warrant immediate treatment will be excluded and referred for care.
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 |
|---|---|---|
| ClockWorkClockWork is a behavioral weight loss intervention comprised of coaching sessions as well as digital monitoring and feedback tools. It addresses 4 key behaviors related to the CTS, weight, and health and their Amount, Regularity \& Timing-the ART of ClockWork. Women will receive 12 tailored coaching sessions to review their digital monitoring of each key behavior, learn intervention content, and set goals, which are delivered in-person, by phone, or web to fit women's needs postpartum. Coaches will use women's baseline responses to tailor sessions around the key behaviors. The investigators will protocolize real-time monitoring to increase engagement and adherence, and to facilitate just-in-time adaptive reminders, recommendations, and coaching sessions. | Behavioural | ClockWork |
| Usual CareUsual Care consists of the standard care that postpartum women receive without any additional intervention components. | Other | Usual Care |
Primary outcome
Number of sessions attended among women randomized to receive the ClockWork Intervention
Time frame: First 4 months postpartum
Number of sessions attended will be calculated for each participant
The percentage of days with completed monitoring among women randomized to receive the ClockWork Intervention
Time frame: First 4 months postpartum
Women will be asked to monitor daily
Participant liking of ClockWork (sessions, content, digital monitoring interface)
Time frame: First 4 months postpartum
Participant liking will be assessed using a Program Evaluation measure designed for this study. The measure uses a 10-point Likert Scale ranging from "not at all" (1) to "a lot" (10). Higher scores on this measure indicate greater satisfaction with ClockWork program components.
Perceived utility ratings of ClockWork (sessions, content, digital monitoring interface)
Time frame: First 4 months postpartum
Perceived utility will be assessed using a Program Evaluation measure designed for this study. The measure uses a 10-point Likert Scale ranging from "not helpful at all" (1) to "extremely helpful" (10). Higher scores on this measure indicate greater satisfaction with ClockWork program components.
Changes in the "ART" (amount, regularity, and timing of targeted intervention behaviors) from baseline to 4 months postpartum
Time frame: First 4 months postpartum
A composite score will be calculated to assess changes in the "ART" of behaviors. Participants will record the "ART" of targeted intervention behaviors using self-monitoring forms designed for the study.
Weight change from delivery to 4 months postpartum
Time frame: First 4 months postpartum
Weight in lbs.
Weight change from prepregnancy to 4 months postpartum
Time frame: Pre-pregnancy through 4 months postpartum
Weight in lbs.
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 3 Nov 2023.
- 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.
Rachel Kolko, 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 ClockWork in people with Obesity and Postpartum Weight Retention, 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 5 inclusion and 5 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 3 Nov 2023. 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?
Number of sessions attended among women randomized to receive the ClockWork Intervention (time frame: First 4 months postpartum). The study lists 7 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 3 Nov 2023.