Clinical trial NCT04992637: ClockWork Postpartum Weight Management Study
Official title: ClockWork: Harnessing the Circadian Timing System for Postpartum Weight Management & Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Postpartum Weight Retention
Weight Gain, Maternal
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: The Obesity Society
name: WW International Inc
First posted: 2021-08-05
Enrollment: 17
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Women will be randomized to receive either the ClockWork intervention or Usual Care.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* At least 18 years of age
* Prenatal BMI greater than or equal to 25
* At least 28 weeks gestation
* English speaking
* Singleton pregnancy

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Number of sessions attended among women randomized to receive the ClockWork Intervention
timeFrame: First 4 months postpartum
measure: The percentage of days with completed monitoring among women randomized to receive the ClockWork Intervention
timeFrame: First 4 months postpartum
measure: Participant liking of ClockWork (sessions, content, digital monitoring interface)
timeFrame: First 4 months postpartum
measure: Perceived utility ratings of ClockWork (sessions, content, digital monitoring interface)
timeFrame: First 4 months postpartum
measure: Changes in the "ART" (amount, regularity, and timing of targeted intervention behaviors) from baseline to 4 months postpartum
timeFrame: First 4 months postpartum
measure: Weight change from delivery to 4 months postpartum
timeFrame: First 4 months postpartum
measure: Weight change from prepregnancy to 4 months postpartum
timeFrame: Pre-pregnancy through 4 months postpartum
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Rachel Kolko, PhD
role: PRINCIPAL_INVESTIGATOR
References: