ClockWork Postpartum Weight Management Study

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Weight Gain, Maternal; Postpartum Weight Retention
• Intervention / Treatment: Behavioral: ClockWork; Other: Usual Care

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 Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ClockWork; Participants who are randomized to treatment will receive the ClockWork intervention	Behavioral: ClockWork; 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.
Active Comparator: Usual Care; Participants will receive usual care during the postpartum period.	Other: Usual Care; Usual Care consists of the standard care that postpartum women receive without any additional intervention components.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of sessions attended among women randomized to receive the ClockWork Intervention	Number of sessions attended will be calculated for each participant	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	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.	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.	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.	First 4 months postpartum
Weight change from delivery to 4 months postpartum	Weight in lbs.	First 4 months postpartum
Weight change from prepregnancy to 4 months postpartum	Weight in lbs.	Pre-pregnancy through 4 months postpartum

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: The Obesity Society; Weight Watchers International
• Investigators: Principal Investigator: Rachel Kolko, PhD, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2021
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: July 28, 2021
• First Submitted That Met QC Criteria: July 28, 2021
• First Posted (Actual): August 5, 2021

Study Record Updates

• Last Update Posted (Estimated): November 3, 2023
• Last Update Submitted That Met QC Criteria: November 1, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight Changes; Body Weight; Weight Gain; Gestational Weight Gain
• Other Study ID Numbers: STUDY19120236

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No