ClockWork Postpartum Weight Management Study

Obesity Clinical Trial

Official title:

ClockWork: Harnessing the Circadian Timing System for Postpartum Weight Management & Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04992637
• Other study ID #: STUDY19120236
• Status: Completed
• Phase: N/A
• Start date: July 30, 2021
• Est. completion date: June 30, 2023

Study information

• Verified date: November 2023
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Body Weight
• Gestational Weight Gain
• Obesity
• Postpartum Weight Retention
• Weight Gain
• Weight Gain, Maternal

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.

Other:
• Usual Care
Usual Care consists of the standard care that postpartum women receive without any additional intervention components.

Locations

Country	Name	City	State
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
University of Pittsburgh	The Obesity Society, Weight Watchers International

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Weight change from delivery to 4 months postpartum	Weight in lbs.	First 4 months postpartum
Primary	Weight change from prepregnancy to 4 months postpartum	Weight in lbs.	Pre-pregnancy through 4 months postpartum