ClockWork Postpartum Weight Management Study

NCT ID: NCT04992637

Last Updated: 2023-11-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-30
• Study Completion Date: 2023-06-30

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.

Conditions

Obesity; Postpartum Weight Retention; Weight Gain, Maternal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ClockWork

Participants who are randomized to treatment will receive the ClockWork intervention

Group Type: EXPERIMENTAL

ClockWork

Intervention Type: BEHAVIORAL

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 Care

Participants will receive usual care during the postpartum period.

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: BEHAVIORAL

Usual Care

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The Obesity Society

OTHER

Sponsor Role: collaborator

WW International Inc

INDUSTRY

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Rachel Kolko

Research Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rachel Kolko, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

STUDY19120236

Identifier Type: -

Identifier Source: org_study_id