ClockWork Postpartum Weight Management Study

University of Pittsburgh

Status: Completed

Conditions: Postpartum Weight Retention; Obesity; Weight Gain, Maternal

Treatments: Behavioral: ClockWork; Other: Usual Care

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04992637

STUDY19120236

Details and patient eligibility

About

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.

Full 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.

Enrollment: 17 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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17 participants in 2 patient groups

ClockWork

Experimental group

Description:

Participants who are randomized to treatment will receive the ClockWork intervention

Treatment:

Behavioral: ClockWork

Usual Care

Active Comparator group

Description:

Participants will receive usual care during the postpartum period.

Treatment:

Other: Usual Care