ClockWork Postpartum Weight Management Study

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Obesity, Postpartum Weight Retention, Weight Gain, Maternal

Intervention / Treatment
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* Behavioral: ClockWork
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Women will be randomized to receive either the ClockWork intervention or Usual Care.
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 |