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ClockWork Postpartum Weight Management Study

Primary Purpose

Obesity, Postpartum Weight Retention, Weight Gain, Maternal

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ClockWork
Usual Care
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • At least 18 years of age
  • Prenatal BMI greater than or equal to 30
  • 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.

Sites / Locations

  • University of Pittsburgh Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ClockWork

Usual Care

Arm Description

Participants who are randomized to treatment will receive the ClockWork intervention

Participants will receive usual care during the postpartum period.

Outcomes

Primary Outcome Measures

Number of sessions attended among women randomized to receive the ClockWork Intervention
Number of sessions attended will be calculated for each participant
The percentage of days with completed monitoring among women randomized to receive the ClockWork Intervention
Women will be asked to monitor daily
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.
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.
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.
Weight change from delivery to 4 months postpartum
Weight in lbs.
Weight change from prepregnancy to 4 months postpartum
Weight in lbs.

Secondary Outcome Measures

Full Information

First Posted
July 28, 2021
Last Updated
December 6, 2022
Sponsor
University of Pittsburgh
Collaborators
The Obesity Society, Weight Watchers International
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1. Study Identification

Unique Protocol Identification Number
NCT04992637
Brief Title
ClockWork Postpartum Weight Management Study
Official Title
ClockWork: Harnessing the Circadian Timing System for Postpartum Weight Management & Health
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 30, 2021 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
The Obesity Society, Weight Watchers International

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 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 (N=50) will complete baseline assessments in the first month postpartum and be randomized to either usual care (n=25) or ClockWork (n=25) 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 consists of an e-newsletter on maternal health, postpartum weight loss, and general calorie guidelines for lactating/nonlactating women.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Postpartum Weight Retention, Weight Gain, Maternal

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Women will be randomized to receive either the ClockWork intervention or Usual Care.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ClockWork
Arm Type
Experimental
Arm Description
Participants who are randomized to treatment will receive the ClockWork intervention
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
Participants will receive usual care during the postpartum period.
Intervention Type
Behavioral
Intervention Name(s)
ClockWork
Intervention Description
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
Other
Intervention Name(s)
Usual Care
Intervention Description
Usual Care consists of an e-newsletter on maternal health, postpartum weight loss, and general calorie guidelines for lactating/nonlactating women.
Primary Outcome Measure Information:
Title
Number of sessions attended among women randomized to receive the ClockWork Intervention
Description
Number of sessions attended will be calculated for each participant
Time Frame
First 4 months postpartum
Title
The percentage of days with completed monitoring among women randomized to receive the ClockWork Intervention
Description
Women will be asked to monitor daily
Time Frame
First 4 months postpartum
Title
Participant liking of ClockWork (sessions, content, digital monitoring interface)
Description
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.
Time Frame
First 4 months postpartum
Title
Perceived utility ratings of ClockWork (sessions, content, digital monitoring interface)
Description
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.
Time Frame
First 4 months postpartum
Title
Changes in the "ART" (amount, regularity, and timing of targeted intervention behaviors) from baseline to 4 months postpartum
Description
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.
Time Frame
First 4 months postpartum
Title
Weight change from delivery to 4 months postpartum
Description
Weight in lbs.
Time Frame
First 4 months postpartum
Title
Weight change from prepregnancy to 4 months postpartum
Description
Weight in lbs.
Time Frame
Pre-pregnancy through 4 months postpartum

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: At least 18 years of age Prenatal BMI greater than or equal to 30 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rachel Kolko, PhD
Phone
412-647-1827
Email
kolkorp2@upmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Gina Sweeny
Phone
412-647-7183
Email
dianagm@upmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel Kolko, PhD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gina Sweeny
Phone
412-647-7183
Email
dianagm@upmc.edu
First Name & Middle Initial & Last Name & Degree
Rachel Kolko, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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ClockWork Postpartum Weight Management Study

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