ClockWork Postpartum Weight Management Study

NCT04992637 | Completed

• 1 other identifier: STUDY19120236
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Postpartum Weight Retention; Weight Gain, Maternal

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (2)

ClockWork

EXPERIMENTAL

Participants who are randomized to treatment will receive the ClockWork intervention

Behavioral: ClockWork

Usual Care

ACTIVE COMPARATOR

Participants will receive usual care during the postpartum period.

Other: Usual Care

Interventions

ClockWork 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.

ClockWork

Usual Care OTHER

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

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age
• Prenatal BMI greater than or equal to 25
• At least 28 weeks gestation
• English speaking
• Singleton pregnancy

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead
• The Obesity Society: collaborator
• WW International Inc: collaborator

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Obesity; Gestational Weight Gain

Interventions

Cwo protein, Drosophila

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Weight Gain; Body Weight Changes

Study Officials

• Rachel Kolko, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Model Details: Women will be randomized to receive either the ClockWork intervention or Usual Care.

Study Record Dates

• First Submitted: July 28, 2021
• First Posted: August 5, 2021
• Study Start: July 30, 2021
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: November 3, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)