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Completed

NCT Number: NCT04992637

ClockWork Postpartum Weight Management Study

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.

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Key information

Conditions

Obesity Body Weight Body Weight Changes Gestational Weight Gain Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Postpartum Weight Retention Signs and Symptoms Weight Gain Weight Gain, Maternal

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Usual Care

Other

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

Primary outcomes

  1. Number of sessions attended among women randomized to receive the ClockWork Intervention

    Time frame: First 4 months postpartum

    Number of sessions attended will be calculated for each participant

  2. The percentage of days with completed monitoring among women randomized to receive the ClockWork Intervention

    Time frame: First 4 months postpartum

    Women will be asked to monitor daily

  3. Participant liking of ClockWork (sessions, content, digital monitoring interface)

    Time frame: First 4 months postpartum

    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.

  4. Perceived utility ratings of ClockWork (sessions, content, digital monitoring interface)

    Time frame: First 4 months postpartum

    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.

  5. Changes in the "ART" (amount, regularity, and timing of targeted intervention behaviors) from baseline to 4 months postpartum

    Time frame: First 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.

  6. Weight change from delivery to 4 months postpartum

    Time frame: First 4 months postpartum

    Weight in lbs.

  7. Weight change from prepregnancy to 4 months postpartum

    Time frame: Pre-pregnancy through 4 months postpartum

    Weight in lbs.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • The Obesity Society
  • WW International Inc

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 5, 2021
Registry last updated
Nov 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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