Sleep Goal-focused Online Access to Lifestyle Support (SGOALS)

March 3, 2026 updated by: Marquis Hawkins, University of Pittsburgh

Sleep GOALS (Goal-focused Online Access to Lifestyle Support), an Internet Assisted Diet, Physical Activity, and Sleep Weight Loss Intervention for Postpartum Women

The overall goal of the study is to develop a novel weight loss intervention for postpartum people by providing strategies to improve sleep, diet, and physical activity behaviors. In this study, we will recruitment and enroll 40 postpartum people and randomize them to receive the Sleep GOALS intervention or education control to evaluate the intervention's feasibility, acceptability, and preliminary efficacy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15261
        • University of Pittsburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Stated willingness to comply with all study procedures and availability for the duration of the study,
  • Primiparous, singleton pregnancy,
  • Between 3+1 and 6+1 months postpartum,
  • Has a body mass index >25 kg/m2,
  • Physically inactive, defined as self-reporting <150 minutes/week of moderate-to-vigorous intensity physical activity,
  • Endorse >1 indicator of poor sleep health based on the RU_SATED questionnaire, and
  • Has smartphone and home Internet access

Exclusion Criteria:

  • current use of medications that affect weight,
  • currently pregnant or plan to become pregnant during the study period (18 weeks), and
  • participating in another weight loss intervention.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Sleep GOALS
Weekly 15-to-20 minute educational video each, a commercial activity tracker (e.g., Fitbit) to monitor sleep and physical activity, wireless scale to monitor weight, and a lifestyle coach who will provide personalized support.
Behavioral: Sleep GOALS
Web-based interventions
Active Comparator: Education
Brochures that provide tips for improving sleep health, diet, and physical activity
Behavioral: Education
Brochures from the American Academy of Sleep Medicine (e.g., sleep hygiene, sleep in women) and SNAP education connection (e.g., family-friendly activities, meal planning)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Recruitment - Number of the Total Sample
Time Frame: Baseline
The number of participants enrolled in 12 months
Baseline
Recruitment - Proportion of Ethnic Minority
Time Frame: Baseline
The proportion of ethnic minority participants was calculated as the percentage of participants who did not identify as Non-Hispanic White. For this study, 'Ethnic Minority' includes participants who self-identified as: (1) Hispanic or Latino (of any race), or (2) Non-Hispanic and any of the following races: American Indian or Alaska Native, Asian, Native Hawaiian or Other Pacific Islander, Black or African American, or More than One Race.
Baseline
Retention Rate
Time Frame: Post-intervention at week 17
Retention rate is defined as the number of participants who completed the final study visit at week 17, divided by the total number of participants randomized in each arm.
Post-intervention at week 17
Engagement - Number of Modules Completed
Time Frame: Week 1 to 16
The number of modules completed within 16 weeks
Week 1 to 16
Engagement - Number of Self-monitoring of Diet, Sleep and Physical Activity Weekly
Time Frame: Week 1 to 16
The number of weeks in which self-monitoring of diet, sleep, and physical activity is performed at least once a week
Week 1 to 16
Engagement - Number of Weekly Weigh-ins
Time Frame: Week 1 to 16
The number of weeks in which weigh-in is performed at least once a week
Week 1 to 16
Engagement - Total Time Logged in
Time Frame: Week 1 to 16
Total time logged in during the 16-week intervention
Week 1 to 16
Acceptability - Proportion of Agreeing
Time Frame: Assessed weekly from Week 1 to Week 16; average score across all weeks reported.
Acceptability was assessed using a weekly 3-item intervention acceptability questionnaire focused on the participants' experience with the intervention. This outcome specifically reports on three key items: (1) the usefulness of implementing weekly action plans, (2) the clarity of content regarding overcoming barriers or challenges, and (3) the ease of using the intervention platform. Participants rated their level of agreement with statements such as 'The weekly action plans were useful for my behavior change' and 'The materials clearly addressed how to manage barriers.' Each item scored from 1 to 5 (1=Strongly Disagree to 5=Strongly Agree). A higher score represents a higher level of acceptability. Acceptability scores were assessed weekly from Week 1 to Week 16. The value reported represents the average score across all 16 weeks.
Assessed weekly from Week 1 to Week 16; average score across all weeks reported.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Weight Change
Time Frame: Baseline and Post-intervention at week 17
Baseline and post-intervention differences in weight. Weight was measured with a digital scale, with the participant wearing light clothing at baseline and post-intervention.
Baseline and Post-intervention at week 17
Number of Participants With Postpartum Weight Retention >11 Lbs
Time Frame: Post-intervention at week 17
Postpartum Weight Retention was calculated as the difference between the measured weight at post-intervention and the self-reported pre-pregnancy weight. This measure reports the number of participants who retained more than 11 pounds of weight compared to their pre-pregnancy weight.
Post-intervention at week 17

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pittsburgh

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marquis Hawkins, PhD, University of Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 21, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 22, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 22, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 23, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 3, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 12, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY23020169
  • K01HL161439 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that underlie the results reported in the article after deidentification (text, tables, figures, and appendices)

IPD Sharing Time Frame

Data will be made available after primary outcome manuscripts are published. Data will remain available in de-identified format with no end date specified.

IPD Sharing Access Criteria

Data will be shared with investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. Researchers requesting use of data must submit their request in writing to the MPIs, including the purpose for which they are requesting use of the data. These requests will be reviewed by the Investigators and will require engaging in a Data Use Agreement (DUA), in cooperation with the University of Pittsburgh. Data will be shared to achieve aims in the approved proposal. We plan to use the Open Science generalist platform to share data, as requested. As the study is completed, we will share data using the NIDA data share website.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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