Sleep Goal-focused Online Access to Lifestyle Support

NCT05942326 | Completed Results

• 2 other identifiers: STUDY23020169K01HL161439
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Weight Loss; Weight, Body

Outcome Measures

Primary Outcomes (8)

• Recruitment - Number of the Total Sample

  The number of participants enrolled in 12 months

  Baseline

• Recruitment - Proportion of Ethnic Minority

  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

  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

  The number of modules completed within 16 weeks

  Week 1 to 16

• Engagement - Number of Self-monitoring of Diet, Sleep and Physical Activity Weekly

  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

  The number of weeks in which weigh-in is performed at least once a week

  Week 1 to 16

• Engagement - Total Time Logged in

  Total time logged in during the 16-week intervention

  Week 1 to 16

• Acceptability - Proportion of Agreeing

  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 Outcomes (2)

• Weight Change

  Baseline and Post-intervention at week 17

• Number of Participants With Postpartum Weight Retention >11 Lbs

  Post-intervention at week 17

Study Arms (2)

Sleep GOALS

EXPERIMENTAL

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

Education

ACTIVE COMPARATOR

Brochures that provide tips for improving sleep health, diet, and physical activity

Behavioral: Education

Interventions

Sleep GOALS BEHAVIORAL

Web-based interventions

Sleep GOALS

Education BEHAVIORAL

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)

Education

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15261, United States

Location

Related Publications (1)

• Hawkins MS, Davis EM, Abebe KZ, McTigue KM, Kim N, Goswami M, Buysse DJ, Chang JC, Levine MD. An internet-assisted sleep, dietary, and physical activity intervention to support weight-loss among postpartum people (Sleep GOALS): protocol for a pilot randomized controlled trial. Pilot Feasibility Stud. 2025 Nov 13;11(1):140. doi: 10.1186/s40814-025-01733-2.

  PMID: 41233902 DERIVED

MeSH Terms

Conditions

Weight Loss; Body Weight

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Body Weight Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Results Point of Contact

• Title: Dr. Marquis Hawkins
• Organization: University of Pittsburgh

mah400@pitt.edu

412-347-1634

Study Officials

• Marquis Hawkins, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 16-week pilot study will use a single-blind, parallel-arm randomized controlled trial design. Participants will be randomized at a 1:1 ratio to Sleep GOALS intervention (n=20) or an education control group (n=20)

Study Record Dates

• First Submitted: May 23, 2023
• First Posted: July 12, 2023
• Study Start: September 21, 2023
• Primary Completion: January 22, 2025
• Study Completion: January 22, 2025
• Last Updated: March 24, 2026
• Results First Posted: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• 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.
• 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.

Locations

US (1)