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

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: Completed
• Conditions: Weight Loss; Weight, Body
• Intervention / Treatment: Behavioral: Sleep GOALS; Behavioral: Education

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight Change	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	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

• Sponsor: University of Pittsburgh
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Marquis Hawkins, PhD, University of Pittsburgh

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2023
• Primary Completion (Actual): January 22, 2025
• Study Completion (Actual): January 22, 2025

Study Registration Dates

• First Submitted: May 23, 2023
• First Submitted That Met QC Criteria: July 3, 2023
• First Posted (Actual): July 12, 2023

Study Record Updates

• Last Update Posted (Actual): March 24, 2026
• Last Update Submitted That Met QC Criteria: March 3, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight Changes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Weight Loss; Body Weight; Socioeconomic Factors; Population Characteristics; Educational Status
• Other Study ID 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