Weight LossSGOALSNCT05942326
Sleep Goal-focused Online Access to Lifestyle Support
A study testing Sleep GOALS and Education in people with Weight Loss and Weight, Body, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Weight Loss, Weight, Body
- What is being tested?
- Sleep GOALS and Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2023to 22 Jan 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261
About this study
Official title: 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.
- Conditions
- Weight Loss, Weight, Body
- Being tested
- Sleep GOALS, Education
- Medical subject headings
- Weight Loss, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep GOALSBehavioural
Web-based interventions
EducationBehavioural
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Sleep GOALS |
| Education | Active comparator | Brochures that provide tips for improving sleep health, diet, and physical activity Receives: Behavioral: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment - Number of the Total Sample
The number of participants enrolled in 12 months
Measured: 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.
Measured: 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.
Measured: Post-intervention at week 17
Engagement - Number of Modules Completed
The number of modules completed within 16 weeks
Measured: 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
Measured: 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
Measured: Week 1 to 16
Engagement - Total Time Logged in
Total time logged in during the 16-week intervention
Measured: 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.
Measured: Assessed weekly from Week 1 to Week 16; average score across all weeks reported.
Secondary outcomes (2)
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.
Measured: 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.
Measured: Post-intervention at week 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start21 Sep 2023
- Primary completion22 Jan 2025
- Study completion22 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Weight LossStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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)
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Marquis Hawkins, University of Pittsburgh
- Investigators
- Marquis Hawkins, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05942326
- Sponsor's protocol ID
- STUDY23020169
- Other IDs
- K01HL161439
- Acronym
- SGOALS
- Status last verified
- Mar 2026
- First submitted
- 23 May 2023
- Last updated
- 24 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in the article after deidentification (text, tables, figures, and appendices)
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.
PubMed 41233902
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep GOALS (Goal-focused Online Access to Lifestyle Support), an Internet Assisted Diet, Physical Activity, and Sleep Weight Loss Intervention for Postpartum Women
- ClinicalTrials.gov ID
- NCT05942326
- Acronym / sponsor ID
- SGOALS / STUDY23020169
- Conditions
- Weight Loss, Weight, Body
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 21 Sep 2023 (actual)
- Primary completion
- 22 Jan 2025 (actual)
- Study completion
- 22 Jan 2025 (actual)
- First posted
- 12 Jul 2023 (actual)
- Results
- Posted 24 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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)
| Arm | Type | Receives |
|---|---|---|
| Sleep GOALS | Experimental | Behavioral: Sleep GOALSWeekly 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. |
| Education | Active comparator | Behavioral: EducationBrochures that provide tips for improving sleep health, diet, and physical activity |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep GOALSWeb-based interventions | Behavioural | Sleep GOALS |
| EducationBrochures 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) | Behavioural | Education |
Primary outcome
Recruitment - Number of the Total Sample
Time frame: Baseline
The number of participants enrolled in 12 months
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.
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.
Engagement - Number of Modules Completed
Time frame: Week 1 to 16
The number of modules completed within 16 weeks
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
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
Engagement - Total Time Logged in
Time frame: Week 1 to 16
Total time logged in during the 16-week intervention
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.
2 secondary outcomes
Weight Change
Time frame: Baseline and Post-intervention at week 17
Number of Participants With Postpartum Weight Retention >11 Lbs
Time frame: Post-intervention at week 17
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41233902Hawkins 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.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in the article after deidentification (text, tables, figures, and appendices)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marquis Hawkins, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep GOALS and Education in people with Weight Loss and Weight, Body, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment - Number of the Total Sample (time frame: Baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05942326, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.