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| ID | Type | Description | Link |
|---|---|---|---|
| K01HL161439 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Education | Active Comparator | Brochures that provide tips for improving sleep health, diet, and physical activity |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sleep GOALS | Behavioral | Web-based interventions |
| |
| Education |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marquis Hawkins, PhD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15261 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41233902 | Derived | 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. |
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Individual participant data that underlie the results reported in the article after deidentification (text, tables, figures, and appendices)
Data will be made available after primary outcome manuscripts are published. Data will remain available in de-identified format with no end date specified.
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.
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After initial eligibility pre-screening, eligible participants provided written informed consent. Baseline assessments were completed prior to randomization. Participants were excluded before assignment if they no longer met eligibility criteria, including changes in pregnancy status, initiation of another weight-loss intervention, or identification of medical contraindications to physical activity.
Participants were recruited from Allegheny County, Pennsylvania, using multiple strategies, including a university-based research registry (Pitt+Me), university-wide email listservs, online recruitment platforms, targeted mailings through obstetric databases, community-based organizations, and clinician referral programs. Recruitment occurred over approximately 11 months at academic medical and community-affiliated clinical settings.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Education | Brochures that provide tips for improving sleep health, diet, and physical activity |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The baseline analysis population included all participants who were randomized into the Sleep GOALS or Education groups. There were no differences between the baseline analysis population and the numbers assigned to each arm.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Education |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Participant age in years at baseline. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Recruitment - Number of the Total Sample | The number of participants enrolled in 12 months | Posted | Count of Participants | Participants | Baseline |
|
|
From enrollment until end of follow-up, up to 17 weeks
Adverse events were monitored through weekly coaching check-ins for the intervention group and spontaneous self-reporting for the control group.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Marquis Hawkins | University of Pittsburgh | 412-347-1634 | mah400@pitt.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 28, 2024 | Jan 19, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 3, 2024 | Jan 21, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D015431 | Weight Loss |
| D001835 | Body Weight |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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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)
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| 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) |
|
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. |
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 |
Brochures that provide tips for improving sleep health, diet, and physical activity |
| BG002 | Total | Total of all reporting groups |
Baseline age data were not collected for a subset of participants (n=4 in the Sleep GOALS Arm and n=4 in the Education Arm) because these individuals were enrolled prior to a protocol amendment that added an age question to the baseline questionnaire. Age was initially only verified as being ≥18 years for eligibility without recording the specific age.
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Participant sex at baseline | Count of Participants | Participants |
|
| Race (NIH/OMB) | Race reported by participants at baseline | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Ethnicity as reported by participants at baseline | Count of Participants | Participants |
|
| Education | Highest Level of Education | Count of Participants | Participants |
|
| Marital Status | Participants' marital status at baseline | Count of Participants | Participants |
|
| Income | Annual household income at baseline | Count of Participants | Participants |
|
| Number of people in household | Number of people in household at baseline | Mean | Standard Deviation | people |
|
| Years in the US | Number of years in the US | Mean | Standard Deviation | years |
|
| English Language Proficiency | English language proficiency was assessed using a self-reported 4-point scale (Very Well, Well, Not Well, Not at All). Participants were asked to subjectively rate their own ability to speak English. 'Very Well' represents the highest level of self-perceived proficiency, while 'Well' indicates a high level of functional proficiency but with more perceived effort or less fluency than the 'Very Well' category. | Count of Participants | Participants |
|
| Weight | Participants' weight at baseline | Mean | Standard Deviation | lbs |
|
| Depressive Symptoms | The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report questionnaire used to screen for postnatal depressive symptoms. Each item is scored on a 4-point scale (0 to 3), resulting in a total score ranging from 0 to 30. A higher total score indicates more severe depressive symptoms. | Mean | Standard Deviation | Score on a scale |
|
| Stress | The Perceived Stress Scale (PSS) is a 14-item self-report questionnaire used to measure the degree to which situations in one's life are appraised as stressful. Each item is rated on a 5-point scale (0 to 4), resulting in a total score ranging from 0 to 56. A higher total score indicates greater perceived stress. | Mean | Standard Deviation | Score on a scale |
|
| Postpartum Functioning | The Barkin Index of Maternal Functioning (BIMF) is a 20-item self-report questionnaire designed to assess a mother's functional status during the postpartum period. Each item is scored on a 7-point Likert scale (0 to 6), resulting in a total score ranging from 0 to 120. A higher total score indicates a higher level of maternal functioning. | Mean | Standard Deviation | Score on a scale |
|
| Diet Quality | The Healthy Eating Index (HEI) is a measure of diet quality used to assess how well a set of foods aligns with the Dietary Guidelines for Americans. The total score is calculated by summing multiple component scores, resulting in a total score ranging from 0 to 100. A higher total score indicates better diet quality and closer alignment with dietary recommendations. | Mean | Standard Deviation | Score on a scale |
|
| Multidimensional Sleep Health | A 5-item version of the Multidimensional Sleep Health (RU-SATED) scale was used to assess sleep health. This version includes five dimensions: Regularity, Satisfaction, Alertness, Timing, and Efficiency (excluding the Duration item). Each item is scored on a 3-point scale (0 = Rarely/never, 1 = Sometimes, 2 = Usually/always), resulting in a total score ranging from 0 to 10. A higher total score indicates better sleep health. | Mean | Standard Deviation | Score on a scale |
|
| Physical Activity | Participants were categorized into two groups based on the sample-specific median of total physical activity levels, measured using the Pregnancy Physical Activity Questionnaire (PPAQ). The median value was calculated from the baseline data of all study participants. The 'At or Above Median' group includes participants with physical activity scores greater than or equal to the sample median, and the 'Below Median' group includes those with scores below the sample median. | Count of Participants | Participants |
|
|
| Primary | 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. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Primary | 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. | Posted | Count of Participants | Participants | Post-intervention at week 17 |
|
|
|
| Primary | Engagement - Number of Modules Completed | The number of modules completed within 16 weeks | Only Sleep GOALS group completed modules. | Posted | Mean | Standard Deviation | modules | Week 1 to 16 |
|
|
|
| Primary | 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 | Due to a malfunction of the tracking software on the SGOALS platform, participants were unable to record weekly weight, sleep, physical activity, and dietary data. The malfunction also prevented monitoring of log-ins and platform usage. As a result, no participant-level data were captured or stored, and no participants were measured or analyzed. Retrospective recovery is not possible, and no future data collection is planned. | Posted | Mean | Standard Deviation | weeks | Week 1 to 16 |
|
|
| Secondary | 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. | The weight change analysis population included 14 participants in Sleep GOALS group and 13 participants in Education group with complete baseline and post-intervention weight data. Participants lost to follow-up were excluded due to missing post-intervention measurements. | Posted | Mean | Standard Deviation | lb | Baseline and Post-intervention at week 17 |
|
|
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| Secondary | 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. | The weight change analysis population included 14 participants in Sleep GOALS group and 13 participants in Education group with complete baseline and post-intervention weight data. Participants lost to follow-up were excluded due to missing post-intervention measurements. | Posted | Count of Participants | Participants | Post-intervention at week 17 |
|
|
|
| Primary | Engagement - Number of Weekly Weigh-ins | The number of weeks in which weigh-in is performed at least once a week | Due to a malfunction of the tracking software on the SGOALS platform, participants were unable to record weekly weight, sleep, physical activity, and dietary data. The malfunction also prevented monitoring of log-ins and platform usage. As a result, no participant-level data were captured or stored, and no participants were measured or analyzed. Retrospective recovery is not possible, and no future data collection is planned. | Posted | Mean | Standard Deviation | weeks | Week 1 to 16 |
|
|
| Primary | Engagement - Total Time Logged in | Total time logged in during the 16-week intervention | Due to a malfunction of the tracking software on the SGOALS platform, participants were unable to record weekly weight, sleep, physical activity, and dietary data. The malfunction also prevented monitoring of log-ins and platform usage. As a result, no participant-level data were captured or stored, and no participants were measured or analyzed. Retrospective recovery is not possible, and no future data collection is planned. | Posted | Mean | Standard Deviation | hours | Week 1 to 16 |
|
|
| Primary | 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. | Only Sleep GOALS group completed modules and acceptability surveys. | Posted | Mean | Standard Deviation | Score on a scale | Assessed weekly from Week 1 to Week 16; average score across all weeks reported. |
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|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Education | Brochures that provide tips for improving sleep health, diet, and physical activity | 0 | 20 | 0 | 20 | 0 | 20 |
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| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Unknown or Not Reported |
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| Bachelor's degree |
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| Master's degree |
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| Doctorate or Professional degree |
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| $30,000-$39,999 |
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| $40,000-$49,999 |
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| $50,000-$59,999 |
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| $60,000-$74,999 |
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| $75,000-$99,999 |
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| $100,000-$149,999 |
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| $150,000-$199,999 |
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| $200,000 or more |
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| Don't know |
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| Prefer not to answer |
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| Not well |
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| Not at all |
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