SGOALS: Sleep Goal-focused Online Access to Lifestyle Support
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| 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)
|
Outcome Measures
Primary Outcome Measures
- Recruitment/Enrollment - Number of the total sample [Baseline]
The number of participants enrolled in 12 months
- Recruitment/Enrollment - Proportion of ethnic minority [Baseline]
The proportion of ethnic minority
- Retention rates [Post-intervention at week 17]
1-Attrition rates, % with complete post-intervention data collection
- Engagement - Number of modules completed [Week 1 to 16]
The number of modules completed within 16 weeks
- Engagement - Number of self-monitoring of diet, sleep and physical activity weekly [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 [Week 1 to 16]
The number of weeks in which weigh-in is performed at least once a week
- Engagement - Total time logged in [Week 1 to 16]
Total time logged in during the 16-week intervention
- Acceptability - Proportion of agreeing [Week 1 to Post-intervention at week 17]
Participant ratings on the intervention delivery; behavior change curricula; action plan; intervention platform. The questionnaire asks participants to provide answers on a 5-point scale (1=don't agree at all to 5=totally agree) to 39 items about the intervention delivery (e.g., logical, understandable), curricula (e.g., was it logical, relevant, instructive), action plans (e.g., useful, easy to follow), and intervention platform (e.g., user friendly).
Secondary Outcome Measures
- Weight change [Baseline and Post-intervention at week 17]
Baseline and post-intervention differences in weight. Weight will be measured with a digital scale, with the participant wearing light clothing and no shoes at baseline and post-intervention.
- Postpartum weight retention [Post-intervention at week 17]
Pre-pregnancy and post-intervention differences in weight. Participants will self-report pre-pregnancy weight, and post-intervention weight will be measured with a digital scale, with the participant wearing light clothing and no shoes. The power-to-weight ratio (PWR) will be estimated as the difference in measured weight at post-intervention and self-reported pre-pregnancy weight.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Stated willingness to comply with all study procedures and availability for the duration of the study,
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Primiparous, singleton pregnancy,
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Between 3+1 and 6+1 months postpartum,
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Has a body mass index >25 kg/m2,
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Physically inactive, defined as self-reporting <150 minutes/week of moderate-to-vigorous intensity physical activity,
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Endorse >1 indicator of poor sleep health based on the RU_SATED questionnaire, and
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Has smartphone and home Internet access
Exclusion Criteria:
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current use of medications that affect weight,
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currently pregnant or plan to become pregnant during the study period (18 weeks), and
-
participating in another weight loss intervention.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Pittsburgh | Pittsburgh | Pennsylvania | United States | 15261 |
Sponsors and Collaborators
- University of Pittsburgh
- National Heart, Lung, and Blood Institute (NHLBI)
Investigators
- Principal Investigator: Marquis Hawkins, PhD, University of Pittsburgh
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STUDY23020169
- 1K01HL161439-01