Sleep Goal-focused Online Access to Lifestyle Support

Not Applicable

Completed

• Conditions: Weight, Body; Weight Loss
• Interventions: Behavioral: Sleep GOALS; Behavioral: Education

• Registration Number: NCT05942326
• Lead Sponsor: University of Pittsburgh

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-23
• Study First Submitted QC: 2023-07-03
• Study First Posted: 2023-07-12
• Study Start: 2023-09-21
• Primary Completion: 2025-01-22
• Study Completion: 2025-01-22
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sleep GOALS	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.
Education	Education	Brochures that provide tips for improving sleep health, diet, and physical activity

Primary Outcome Measures

Name	Time	Method
Engagement - Total time logged in	Week 1 to 16	Total time logged in during the 16-week intervention
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 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
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).
Recruitment/Enrollment - Number of the total sample	Baseline	The number of participants enrolled in 12 months
Engagement - Number of modules completed	Week 1 to 16	The number of modules completed within 16 weeks
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

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States