N/A
Completed N=40
Sleep Goal-focused Online Access to Lifestyle Support
Weight Loss · Weight, Body
Source: ClinicalTrials.gov NCT05942326 ↗
Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Mar 2026
Primary outcomePrimary: Recruitment - Number of the Total Sample — 40 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Recruitment - Number of the Total Sample |
40 | — |
| PRIMARY Recruitment - Proportion of Ethnic Minority |
2; 6 | — |
| PRIMARY Retention Rate |
14; 14 | — |
| PRIMARY Engagement - Number of Modules Completed |
10.8 | — |
| PRIMARY Engagement - Number of Self-monitoring of Diet, Sleep and Physical Activity Weekly |
— | — |
| PRIMARY Engagement - Number of Weekly Weigh-ins |
— | — |
| PRIMARY Engagement - Total Time Logged in |
— | — |
| PRIMARY Acceptability - Proportion of Agreeing |
4.2; 3.7; 3.6 | — |
| SECONDARY Weight Change |
-3.08; -2.88 | — |
| SECONDARY Number of Participants With Postpartum Weight Retention >11 Lbs |
5; 5 | — |
Eligibility Criteria
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 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.
Data sourced from ClinicalTrials.gov (NCT05942326). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.