Trial Outcomes & Findings for Sleep Goal-focused Online Access to Lifestyle Support (NCT NCT05942326)

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.

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.

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.

The number of participants enrolled in 12 months

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 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.

The number of modules completed within 16 weeks

The number of weeks in which self-monitoring of diet, sleep, and physical activity is performed at least once a week

The number of weeks in which weigh-in is performed at least once a week

Total time logged in during the 16-week intervention

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.

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.

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.