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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
40
Web-based interventions
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)
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Recruitment - Number of the Total Sample
The number of participants enrolled in 12 months
Time frame: 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.
Time frame: 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.
Time frame: Post-intervention at week 17
Engagement - Number of Modules Completed
The number of modules completed within 16 weeks
Time frame: 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
Time frame: 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
Time frame: Week 1 to 16
Engagement - Total Time Logged in
Total time logged in during the 16-week intervention
Time frame: Week 1 to 16
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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.
Time frame: Assessed weekly from Week 1 to Week 16; average score across all weeks reported.
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.
Time frame: Baseline and Post-intervention at week 17
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.
Time frame: Post-intervention at week 17