Sleep Goal-focused Online Access to Lifestyle Support (SGOALS)

Sleep GOALS (Goal-focused Online Access to Lifestyle Support), an Internet Assisted Diet, Physical Activity, and Sleep Weight Loss Intervention for Postpartum Women

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.

16-week pilot study will use a single-blind, parallel-arm randomized controlled trial design. Participants will be randomized at a 1:1 ratio to Sleep GOALS intervention (n=20) or an education control group (n=20)

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.

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)

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

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).

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.

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.

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.

Individual participant data that underlie the results reported in the article after deidentification (text, tables, figures, and appendices)

Data will be made available after primary outcome manuscripts are published. Data will remain available in de-identified format with no end date specified.

Data will be shared with investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. Researchers requesting use of data must submit their request in writing to the MPIs, including the purpose for which they are requesting use of the data. These requests will be reviewed by the Investigators and will require engaging in a Data Use Agreement (DUA), in cooperation with the University of Pittsburgh. Data will be shared to achieve aims in the approved proposal. We plan to use the Open Science generalist platform to share data, as requested. As the study is completed, we will share data using the NIDA data share website.