Sleep Goal-focused Online Access to Lifestyle Support

Study Overview
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Brief Summary
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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.

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

Conditions
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Weight Loss, Weight, Body

Intervention / Treatment
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* Behavioral: Sleep GOALS
* Behavioral: Education


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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)
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sleep GOALS<br>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. | Behavioral: Sleep GOALS<br>* Web-based interventions<br>|
| Active Comparator: Education<br>Brochures that provide tips for improving sleep health, diet, and physical activity | Behavioral: Education<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment/Enrollment - Number of the total sample | The number of participants enrolled in 12 months | Baseline | 
| Recruitment/Enrollment - Proportion of ethnic minority | The proportion of ethnic minority | Baseline | 
| Retention rates | 1-Attrition rates, % with complete post-intervention data collection | Post-intervention at week 17 | 
| Engagement - Number of modules completed | The number of modules completed within 16 weeks | 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 | 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 | Week 1 to 16 | 
| Engagement - Total time logged in | Total time logged in during the 16-week intervention | Week 1 to 16 | 
| Acceptability - Proportion of agreeing | 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). | Week 1 to Post-intervention at week 17 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight change | 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. | Baseline and Post-intervention at week 17 | 
| Postpartum weight retention | 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. | Post-intervention at week 17 |