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.

Study Overview

• Status: Recruiting
• Conditions: Weight Loss; Weight, Body
• Intervention / Treatment: Behavioral: Sleep GOALS; Behavioral: Education

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marquis Hawkins, PhD; Phone Number: 412-532-9476; Email: momstudy@pitt.edu

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15261
      • Recruiting
      • University of Pittsburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Marquis Hawkins, PhD, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: May 23, 2023
• First Submitted That Met QC Criteria: July 3, 2023
• First Posted (Actual): July 12, 2023

Study Record Updates

• Last Update Posted (Actual): November 2, 2023
• Last Update Submitted That Met QC Criteria: November 1, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight Changes; Weight Loss; Body Weight
• Other Study ID Numbers: STUDY23020169; 1K01HL161439-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in the article after deidentification (text, tables, figures, and appendices)
• IPD Sharing Time Frame: Data will be made available after primary outcome manuscripts are published. Data will remain available in de-identified format with no end date specified.
• IPD Sharing Access Criteria: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No