Sleep Goal-focused Online Access to Lifestyle Support

NCT ID: NCT05942326

Last Updated: 2025-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-21

Study Completion Date

2025-01-22

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.

Detailed Description

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Conditions

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Weight Loss Weight, Body

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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)
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Sleep GOALS

Intervention Type BEHAVIORAL

Web-based interventions

Education

Brochures that provide tips for improving sleep health, diet, and physical activity

Group Type ACTIVE_COMPARATOR

Education

Intervention Type BEHAVIORAL

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)

Interventions

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Sleep GOALS

Web-based interventions

Intervention Type 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)

Intervention Type BEHAVIORAL

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Marquis Hawkins

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marquis Hawkins, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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K01HL161439

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY23020169

Identifier Type: -

Identifier Source: org_study_id

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