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

University of Pittsburgh

Status: Completed

Conditions: Weight Loss; Weight, Body

Treatments: Behavioral: Sleep GOALS; Behavioral: Education

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05942326

STUDY23020169

K01HL161439 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Sleep GOALS

Experimental group

Description:

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.

Treatment:

Behavioral: Sleep GOALS

Education

Active Comparator group

Description:

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

Treatment:

Behavioral: Education