Clinical trial NCT05942326: Sleep Goal-focused Online Access to Lifestyle Support
Official title: Sleep GOALS (Goal-focused Online Access to Lifestyle Support), an Internet Assisted Diet, Physical Activity, and Sleep Weight Loss Intervention for Postpartum Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Loss
Weight, Body
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2023-07-12
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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)
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Recruitment/Enrollment - Number of the total sample
timeFrame: Baseline
measure: Recruitment/Enrollment - Proportion of ethnic minority
timeFrame: Baseline
measure: Retention rates
timeFrame: Post-intervention at week 17
measure: Engagement - Number of modules completed
timeFrame: Week 1 to 16
measure: Engagement - Number of self-monitoring of diet, sleep and physical activity weekly
timeFrame: Week 1 to 16
measure: Engagement - Number of weekly weigh-ins
timeFrame: Week 1 to 16
measure: Engagement - Total time logged in
timeFrame: Week 1 to 16
measure: Acceptability - Proportion of agreeing
timeFrame: Week 1 to Post-intervention at week 17
Secondary outcomes:
measure: Weight change
timeFrame: Baseline and Post-intervention at week 17
measure: Postpartum weight retention
timeFrame: Post-intervention at week 17
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Marquis Hawkins, PhD
role: PRINCIPAL_INVESTIGATOR
References: