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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05942326
Other study ID # STUDY23020169
Secondary ID 1K01HL161439-01
Status Recruiting
Phase N/A
First received
Last updated
Start date September 21, 2023
Est. completion date December 2024

Study information

Verified date November 2023
Source University of Pittsburgh
Contact Marquis Hawkins, PhD
Phone 412-532-9476
Email momstudy@pitt.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Sleep GOALS
Web-based interventions
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)

Locations

Country Name City State
United States University of Pittsburgh Pittsburgh Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
University of Pittsburgh National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

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