Sleep Goal-focused Online Access to Lifestyle Support

Weight Loss Clinical Trial

— SGOALS  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05942326
• Other study ID #: STUDY23020169
• Secondary ID: 1K01HL161439-01
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Body Weight
• Weight Loss
• Weight, Body

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