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Completed

NCT Number: NCT05942326

Sleep Goal-focused Online Access to Lifestyle Support

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.

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Key information

Conditions

Weight Loss Body Weight Body Weight Changes Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight, Body

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15261, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sleep GOALS

Behavioral

Web-based interventions

Education

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)

Primary outcomes

  1. Recruitment - Number of the Total Sample

    Time frame: Baseline

    The number of participants enrolled in 12 months

  2. Recruitment - Proportion of Ethnic Minority

    Time frame: Baseline

    The proportion of ethnic minority participants was calculated as the percentage of participants who did not identify as Non-Hispanic White. For this study, 'Ethnic Minority' includes participants who self-identified as: (1) Hispanic or Latino (of any race), or (2) Non-Hispanic and any of the following races: American Indian or Alaska Native, Asian, Native Hawaiian or Other Pacific Islander, Black or African American, or More than One Race.

  3. Retention Rate

    Time frame: Post-intervention at week 17

    Retention rate is defined as the number of participants who completed the final study visit at week 17, divided by the total number of participants randomized in each arm.

  4. Engagement - Number of Modules Completed

    Time frame: Week 1 to 16

    The number of modules completed within 16 weeks

  5. Engagement - Number of Self-monitoring of Diet, Sleep and Physical Activity Weekly

    Time frame: Week 1 to 16

    The number of weeks in which self-monitoring of diet, sleep, and physical activity is performed at least once a week

  6. Engagement - Number of Weekly Weigh-ins

    Time frame: Week 1 to 16

    The number of weeks in which weigh-in is performed at least once a week

  7. Engagement - Total Time Logged in

    Time frame: Week 1 to 16

    Total time logged in during the 16-week intervention

  8. Acceptability - Proportion of Agreeing

    Time frame: Assessed weekly from Week 1 to Week 16; average score across all weeks reported.

    Acceptability was assessed using a weekly 3-item intervention acceptability questionnaire focused on the participants' experience with the intervention. This outcome specifically reports on three key items: (1) the usefulness of implementing weekly action plans, (2) the clarity of content regarding overcoming barriers or challenges, and (3) the ease of using the intervention platform. Participants rated their level of agreement with statements such as 'The weekly action plans were useful for my behavior change' and 'The materials clearly addressed how to manage barriers.' Each item scored from 1 to 5 (1=Strongly Disagree to 5=Strongly Agree). A higher score represents a higher level of acceptability. Acceptability scores were assessed weekly from Week 1 to Week 16. The value reported represents the average score across all 16 weeks.

Secondary outcomes

  1. Weight Change

    Time frame: Baseline and Post-intervention at week 17

    Baseline and post-intervention differences in weight. Weight was measured with a digital scale, with the participant wearing light clothing at baseline and post-intervention.

  2. Number of Participants With Postpartum Weight Retention >11 Lbs

    Time frame: Post-intervention at week 17

    Postpartum Weight Retention was calculated as the difference between the measured weight at post-intervention and the self-reported pre-pregnancy weight. This measure reports the number of participants who retained more than 11 pounds of weight compared to their pre-pregnancy weight.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Sleep GOALS (Goal-focused Online Access to Lifestyle Support), an Internet Assisted Diet, Physical Activity, and Sleep Weight Loss Intervention for Postpartum Women

Acronym: SGOALS

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 12, 2023
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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