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Behavioural Intervention
Sleep-Focused Lifestyle Support for Postpartum Weight Loss (SGOALS Trial)
N/A
Recruiting
Led By Marquis Hawkins, PhD
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights
SGOALS Trial Summary
This trial will assess a new approach to help postpartum people lose weight by improving sleep, diet, and exercise habits. 40 people will be recruited to test its effectiveness.
Who is the study for?
This trial is for new mothers who are 3 to 6 months postpartum, overweight with a BMI over 25, not very active (less than 150 minutes of exercise per week), and have poor sleep according to the RU_SATED questionnaire. They must have a smartphone, internet at home, and be willing to follow the study plan.Check my eligibility
What is being tested?
The study tests a new weight loss program called Sleep GOALS that aims to improve sleep, diet, and physical activity. Participants will either receive this intervention or just educational material. The goal is to see if it's feasible, acceptable, and effective in helping lose weight.See study design
What are the potential side effects?
Since this trial involves lifestyle changes rather than medication there may not be traditional side effects; however participants might experience fatigue or stress from adjusting their routines or using new technologies involved in the program.
SGOALS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 1 to 16
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 1 to 16
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Acceptability - Proportion of agreeing
Engagement - Number of modules completed
Engagement - Number of self-monitoring of diet, sleep and physical activity weekly
+5 moreSecondary outcome measures
Postpartum weight retention
Weight change
SGOALS Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Sleep GOALSExperimental Treatment1 Intervention
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.
Group II: EducationActive Control1 Intervention
Brochures that provide tips for improving sleep health, diet, and physical activity
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Who is running the clinical trial?
University of PittsburghLead Sponsor
1,723 Previous Clinical Trials
16,343,116 Total Patients Enrolled
24 Trials studying Weight Loss
4,156 Patients Enrolled for Weight Loss
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,840 Previous Clinical Trials
47,852,084 Total Patients Enrolled
37 Trials studying Weight Loss
7,721 Patients Enrolled for Weight Loss
Marquis Hawkins, PhDPrincipal InvestigatorUniversity of Pittsburgh
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am taking medication that affects my weight.I gave birth between 4 and 7 months ago.
Research Study Groups:
This trial has the following groups:- Group 1: Education
- Group 2: Sleep GOALS
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What criteria must individuals fulfill to participate in this experiment?
"Candidates for this medical trial should be within the ages of 18 and 45, with a history of weight loss. Approximately 40 participants are needed to fulfil requirements."
Answered by AI
Does the criteria for entry into this trial encompass those over 65 years of age?
"The specified age limits of this trial are 18 and 45, respectively. All participants must be within these boundaries to qualify for enrolment."
Answered by AI
Is there still an opportunity to join this clinical investigation?
"As verified on clinicaltrials.gov, this medical study is not currently recruiting participants. Initially posted on August 1st 2023 and last modified on July 3rd 2023, the trial has yet to begin seeking applicants; however there are 325 other trials actively accepting candidates at present."
Answered by AI
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