What side effects are associated with this type of intervention?

Behavioral modifications for weight loss, including improving sleep, diet, and physical activity, are generally safe but can have some side effects. Improving sleep may initially cause changes in sleep patterns and temporary sleep disturbances. Dietary changes can lead to gastrointestinal issues such as bloating, constipation, or diarrhea as the body adjusts to new foods. Increasing physical activity may result in muscle soreness, fatigue, or minor injuries, especially if the individual is not accustomed to regular exercise. Overall, these side effects are typically mild and transient.

What prior FDA approvals exist?

FDA-approved treatments for weight loss that align with the behavioral modification approach include medications such as orlistat, which reduces fat absorption, and liraglutide, which regulates appetite. Additionally, combination drugs like phentermine-topiramate and naltrexone-bupropion have been approved for their synergistic effects on appetite suppression and energy expenditure. These pharmacological treatments are often recommended alongside lifestyle interventions focusing on diet, physical activity, and behavioral changes to enhance overall efficacy in weight management.

What other types of research exist?

Promising alternatives to Sleep GOALS for weight loss patients include: 1) Cognitive Behavioral Therapy for Insomnia (CBT-I), which has shown efficacy in improving sleep and related health outcomes. 2) Combined physical exercise and dietary therapy, which has been effective in managing weight and improving cardiometabolic health. 3) Digital health interventions, such as internet-delivered CBT-I, which offer accessibility and tailored support for sleep, diet, and physical activity improvements.

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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

Summary

This trial aims to help new mothers lose weight by improving their sleep, diet, and physical activity through the Sleep GOALS program. The study will test if this approach is practical and effective.

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 1 to 16

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 1 to 16

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 1 to 16 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acceptability - Proportion of agreeing

Engagement - Number of modules completed

Engagement - Number of self-monitoring of diet, sleep and physical activity weekly

+5 more

Secondary study objectives

Postpartum weight retention

Weight change

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

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common weight loss treatments, particularly those focusing on behavioral modifications like improving sleep, diet, and physical activity, work through several mechanisms. Improved sleep helps regulate hunger and satiety hormones, reducing overeating. Dietary changes reduce caloric intake and improve nutrition, aiding in weight management. Increased physical activity boosts energy expenditure and metabolic rate. These combined strategies create a caloric deficit, enhance metabolic function, and improve overall health, making them effective and sustainable for weight loss patients.

Mindfulness and Behavior Change.Treatment of compulsive exercise in eating disorders and muscle dysmorphia: protocol for a systematic review.A Systematic Review and Network Meta-Analysis of Randomized Controlled Trials Evaluating the Evidence Base of Melatonin, Light Exposure, Exercise, and Complementary and Alternative Medicine for Patients with Insomnia Disorder.

Find a Location

Who is running the clinical trial?

University of PittsburghLead Sponsor

1,762 Previous Clinical Trials

16,347,963 Total Patients Enrolled

24 Trials studying Weight Loss

4,156 Patients Enrolled for Weight Loss

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

3,889 Previous Clinical Trials

47,834,167 Total Patients Enrolled

39 Trials studying Weight Loss

8,036 Patients Enrolled for Weight Loss

Marquis Hawkins, PhDPrincipal InvestigatorUniversity of Pittsburgh

Media Library

Education (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05942326 — N/A

Weight Loss Research Study Groups: Education, Sleep GOALS

Weight Loss Clinical Trial 2023: Education Highlights & Side Effects. Trial Name: NCT05942326 — N/A

Education (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05942326 — N/A

~6 spots leftby Dec 2024

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