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Recruiting NCT05648344

WW Improving Nutrition Study: A Randomized Controlled Trial

Conditions: Overweight and Obesity

Sex: All
Ages: 18 Years – 70 Years
Phase: NA
Enrollment: 376
Sponsor: Georgia Southern University

Location: United States

Summary

The main objective of this study is to determine whether a behavior change weight management and wellness program (WW) delivered via an app for 6-months will be effective in improving diet quality in U.S. adult participants, relative to a control group through a randomized controlled trial.

Eligibility Criteria

Inclusion Criteria:Self-reported desire to lose weightEnglish proficiencyAges: 18 - 70 years oldBMI between 27-45 kg/m2Owns a smartphone with a cameraWi-Fi connectivity at homeWilling to follow recommendations required by study protocolWilling to actively participate in a behavioral weight loss program for 6 months and to attend virtual workshop meetingsWilling to include demographic information (e.g., ethnicity, income, and education)US residence (48 contiguous States)Must be able to receive in the mail a weight scale.Exclusion Criteria:Pregnant, lactating, or plans to become pregnant during study periodSelf-reported bipolar disorder, substance abuse, psychosis, bulimia.Meets criteria for severe depression on the Patient Health Questionnaire-8 (PHQ-8) (score of >20)All other mental health, including other eating disorders will be assessed using a self-report question on the initial screening survey.Had bariatric surgery or plans to have any surgery during the studyUnable or not willing to make dietary changes or increase physical activityUnable to walk ¼ mile unaided without stoppingDaily nicotine user: smoke, vape, tobacco, otherParticipants that are currently trying to lose weight via a structured weight-loss program (e.g., at a medical center, university, commercial programs)Participants who were a member of WW within the past 12 monthsParticipants who are involved in any other research studies at this timeWeight loss of ≥ 5 kg (11 lb) in the previous 6 monthsReported health problems that make weight loss or unsupervised exercise unsafe or unreasonable (e.g., chronic pain, orthopedic limitations, heart problems)Untreated thyroid disease or any changes (type or dose) in thyroid medication in last 6 monthsTaking any prescription medication with known effects on appetite or weight (e.g., oral steroids, weight loss medications such as Qysmia, Contrave, Phentermine (Adipex-P, Lomaira) and others except for subjects on a stable dose of Selective serotonin reuptake inhibitors (SSRIs) for 6 months or longerChronic/inflammatory gastrointestinal disorders (irritable bowel syndrome is acceptable)History of heart problems (e.g., angina, bypass surgery, myocardial infarction, etc.) within previous 6 monthsDiagnosis of type 1 or type 2 diabetesMajor surgery within the previous 6 monthsPresence of implanted cardiac defibrillator or pacemakerHistory of cancer within past 5 years or current treatment for cancerHospitalization for psychiatric disorders during the past 12 months

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05648344). StuddyBuddy aggregates publicly available trial information.