Evaluation of a Commercial Program on Weight Loss and Health Outcomes

Medical University of South Carolina (MUSC)

Status and phase

Completed

Early Phase 1

Conditions

Weight Loss

Obesity

Treatments

Behavioral: Modified WW Food program

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03928483

Pro00085970

Details and patient eligibility

About

To examine weight loss and acceptability of a modified WW program. This study is designed to detect differences in weight loss at the end of 24 weeks of intervention.

Full description

This trial is an examination of a modified WW food program. The intention is to document the acceptability and efficacy of the dietary plan over 24 weeks. Subjects will participate in a program similar to WW Freestyle and have access to study-specific weekly workshops and a suite of study-specific digital tools for tracking eating, activity, and weight. Within a WW program, participants are provided instructions on calculating points for the foods and beverages they eat and drink. This study will examine the impact of the modified WW food program on weight and fitness levels of adults with overweight and obesity.

Enrollment

143 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

Ages 18-75 years
Body Mass Index (BMI) of 25 to 43
Self-reported desire to lose weight
Willing to discontinue any current over-the-counter (OTC) supplements not recommended/prescribed by physician, with the exception of multivitamins or other vitamin supplement
Willing to follow recommendations required by study protocol
Willing to include demographic information (e.g., ethnicity, income and education)
Use of a personal iPhone on a daily basis
Basic app skills
Reliable home Wi-Fi access
Ability to commit to attending up to 27 study visits in approximately 26 weeks

Exclusion Criteria

Participants that are currently, or within the last 6 months, trying to lose weight by following guidelines (e.g., self-initiated programs) or 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 months.
Participants who are involved in any other research studies at this time (also, cannot join other research studies while in this study, over the next 6 months).
Pregnant, nursing, or planning on becoming pregnant over the next 9 months.
Weight loss of ≥ 5 kg in the previous 6 months.
History of clinically diagnosed eating disorder.
Reported health problems that make weight loss or unsupervised exercise unsafe or unreasonable (e.g., orthopedic limitations, heart problems)
Untreated thyroid disease or any changes (type or dose) in thyroid medication in last 6 months.
Taking any prescription medication with known effects on appetite or weight (e.g., oral steroids, weight loss medications such as Qysmia, Contrave, etc.) with the exception of subjects on a stable dose of SSRIs for 6 months
Diuretic use, unless taken on a regular, daily basis for hypertension and on a stable dose for at least 30 days
Chronic/inflammatory gastrointestinal disorders (irritable bowel syndrome is acceptable).
History of heart problems (e.g., angina, bypass surgery, myocardial infarction, etc.) within previous 6 months.
Resting systolic blood pressure >160 mmHg or resting diastolic blood pressure >100 mmHg
Diagnosis of type 1 or type 2 diabetes
Previous surgical procedure for weight loss.
Major surgery within the previous 6 months.
Presence of implanted cardiac defibrillator or pacemaker.
History of cancer within past 5 years or current treatment for cancer (completely resected basal or squamous cell carcinoma acceptable if treatment completed more than 6 months prior to enrollment).
Hospitalization for psychiatric disorders during the past 12 months
Self-reported alcohol use > 7/week standard drinks for females and > 14/week for males or meets DSM-5 criteria for mild or greater, Alcohol Use Disorder
Planning to relocate in the next 9 months