April 26, 2019
December 11, 2019
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.
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.
|Experimental: Modified WW Food program
Participants will be assigned to a SmartPoints budget and number and types of ZeroPoint foods.
Behavioral: Modified WW Food program
Participants will receive a structured, holistic, behavioral weight management program that encourages development of healthy habits to help individuals eat healthier, move more, and shift to a more helpful mindset.
- 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
- 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
- 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
- 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
- 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
- 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
United States, South Carolina
Medical University of South Carolina
Medical University of South Carolina