Evaluation of a Commercial Program on Weight Loss and Health Outcomes

Study Overview
=================
Brief Summary
-----------------
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.

Detailed 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.

Official Title
-----------------
Evaluation of a Commercial Program on Weight Loss and Health Outcomes

Conditions
-----------------
Obesity, Weight Loss

Intervention / Treatment
-----------------
* Behavioral: Modified WW Food program


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: This single-armed trial will have one condition: the modified WW Food program.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Modified WW Food program<br>Participants will be assigned to a SmartPoints budget and number and types of ZeroPoint foods. | Behavioral: Modified WW Food program<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body weight change (kg) | average body weight change (kg) from baseline to six months | baseline to six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-month change in weight (kg) | average 3-month change in weight (kg) | baseline to 3-months | 
| 3-month change in weight, as a percentage of start weight | 3-month change in weight, as a percentage of start weight | baseline to 3-months | 
| 6-month changes in body weight as a percentage of start weight | 6-month changes in body weight as a percentage of start weight | baseline to 6-months | 
| changes in Body Mass Index (BMI) | changes in Body Mass Index (BMI) | baseline, 3-months and 6-months | 
| waist circumference | change in waist circumference as measured at natural waist with a non-stretch tape measure. | baseline, 3-months and 6-months | 
| flexibility | change in flexibility as measured via standard sit-and-reach protocol | baseline, 3-months and 6-months | 
| aerobic stamina | change in aerobic stamina as measured with the 6-minute walk test | baseline, 3-months and 6-months | 
| blood pressure | change in blood pressure as measured by a blood pressure monitor | baseline, 3-months and 6-months | 
| food cravings | change in reported food cravings as measured by the FCI-II | baseline, 3-months and 6-months | 
| happiness | change in reported happiness as measured using the Oxford Happiness Questionnaire | baseline, 3-months and 6-months | 
| sleep quality and duration: Pittsburgh Sleep Quality Index | change in sleep quality and duration as measured by the Pittsburgh Sleep Quality Index | baseline, 3-months and 6-months | 
| weight related quality of life: Impact of Weight Related Quality of Life- Lite (IWQOL-Lite) | change in reported weight related quality of life as measured by the Impact of Weight Related Quality of Life- Lite (IWQOL-Lite) | baseline, 3-months and 6-months | 
| subjective sensations of hunger | change in subjective sensations of hunger as measured by the Hunger Visual Analog Scale | baseline, 3-months and 6-months | 
| personal food assessment | changes in reported personal food assessment as measured by the Block Food Frequency Questionnaire | baseline and 6-months | 
| program satisfaction: WW generated satisfaction questionnaire | program satisfaction as measured by the WW generated satisfaction questionnaire | 3-months and 6-months | 
| health related quality of life: SF-36 | changes in reported health related quality of life as measured through the SF-36 | baseline, 3-months and 6-months |