WW Improving Nutrition Study: A Randomized Controlled Trial

Study Overview
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Brief Summary
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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.

Detailed Description
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The WW Unlimited Workshops and Digital Program is an evidence-based behavioral weight management program that guides members toward personal weight and wellness goals through a personalized curriculum, complemented with behavioral weekly goals to drive healthy habits. The program includes foods that can be eaten in moderation without the need to tracking, as well as a points system that rates foods. In addition, members have access to food, activity, water, sleep, and weight trackers, meal planning tools, recipes, guided meditations and workouts, peer support, and access to online workshops and WW-trained behavior change coach. To compare the 6-month changes in diet quality (HEI-2015 total score), in adult participants enrolled in a commercial weight-loss program (WW) vs. control, a total of 376 adults will be recruited via social media and other online platforms in the contiguous 48 States of the US. Participants will be randomly assigned to access the WW app, or a control, and will be followed-up for 6 months.

Official Title
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WW Improving Nutrition Study: A Randomized Controlled Trial

Conditions
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Overweight and Obesity

Intervention / Treatment
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* Behavioral: WW
* Behavioral: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Self-reported desire to lose weight English proficiency Ages: 18 - 70 years old BMI between 27-45 kg/m2 Owns a smartphone with a camera Wi-Fi connectivity at home Willing to follow recommendations required by study protocol Willing to actively participate in a behavioral weight loss program for 6 months and to attend virtual workshop meetings Willing 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 period Self-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 study Unable or not willing to make dietary changes or increase physical activity Unable to walk ¼ mile unaided without stopping Daily nicotine user: smoke, vape, tobacco, other Participants 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 months Participants who are involved in any other research studies at this time Weight loss of ≥ 5 kg (11 lb) in the previous 6 months Reported 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 months Taking 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 longer 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 Diagnosis of type 1 or type 2 diabetes 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 Hospitalization for psychiatric disorders during the past 12 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Access to WW app for 6 months<br>Participants will be randomized to access the WW application for 6 months | Behavioral: WW<br>* WW assigns foods to a point value calculated through a proprietary algorithm that accounts for the food's caloric value, saturated and unsaturated fat, sugar, fiber, and protein. Members are encouraged to track their food and beverage intake, with the goal of staying within their personal points targets assigned based in an individual's sex, age height, weight, goals, and activity. The program also has Zero Point Foods (list of healthy foods with no point value) and can be eaten freely. In addition to the personal points, participants will be asked to attend WW coach-led virtual workshops conducted over Zoom, engage with peer- support, and WW-trained behavior change experts via 24/7 chat.<br>|
| Placebo Comparator: Control<br>Participants will be randomized to receive emails with information available from myplate.gov | Behavioral: Control<br>* Usual care with information from myplate.gov<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diet quality (Healthy Eating Index - 2015 score) | Diet quality scores (HEI-2015 total score), measured with the Automated Self-Administered Dietary Assessment Tool 24-hour dietary recalls (ASA 24) | Baseline to 6-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent (%) body weight loss | Weight (lb); % body weight loss defined as baseline to 6-month weight change divided by baseline weight multiplied by 100. | Baseline to 6-months | 
| Achievement of 3% weight loss | Proportion of participants that achieve at least 3% body weight loss at 6 months | Baseline to 6-months | 
| Achievement of 5% weight loss | Proportion of participants that achieve at least 5% body weight loss at 6 months | Baseline to 6-months | 
| Achievement of 10% weight loss | Proportion of participants that achieve at least 10% body weight loss at 6 months | Baseline to 6-months | 
| Impact of weight on quality of life | Measured using the Impact of Weight on Quality of Life - Lite (IWQOL). The IWQOL-Lite is a reliable and valid brief measure of quality of life in people with obesity. There are 31 items rated on a Likert scale 5-Always True to 1-Never True. Items are broken into subscales for physical function, self-esteem, sexual life, public distress, and work. Subscale scores and total score range from 0-100, with higher scores reflecting better levels of functioning. | Baseline to 6-months | 
| Feelings of hunger over the past 7 days | Measured using a Hunger Visual Analog scale (VAS) which includes a question that asks participants to rate how hungry they felt over the past week on a horizontal line with endpoints of Not at all hungry (0) to Extremely hungry (100). VAS are scored by measuring in where the participant places their tick mark on the horizontal line with endpoints of 0-100. Higher scores indicate greater feelings of hunger. | Baseline to 6-months | 
| Food cravings | Measured using the Food-craving Inventory (FCI-II). The FCI-II is a validated 33-item self-report measure that assesses the subjective experience of food craving across 33 different foods. The FCI-II assesses the frequency of cravings for a specified food with a five-point Likert scale (1, never; 2, rarely; 3, sometimes; 4, often; 5, always) and consists of 5 factors: high fats, sweets, carbohydrates/starches, fast food fats, & fruits and vegetables, that constitute the total food craving inventory score which averages all 33 items. Scores can range between 1 and 5, with higher scores indicating greater frequency of cravings. | Baseline to 6-months | 
| Self-reported physical activity over the past 7 days | Measured using the Global Physical Activity Questionnaire (GPAQ). The GPAQ collects information on physical activity participation in the following domains: activity at work, travel to- and from- places, recreational activities, and sedentary behavior. From these inputs, the minutes per week spent in moderate activity, vigorous activity, moderate and vigorous activity, and sedentary behavior can be calculated. | Baseline to 6-months | 
| Self-reported Wellbeing | Measured using the World Health Organization Well-being Index-5 (WHO-5). The WHO-5 consists of five statements rated by study participants with a Likert Scale: All of the time=5, Most of the time=4, More than half of the time=3, Less than half of the time=2, Some of the time=1, At no time=0. The total raw score, ranging from 0 to 25, is multiplied by 4 to give the final score with 0 representing the worst imaginable well-being and 100 representing the best imaginable well-being. | Baseline to 6-months | 
| Perceived stress | Measured using the Perceived Stress Scale (PSS). The 10-item PSS measures the extent to which a participant's life is unpredictable, uncontrollable, and overloading. It was designed for use in older adolescents and adults, and is considered to have adequate internal reliability and construct validity. Each question asks about how the participant has felt or thought in the past month and uses a 5-point Likert scale (0=never, 4=very often). Scores are calculated by summing responses, creating a possible score range of 0-40, with higher scores indicating greater perceived stress. | Baseline to 6-months | 
| Habit strength | Measured with the Self-Reported Behavioral Automaticity Index. The self-reported behavioral automaticity index (SRBAI) captures habitual patterns of behavior. Each behavior of interest is assessed by 4 items rated on a Likert scale 1-strongly disagree to 7-strongly agree. Scores are calculated for each behavior by taking an average of the response values, creating a possible score range between 1 and 7. Higher scores indicate greater habit strength for the behavior being measured. | Baseline to 6-months | 
| Alternate Mediterranean Diet Score (AMED) | The AMED score includes seven healthy components: a. fruits, b. vegetables, c. fish, d. legumes, e. nuts, f. whole grains, and g. ratio of monounsaturated fat to saturated fat), and two additional components: h. red and processed meat, and i. alcohol consumption. Each component, except alcohol, will be categorized into quintiles (Q) and positive scores to the seven healthy components will be assigned as follows: (Q1=1, Q2=2, Q3=3, Q4=4, Q5=5). Reverse scores to red and processed meat will be assigned as follows: (Q5=1, Q4=2, Q3=3, Q2=4, Q1=5). For alcohol consumption (g/d), points will be assigned as follows: 5-15=5, 0-5 or 15-25=4, 0 or 25-30=3, 30-35=2, and ≥35=1 for women and 10-30=5, 0-10 or 30-40=4, 0 or 40-45=3, 45-50=2, and ≥50=1 for men. | Baseline to 6-months | 
| Dietary intake | Macro- and micro-nutrient intakes will be measured with the validated Automated Self-Administered 24-hour (ASA24®) Dietary Assessment Tool. Participants will be asked to complete three recalls at each timepoint. Participants will be asked to complete three recalls at each timepoint. [Time Frame; Baseline and 6-months] Measured using the measured with the Automated Self-Administered Dietary Assessment Tool 24-hour dietary recalls (ASA 24) | Baseline to 6-months | 
| Self-reported sleep quality | Measured with the sleep assessment module from the validated Automated Self-Administered 24-hour (ASA24®) Dietary Assessment Tool | Baseline to 6-months | 
| HEI-2015 component-scores | Measured with the Automated Self-Administered Dietary Assessment Tool 24-hour dietary recalls (ASA24®). | Baseline to 6-months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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behavioral weight management, digital health, diet quality