WW Improving Nutrition Study: A Randomized Controlled Trial (WINS)

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.

Study Overview

• Status: Completed
• Conditions: Overweight and Obesity
• Intervention / Treatment: Behavioral: WW; Behavioral: Control

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 376
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Savannah, Georgia, United States, 31419
      • Georgia Southern University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Access to WW app for 6 months; Participants will be randomized to access the WW application for 6 months	Behavioral: WW; 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.
Placebo Comparator: Control; Participants will be randomized to receive emails with information available from myplate.gov	Behavioral: Control; Usual care with information from myplate.gov

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Georgia Southern University
• Collaborators: Indiana University; WW International Inc
• Investigators: Principal Investigator: Ana M Palacios, MD, PhD, Georgia Southern

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2023
• Primary Completion (Actual): November 22, 2023
• Study Completion (Actual): December 1, 2023

Study Registration Dates

• First Submitted: December 5, 2022
• First Submitted That Met QC Criteria: December 5, 2022
• First Posted (Actual): December 13, 2022

Study Record Updates

• Last Update Posted (Actual): April 16, 2025
• Last Update Submitted That Met QC Criteria: April 11, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: digital health; diet quality; behavioral weight management
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight
• Other Study ID Numbers: H23120

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Participant data used in publications will be made available in a public repository. Data will be deidentified.
• IPD Sharing Time Frame: Will be made public after publications.
• IPD Sharing Access Criteria: Will be public
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No