WW Improving Nutrition Study: A Randomized Controlled Trial

NCT ID: NCT05648344

Last Updated: 2025-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 376 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-19
• Study Completion Date: 2023-12-01

Brief Summary

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

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.

Conditions

Overweight and Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Access to WW app for 6 months

Participants will be randomized to access the WW application for 6 months

Group Type: EXPERIMENTAL

WW

Intervention Type: BEHAVIORAL

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.

Control

Participants will be randomized to receive emails with information available from myplate.gov

Group Type: PLACEBO_COMPARATOR

Control

Intervention Type: BEHAVIORAL

Usual care with information from myplate.gov

Interventions

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.

Intervention Type: BEHAVIORAL

Control

Usual care with information from myplate.gov

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

WW International Inc

INDUSTRY

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: collaborator

Georgia Southern University

OTHER

Sponsor Role: lead

Responsible Party

Ana Palacios

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ana M Palacios, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Georgia Southern

Locations

Georgia Southern University

Savannah, Georgia, United States

Countries

United States

References

Palacios AM, Lee AM, Parker C, Watts CQ, Dickinson SL, Henschel B, Anderson G, Kersey JX, Allison DB, Foster GD, Cardel MI. Effectiveness of a digital weight management program on diet quality: a randomized controlled trial. Am J Clin Nutr. 2025 Sep;122(3):830-840. doi: 10.1016/j.ajcnut.2025.06.024. Epub 2025 Jul 1.

Reference Type: DERIVED

PMID: 40609748 (View on PubMed)

Other Identifiers

H23120

Identifier Type: -

Identifier Source: org_study_id