WW Improving Nutrition Study: A Randomized Controlled Trial

NCT05648344 | Completed

• 1 other identifier: H23120
• Study Type: interventional
• Target: 376
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight and Obesity

Keywords

behavioral weight management; digital health; diet quality

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• Percent (%) body weight loss

  Baseline to 6-months

• Achievement of 3% weight loss

  Baseline to 6-months

• Achievement of 5% weight loss

  Baseline to 6-months

• Achievement of 10% weight loss

  Baseline to 6-months

• Impact of weight on quality of life

  Baseline to 6-months

Study Arms (2)

Access to WW app for 6 months

EXPERIMENTAL

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

Behavioral: WW

Control

PLACEBO COMPARATOR

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

Behavioral: Control

Interventions

WW 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.

Access to WW app for 6 months

Control BEHAVIORAL

Usual care with information from myplate.gov

Control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Georgia Southern University: lead
• WW International Inc: collaborator
• Indiana University: collaborator

Study Sites (1)

Georgia Southern University

Savannah, Georgia, 31419, United States

Location

Related Publications (1)

• 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.

  PMID: 40609748 DERIVED

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ana M Palacios, MD, PhD

  Georgia Southern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 5, 2022
• First Posted: December 13, 2022
• Study Start: January 19, 2023
• Primary Completion: November 22, 2023
• Study Completion: December 1, 2023
• Last Updated: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Will be made public after publications.
• Access Criteria: Will be public

Locations

US (1)