---
title: "WW Improving Nutrition Study: A Randomized Controlled Trial"
nct_id: NCT05648344
overall_status: COMPLETED
phase: NA
sponsor: Georgia Southern University
study_type: INTERVENTIONAL
primary_condition: Overweight and Obesity
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05648344.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05648344"
ct_last_update_post_date: 2025-04-16
last_seen_at: "2026-05-12T07:21:47.885Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# WW Improving Nutrition Study: A Randomized Controlled Trial

**NCT ID:** [NCT05648344](https://clinicaltrials.gov/study/NCT05648344)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 376
- **Lead Sponsor:** Georgia Southern University
- **Collaborators:** WW International Inc, Indiana University
- **Conditions:** Overweight and Obesity
- **Start Date:** 2023-01-19
- **Completion Date:** 2023-12-01
- **CT.gov Last Update:** 2025-04-16

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 70 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Access to WW app for 6 months** (EXPERIMENTAL) — Participants will be randomized to access the WW application for 6 months
- **Control** (PLACEBO_COMPARATOR) — Participants will be randomized to receive emails with information available from myplate.gov

## 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.
- **Control** (BEHAVIORAL) — Usual care with information from myplate.gov

## Primary Outcomes

- **Diet quality (Healthy Eating Index - 2015 score)** _(time frame: Baseline to 6-months)_ — Diet quality scores (HEI-2015 total score), measured with the Automated Self-Administered Dietary Assessment Tool 24-hour dietary recalls (ASA 24)

## Secondary Outcomes

- **Percent (%) body weight loss** _(time frame: Baseline to 6-months)_
- **Achievement of 3% weight loss** _(time frame: Baseline to 6-months)_
- **Achievement of 5% weight loss** _(time frame: Baseline to 6-months)_
- **Achievement of 10% weight loss** _(time frame: Baseline to 6-months)_
- **Impact of weight on quality of life** _(time frame: Baseline to 6-months)_
- **Feelings of hunger over the past 7 days** _(time frame: Baseline to 6-months)_
- **Food cravings** _(time frame: Baseline to 6-months)_
- **Self-reported physical activity over the past 7 days** _(time frame: Baseline to 6-months)_
- **Self-reported Wellbeing** _(time frame: Baseline to 6-months)_
- **Perceived stress** _(time frame: Baseline to 6-months)_
- **Habit strength** _(time frame: Baseline to 6-months)_
- **Alternate Mediterranean Diet Score (AMED)** _(time frame: Baseline to 6-months)_
- **Dietary intake** _(time frame: Baseline to 6-months)_
- **Self-reported sleep quality** _(time frame: Baseline to 6-months)_
- **HEI-2015 component-scores** _(time frame: Baseline to 6-months)_

## Locations (1)

- Georgia Southern University, Savannah, Georgia, United States

## Recent Field Changes (last 30 days)

- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.georgia southern university|savannah|georgia|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT05648344.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT05648344*  
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