Overweight and ObesityWINSNCT05648344
WW Improving Nutrition Study: A Randomized Controlled Trial
A study testing WW in people with Overweight and Obesity, run by Georgia Southern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- WW
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 376 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jan 2023to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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.
Who cannot join
- 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
Show all 22Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Georgia Southern University
Savannah, Georgia, 31419
About this study
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.
Read the 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
- Being tested
- WW, Control
- Keywords
- behavioral weight management, digital health, diet quality
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WWBehavioural
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.
ControlBehavioural
Usual care with information from myplate.gov
| Study group | Role | What they receive |
|---|---|---|
| Access to WW app for 6 months | Experimental | Participants will be randomized to access the WW application for 6 months Receives: Behavioral: WW |
| Control | Placebo comparator | Participants will be randomized to receive emails with information available from myplate.gov Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline to 6-months
Secondary outcomes (15)
Percent (%) body weight loss
Weight (lb); % body weight loss defined as baseline to 6-month weight change divided by baseline weight multiplied by 100.
Measured: Baseline to 6-months
Achievement of 3% weight loss
Proportion of participants that achieve at least 3% body weight loss at 6 months
Measured: Baseline to 6-months
Achievement of 5% weight loss
Proportion of participants that achieve at least 5% body weight loss at 6 months
Measured: Baseline to 6-months
Achievement of 10% weight loss
Proportion of participants that achieve at least 10% body weight loss at 6 months
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
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.
Measured: 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)
Measured: 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
Measured: Baseline to 6-months
HEI-2015 component-scores
Measured with the Automated Self-Administered Dietary Assessment Tool 24-hour dietary recalls (ASA24®).
Measured: Baseline to 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2022
- Study start19 Jan 2023
- Primary completion22 Nov 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 376 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgia Southern University
- Sponsor type
- University, hospital or other
- Collaborators
- WW International Inc, Indiana University
- Responsible party
- Principal investigator, Ana Palacios, Georgia Southern University
- Investigators
- Ana M Palacios, MD, PhD, Principal investigator, Georgia Southern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05648344
- Sponsor's protocol ID
- H23120
- Acronym
- WINS
- Status last verified
- Apr 2025
- First submitted
- 5 Dec 2022
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Participant data used in publications will be made available in a public repository. Data will be deidentified.
Publications
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.
PubMed 40609748
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WW Improving Nutrition Study: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05648344
- Acronym / sponsor ID
- WINS / H23120
- Conditions
- Overweight and Obesity
- Keywords
- behavioral weight management, digital health, diet quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 376 participants (actual)
- Lead sponsor
- Georgia Southern UniversityUniversity, hospital or other
- Collaborators
- WW International Inc, Indiana University
- Study start
- 19 Jan 2023 (actual)
- Primary completion
- 22 Nov 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 13 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Access to WW app for 6 months | Experimental | Behavioral: WWParticipants will be randomized to access the WW application for 6 months |
| Control | Placebo comparator | Behavioral: ControlParticipants will be randomized to receive emails with information available from myplate.gov |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WWWW 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. | Behavioural | Access to WW app for 6 months |
| ControlUsual care with information from myplate.gov | Behavioural | Control |
Primary outcome
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)
15 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Derived from this study: PubMed 40609748Palacios 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.
- Individual participant dataSharing planned: Yes. Participant data used in publications will be made available in a public repository. Data will be deidentified.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana M Palacios, MD, PhD principal investigator
Georgia Southern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WW in people with Overweight and Obesity, run by Georgia Southern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diet quality (Healthy Eating Index - 2015 score) (time frame: Baseline to 6-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05648344, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.