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

Georgia Southern University

Status

Completed

Conditions

Overweight and Obesity

Treatments

Behavioral: Control

Behavioral: WW

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05648344

H23120

Details and patient eligibility

About

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.

Full 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.

Enrollment

376 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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