Clinical trial NCT05648344: WW Improving Nutrition Study: A Randomized Controlled Trial
Official title: WW Improving Nutrition Study: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Keywords: behavioral weight management
digital health
diet quality
Lead sponsor: Georgia Southern University
Sponsor class: OTHER
Collaborators: name: WW International Inc
name: Indiana University
First posted: 2022-12-13
Enrollment: 376
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Diet quality (Healthy Eating Index - 2015 score)
timeFrame: Baseline to 6-months
Secondary outcomes:
measure: Percent (%) body weight loss
timeFrame: Baseline to 6-months
measure: Achievement of 3% weight loss
timeFrame: Baseline to 6-months
measure: Achievement of 5% weight loss
timeFrame: Baseline to 6-months
measure: Achievement of 10% weight loss
timeFrame: Baseline to 6-months
measure: Impact of weight on quality of life
timeFrame: Baseline to 6-months
measure: Feelings of hunger over the past 7 days
timeFrame: Baseline to 6-months
measure: Food cravings
timeFrame: Baseline to 6-months
measure: Self-reported physical activity over the past 7 days
timeFrame: Baseline to 6-months
measure: Self-reported Wellbeing
timeFrame: Baseline to 6-months
measure: Perceived stress
timeFrame: Baseline to 6-months
measure: Habit strength
timeFrame: Baseline to 6-months
measure: Alternate Mediterranean Diet Score (AMED)
timeFrame: Baseline to 6-months
measure: Dietary intake
timeFrame: Baseline to 6-months
measure: Self-reported sleep quality
timeFrame: Baseline to 6-months
measure: HEI-2015 component-scores
timeFrame: Baseline to 6-months
Other outcomes:
Locations:
city: Savannah
country: United States
facility: Georgia Southern University
state: Georgia
Study officials:
affiliation: Georgia Southern
name: Ana M Palacios, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: