Clinical trial NCT06972277: A Randomized Controlled Trial Comparing the Efficacy of Commercial Weight Management Programs
Official title: The Comparative Effectiveness of Commercial Weight Management Programs in Adults Living With Overweight or Obesity: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity and Overweight
Lead sponsor: WW International Inc
Sponsor class: INDUSTRY
First posted: 2025-05-14
Enrollment: 459
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study compares the effectiveness of three commercial weight management programs. The primary outcome is absolute and percentage weight change at 12-weeks.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* BMI ≥27 kg/m²
* Own a bodyweight scale that they can weigh themselves with during the study
* Willing and able to comply with study protocol
* Capable of providing informed consent
* Able to read and write in English
* Willing to be randomized
* Willing to sign a Non Disclosure Agreement

Exclusion Criteria:

* Pregnant, lactating, or plans to become pregnant in the next 6 months
* Previous bariatric surgery or planned bariatric surgery during the study period
* Major surgery within the past 6 months or plans to have surgery during the study period
* Participation in the previous 3 months or current participation in a structured behavioral weight loss program
* Participation in another structured weight loss program during the study period (i.e., the next 3 months)
* Communication needs that would render them unable to understand the study and/or intervention materials
* Current or previous history of anorexia or bulimia nervosa
* Engagement with vomiting or laxative use within the last 28 days with the aim of controlling their shape or weight
* Currently taking anti-obesity medications, planning to take anti-obesity medications in the next 6 months, or previously taken anti-obesity medications in the previous 3 months
* Weight loss of ≥ 5 kg (11 lb) in the previous 6 months
* Self-reported diagnosis of severe depression, bipolar disorder, substance abuse, or psychosis
* Participants who are involved in any other research studies at this time
* Untreated thyroid disease or any changes (type or dose) in thyroid medication in last 6 months
* 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
* 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 last 12 months

Primary outcomes:
measure: Percent body weight lost at 12 weeks
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
measure: Change in body weight (in kg or pounds) at 12 weeks
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
Secondary outcomes:
measure: Physical Activity and Sedentary Behavior
timeFrame: Baseline, 12 weeks
measure: Dietary intake
timeFrame: Baseline, 12 weeks
measure: Hunger
timeFrame: Baseline, 12 weeks
measure: Impact of Weight on Quality
timeFrame: Baseline, 12 weeks
measure: Wellbeing
timeFrame: Baseline, 12 weeks
measure: Body appreciation
timeFrame: Baseline, 12 weeks
measure: Self-Compassion
timeFrame: Baseline, 12 weeks
measure: Weight Bias Internalization
timeFrame: Baseline, 12 weeks
measure: Food cravings
timeFrame: Baseline, 12 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: WW International, Inc
state: New York
Study officials:
affiliation: WW International Inc
name: Michelle I Cardel, PhD, MS, RD
role: PRINCIPAL_INVESTIGATOR
References: