A Randomized Controlled Trial Comparing the Efficacy of Commercial Weight Management Programs

WW International Inc

Status: Completed

Conditions: Obesity and Overweight

Treatments: Behavioral: Commercial weight management program

Study type: Interventional

Funder types: Industry

Identifiers

NCT06972277

The ACE Study

Details and patient eligibility

About

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

Enrollment: 459 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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459 participants in 3 patient groups

Commercial weight management program 1

Experimental group

Description:

Participants in this group receive behavioral / lifestyle support from an evidence-based commercial weight management program.

Treatment:

Behavioral: Commercial weight management program

Commercial weight management program 2

Experimental group

Description:

Participants in this group receive behavioral / lifestyle support from an evidence-based commercial weight management program.

Treatment:

Behavioral: Commercial weight management program

Commercial weight management program 3

Experimental group

Description:

Participants in this group receive behavioral / lifestyle support from an evidence-based commercial weight management program.

Treatment:

Behavioral: Commercial weight management program