Study of an International Commercial Program on Weight Loss and Health Outcomes

Completed · Not applicable

Conditions studied: Weight Loss, Weight Change, Body, Obesity, Diet Modification

In brief

This study is a randomized controlled trial (RCT) of the Weight Watchers (WW) Freestyle ® (Flex® in UK) weight loss program compared to a control group following a do-it-yourself (DIY) approach for 12 months. Participants in the United States, Canada and the UK (n=360 total) will be randomly assigned to either participate in the commercially available WW program in their local community or to follow their own approach for weight loss. This study will examine the impact of the WW program on weight, fitness levels, quality of life, health behaviors and other health outcomes in overweight and obese adults after 3 and 12 months.

Key facts

Study ID

NCT03571893

Run by

University of North Carolina, Chapel Hill

People needed

373

Starts

2018-06-19

Expected to finish

2019-11-04

Last updated by the study team

2020-03-13

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female ages 18-75 years
• With or without previous WW experience
• Self-reported height/weight resulting in a Body Mass Index (BMI) of 25 to 45 (will be confirmed at the Baseline Assessment visit).
• Self report that he/she feels the need to lose weight.
• Willing to discontinue any current over-the-counter (OTC) supplements not recommended/prescribed by physician, with the exception of multivitamins or other vitamin supplement.
• Willing to be randomized to one of two groups and follow recommendations according to study protocol.
• Willing to include demographic information (e.g., ethnicity, income and education).
• Use of a personal smartphone (iOS 9.0 or Android 4.1)
• The willingness and ability to download, navigate and use applications on their smartphone on a daily basis (minimum training will be provided)
• Ability to commit to attending study assessment visits at 0, 3 and 12 months
• Residing within 30 miles of a study assessment location
• Read, write and speak English

You may not qualify if…

• Participants that were a member of Weight Watchers within the past 12 months.
• Unwilling to refrain from using Weight Watchers if assigned to the DIY group.
• Participants that are involved in any other research studies at this time (also, cannot join other research studies while in this study, over the next 12 months) that would interfere with their ability to adhere to the protocol (i.e., attend assessment visits, attend WW meetings).
• Given birth past six months, currently pregnant, or planning on becoming pregnant over the next 12 months.
• Weight loss of ≥ 5 kg in the previous 6 months (and kept > 5 kg off).
• Ever been diagnosed with an eating disorder (anorexia nervosa, bulimia).
• Reported health problems that make weight loss or unsupervised exercise unsafe or unreasonable (e.g., 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 Qsymia, Contrave, etc.) with the exception of subjects on a stable dose of Selective serotonin reuptake inhibitors (SSRIs) for 6 months
• Currently have chronic/inflammatory gastrointestinal disorder (irritable bowel syndrome acceptable).
• History of heart problems (e.g., angina, bypass surgery, myocardial infarction, etc.) within previous 6 months.
• Resting systolic blood pressure >160 mmHg or resting diastolic blood pressure >100 mmHg (confirmed at baseline visit)
• Currently have type 1 or type 2 diabetes
• Ever had surgical procedure for weight loss.
• Major surgery within the previous 6 months that would interfere with consuming a regular diet and performing physical activity such as walking.
• Presence of implanted cardiac defibrillator or pacemaker.
• History of cancer within past 5 years or current treatment for cancer (completely resected basal or squamous cell carcinoma acceptable if treatment completed more than 6 months prior to enrollment).
• Hospitalization for psychiatric problems during the past 12 months
• Planning to relocate in the next 12 months
• Another member of the household is participating in this research study

Where it is running

• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• University of British Columbia-Okanagan — Kelowna, British Columbia, Canada
• University of British Columbia-Vancouver — Vancouver, British Columbia, Canada
• University of Leeds — Leeds, United Kingdom

Full record on ClinicalTrials.gov

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