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

NCT03571893 | Completed

• 1 other identifier: 18-1026
• Study Type: interventional
• Target: 373
• Locations: 3 countries
• Sites: 4

Brief Summary

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.

Conditions

Weight Loss; Weight Change, Body; Obesity; Diet Modification

Outcome Measures

Primary Outcomes (1)

• Change in Weight from Baseline to Month 12

  Weight will be measured in kg on a digital scale

  Baseline, Month 12

Secondary Outcomes (33)

• Change in weight from Baseline to Month 3

  Baseline, Month 3

• Change in Body Mass Index (BMI) from Baseline to Month 3

  Baseline, Month 3

• Change in Body Mass Index (BMI) from Baseline to Month 12

  Baseline, Month 12

• Percent weight change at Month 3

  Month 3

• Percent weight change at Month 12

  Month 12

Study Arms (2)

Weight Watchers Freestyle (Flex)

EXPERIMENTAL

Participate in Commercially Available behavioral weight loss program delivered by Weight Watchers International in the community

Behavioral: Weight Watchers Freestyle (Flex)

DIY Personal Plan

ACTIVE COMPARATOR

Receive informational resources for healthy lifestyle change to promote weight loss

Behavioral: DIY Personal Plan

Interventions

Weight Watchers Freestyle (Flex) BEHAVIORAL

Participants will be referred to their local Weight Watchers meeting and provided with a promotional code to allow them to participate in the Weight Watchers program free of charge for 12 months. At the randomization visit, study staff will help participants identify a convenient Weight Watchers meeting location and download the program app onto their smartphone.

Weight Watchers Freestyle (Flex)

DIY Personal Plan BEHAVIORAL

Participants will be provided with a written resource with descriptions of a variety of approaches that have been shown to promote healthy weight loss through behavioral modification. Participants will be encouraged to assess their preferences for dietary change and physical activity and adopt an approach that will lead to negative energy balance and moderate (1-2 lbs. per week) weight loss.

DIY Personal Plan

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• WW International Inc: collaborator

Study Sites (4)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27615, United States

Location

University of British Columbia-Okanagan

Kelowna, British Columbia, V1V 1V7, Canada

Location

University of British Columbia-Vancouver

Vancouver, British Columbia, V1V 1V7, Canada

Location

University of Leeds

Leeds, United Kingdom

Location

Related Publications (1)

• Tate DF, Lutes LD, Bryant M, Truesdale KP, Hatley KE, Griffiths Z, Tang TS, Padgett LD, Pinto AM, Stevens J, Foster GD. Efficacy of a Commercial Weight Management Program Compared With a Do-It-Yourself Approach: A Randomized Clinical Trial. JAMA Netw Open. 2022 Aug 1;5(8):e2226561. doi: 10.1001/jamanetworkopen.2022.26561.

  PMID: 35972742 DERIVED

MeSH Terms

Conditions

Weight Loss; Body Weight Changes; Obesity

Condition Hierarchy (Ancestors)

Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Deborah F. Tate, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessor will be blinded to participant treatment condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned to one of two conditions, with assessments occurring prior to randomization, at 3 months and 12 months. Participants will be referred to either Weight Watchers or provided DIY resources. Study staff will not deliver intervention.

Study Record Dates

• First Submitted: June 1, 2018
• First Posted: June 28, 2018
• Study Start: June 19, 2018
• Primary Completion: November 4, 2019
• Study Completion: November 4, 2019
• Last Updated: March 13, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1); US (1); CA (2)