Clinical trial NCT03571893: Study of an International Commercial Program on Weight Loss and Health Outcomes
Official title: Randomized Controlled Trial of an International Commercial Program on Weight Loss and Health Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Loss
Weight Change, Body
Obesity
Diet Modification
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: WW International Inc
First posted: 2018-06-28
Enrollment: 373
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: The purpose of this study is to compare the effectiveness of the Weight Watchers program delivered in the community to a DIY approach for weight loss.

Potential participants will be recruited through a variety of advertisement methods. Those individuals responding to these advertisements will undergo web-based preliminary screening. Initially eligible individuals will be contacted by phone to receive more detailed information and to complete screening. Eligible and interested participants will be consented in person and complete screening assessments that will be used to confirm eligibility (height and weight to determine body mass index, resting blood pressure. For participants deemed to be eligible and randomized to participate in this study, these measures will also be used as their baseline data from analysis. Additional data collection will be collected at the baseline assessment visit, with assessments repeated at 3 months and after the intervention at 12 months. Assessments will include the following:

Height and Weight Resting Blood Pressure and Heart Rate Aerobic Stamina Flexibility Waist Circumference Dietary Intake Additional Questionnaires to assess demographics, sleep, food cravings, hunger and satiety, weight control strategies, affect, lifestyle activities

Group assignment will be revealed to study participants in a separate visit/contact after all assessment procedures and randomization is completed. The contact will last 15-30 minutes and participants will be provided with the resources they need to either follow the Weight Watchers program or the DIY approach. The Weight Watchers orientation and DIY intervention will not be provided by staff who collect measurements in order to preserve the blinding of the measurement staff. Following randomization reveal, the staff will maintain communication in order to promote retention (e.g., birthday card or small token reinforcer such as a water bottle sent to all participants).

WEIGHT WATCHERS FREESTYLE (FLEX) GROUP Intervention Description Participants randomized to the WW Freestyle (Flex) treatment arm will be referred to their local WW Meetings + Online Plus program delivered at a WW center / meeting convenient to them. At the randomization visit, they will be provided with a code to sign up for the Weight Watchers program free of charge for 12 months. They will also be guided to download the smartphone app on their phone, provided with a list of local meetings, and instructed on how to start the Weight Watchers intervention.

The following describes the weight loss intervention that is delivered solely through the commercially available Weight Watchers program. Measurement staff will not be involved in delivery of this intervention.

Program type. Participants will receive a program with a structured, lifestyle modification, weight-loss methodology. Specifically, it will include 1) a food plan, which is based on balanced diet and healthy eating, 2) an activity plan, designed to promote progressive physical activity increase, 3) group support, and 4) cognitive behavior modification. Participants will determine their weight goal and will be encouraged to utilize all intervention components.

Beyond the Scale. This holistic and personalized program focuses on multiple ways for participants to define success, on and off the scale. The three main components are: eating healthier, moving more, and finding and shifting the study subject's mindset.

Weekly meetings. Weight Watchers members attend weekly Weight Watchers meetings conducted in local commercial centers with a group Leader and a receptionist and last30-60 minutes. Meetings consist of lesson delivery of a new behavioral skill or knowledge transfer on healthy habits, check-ins with each participant on their previous week, and group discussions on the week's topic and application of that skill in their own lives. The discussions are led by Weight Watchers Leaders, who are Lifetime members who have successfully achieved and maintained a healthier body weight through the Weight Watchers program, and have successfully completed a leader skills training course and ongoing professional development and quality assurance (QA). WW participants have their weight measured at each meeting on regularly calibrated scales.

Intervention materials. Weight Watchers participants receive: 1) access to an app for food and activity tracking, 2) welcome packet a menu of 'how to's' and inspiration to get started and weekly lesson plans delivered by the Meeting Leader, 3) weekly take-home skill builder worksheet and content within the app 4) Weight Watchers emails, and 4) access to social support from other WW Leaders and WW members through on online support portal.

Dietary goals. Dietary plan. The core of the Food Program is the SmartPoints® weight loss system, which is a method of self-monitoring dietary intake. The SmartPoints system assigns each food and beverage a SmartPoints value per portion based on its nutrition, factoring in four components: calories, sugar, saturated fat, and protein. SmartPoints encourages a healthier pattern of eating. This is translated into the following general guidelines: certain foods have a SmartPoints value of zero which includes plant-based proteins, skinless chicken and turkey breast, eggs, non-fat yogurt, skinless fish, fruits and most vegetables (excludes starchy vegetables). For foods outside these categories, foods higher in lean protein, such as lean cuts of steak and ham, have lower SmartPoints values while foods higher in unhealthy saturated fats and sugar have higher Smartpoints values

SmartPoints Budget. Based on the Mifflin St-Jeor formula, which factors in age, gender, height, and weight, participants will get a personalized SmartPoints Budget. The SmartPoints budget consists of: a daily SmartPoints Target plus an extra bank of Weekly SmartPoints for flexibility. Participants are free to spend their SmartPoints however they wish and can 'roll over' up to 4 SmartPoints a day into their weeklies for added flexibility.

Food Log. Participants will be encouraged to track their SmartPoints each day on the Weight Watchers app provided to them. Within the app there is a wealth of tools to help find and track food choices, which includes; a barcode scanner to quickly identify foods, recipes, restaurant and grocery store items in a database.

Activity goals. FitPoints. A large part of the Beyond the Scale program is the FitPoints™ system, which is a method of self-monitoring physical activity. The FitPoints system assigns each activity a FitPoint value based on its duration (minutes) and intensity based on a participant's current weight and FitPoints emphasizes activity because it feels good, not solely as a means to swap for SmartPoints. FitPoints highlights that all activity counts and adds up; "some is better than none".

FitPoints goal. Participants will receive a personalized daily FitPoints goal based on their fitness level and goals.

Activity Log Participants will be encouraged to track their FitPoints each day on the Weight Watchers app provided to them.

Mindset Approach. The Weight Watchers Freestyle/Flex program promotes the adoption of skills and techniques to adopt a positive mindset in order to support lifestyle change and healthy weight Participants receive digital and print materials around these topics and in person support in the meetings.

DO-IT-YOURSELF GROUP Participants randomized to the DIY group will be provided with a brief resource guide with basic information about a variety of healthful behavioral weight loss approaches (meal plans, apps for calorie tracking, meal replacements, dietary approaches to reduce calories healthfully such as following a low fat or low carb diet, and moderate physical activity) and encouraged to choose an approach that would fit with their lifestyle. The resource guide will provide model "profiles" of lifestyle factors that may help the individual choose the approach that would work best for them. These approaches are consistent with information that can be found in the general press and will be limited to approaches that are deemed healthful by weight loss and medical professionals. Participants will be informed that many people follow a DIY approach and can be successful (will reference the National Weight Control Registry which is a research-based registry of individuals who have lost weight and kept is off successfully; 50% of whom followed a DIY approach). For retention, participants in the DIY group will be notified that if they choose to utilize WW after the completion of the study, they will be offered free vouchers for 12 months of the WW program.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in Weight from Baseline to Month 12
timeFrame: Baseline, Month 12
Secondary outcomes:
measure: Change in weight from Baseline to Month 3
timeFrame: Baseline, Month 3
measure: Change in Body Mass Index (BMI) from Baseline to Month 3
timeFrame: Baseline, Month 3
measure: Change in Body Mass Index (BMI) from Baseline to Month 12
timeFrame: Baseline, Month 12
measure: Percent weight change at Month 3
timeFrame: Month 3
measure: Percent weight change at Month 12
timeFrame: Month 12
measure: Change in Blood pressure from Baseline to Month 3
timeFrame: Baseline, Month 3
measure: Change in Blood pressure from Baseline to Month 12
timeFrame: Baseline, Month 12
measure: Change in resting pulse from Baseline to Month 3
timeFrame: Baseline, Month 3
measure: Change in resting pulse from Baseline to Month 12
timeFrame: Baseline, Month 12
measure: Change in Sleep Scores from Baseline to Month 3
timeFrame: Baseline, Month 3
measure: Change in Sleep Scores from Baseline to Month 12
timeFrame: Baseline, Month 12
measure: Change in Food craving Scores from Baseline to Month 3
timeFrame: Baseline, Month 3
measure: Change in Food craving Scores from Baseline to Month 12
timeFrame: Baseline, Month 12
measure: Change in VAS Scores for Hunger and fullness from Baseline to Month 3
timeFrame: Baseline, Month 3
measure: Change in VAS Scores for Hunger and fullness from Baseline to Month 12
timeFrame: Baseline, Month 12
measure: Change in weight control strategies used from Baseline to Month 3
timeFrame: Baseline, Month 3
measure: Change in weight control strategies used from Baseline to Month 12
timeFrame: 12 months
measure: Change in Dietary intake Score from Baseline to Month 3
timeFrame: Baseline, Month 3
measure: Change in Happiness Scores from Baseline to Month 3
timeFrame: 3 months
measure: Change in Dietary intake Score from Baseline to Month 12
timeFrame: Baseline, Month 12
measure: Change in Happiness Scores from Baseline to Month 12
timeFrame: Baseline, Month 12
measure: Change in Quality of Life Score from Baseline to Month 3
timeFrame: Baseline, Month 3
measure: Change in Quality of Life Score from Baseline to Month 12
timeFrame: Baseline, Month 12
measure: Change in Positive and Negative affect Score from Baseline to Month 3
timeFrame: 3 months
measure: Change in Positive and Negative affect Score from Baseline to Month 12
timeFrame: Baseline, Month 12
measure: Change in Health-Promoting Lifestyle Practices Score from Baseline to Month 3
timeFrame: 3 months
measure: Change in Health-Promoting Lifestyle Practices Score from Baseline to Month 12
timeFrame: Baseline, Month 12
measure: Change in Flexibility from Baseline to Month 3
timeFrame: Baseline, Month 3
measure: Change in Flexibility from Baseline to Month 12
timeFrame: Baseline, Month 12
measure: Change in Aerobic stamina from Baseline to Month 3 (walk test)
timeFrame: 3 months
measure: Change in Aerobic stamina from Baseline to Month 12 (walk test)
timeFrame: Baseline, Month 12
measure: Change in exercise capacity from baseline to 3 months (sit to stand test)
timeFrame: Baseline, Month 3
measure: Change in exercise capacity from Baseline to 12 months (sit to stand test)
timeFrame: Baseline, Month 12
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Kelowna
country: Canada
facility: University of British Columbia-Okanagan
state: British Columbia
city: Vancouver
country: Canada
facility: University of British Columbia-Vancouver
state: British Columbia
city: Leeds
country: United Kingdom
facility: University of Leeds
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Deborah F. Tate, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.