Study of an International Commercial Program on Weight Loss and Health Outcomes
Condition: Weight Loss; Weight Change, Body; Obesity; Diet Modification
MeSH terms: Body Weight; Weight Loss; Body Weight Changes
Study type: Interventional

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.
    

Intervention name(s): Weight Watchers Freestyle (Flex); DIY Personal Plan
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
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.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment