The WEIGH Study: Weighing to Improve and Gain Health
Condition: Overweight and Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The purpose of this research project is to assess the efficacy of a weight loss intervention
      for chronic disease prevention that focuses on daily self-weighing as the primary
      self-monitoring strategy compared to a delayed-intervention control group. While daily
      self-weighing has been shown to be effective for weight loss in observational research, there
      is limited experimental evidence testing this association and most is derived from intensive
      interventions that may overshadow the effects of self-weighing. To mitigate this, the
      investigators will examine whether daily self-weighing is effective for weight loss under
      self-directed conditions using a randomized-controlled design.

      The investigators will conduct a 6-month randomized trial in 88 overweight and obese adults
      to compare a daily self-weighing intervention to a delayed-intervention control group.
      Changes in weight, diet and physical activity, and psychosocial measures will be examined.

      Main Study Hypothesis: Participants in the group randomized to receive the daily
      self-weighing intervention will have greater percent weight loss at 6 months compared to
      those in the delayed control group.

      Secondary Hypothesis: Participants in the group receiving the daily self-weighing
      intervention will report greater engagement in diet and physical activity behaviors that
      produce caloric deficits, greater self-efficacy and motivation, and no differences in body
      satisfaction, disordered eating, or depressive symptoms compared to those in the control
      group.
    

Detailed description: 
      Obesity continues to be a challenging public health problem. Despite producing large
      reductions in weight, weight loss interventions require a significant amount of effort
      because of the detailed self-monitoring of dietary intake and exercise habits that is
      involved. Consequently, this behavior is difficult to sustain and weight regain occurs.
      Interventions focused on enhancing simple strategies for self-monitoring may be just as
      effective and provide more lasting effects.

      One of the simplest forms of self-monitoring is self-weighing. Self-weighing is an important
      tool for regulation of body weight as it provides proximal feedback on how eating and
      exercise behaviors are impacting weight, and allows individuals to make adjustments to these
      behaviors to affect energy balance. Observational research indicates that daily self-weighing
      is associated with greater weight loss as compared to less frequent self-weighing. However,
      there is limited experimental evidence testing this association and most is derived from
      intensive interventions that may overshadow the effects of self-weighing. To mitigate this,
      the investigators will examine whether daily self-weighing is effective under self-directed
      conditions with minimal contact. The results of this proposal will provide evidence about the
      efficacy of daily self-weighing on weight loss using a randomized controlled design. Most
      assessments of self-weighing are measured via self-report, which introduces measurement
      error. This proposal will improve on this by using an objective measure of self-weighing with
      a scale that can store and transmit weight data.

      Given that self-weighing does not impact weight loss directly but rather via changes in diet
      and physical activity behaviors, a full understanding of the mechanisms explaining this
      relationship is necessary. Furthermore, despite evidence indicating that more frequent
      self-weighing has no adverse psychological effects in adults participating in weight control
      interventions, there remains debate as to the negative psychological consequences of this
      behavior. Therefore, it would be informative to test for any adverse effects between
      treatment groups to further add to the evidence surrounding this debate.

      The objective of the WEIGH Study (Weighing to Improve and Gain Health) is to test the
      efficacy of a self-directed intervention focused on daily self-weighing as the main
      self-monitoring strategy on weight loss at 6 months compared to a delayed-intervention
      control group. This will be tested using a 2-group randomized control design. Participants
      will be randomly assigned to either: [1] Daily Self-weighing Intervention Group or [2]
      Delayed-Intervention control group. The daily self-weighing intervention group will receive
      access to a "smart scale" for daily self-weighing and viewing of weight trends over time, and
      receive weekly emails with tailored messages reinforcing self-weighing and other behaviors
      associated with reaching weight loss goals. This group will also receive weekly lessons with
      basic information for weight loss and strategies on how to use the scale to maximize weight
      loss. The control group will be given the "smart scale" and be told to weigh as often as they
      normally do, with the goal of observing natural weighing frequency trends in this group.
      After the end of the 6-month study, they will receive a 3-month modified version of the daily
      self-weighing intervention, which will include weekly emails, prescription for daily
      self-weighing, and weight monitoring via the smart scale website. Detailed descriptions of
      these components are outlined below.

      Recruitment and Informed Consent Participants will first undergo screening at
      www.uncweightresearch.org via Qualtrics or call the study center to complete the screening
      questionnaire over the phone. For those filling out the questionnaire online, they are still
      required to call the study center to complete the screening questionnaire, as sensitive
      medical-related questions are more appropriate to ask over the phone.

      Once they are considered eligible, participants will be invited to an orientation session
      where they can hear more about the program and ask any questions before deciding whether or
      not to participate. For those who want to participate, the study PI and/or other study
      personnel listed on this application will explain the consent form and ask the participant to
      read the form. Once the participant has finished reading the form, the study personnel member
      will ask the participant if he/she has any questions. Then both parties will sign the
      questionnaire and the participant will receive a copy of the consent form.

      Randomization Consented individuals will be provided with a Qualtrics link to complete
      baseline questionnaire measures. A computer algorithm will randomly assign them to one of the
      two study groups. Baseline anthropometrics will be measured at the kick-off session where
      randomization will be revealed to all participants. At both the 3 and 6-month assessments,
      the enrolled patients will repeat all baseline measures, with the exception of demographic
      characteristics. At 9 months, participants in both groups will be asked to stop on their
      smart scale to provide a final weight measurement and the control group will complete 1 final
      questionnaire. Following randomization, participants will either receive the components
      outlined below for the intervention group or for the delayed-intervention control group.

      Detailed Descriptions of the Intervention Components Kick-off Group Meeting Initially,
      individuals will attend a group kick-off meeting where they will receive scales (see below)
      and other materials for getting started. This meeting will also emphasize the objective of
      the study, which is to examine the effect of a self-directed approach for weight loss
      emphasizing daily self-weighing. The kick-off session will provide participants will a
      start-up guide for how to use the scale as well as access to the study website
      (www.bodytrace.com) for viewing of weight trends overtime. The session will focus on the
      benefits of daily self-weighing for weight loss, addressing certain myths regarding daily
      self-weighing and emphasizing the use of the scale as a barometer for progress with diet and
      physical activity behaviors. In addition, this session will also provide a brief overview of
      "Weight Loss 101" through a discussion focused on calorie balance, as it outlined in the
      Diabetes Prevention Program materials.

      Smart Scales Participants in the intervention group will be instructed to weigh themselves
      daily using "smart" scales. These scales send weight data directly to a website
      (www.bodytrace.com) via the wireless cellular network. Participants will be able to view
      their weight on the scale and can also utilize the website to view weight trends overtime.
      Participants will be loaned these scales, and will be told in the consent form that they will
      be be able to keep the smart scale upon completion of all study assessment visits.
      Participants will be told that if they do not complete the assessment visits, they will be
      asked to return to the UNC Weight Research Program.

      Intervention Weekly Emails All intervention participants will receive weekly emails that
      include basic skills training materials about weight control, and tailored feedback based on
      rate of weight loss and daily self-weighing frequency. The skills training materials will
      include instructional lessons about topics such as portion control, label reading, restaurant
      eating, structured exercise, and lifestyle activity, and behavioral topics such as problem
      solving, stimulus control and relapse prevention. The behavioral topics are based on the
      evidence based Diabetes Prevention Program. This program has been used in various research
      studies, including those conducted at the UNC Weight Research Program. Additionally, the
      investigators will reinforce self-weighing through behavioral weight control topics to
      enhance self-regulation.

      The emails will begin with a tailored feedback message about daily self-weighing frequency
      and a message to reinforce daily self-weighing to help participants respond effectively to
      weight changes by learning how to utilize their scale to make adjustments to diet and
      physical activity behaviors in order to produce caloric deficits. An algorithm based on
      self-weighing frequency compliance will determine which feedback message they receive

      Diet and Physical Activity Level Suggestions Participants in the intervention group will also
      receive examples of meal plans for each of the calorie levels associated with weight loss
      (e.g., 1200-1800 calories per day) and be given suggestions for which meal plan to follow
      based on baseline weight, Furthermore, all participants will be provided with a physical
      activity goal of 150-250 minutes per week of exercise similar to brisk walking, as this level
      is shown to be associated with weight loss. They will be encouraged to begin with 10 minutes
      of walking each day and to add 5 minutes per day each week until they reach the 150-200
      minutes. For example, Week 1 walk 10 minutes x 5 days (50 minutes), Week 2 walk 15 minutes x
      5 days (75 minutes), Week 3 walk 20 minutes x 5 days (100 minutes), etc.

      Delayed-Intervention Control Group The delayed-intervention control group will receive a
      kick-off session where they will be told that the study is testing a self-directed approach
      to weight loss focusing on careful tracking of weight, and that they will receive a modified
      version of the intervention after the 6-month period is complete. They will also be provided
      with the "smart scales" but not website access (bodytrace.com), and be told to use them as
      they normally would, so that the investigators could get a sense of their normal weighing
      habits. They will be told that the investigators will be able to view their weighing
      frequency on the bodytrace.com website. They will receive a modified version of the
      intervention for 3 months, which will include the same components as the intervention group
      with the exception of the weekly feedback emails. After 3 months, the investigators will call
      and/or email participants to ask them to step on the scale and provide a final weight and
      complete 1 final questionnaire on process measures.
    

Intervention name(s): Daily Self-weighing + weekly feedback+ weekly lessons
Intervention type(s): Behavioral
Intervention description(s): Daily self-weighing as a form of self-monitoring of body weight using a smart scale that sends their weights directly to a website (www.bodytrace.com) via the cellular network. They will be able to review weight trends overtime on this website via a graph showing both changes in weight and BMI. They will also receive weekly emailed feedback on their weight loss progress and compliance to the daily self-weighing prescription from a registered dietitian, as well as weekly emailed lessons with content related to behavioral weight control (e.g, how to control portion sizes, how to develop and exercise routine).
Other intervention name(s): Daily Self-weighing Intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: self-weighing; self-monitoring; weight loss; obesity