Study of a Personalized vs. Standard Approach to Weight Loss Recommendations
Condition: Overweight and Obesity
MeSH terms: Overweight; Weight Loss
Study type: Interventional

Summary: 
      The purpose of this study is to develop and test the feasibility of a behavioral weight loss
      intervention that uses personalized recommendations for diet and physical activity behaviors
      in a behavioral weight loss program and to explore factors associated with treatment
      adherence and response. The 12-week intervention will utilize digital tools for
      self-monitoring and counseling by weight management professionals. Exploratory analyses will
      be conducted to determine if there are genetic, metabolomic, microbiome, or psychosocial
      factors associated with treatment response.
    

Detailed description: 
      The primary objective of the study is to test a personalized approach for prescribing weight
      loss strategies in overweight adults participating in a weight loss intervention and to
      determine if a personalized approach can optimize weight loss compared to a standard
      behavioral weight loss intervention. Thus, all participants will receive a behavioral weight
      loss intervention delivered via remote counseling and digital tools including a smart phone
      app, Wi-Fi- enabled smart scale, physical activity tracker. Participants in the personalized
      group will also use a continuous blood glucose monitoring (CGM) device.

      The differences between the two groups will be the approach used to recommend diet and
      physical activity changes. The study will compare a Standard Behavioral Weight Loss (BWL)
      approach tested in numerous previous studies and consistent with current clinical practice,
      to a Personalized Behavioral Weight Loss (PBWL) approach that tests a combination of diet and
      physical activity prescriptions to determine the best "fit" for the participant. The PWBL
      group will actively use CGM information during the intervention period to inform diet and
      activity behaviors. Participants will be randomized in a 3:1 ratio to PBWL or BWL (i.e., 30
      to PBWL and 10 to BWL).

        1. Behavioral Weight Loss: The BWL group will receive a standard weight loss intervention
           based on the evidence-based interventions currently being recommended for clinical
           practice, with general recommendations for caloric reductions based on starting weight
           and aimed at achieving a 1-2 lb. average weekly weight loss, and progressive weekly
           increases of physical activity. Supporting behavioral lessons adapted from materials
           used in the Diabetes Prevention Program, a landmark behavioral weight loss intervention,
           will also be delivered. The weight loss 'prescription' will remain consistent throughout
           the 3 month trial.

        2. Personalized Behavioral Weight Loss: The PBWL group will receive a weight loss
           intervention that is personalized for diet and physical activity recommendations based
           on a testing period where various approaches to eating and physical activity that may
           result in differential adherence and response are tested. Calorie recommendations will
           be based on measured resting energy expenditure and expected activity levels and aimed
           at achieving a 1-2 lb. average weekly weight loss. In the initial weeks, participants
           will test various diet and physical activity prescriptions. Following this period, the
           optimal combination will be identified by the participant, in consultation with their
           interventionist, based on measured blood glucose, weight loss, hunger and ability to
           adhere to the prescription. Diet composition (percentage of calories from fat,
           carbohydrates, and protein) will be personalized along with meal frequency and physical
           activity goals. This group will receive the same supporting behavioral lessons as the
           BWL group along with additional resources specific to their personalized prescription.
           The weight loss 'prescription' will vary across the 3-month trial based on response to
           treatment.
    

Intervention name(s): Behavioral Weight Loss Program; Personalized Behavioral Weight Loss Program
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The BWL group will receive a standard weight loss intervention based on the evidence-based interventions currently being recommended for clinical practice, with general recommendations for caloric reductions based on starting weight and progressive weekly increases of physical activity (PA). Supporting behavioral lessons based on materials used in the Diabetes Prevention Program (DPP) will also be delivered. The weight loss 'prescription' will remain consistent throughout the 3 month trial. Participants will receive digital tools including a study smart phone app that incorporates diet self-monitoring, tracking of behavioral goals, behavioral lessons and resources, and integration of data from a study-provided Wi-Fi enabled scale and physical activity tracker.; The PBWL group will receive a calorie goal based on measured resting energy expenditure and baseline PA. In Weeks 1-4, participants will be randomly assigned to test patterns that manipulate diet composition (low-fat or low-carbohydrate), meal frequency (3 or 5-6 meals/day), and PA goals (weekly minutes or daily minutes goals). Following this period, the optimal combination will be identified by the participant and interventionist, based on weight loss, blood glucose, hunger and ability to adhere to the prescription. This group will receive the same supporting behavioral lessons as the BWL group along with additional resources specific to their personalized prescription. The weight loss 'prescription' will vary across the 3-month trial based on response to treatment. Participants will receive the same digital tools as the BWL group with resources specific to following the prescription they are following during any given program week.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment