Project THRIVE: Evaluating Different Approaches to Dietary Self-Monitoring for Weight Loss
Condition: Obesity; Overweight
MeSH terms: Overweight; Weight Loss
Study type: Interventional

Summary: 
      This randomized pilot trial will compare two approaches to dietary self-monitoring for weight
      loss in the context of a low-intensity, remotely-delivered lifestyle modification program.
      Participants (N=40) will be randomized to perform detailed self-monitoring of all food and
      drink consumed each day or a reduced frequency, partial prescription involving recording only
      a subset of daily intake. The investigators will compare differences in weight loss as well
      as on relevant mechanistic, behavioral outcomes between groups at 12 weeks.
    

Detailed description: 
      Most lifestyle modification programs for weight loss require comprehensive, precise dietary
      self-monitoring (DSM) of all food and drink consumed each day. Although theoretically, such
      approaches should maximize the ability to identify dietary modifications leading to weight
      loss, the high level of burden associated with these requirements may produce suboptimal
      weight loss outcomes for many individuals by compromising DSM compliance, accuracy, and
      utilization for behavior change. A few prior trials have attempted to address this concern by
      relaxing the standard DSM requirement to record caloric intake precisely. However, such
      approaches are likely limited in efficacy because they reduce the utility DSM for
      implementing specific dietary changes. An alternative, as-of-yet untested approach to lower
      DSM burden would be to require that DSM be performed precisely but with reduced frequency,
      i.e., only during eating occasions strongly associated with eating patterns that threaten
      weight control. Thus, the purpose of the current pilot trial will be to compare the standard
      DSM protocol to a novel, reduced-frequency DSM approach in the context of a 12-week,
      low-intensity weight loss intervention. Participants (N = 40) will be randomized to receive
      either standard DSM advice or a reduced-frequency prescription and will receive four
      remotely-delivered individual coaching calls. The primary aim will be to investigate whether
      relative to standard DSM, reduced-frequency DSM can yield superior outcomes on four
      prospective indicators of long-term weight loss success (attitudes, DSM accuracy, utilization
      of DSM, and sustained compliance with DSM) and also produce comparable weight outcomes by 12
      weeks.

      All participants will receive a 12-week, low-intensity coaching-based intervention consisting
      of four individual coaching contacts. All study contacts will occur remotely using the
      HIPAA-compliant Zoom service at Drexel University. Participants will first complete
      preliminary eligibility screening via telephone and eligibility will be confirmed during an
      individual baseline assessment, during which participants will also receive an overview of
      study procedures. Following the baseline assessment but prior to the first coaching call,
      participants will engage in fully comprehensive, standard DSM for one week to generate data
      on the participant's typical dietary patterns, and these data will be used to tailor the DSM
      prescription in the reduced-frequency DSM group. Participants will also be provided with
      weekly electronic reading material on principles of behavioral weight control. The first
      coaching call will be one hour in duration and will provide an overview of general behavioral
      principles of weight control, including requiring the participant to set specific calorie
      reduction, self-monitoring and physical activity goals. Participants will also be randomized
      at during the first coaching call one-to-one fashion to either receive standard DSM advice or
      to receive a reduced frequency prescription that requires recording only a subset of eating
      each day throughout the intervention. Permuted block randomization will be performed,
      stratified on baseline BMI (groups: BMI <30, BMI 30-35, BMI >35). Depending on the
      participant's assignment, he/she/they will be assigned during the baseline coaching call to
      either continue recording all dietary intake each day (using the Fitbit mobile application)
      or record a subset of eating tailored to the individual's within-day dietary patterns using a
      simple algorithm. Subsequent coaching calls will focus on a review of adherence to dietary
      and physical activity goals and problem-solving solutions to the participant's stated
      barriers to adherence. Participants in the reduced-frequency group will also have
      opportunities to modify the self-monitoring prescription during subsequent coaching calls
      depending on the perceived feasibility of their current prescription. Lastly, participants in
      both groups will complete a post-treatment assessment during which self-report measures will
      be completed and skills to maintain after treatment will be reviewed.
    

Intervention name(s): Reduced Frequency Self-Monitoring; Full-Frequency Self-Monitoring; Standard Behavioral Treatment
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Participants will be asked to record only a subset of daily eating throughout the intervention, with the prescription for self-monitoring individually tailored at baseline dependent on participants' self-reported eating patterns.; Participants will be asked to record all contents of their diet throughout the intervention.; Participants will receive four individual coaching calls over 12 weeks. During coaching calls, participants will receive guidance on lowering calorie intake, increasing physical activity and use of specific behavioral strategies to increase the probability of success with weight loss.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial with two arms (standard versus reduced-frequency). Participants will be assigned in a one-to-one fashion at baseline to one of the two groups.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment