A Protocol for a 2.5 Year Weight Management using Noom Health: Randomized Controlled Trial (Preprint)

BACKGROUND Overweight and obesity are serious public health concerns. As the prevalence of excess weight among individuals continues to increase, there is a parallel need for inexpensive, highly accessible, and evidence-based weight loss programs. OBJECTIVE This weight loss trial will examine the efficacy of the Noom weight-loss program in comparison to a digital health control after a 6-month intervention phase and a 24-month maintenance phase with assessments occurring for two-years beyond the intervention (to 30 months post-baseline). Secondary outcomes include quality of life, psychosocial functioning, sleep quality, physical activity, diet, and health status. This trial will also examine severity of obesity-related functional impairment, weight loss history, and demographic moderators along with adherence and self-efficacy as mediators of outcome. METHODS A total of 600 participants were randomized in a parallel group-controlled trial to either Noom Healthy Weight Program (intervention) or Noom Healthy Weight Control (control) for a 6-month intervention. Both the intervention and control include diet and exercise recommendations, daily logging capabilities, and daily weigh-in entries. The Noom Healthy Weight Program also includes coach support for weight loss. Remote follow-up assessments of eating, physical activity, psychosocial factors, app use data, and weight will occur at 1-, 4-, 6-, 12-, 18-, 24-, and 30-months post-baseline. Weight is measured at each follow-up point during a Zoom call using the participants’ own scale. RESULTS Enrollment began in March 2021 and the 6-month intervention phase is expected to end for all participants in March 2022. Data collection for the final assessment will be completed in March 2024. CONCLUSIONS This study tests commercially available digital lifestyle-intervention for individuals with overweight and obesity seeking weight loss support. Data obtained from the study will evaluate whether the Noom Healthy Weight Control Program can help individuals overcome weight loss, achieve long-term maintenance, adhere to lifestyle changes, and feature-use barriers that are present in other traditional weight loss treatments. CLINICALTRIAL A ClinicalTrials.gov record (NCT04797169) was created prior to the start of enrollment.