A 2.5-Year Weight Management Program Using Noom Health: Protocol for a Randomized Controlled Trial

Abstract

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 aim to examine the efficacy of the Noom weight loss program in comparison to a digital control after a 6-month intervention phase and a 24-month maintenance phase, with assessments continuing for 2 years beyond the intervention (to 30 months—after the baseline). The secondary outcomes include quality of life, psychosocial functioning, sleep quality, physical activity, diet, and health status. This trial will also examine the severity of obesity-related functional impairment, weight loss history, and demographic moderators, along with adherence and self-efficacy as mediators of the 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 intervention and control groups include diet and exercise recommendations, educational content, daily logging capabilities, and daily weigh-in entries. The Noom Healthy Weight Program also includes a coach support for weight loss. Remote follow-up assessments of eating, physical activity, psychosocial factors, app use data, and weight will be conducted at 1, 4, 6, 12, 18, 24, and 30 months after baseline. Weight is measured at each follow-up point during a Zoom call using the participants’ scales. Results Enrollment began in March 2021 and the 6-month intervention phase ended in March 2022. Data collection for the final assessment will be completed in March 2024. Conclusions This study tests commercially available digital lifestyle interventions 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. Trial Registration ClinicalTrials.gov NCT04797169; https://clinicaltrials.gov/ct2/show/NCT04797169 International Registered Report Identifier (IRRID) DERR1-10.2196/37541

Weight loss maintenance after a digital commercial behavior change program (Noom Weight): Observational cross‐sectional survey study

“…Our results compare favorably to results from previous studies, 7,13,14,38 as well as to results with more selective samples from WW or the National Weight Control Registry 15–17 . In a well‐powered randomized controlled trial, future research will investigate which specific behavior change techniques and program components of Noom were responsible for the amount of maintenance achieved 18 . In addition to the behavior change techniques (e.g., self‐monitoring) and healthy eating and physical activity behaviors emphasized by the program, which are common to many weight management programs, it is possible that the considerable maintenance achieved was due to the cognitive behavioral therapy (CBT) and acceptance‐commitment therapy (ACT)‐based components of the program that helped to encourage cognitive flexibility.…”

“…[15][16][17] In a wellpowered randomized controlled trial, future research will investigate which specific behavior change techniques and program components of Noom were responsible for the amount of maintenance achieved. 18 In addition to the behavior change techniques (e.g., selfmonitoring) and healthy eating and physical activity behaviors emphasized by the program, which are common to many weight management programs, it is possible that the considerable mainte- articles) as well as maintenance-related behaviors that were measured by the program, such as self-monitoring of exercise and food intake. The findings suggest that the longer participants used the program, the better their maintenance success even when accounting for behaviors during maintenance.…”

“…Additionally, two studies of participants in a commercial weight loss program showed that 35%–45% of participants maintained 10% weight at 2 years and 51.6%–54% maintained 10% weight 1 year after finishing the program 16,17 . Data from the National Weight Control Registry also show that 88% of participants maintained 10% weight loss at 5 years, using a sample that had already maintained 10% weight loss for 1 year 18 . Research suggests that those who are best able to maintain weight loss tend to engage in regular physical activity and continue to monitor their weight and food intake 2,18 …”

“…16,17 Data from the National Weight Control Registry also show that 88% of participants maintained 10% weight loss at 5 years, using a sample that had already maintained 10% weight loss for 1 year. 18 Research suggests that those who are best able to maintain weight loss tend to engage in regular physical activity and continue to monitor their weight and food intake. 2,18 Most of the data on maintenance come from clinical or prospective trials (i.e., formal research or clinical settings) or in-person commercial programs.…”

“…18 Research suggests that those who are best able to maintain weight loss tend to engage in regular physical activity and continue to monitor their weight and food intake. 2,18 Most of the data on maintenance come from clinical or prospective trials (i.e., formal research or clinical settings) or in-person commercial programs. 19 However, there is a need to better understand how much weight loss is maintained after use of digital commercial programs in real-world settings, which could produce different weight maintenance results for a variety of reasons.…”