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. 2022 May:116:106750.
doi: 10.1016/j.cct.2022.106750. Epub 2022 Apr 1.

The EVO study protocol for a randomized controlled evaluation trial of an optimized weight management intervention

Angela Fidler Pfammatter  1 , Samuel L Battalio  2 , Charlie Olvera  2 , Margaret DeZelar  2 , Dominique Moore  2 , Laura Scanlan  2 , Juned Siddique  2 , Bonnie Spring  2 , Su-Hsin Chang  3
Affiliations

The EVO study protocol for a randomized controlled evaluation trial of an optimized weight management intervention

Angela Fidler Pfammatter et al. Contemp Clin Trials. 2022 May.

Abstract

Background: Obesity is a substantial public health concern; however, gold-standard behavioral treatments for obesity are costly and burdensome. Existing adaptations to the efficacious Diabetes Prevention Program (DPP) demonstrate mixed results. Our prior research applying the Multiphase Optimization Strategy (MOST) to DPP identifies a more parsimonious, less costly intervention (EVO) resulting in significant weight loss.

Objective: The aim of the remotely conducted EVO trial is to test the non-inferiority of EVO against DPP. We will conduct economic evaluations alongside the trial to estimate delivery and patient costs, cost-effectiveness, and lifetime healthcare costs of EVO as compared to DPP. Exploratory analyses will examine maintenance, moderators, and mediators of the treatment effect.

Study design: The EVO trial will recruit nationally to randomize 524 participants with obesity. Participants will receive either EVO or DPP over a 6 month period. EVO participants will be provided online lessons, a smartphone application to self-monitor diet, physical activity, and weight, and attend 12 brief calls with a Health Promotionist. DPP participants will receive the first 6 months of the Center for Disease Control's T2D materials and attend 16 one-hour video call sessions with staff certified in DPP delivery. Weight will be measured at baseline, 3-, 6-, and 12-months. Itemized delivery cost will be collected. Staff and participants will also provide information to estimate costs for intervention-related activities.

Significance: The EVO trial could establish evidence supporting dissemination of a scalable, cost-effective behavioral treatment with potential to shift clinical practice guidelines, inform policy, and reduce the prevalence of obesity.

Keywords: Economic evaluation; Obesity; Optimization; Telehealth; Weight loss; mHealth.

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Conflict of interest statement

Declaration of interests

The authors declare the following financial interests/personal relationships which may be considered as potential competing interests:

Figures

Figure 1.
Figure 1.
EVO Study Design
Figure 2.
Figure 2.
Run-in and main display interface for the custom-built EVO App. Run-in (A) is used as a tool to screen participants interested in the EVO trial. Following randomization to the EVO conditions, the main display (B) allows participants to track their daily calorie and fat gram intake, minutes of physical activity completed, and daily weight.
Figure 3.
Figure 3.
Weight and nutrition goals displayed within the web-based dashboard
See this image and copyright information in PMC

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