Content area
Abstract
Background: Participant compliance is an important measure of study success in randomized control trials (RCTs.) However, there is a lack of literature studying participant compliance in dietary interventions, specifically eating frequency (EF) interventions. EF pattern has begun to spark interest in the field of nutrition, and calls for increased participant compliance research to ensure success of current and future EF protocols. The Frequency of Eating and Satiety Hormone Study (theFRESHstudy) is an ongoing EF RCT that provides opportune conditions to measure participant compliance to a prescribed EF protocol.
Objective: The purpose of this study is to examine participant compliance to a prescribed EF protocol in theFRESHstudy.
Design/Methods: Participants (n=30) completed two 21-day, isocaloric intervention phases in a randomly assigned order. In one treatment arm, participants ate with a low EF pattern (three eating occasions per day.) In the other arm, participants ate with a high EF pattern (six eating occasions per day.) Participants prepared and consumed their own foods using a structured meal plan and calorie (kcal) intake level provided by the study dietitian. During each intervention phase, participants completed an online daily checklist where they reported food group choice, physical activity, sleep, appetite, and extra eating occasions (EEOs.) EEOs and food group choice for each eating occasion were the variables used to measure participant compliance. Data for EEOs and food group choice were extracted from the database, anonymized by subject ID, and transferred to a spreadsheet. Data were then reorganized with new variables to perform statistical analyses. Paired T-tests and chi-squared tests were completed using formula functions programmed within the data spreadsheet.
Results: There was minimal noncompliance in terms of EEOs (<1 EEO per person/day) and no significant differences by EF treatment arm (p=0.44.) Starch and fat food group choices were the primary sources of EEOs. The observed number of undereating and overeating occasions for food group choices in each treatment arm was significant (p<0.05.)
Conclusion: Participant compliance to theFRESHstudy protocol did not differ between low and high EF treatment arms. Continued research is warranted to analyze participant compliance to future EF nutrition interventions.
