Contemporary Clinical Trials Communications (Jun 2021)
Feasibility and acceptability of a randomized controlled trial to investigate withdrawal symptoms in response to caffeinated sugary drink cessation among children
Abstract
Background: Sugary drinks (SDs) are key contributors to excess added sugar intake and the predominant source of caffeine among children. Chronic caffeine intake causes dependence, and evidence for sugar dependence is emerging. Development of withdrawal symptoms may pose an obstacle to SD cessation among children. We examined the feasibility and acceptability of a three-arm randomized controlled trial (RCT) designed to investigate withdrawal symptoms resulting from replacement of children's usual caffeinated SD intake with either caffeine-free alternatives or caffeine-free and sugar-free alternatives, compared with continued consumption of caffeinated SDs. Methods: Twenty-nine children 8–12 years old, who consumed ≥12 ounces caffeinated SDs daily, enrolled. The two-week RCT required three in-person meetings and daily completion of electronic questionnaires to assess withdrawal symptoms and intervention adherence. Children were randomized to replace their usual caffeinated SD consumption with 1) caffeine-free alternatives, 2) caffeine-free and sugar-free alternatives, or 3) caffeinated SDs (control), provided by the study team. Feasibility and acceptability were assessed quantitatively and qualitatively. Results: Twenty-eight participants (97%) completed the study. Adherence was high, with 73% reporting compliance with beverage assignments, and 76% completing all questionnaires. In qualitative interviews at follow-up, children described feelings of importance and commitment, and parents did not find the procedures to be overly burdensome. While challenges to adherence were reported (e.g., child wanting other SDs, time commitment), participants described innovative strategies (e.g., designating a place for study drinks in the refrigerator) to maintain adherence. Conclusion: Results indicated high levels of RCT feasibility and acceptability. The reported barriers and strategies for adherence will inform modifications required to design a larger and longer-term trial investigating withdrawal symptoms after SD cessation in children.
