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Long-term dietary intervention trials: critical issues and challenges
Georgina E Crichton1, Peter R C Howe, Jonathan D Buckley
1Nutritional Physiology Research Centre, University of South Australia, Adelaide, South Australia, Australia. whige003@mymail.unisa.edu.au
Trials
|July 21, 2012
Summary
Recruiting for long-term dietary intervention trials is challenging. High attrition and adherence issues were observed, necessitating strategies like run-in periods and flexible protocols for future studies.
Area of Science:
- Nutrition science
- Clinical trial methodology
- Public health
Background:
- Running randomized controlled dietary intervention trials presents significant challenges.
- This paper evaluates recruitment, retention, and challenges in a dairy intervention trial.
- Strategies are proposed to overcome difficulties in long-term dietary intervention trials.
Purpose of the Study:
- To evaluate the recruitment process and participant retention in a dairy intervention trial.
- To identify challenges faced by participants in a long-term dietary intervention study.
- To provide actionable strategies for improving future dietary intervention trials.
Main Methods:
- A 12-month, randomized, two-way crossover study involving overweight adults with low dairy intake.
- Assessed effects of high (4 servings/day) vs. low (1 serving/day) reduced-fat dairy intake on cardiometabolic and cognitive health.
- Participant interviews were conducted post-intervention to evaluate trial experiences.
Main Results:
- Recruitment targets were met, but participant attrition was high at 49.3%.
- Maintaining participant compliance was difficult, reported by 37.8% of participants.
- Key attrition factors included dietary non-compliance (27.0%), health issues/medication changes (24.3%), and time commitment (10.8%).
Conclusions:
- High attrition and adherence issues challenge trials requiring long-term dietary changes.
- Recommendations include run-in periods, regular contact, minimized time commitment, and dietary flexibility.
- Stringent diet monitoring and facilitating positive participant experiences are crucial for future trials.
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