Long-term dietary intervention trials: critical issues and challenges

Trials. 2012 Jul 20;13:111. doi: 10.1186/1745-6215-13-111.

Abstract

Background: There are many challenges involved in running randomised controlled dietary intervention trials that investigate health outcomes. The aim of this paper was to evaluate the recruitment process, retention of participants and challenges faced in our dairy intervention trial, and to provide strategies to combat the difficulties of running long-term dietary intervention trials.

Methods: A 12-month, randomised, two-way crossover study was conducted in overweight adults with habitually low dairy food consumption to assess the effects of a high dairy intake (4 servings of reduced-fat dairy per day) compared with a low dairy intake (1 serving of reduced-fat dairy per day) on measures of cardiometabolic and cognitive health. On completion of the high dairy intake phase, each participant was interviewed about their experience in the trial and responses were used to evaluate the key issues for study participants.

Results: Although the recruitment target was achieved, high rates of attrition (49.3%) and difficulties maintaining participant compliance (reported by 37.8% of participants) were major threats to the viability of the study. Factors that contributed to the high attrition included inability to comply with the dietary requirements of the study protocol (27.0%), health problems or medication changes (24.3%) and time commitment (10.8%).

Conclusion: Attrition and adherence to study requirements present challenges to trials requiring longer-term dietary change. Including a run-in period to further assess the motivation, commitment and availability of participants, maintaining regular contact with participants during control phases, minimising time commitment, providing flexibility with dietary requirements, facilitating positive experiences, and stringent monitoring of diet are some key recommendations for future dietary intervention trials.

Trial registration: Australia and New Zealand Clinical Trials Registry (ACTRN 12608000538347).

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Cross-Over Studies
  • Dairy Products*
  • Feeding Behavior*
  • Female
  • Humans
  • Male
  • Middle Aged
  • Motivation
  • Overweight / diagnosis
  • Overweight / diet therapy*
  • Patient Compliance
  • Patient Dropouts
  • Research Design
  • South Australia
  • Surveys and Questionnaires
  • Time Factors
  • Treatment Outcome
  • Weight Loss