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The randomization process involves assigning study participants randomly to experimental or control groups based on their probability of being equally assigned. Randomization is meant to eliminate selection bias and balance known and unknown confounding factors so that the control group is similar to the treatment group as much as possible. A computer program and a random number generator can be used to assign participants to groups in a way that minimizes bias.
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Regression toward the mean (“RTM”) is a phenomenon in which extremely high or low values—for example, and individual’s blood pressure at a particular moment—appear closer to a group’s average upon remeasuring. Although this statistical peculiarity is the result of random error and chance, it has been problematic across various medical, scientific, financial and psychological applications. In particular, RTM, if not taken into account, can interfere when...
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Blinding is a commonly used method of not telling participants which treatment a subject is receiving. Blinding is a critical part of a randomized control trial or RCT. It reduces the bias that affects the results. In an RCT, blinding is used in the form of a placebo. A placebo effect occurs when untreated subjects falsely believe they have received the treatment and report improved symptoms. A placebo or a dummy treatment is administered to subjects to negate the bias caused by such an effect.
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Author Spotlight: Exploring the Impact of Reduced Resistance Exercise Volume on Metabolic Health
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Recruitment and Retention for a Weight Loss Maintenance Trial Involving Weight Loss Prior to Randomization.

C I Voils1, J M Grubber2, M A McVay3

  • 1Center for Health Services Research in Primary Care Durham Veterans Affairs Medical Center Durham NC USA; Department of Medicine Duke University Medical Center Durham NC USA.

Obesity Science & Practice
|January 17, 2017
PubMed
Summary

Weight loss maintenance trials face challenges with participant dropout and insufficient weight loss. Younger age, tobacco use, and lack of social support were linked to lower retention and success in the MAINTAIN trial.

Keywords:
clinical trialsrecruitmentretentionweight loss maintenance

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Area of Science:

  • Behavioral science
  • Clinical research
  • Obesity studies

Background:

  • Weight loss maintenance trials are crucial for long-term health but face significant challenges.
  • Participant dropout and failure to achieve sufficient weight loss prior to randomization are common hurdles.
  • Understanding factors influencing trial initiation and retention is vital for successful study design.

Purpose of the Study:

  • To examine the rates and correlates of non-initiation, dropout, and insufficient weight loss in a weight loss maintenance trial.
  • To identify demographic and psychosocial factors associated with poor trial engagement.
  • To inform strategies for improving recruitment and retention in future weight loss studies.

Main Methods:

  • The MAINTAIN trial involved a 16-week weight loss program preceding randomization.
  • Eligibility required losing at least 4 kg.
  • Psychosocial measures and weight were assessed at screening and during the program.

Main Results:

  • Of 573 eligible participants, 69 failed to initiate the program, associated with younger age and lack of social support.
  • Among those who initiated, 200 dropped out (linked to younger age, tobacco use) and 82 lost insufficient weight (linked to non-White race, controlled motivation).
  • 222 participants achieved sufficient weight loss for randomization.

Conclusions:

  • Strategies are needed to improve recruitment and retention in weight loss maintenance trials.
  • Specific subgroups require targeted interventions to enhance participation.
  • Further research should focus on addressing barriers to initiation and sustained engagement.