Consultation on an RCT on Vitamin D and Insulin

By Minervation,

A Consultative approach exploring user views on an RCT looking at The Effect of Vitamin D on Insulin Resistance and Secretion in Obese Adolescent

The proposed study was looking at exploring user views on an RCT looking at, “The Effect of Vitamin D on Insulin Resistance and Secretion in Obese Adolescents.”

Aims of Consultation

The aim of the consultation exercise was to establish users’ views about the proposed RCT, exploring themes such as patient benefit, value for money of research, ethics, and design of trial?


Focus Group 1: Five parents and seven young people (aged between 8 and 17) who were research savvy members of the CRN: Chidren East Young Person’s Group, originally recruited to help develop another proposed RCT for Clinically Obese Adolescents. Focus Group 2: 4 parents and 4 young people (aged between 12 and 16), who would otherwise satisfy the inclusion criteria of the study. An emphasis for both focus groups was to engage with relevant users.


The consultation activities employed a focus group methodology. Attendees were presented with essential information about the RCT and given opportunities for questions. Attendees were then invited to interact and discuss the RCT and relevant themes in detail. Discussions were recorded alongside handwritten notes. Subsequently, recordings were transcribed and analysis of materials undertaken using NVivo. Content Analysis methodology allowed identification and incidence of themes. Once data had been collated, reports were sent to parents and young people for further clarification and rigour.


Many themes emerged and clarification of these were sought from families following consultations providing further validity. The RCT under scrutiny received mostly positive comments related to value for money and patient benefit.   The main concern was the difficulty of supplement compliance.

Another important observation was how inadvertently potential participants may take on information from studies. For example, on both occasions, the facilitator had to emphasis several times to the groups that the use of Vitamin D as an intervention for young people with Type II diabetes hadn’t a robust evidence base. This was because it was observed several times that group members had adopted the assumption that vitamin D could stop type II diabetes, even though it was clearly stated it was a study to confirm this.

Further studies

This consultation provided some useful points and identified future area’s that could be examined with users. These are:

  • Looking at problems with compliance of medication
  • Examine how different cultures, communities and social classes experience different issues regarding lifestyles which could affect diet
  • What consultation has taken place to inform current interventions that attempt to address the problem of obesity and/or if planning of these interventions involved consumer engagement.
  • What type of preventative media could encourage prevention of health related diseases, compliance with medication and promotion of paediatric research?


This work clearly illustrates how young people and their parents can help confirm or improve the design of research.