Clinical Trials Logo

Clinical Trial Summary

A recent Diabetes UK Position Statement identified several key gaps in the evidence base that might improve mental wellbeing for people with diabetes; one of which was supporting people with diabetes and eating disorders. There is evidence indicating that disordered eating may be more prevalent in children and young people (CYP). Additionally, there is mounting supporting evidence for family-based treatments in both anorexia and bulimia. This study proposes to develop a psycho-education intervention for parents of CYP with Type 1 diabetes (T1D), which will include a one-day workshop with online, downloadable content, and to assess the feasibility of this intervention. Parents will be asked to complete questionnaires about eating habits, diabetes management (both behaviour and knowledge) and wellbeing at three time-points (baseline, one-month and three-months postintervention). Children will also be asked to complete measures on diabetes eating problems at the same time intervals. Parents randomised to the intervention arm will be invited to take part in a semi-structured interview and all parents will be invited to feedback on their participation. It is hypothesised that a psycho-education intervention aimed at parents will help prevent disordered eating in CYP with T1D and improve parental wellbeing.


Clinical Trial Description

A recent Diabetes UK Position Statement identified several key gaps in the evidence base that might help improve mental wellbeing for people with diabetes, one of which was supporting people with diabetes and eating disorders. The position statement recommends focusing on people in general, citing studies which observe that 30% of women with T1D omit insulin to control their weight. However, there is evidence indicating that disordered eating may be more prevalent in CYP. A recent meta-analysis found that clinical eating disorders (i.e. anorexia and bulimia) and maladaptive eating and dieting practices (fasting, binge eating, self-induced vomiting, abuse of laxatives, diet pills or other medications including intentional insulin omission - diabulimia) were more prevalent in CYP with T1D (7.0% and 39.3% respectively) than those without T1D (2.7% and 32.5%). Management of T1D places an inherent focus on dietary intake, specifically carbohydrate counting, physical activity, regular blood sugar monitoring and correct and timely administration of insulin based on these factors. Many high carbohydrate foods can be perceived as 'bad' for blood glucose levels and are subsequently avoided or prohibited within families. This can lead to tensions between CYP and their parents, where CYP may be chastised for eating particular foods or for eating 'forbidden' foods in secret. Additionally, treatment and avoidance of hypoglycaemic episodes can add further complexities to a CYP with T1D's relationship with food, as they may overeat during hypos or save restricted or forbidden foods for hypo treatment. Some CYP may also be discouraged from participating in sport activities due to concerns about a potential hypoglycaemic event. Additionally, depending on age and pre-diagnosis symptoms of T1D, some CYP may also have experienced significant weight loss pre-diagnosis that was quickly regained upon starting insulin treatment; this may provide evidence to CYP that insulin causes them to gain unwanted body weight. Whilst systematic reviews and meta-analyses exist on the prevalence of eating problems and diabetes as well as associations between eating problems and glycaemic control, the focus of interventions for CYP with T1D has been on the improvement of psychological distress and long-term glycaemic control. Although some interventions included in these reviews have focused on family therapy, they did not explicitly target disordered eating and none were based in the UK. More recently published parenting interventions also do not address disordered eating. Therefore, due to this paucity of evidence for existing interventions, the evidence-base for interventions for clinical eating disorders not specific to T1D is reviewed instead. The rationale for focusing on interventions aimed at parents is that parents are more responsive to psychological interventions than their offspring. Furthermore, studies have highlighted the protective influence of parents for CYP with clinical eating disorders with family-based treatments playing a key role in supporting CYP in their recovery. Families are a resource in the treatment of eating disorders in CYP and there is mounting evidence that supports family-based treatments in both anorexia and bulimia. Mobilisation of the family system as a resource and an emphasis on promoting specific change early on in treatment in eating disorder-related behaviours have been found to be key elements. The involvement of parents is a key recommendation in the NICE guidelines for eating disorders. Additionally, the Access and Waiting Times Standard for CYP with eating disorders emphasises the necessity of rapid and effective treatment for CYP, along with their families and carers. Parent-focused psychoeducation groups can be a useful tool to support early change in the treatment of eating disorders. A parent-focused psychoeducation group has been developed at a specialist CYP Eating Disorder service with the aim of offering treatment within a timely manner that promoted early change. The programme is based on key principles from the parenting programme literature and the evidence base for the treatment of eating disorders. Emerging evidence from this group indicated significant positive effects and highlighted that parents benefitted most from the information about managing their CYP's eating disorder and meeting other parents. Another recent evaluation found the group to be an effective source of support for parents, improved their confidence and knowledge in managing their child's eating disorder and their ability to manage their child's adherence to meal plans. Therefore, it is evident that the involvement of parents could be crucial to facilitate recovery in CYP with eating disorders. Less specific to eating disorders, a recent review of parental interventions to prevent body dissatisfaction or eating disorders in CYP also found encouraging results. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04741568
Study type Interventional
Source University of Surrey
Contact
Status Completed
Phase N/A
Start date June 7, 2021
Completion date March 22, 2023

See also
  Status Clinical Trial Phase
Completed NCT04030091 - Pulsatile Insulin Infusion Therapy in Patients With Type 1 and Type 2 Diabetes Mellitus Phase 4
Terminated NCT03605329 - Evaluation of the Severity of Cardiovascular Autonomic Neuropathy in Type 1 Diabetic Patients With OSAS N/A
Completed NCT01696266 - An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
Recruiting NCT06050642 - Study of the Impact of PROximity Support for Patients With Type 1 DIABetes Treated With an Insulin Pump or Closed Loop. N/A
Completed NCT05107544 - Metabolic, Physical Fitness and Mental Health Effects of High Intensity Interval Training (HIIT) in Adolescents With Type 1 Diabetes N/A
Active, not recruiting NCT04443153 - Adapting Diabetes Treatment Expert Systems to Patient in Type 1 Diabetes N/A
Completed NCT04569994 - A Study to Look at the Safety of NNC0363-0845 in Healthy People and People With Type 1 Diabetes Phase 1
Completed NCT04521634 - Glycaemic Variability in Acute Stroke
Completed NCT04089462 - Effects of Frequency and Duration of Exercise in People With Type 1 Diabetes A Randomized Crossover Study N/A
Completed NCT03143816 - Study Comparing Prandial Insulin Aspart vs. Technosphere Insulin in Patients With Type 1 Diabetes on Multiple Daily Injections: Investigator-Initiated A Real-life Pilot Study-STAT Study Phase 4
Completed NCT01892319 - An International Non-interventional Cohort Study to Evaluate the Safety of Treatment With Insulin Detemir in Pregnant Women With Diabetes Mellitus. Diabetes Pregnancy Registry
Recruiting NCT04039763 - RT-CGM in Young Adults at Risk of DKA N/A
Completed NCT04042207 - Diabeloop for Highly Unstable Type 1 Diabetes N/A
Not yet recruiting NCT06068205 - COMPARATIVE ANALYSIS OF THE MORPHO-MECHANICAL PROPERTIES OF RED BLOOD CELLS EXTRACTED FROM DIABETIC PATIENTS WITH AND WITHOUT MICROVASCULAR COMPLICATIONS
Recruiting NCT05909800 - Prolonged Remission Induced by Phenofibrate in Children Newly Diagnosed With Type 1 Diabetes. Phase 2
Active, not recruiting NCT04974528 - Afrezza® INHALE-1 Study in Pediatrics Phase 3
Completed NCT04530292 - Home Intervention and Social Precariousness in Childhood Diabetes N/A
Completed NCT05428943 - OPT101 in Type 1 Diabetes Patients Phase 1
Recruiting NCT03988764 - Monogenic Diabetes Misdiagnosed as Type 1
Completed NCT05597605 - The SHINE Study: Safety of Implant and Preliminary Performance of the SHINE SYSTEM in Diabetic Subjects N/A