Clinical trial NCT04741568: Parent Intervention to Prevent Disordered Eating in Children With Type 1 Diabetes
Official title: Development and Feasibility of a Parent Intervention to Prevent Disordered Eating in Children and Young People With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Disordered Eating
Children, Only
Eating Disorders
Parents
Lead sponsor: University of Surrey
Sponsor class: OTHER
First posted: 2021-02-05
Enrollment: 89
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Parent or primary caregiver of a CYP aged between 11-14 years with a diagnosis of T1D
* Willing to attend group intervention and provide consent
* Fluent in English or Welsh

Exclusion Criteria:

* Parent receiving psychological support for their child's diabetes and disordered eating
* Parent diagnosis of severe mental health or learning difficulty
* Participating in another trial
* Unable to speak or understand English or Welsh

Primary outcomes:
measure: Change in Diabetes Eating Problem Survey Revised (Markowitz et al., 2010)
timeFrame: Baseline, 1-month and 3-months
Secondary outcomes:
measure: Change in child HbA1c
timeFrame: Baseline, 1-month and 3-months
measure: Change in Body Mass Index (weight and height will be combined to report BMI in kg/m^2)
timeFrame: Baseline, 1-month and 3-months
measure: Change in Problem Areas in Diabetes Survey Parent Revised (Markowitz et al., 2012)
timeFrame: Baseline, 1-month and 3-months
measure: Change in Warwick Edinburgh Mental Wellbeing Scale (Tennant et al., 2007)
timeFrame: Baseline, 1-month and 3-months
measure: Change in Psychological Determinants
timeFrame: Baseline, 1-month and 3-months
measure: Intervention Feedback Survey
timeFrame: 3 months
measure: Change in Children's Eating Behaviour Questionnaire (Wardle et al. 2001)
timeFrame: Baseline, 1-month and 3-months
Other outcomes:
measure: Demographics
timeFrame: Baseline
measure: Feasibility Outcomes: Number of Participants Invited to the Study
timeFrame: 3 months
measure: Feasibility Outcomes: Number of Participants Interested in Participating in the Study
timeFrame: 3 months
measure: Feasibility Outcomes: Number of parents meeting eligibility criteria
timeFrame: 3 months
measure: Feasibility Outcomes: Number of parents recruited and participating in the intervention
timeFrame: 3 months
measure: Feasibility Outcomes: Completion Rates (will be calculated from number of parents recruited, number of parents completing the intervention)
timeFrame: 3 months
measure: Feasibility Outcomes: Retention Rates (will be calculated from number of parents recruited and participating in the intervention)
timeFrame: 3 months
measure: Feasibility Outcomes: Usability of Online Content (Google Analytics)
timeFrame: 3 months
Locations:
city: Brighton
country: United Kingdom
facility: Royal Alexandra Children's Hospital
city: Guildford
country: United Kingdom
facility: Royal Surrey Hospital
city: Holywell
country: United Kingdom
facility: Betsi Cadwaladr University Health Board
Study officials:
affiliation: University of Surrey
name: Christina Jones, PhD
role: PRINCIPAL_INVESTIGATOR
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