Parent Intervention to Prevent Disordered Eating in Children With Type 1 Diabetes (PRIORITY)

May 11, 2023 updated by: University of Surrey

Development and Feasibility of a Parent Intervention to Prevent Disordered Eating in Children and Young People With Type 1 Diabetes

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

89

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Brighton, United Kingdom
        • Royal Alexandra Children's Hospital
      • Guildford, United Kingdom
        • Royal Surrey Hospital
      • Holywell, United Kingdom
        • Betsi Cadwaladr University Health Board

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Parental Psychoeducational Intervention
A brief (one-day or two half days) psychoeducation workshop will be provided alongside a website with downloadable content will be made available to review and refresh any skills and techniques. The psychoeducational intervention will be delivered by a research fellow and research assistant with a background in psychology and delivered in line with a protocol.
Behavioral: Parental psychoeducational Intervention

The psychoeducation intervention for parents will focus on providing skills, knowledge and support motivation for caregivers of children with diabetes.

A brief (one-day or two half days) workshop, and a website with downloadable content will be made available to review and refresh any skills and techniques.
No Intervention: Wait List Control
Parents randomised to the control arm will be put on the waiting list (wait-list controls) to receive the group intervention after the active treatment group have completed their final follow-up at 3 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Diabetes Eating Problem Survey Revised (Markowitz et al., 2010)
Time Frame: Baseline, 1-month and 3-months
A child and parent reported survey of eating problems. Responses are scored on a 6-point Likert scale and higher scores indicate greater eating disorder pathology.
Baseline, 1-month and 3-months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in child HbA1c
Time Frame: Baseline, 1-month and 3-months
Parent reported HbA1c of children
Baseline, 1-month and 3-months
Change in Body Mass Index (weight and height will be combined to report BMI in kg/m^2)
Time Frame: Baseline, 1-month and 3-months
Parent reported weight and height of children used to calculate BMI
Baseline, 1-month and 3-months
Change in Problem Areas in Diabetes Survey Parent Revised (Markowitz et al., 2012)
Time Frame: Baseline, 1-month and 3-months
A parent-reported survey to assess diabetes related distress, higher scores indicate greater diabetes distress.
Baseline, 1-month and 3-months
Change in Warwick Edinburgh Mental Wellbeing Scale (Tennant et al., 2007)
Time Frame: Baseline, 1-month and 3-months
A self report survey to assess parental mental wellbeing. Scores range from 14 to 70 and higher scores indicate greater positive mental wellbeing.
Baseline, 1-month and 3-months
Change in Psychological Determinants
Time Frame: Baseline, 1-month and 3-months
Information Motivation Behvaioural Skills model questionnaire devised for this study completed by parents
Baseline, 1-month and 3-months
Intervention Feedback Survey
Time Frame: 3 months
Satisfaction and experience with intervention survey devised for this study
3 months
Change in Children's Eating Behaviour Questionnaire (Wardle et al. 2001)
Time Frame: Baseline, 1-month and 3-months
A parent rated instrument to assess eight dimensions of eating style in children. Includes 35 items rates on a 5-point scale, higher scores indicate greater child behaviour for each dimension (e.g. emotional overeating, enjoyment of food).
Baseline, 1-month and 3-months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demographics
Time Frame: Baseline
Parent completed T1D clinical characteristics and healthcare utilisation survey devised for this study (child age, gender, years with diagnosis, number of hospital visits in the last year)
Baseline
Feasibility Outcomes: Number of Participants Invited to the Study
Time Frame: 3 months
Number of parents invited to the study
3 months
Feasibility Outcomes: Number of Participants Interested in Participating in the Study
Time Frame: 3 months
Number of Participants Interested in Participating in the Study
3 months
Feasibility Outcomes: Number of parents meeting eligibility criteria
Time Frame: 3 months
Number of parents meeting eligibility criteria
3 months
Feasibility Outcomes: Number of parents recruited and participating in the intervention
Time Frame: 3 months
Number of parents recruited and participate in the intervention
3 months
Feasibility Outcomes: Completion Rates (will be calculated from number of parents recruited, number of parents completing the intervention)
Time Frame: 3 months
We look at the number of enrolled parents who have completed the intervention divided by the total number of parents who have completed the intervention or withdrawn or cancelled.
3 months
Feasibility Outcomes: Retention Rates (will be calculated from number of parents recruited and participating in the intervention)
Time Frame: 3 months
The total number of parents students (including any who have withdrawn), minus the number of parents who have withdrawn or cancelled their enrollment, and divide this by the total number of enrolled parents.
3 months
Feasibility Outcomes: Usability of Online Content (Google Analytics)
Time Frame: 3 months
Analysis on usability of online content. Data obtained from Google Analytics (e.g. website traffic, session duration, pages per session)
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Surrey

Investigators

  • Principal Investigator: Christina Jones, PhD, University of Surrey

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 7, 2021

Primary Completion (Actual)

January 31, 2023

Study Completion (Actual)

March 22, 2023

Study Registration Dates

First Submitted

January 15, 2021

First Submitted That Met QC Criteria

February 2, 2021

First Posted (Actual)

February 5, 2021

Study Record Updates

Last Update Posted (Actual)

May 12, 2023

Last Update Submitted That Met QC Criteria

May 11, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPON/2020/07/FHMS
  • 19/0006123 (Other Grant/Funding Number: DiabetesUK)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus, Type 1

Clinical Trials on Parental psychoeducational Intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mongolia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe