Diabetes Mellitus, Type 1 Clinical Trial
— PRIORITYOfficial title:
Development and Feasibility of a Parent Intervention to Prevent Disordered Eating in Children and Young People With Type 1 Diabetes
Verified date | May 2023 |
Source | University of Surrey |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 89 |
Est. completion date | March 22, 2023 |
Est. primary completion date | January 31, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Royal Alexandra Children's Hospital | Brighton | |
United Kingdom | Royal Surrey Hospital | Guildford | |
United Kingdom | Betsi Cadwaladr University Health Board | Holywell |
Lead Sponsor | Collaborator |
---|---|
University of Surrey |
United Kingdom,
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* Note: There are 23 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Demographics | 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 | |
Other | Feasibility Outcomes: Number of Participants Invited to the Study | Number of parents invited to the study | 3 months | |
Other | Feasibility Outcomes: Number of Participants Interested in Participating in the Study | Number of Participants Interested in Participating in the Study | 3 months | |
Other | Feasibility Outcomes: Number of parents meeting eligibility criteria | Number of parents meeting eligibility criteria | 3 months | |
Other | Feasibility Outcomes: Number of parents recruited and participating in the intervention | Number of parents recruited and participate in the intervention | 3 months | |
Other | Feasibility Outcomes: Completion Rates (will be calculated from number of parents recruited, number of parents completing the intervention) | 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 | |
Other | Feasibility Outcomes: Retention Rates (will be calculated from number of parents recruited and participating in the intervention) | 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 | |
Other | Feasibility Outcomes: Usability of Online Content (Google Analytics) | Analysis on usability of online content. Data obtained from Google Analytics (e.g. website traffic, session duration, pages per session) | 3 months | |
Primary | Change in Diabetes Eating Problem Survey Revised (Markowitz et al., 2010) | 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 | Change in child HbA1c | Parent reported HbA1c of children | Baseline, 1-month and 3-months | |
Secondary | Change in Body Mass Index (weight and height will be combined to report BMI in kg/m^2) | Parent reported weight and height of children used to calculate BMI | Baseline, 1-month and 3-months | |
Secondary | Change in Problem Areas in Diabetes Survey Parent Revised (Markowitz et al., 2012) | A parent-reported survey to assess diabetes related distress, higher scores indicate greater diabetes distress. | Baseline, 1-month and 3-months | |
Secondary | Change in Warwick Edinburgh Mental Wellbeing Scale (Tennant et al., 2007) | 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 | |
Secondary | Change in Psychological Determinants | Information Motivation Behvaioural Skills model questionnaire devised for this study completed by parents | Baseline, 1-month and 3-months | |
Secondary | Intervention Feedback Survey | Satisfaction and experience with intervention survey devised for this study | 3 months | |
Secondary | Change in Children's Eating Behaviour Questionnaire (Wardle et al. 2001) | 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 |
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