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

NCT04741568 | Completed DMC

• 2 other identifiers: SPON/2020/07/FHMS19/0006123
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 3

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.

Conditions

Diabetes Mellitus, Type 1; Disordered Eating; Children, Only; Eating Disorders; Parents

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change in child HbA1c

  Baseline, 1-month and 3-months

• Change in Body Mass Index (weight and height will be combined to report BMI in kg/m^2)

  Baseline, 1-month and 3-months

• Change in Problem Areas in Diabetes Survey Parent Revised (Markowitz et al., 2012)

  Baseline, 1-month and 3-months

• Change in Warwick Edinburgh Mental Wellbeing Scale (Tennant et al., 2007)

  Baseline, 1-month and 3-months

• Change in Psychological Determinants

  Baseline, 1-month and 3-months

Other Outcomes (8)

• Demographics

  Baseline

• Feasibility Outcomes: Number of Participants Invited to the Study

  3 months

• Feasibility Outcomes: Number of Participants Interested in Participating in the Study

  3 months

Study Arms (2)

Parental Psychoeducational Intervention

EXPERIMENTAL

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

Wait List Control

NO INTERVENTION

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.

Interventions

Parental psychoeducational Intervention BEHAVIORAL

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.

Parental Psychoeducational Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Surrey: lead

Study Sites (3)

Royal Alexandra Children's Hospital

Brighton, United Kingdom

Location

Royal Surrey Hospital

Guildford, United Kingdom

Location

Betsi Cadwaladr University Health Board

Holywell, United Kingdom

Location

Related Publications (24)

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  PMID: 31177573 BACKGROUND

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  PMID: 29079591 BACKGROUND

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  PMID: 22913589 BACKGROUND

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  PMID: 16803942 BACKGROUND

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  PMID: 27690487 BACKGROUND

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  PMID: 14981230 BACKGROUND

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  PMID: 27543373 BACKGROUND

• Geist R, Heinmaa M, Stephens D, Davis R, Katzman DK. Comparison of family therapy and family group psychoeducation in adolescents with anorexia nervosa. Can J Psychiatry. 2000 Mar;45(2):173-8. doi: 10.1177/070674370004500208.

  PMID: 10742877 BACKGROUND

• Nicholls DE, Yi I. Early intervention in eating disorders: a parent group approach. Early Interv Psychiatry. 2012 Nov;6(4):357-67. doi: 10.1111/j.1751-7893.2012.00373.x. Epub 2012 Jul 3.

  PMID: 22759660 BACKGROUND

• Scott S. National dissemination of effective parenting programmes to improve child outcomes. Br J Psychiatry. 2010 Jan;196(1):1-3. doi: 10.1192/bjp.bp.109.067728.

  PMID: 20044650 BACKGROUND

• Couturier J, Kimber M, Szatmari P. Efficacy of family-based treatment for adolescents with eating disorders: a systematic review and meta-analysis. Int J Eat Disord. 2013 Jan;46(1):3-11. doi: 10.1002/eat.22042. Epub 2012 Jul 23.

  PMID: 22821753 BACKGROUND

• Hart LM, Damiano SR, Chittleborough P, Paxton SJ, Jorm AF. Parenting to prevent body dissatisfaction and unhealthy eating patterns in preschool children: a Delphi consensus study. Body Image. 2014 Sep;11(4):418-25. doi: 10.1016/j.bodyim.2014.06.010. Epub 2014 Aug 9.

  PMID: 25084034 BACKGROUND

• Markowitz JT, Butler DA, Volkening LK, Antisdel JE, Anderson BJ, Laffel LM. Brief screening tool for disordered eating in diabetes: internal consistency and external validity in a contemporary sample of pediatric patients with type 1 diabetes. Diabetes Care. 2010 Mar;33(3):495-500. doi: 10.2337/dc09-1890. Epub 2009 Dec 23.

  PMID: 20032278 BACKGROUND

• Markowitz JT, Volkening LK, Butler DA, Antisdel-Lomaglio J, Anderson BJ, Laffel LM. Re-examining a measure of diabetes-related burden in parents of young people with Type 1 diabetes: the Problem Areas in Diabetes Survey - Parent Revised version (PAID-PR). Diabet Med. 2012 Apr;29(4):526-30. doi: 10.1111/j.1464-5491.2011.03434.x.

  PMID: 21883443 BACKGROUND

• Tennant R, Hiller L, Fishwick R, Platt S, Joseph S, Weich S, Parkinson J, Secker J, Stewart-Brown S. The Warwick-Edinburgh Mental Well-being Scale (WEMWBS): development and UK validation. Health Qual Life Outcomes. 2007 Nov 27;5:63. doi: 10.1186/1477-7525-5-63.

  PMID: 18042300 BACKGROUND

• Wardle J, Guthrie CA, Sanderson S, Rapoport L. Development of the Children's Eating Behaviour Questionnaire. J Child Psychol Psychiatry. 2001 Oct;42(7):963-70. doi: 10.1111/1469-7610.00792.

  PMID: 11693591 BACKGROUND

• Eisler I, Lock J, Le Grange D. Family-based treatments for Adolescents with Anorexia Nervosa. In The treatment of eating disorders: A clinical handbook. 1st ed. Guildford Press; 2011.

  BACKGROUND

• Lock J, Le Grange. Treatment Manual for Anorexia Nervosa. A Family-Based Approach. 2nd ed. Guildford Press; 2015.

  BACKGROUND

• National Collaborating Centre for Mental Health (UK). Eating Disorders: Core Interventions in the Treatment and Management of Anorexia Nervosa, Bulimia Nervosa and Related Eating Disorders. Leicester (UK): British Psychological Society (UK); 2004. Available from http://www.ncbi.nlm.nih.gov/books/NBK49304/

  PMID: 23346610 BACKGROUND

• National Collaborating Centre for Mental Health (2015). Access and Waiting Time Standard for Children and Young People with an Eating Disorder. Commissioning guide. (July). Available from: https://www.england.nhs.uk/wp-content/uploads/2015/07/cyp-eating-disorders-access-waiting-timestandardcomm-guid.pdf

  BACKGROUND

• Treasure J, Smith G, Crane A. Skills-based learning for caring for loved one with an eating disorder. 1st ed. Routledge; 2007.

  BACKGROUND

• Andrews S, Charig R, Hale L, Draycott S. Evaluation of a psychoeducation group for parents with a young person with an eating: prelimary findings. Poster presentation at the International Eating Disorder Conference, London; 2019.

  BACKGROUND

• Akhter K, Turnbull T, Simmons D. A systematic review of parent/peer-based group interventions for adolescents with type 1 diabetes: interventions based on theoretical/therapeutic frameworks. Br J Diabetes 2018;18:51-65.

  BACKGROUND

• Jones CJ, O'Donnell N, John M, Cooke D, Stewart R, Hale L, Skene SS, Kanumakala S, Harrington M, Satherley RM. PaRent InterventiOn to pRevent dIsordered eating in children with TYpe 1 diabetes (PRIORITY): Study protocol for a feasibility randomised controlled trial. Diabet Med. 2022 Apr;39(4):e14738. doi: 10.1111/dme.14738. Epub 2021 Nov 12.

  PMID: 34741779 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Christina Jones, PhD

  University of Surrey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2021
• First Posted: February 5, 2021
• Study Start: June 7, 2021
• Primary Completion: January 31, 2023
• Study Completion: March 22, 2023
• Last Updated: May 12, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3)