Effectiveness of the Diabetes Body Project Among Females With Type 1 Diabetes

NCT04837989 | Terminated

• 1 other identifier: 6860
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

Young females with type 1 diabetes (T1D) is at high risk of eating disorders (ED), with prevalence rates of ED more than double those of non-diabetes peers. T1D and ED are both associated with serious somatic complications, and when occurring together the prognosis is even worse. Despite the frequency and severity of this comorbidity, there is a lack of intervention studies and no consensus on how to best prevent and treat this comorbidity. To remedy this, we have developed a virtual diabetes-adapted version of the ED prevention program Body Project, i.e. the Diabetes Body Project. This study examines the effectiveness of the Diabetes Body Project to reduce ED risk factors and symptoms among young females with T1D.

Conditions

Feeding and Eating Disorders; Diabetes Mellitus, Type 1; Body Image

Outcome Measures

Primary Outcomes (6)

• The Ideal-Body Stereotype Scale-Revised (IBSS-R)

  Thin beauty ideal internalization, scores range from 1-5, higher scores indicate higher levels of internalization

  Baseline, change from baseline to 6 weeks, change from baseline to 6-months

• The Body Parts Scale

  Nine items on body dissatisfaction, scores range from 1-5, higher scores indicate more body dissatisfaction

  Baseline, change from baseline to 6 weeks, change from baseline to 6-months

• Dietary restraint

  Eating restriction, scores range from 1-5, higher scores indicate more eating restriction

  Baseline, change from baseline to 6 weeks, change from baseline to 6-months

• The Diabetes Eating Problem Survey - Revised

  Total score to indicate level of eating disorder psychopathology, scored 0-5, higher scores indicate higher levels of eating disorder psychopathology

  Baseline, change from baseline to 6 weeks, change from baseline to 6-months

• Social attitudes towards appearance questionnaire (SATAQ) 4R

  Appearance pressures and internalization, answers range from 1-5, higher scores indicate more pressures/internalization

  Baseline, change from baseline to 6 weeks, change from baseline to 6-months

• Social Comparison Scale

  The degree to which individuals compare themselves to others, score 1-10, higher scores indicate more favorable social compariso

  Baseline, change from baseline to 6 weeks, change from baseline to 6-months

Secondary Outcomes (3)

• Blood glucose control

  Baseline, change from baseline to 6 weeks, change from baseline to 6-months

• Problem Areas in Diabetes (PAID)

  Baseline, change from baseline to 6 weeks, change from baseline to 6-months

• Brief Illness Perception Questionnaire

  Baseline, change from baseline to 6 weeks, change from baseline to 6-months

Study Arms (2)

Diabetes Body Project

EXPERIMENTAL

Participants randomized to the experimental condition will receive virtual Diabetes Body Project groups immediately.

Behavioral: Diabetes Body Project

Educational

ACTIVE COMPARATOR

Participants randomized to the control condition will receive an education brochure and will be offered the Diabetes Body Project after 6 months.

Behavioral: Psychoeducation

Interventions

Diabetes Body Project BEHAVIORAL

Six virtually delivered Diabetes Body Project groups over six weeks (one hour a week); 5-6 participants and 2 group facilitators

Diabetes Body Project

Psychoeducation BEHAVIORAL

Individuals assigned to the psychoeducational control condition will receive an educational brochure, and complete similar assessments and assessment time points as the experimental condition. Individuals in the control group will be offered Diabetes Body Project group participation after six months.

Educational

Eligibility Criteria

• Age: 16 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Female, 16-35 years, type 1 diabetes, acknowledges at least some level of body image concerns

You may not qualify if:

• Other forms of diabetes, males

Sponsors & Collaborators

• Oslo University Hospital: lead
• The Dam Foundation: collaborator
• Norwegian Diabetes Association: collaborator

Study Sites (1)

Oslo Unviersity Hospital

Oslo, 0424, Norway

Location

MeSH Terms

Conditions

Feeding and Eating Disorders; Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

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

Study Officials

• Line Wisting, PhD

  Oslo University Hospital, Division of Mental Health and Addiction

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher, PhD

Study Record Dates

• First Submitted: March 29, 2021
• First Posted: April 8, 2021
• Study Start: February 1, 2021
• Primary Completion: July 31, 2022
• Study Completion: July 31, 2022
• Last Updated: August 4, 2023

Record last verified: 2023-08

Locations

NO (1)