A randomized controlled trial of an empowerment intervention for female adolescents with diabetes.

A randomized controlled trial and a qualitative interview study of an empowerment intervention (Guided Self-Determination - Young) for female adolescents with diabetes, evaluating glycemic control and perceived health and quality of life, compared with usual care

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN57528404

Enrollment

100

Registered

2015-02-18

Start date

2017-05-01

Completion date

Unknown

Last updated

2023-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Nutritional, Metabolic, Endocrine Type 1 diabetes

Interventions

In addition to standard care the intervention group will receive seven individual Guided Self-Determination-Young (GSD-Y) education visits (1-1.5 h) with a diabetes nurse, dietician or a physician ov

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Female adolescents with diabetes

Exclusion criteria

Exclusion criteria: Difficulties understanding Swedish

Design outcomes

Primary

Measure	Time frame
Current primary outcome measure as of 04/01/2022: Glycemic control assessed using HbA1c measured at baseline and after 6 and 12 months _____ Previous primary outcome measure: Glycemic control, measured with HbA1c Outcome will be measured at baseline and after 6, 12 and 24 months	—

Secondary

Measure	Time frame
Current secondary outcome measures as of 04/01/2022: 1. Self-management assessed using mean frequency of self-monitoring of blood glucose (SMBG) 2. Treatment satisfaction assessed using DTSQ Teen and Parent 3. Perceived health and quality of life assessed using Check your health 4. Diabetes-related family conflicts assessed using Diabetes Family Conflict Scale (DFCS) 5. Psychosocial self-efficacy assessed using Swedish Diabetes Empowerment Scale (Swe-DES 23) All outcomes will be measured at baseline and after 6 and 12 months _____ Previous secondary outcome measures: 1. Self-management: mean frequency of self-monitoring of blood glucose (SMBG) 2. Treatment satisfaction: DTSQ Teen and Parent 3. Perceived health and quality of life: Check your health, 4. Diabetes-related family conflicts: Diabetes Family Conflict Scale (DFCS) 5. Psychosocial self-efficacy: Swedish Diabetes Empowerment Scale (Swe-DES 23) All outcomes will be measured at baseline and after 6, 12 and 24 months	—

Measure

Time frame

Current secondary outcome measures as of 04/01/2022: 1. Self-management assessed using mean frequency of self-monitoring of blood glucose (SMBG) 2. Treatment satisfaction assessed using DTSQ Teen and Parent 3. Perceived health and quality of life assessed using Check your health 4. Diabetes-related family conflicts assessed using Diabetes Family Conflict Scale (DFCS) 5. Psychosocial self-efficacy assessed using Swedish Diabetes Empowerment Scale (Swe-DES 23) All outcomes will be measured at baseline and after 6 and 12 months _____ Previous secondary outcome measures: 1. Self-management: mean frequency of self-monitoring of blood glucose (SMBG) 2. Treatment satisfaction: DTSQ Teen and Parent 3. Perceived health and quality of life: Check your health, 4. Diabetes-related family conflicts: Diabetes Family Conflict Scale (DFCS) 5. Psychosocial self-efficacy: Swedish Diabetes Empowerment Scale (Swe-DES 23) All outcomes will be measured at baseline and after 6, 12 and 24 months

—

Countries

Sweden

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 8, 2026