Type1diabetesNCT05411952
Family-Based Behavioral Medical Nutrition Therapy Education in Children and Adolescents With Type 1 Diabetes
A study testing Medical nutrition therapy and carbohydrate counting education in people with Type1diabetes, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
Trial summary
Type 1 Diabetes Mellitus (T1DM) is a heterogeneous condition and is an absolute insulin deficiency resulting from autoimmune-mediated destruction of pancreatic β-cells (1). The incidence of T1DM has been increasing globally since the 1950s, particularly in children, with an average annual increase of 3-4% over the… Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Type1diabetes
- What is being tested?
- Medical nutrition therapy and carbohydrate counting education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Aug 2020to 15 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 8-18 years old,
- Being diagnosed with T1DM for at least ≥1 year, maximum ≤5 years,
- Latest HbA1c ≥6.5% - <13.5%,
- Receiving intensive insulin therapy (at least 3 times a day bolus and 1 time basal insulin administration or using an insulin pump),
- No communication problems
- Children and adolescents without any other disease accompanying diabetes were included in the study.
Who cannot join
- Celiac, cystic fibrosis etc. with gastrointestinal diseases,
- Using any drug that may affect glucose metabolism,
- Switched from an insulin pen to an insulin pump in less than 6 months,
- Involved in any other intervention work in the last 6 months,
- and individuals with communication problems were not included in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziantep Cengiz Gokcek Gynecology and Pediatrics Hospital
Gaziantep, 27010
About this study
Official title: The Effect of Family-Based Behavioral Medical Nutrition Therapy Education on Nutritional Status and Metabolic Control in Children and Adolescents With Type 1 Diabetes
Type 1 Diabetes Mellitus (T1DM) is a heterogeneous condition and is an absolute insulin deficiency resulting from autoimmune-mediated destruction of pancreatic β-cells (1). The incidence of T1DM has been increasing globally since the 1950s, particularly in children, with an average annual increase of 3-4% over the past three decades.Despite the advances in medical treatment and technology, nutritional therapy continues to be the main component of diabetes treatment. Medical nutrition further improves metabolic control outcomes when T1DM care is combined with other treatments.This study was conducted to examine the effect of family-based behavioral medical nutrition therapy training on nutritional status and metabolic control in children and adolescents with Type 1 diabetes.
Read the detailed description
The research was carried out with children and adolescents aged 8-18 years who were followed up with the diagnosis of Type 1 Diabetes Mellitus in Gaziantep Cengiz Gökçek Gynecology and Pediatrics Hospital. The sample of the study was consisted of 75 (male= 36, female= 39) children and adolescents in total, including Intervention 1 group (n=25), Intervention 2 (n=25) group and Control (n=25) group determined by double-blind, stratified, random method. Medical nutrition therapy and carbohydrate counting training were given to mothers and children in the Intervention 1 group, and only to children and adolescents in the Intervention 2 group. The control group did not receive medical nutrition therapy and carbohydrate counting training. At the beginning (0. month) and at the end (6. month) of the study, 3 consecutive day/24-hour food consumption records and anthropometric measurements of the individuals were assessed, BMI z-scores and height z-scores were calculated, Mediterranean Diet Quality Index Scale (KIDMED), Diabetes Eating Problems Survey-Revised (DEPS-R), Physical Activity Questionnaire for Children and Adolescents (PAQ-C and PAQ-A) were administered and Healthy Eating Index 2015 (HEI-2015) scores were calculated. Routinely assessed blood findings of the individuals were checked at the beginning (0. month), 3rd month and 6th month of the study.
- Conditions
- Type1diabetes
- Being tested
- Medical nutrition therapy and carbohydrate counting education, No intervention
- Keywords
- Type 1 diabetes, nutrition education, metabolic control
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical nutrition therapy and carbohydrate counting educationOther
Children and their mothers have received family-based behavioral medical nutrition therapy and carbohydrate counting education for 6 months by trained dietitian
Medical nutrition therapy and carbohydrate counting educationOther
Only children have received family-based behavioral medical nutrition therapy and carbohydrate counting education for 6 months by trained dietitian
No interventionOther
Control group didn't receive any intervention by trained dietitian. Furthermore they continued their routine health controls.
| Study group | Role | What they receive |
|---|---|---|
| education-mother and child dyad | Experimental | Mother and child dyad have received dietary intervention for 6 months Receives: Other: Medical nutrition therapy and carbohydrate counting education |
| education-only child | Experimental | Children have received dietary intervention for 6 months. But their mothers didn't receive any dietary intervention Receives: Other: Medical nutrition therapy and carbohydrate counting education |
| control | Experimental | Control group did't receive any dietary intervention during the study Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean of HbA1c from baseline to 6 months
All data were analysed by using IBM SPSS Statistics 26 and significance was defined as p< 0.05
Measured: 6 months
Secondary outcomes (2)
Change in mean of Healthy Eating Index 2015 (HEI-2015) score from baseline to 6 Months
All data were analysed by using IBM SPSS Statistics 26 and significance was defined as p< 0.05
Measured: 6 months
Change in mean of Mediterranean Diet Quality Index Scale (KIDMED) from baseline to 6 Months
All data were analysed by using IBM SPSS Statistics 26 and significance was defined as p< 0.05
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start13 Aug 2020
- Primary completion28 Jan 2021
- Study completion15 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type1diabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The sample of the study was consisted of 75 (male= 36, female= 39) children and adolescents in total, including Intervention 1 group (n=25), Intervention 2 (n=25) group and Control (n=25) group determined by double-blind, stratified, random method.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasan Kalyoncu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hulya Yilmaz, Hasan Kalyoncu University
- Investigators
- Gulden KOKSAL, Prof., Study director, Hasan Kalyoncu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05411952
- Sponsor's protocol ID
- Hasan-Kalyoncu-UnivHulyaYilmaz
- Status last verified
- Jun 2022
- First submitted
- 30 May 2022
- Last updated
- 9 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Family-Based Behavioral Medical Nutrition Therapy Education on Nutritional Status and Metabolic Control in Children and Adolescents With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT05411952
- Acronym / sponsor ID
- Hasan-Kalyoncu-UnivHulyaYilmaz
- Conditions
- Type1diabetes
- Keywords
- Type 1 diabetes, nutrition education, metabolic control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Study start
- 13 Aug 2020 (actual)
- Primary completion
- 28 Jan 2021 (actual)
- Study completion
- 15 Sep 2021 (actual)
- First posted
- 9 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Type 1 Diabetes Mellitus (T1DM) is a heterogeneous condition and is an absolute insulin deficiency resulting from autoimmune-mediated destruction of pancreatic β-cells (1). The incidence of T1DM has been increasing globally since the 1950s, particularly in children, with an average annual increase of 3-4% over the past three decades.Despite the advances in medical treatment and technology, nutritional therapy continues to be the main component of diabetes treatment. Medical nutrition further improves metabolic control outcomes when T1DM care is combined with other treatments.This study was conducted to examine the effect of family-based behavioral medical nutrition therapy training on nutritional status and metabolic control in children and adolescents with Type 1 diabetes.
Detailed description
The research was carried out with children and adolescents aged 8-18 years who were followed up with the diagnosis of Type 1 Diabetes Mellitus in Gaziantep Cengiz Gökçek Gynecology and Pediatrics Hospital. The sample of the study was consisted of 75 (male= 36, female= 39) children and adolescents in total, including Intervention 1 group (n=25), Intervention 2 (n=25) group and Control (n=25) group determined by double-blind, stratified, random method. Medical nutrition therapy and carbohydrate counting training were given to mothers and children in the Intervention 1 group, and only to children and adolescents in the Intervention 2 group. The control group did not receive medical nutrition therapy and carbohydrate counting training. At the beginning (0. month) and at the end (6. month) of the study, 3 consecutive day/24-hour food consumption records and anthropometric measurements of the individuals were assessed, BMI z-scores and height z-scores were calculated, Mediterranean Diet Quality Index Scale (KIDMED), Diabetes Eating Problems Survey-Revised (DEPS-R), Physical Activity Questionnaire for Children and Adolescents (PAQ-C and PAQ-A) were administered and Healthy Eating Index 2015 (HEI-2015) scores were calculated. Routinely assessed blood findings of the individuals were checked at the beginning (0. month), 3rd month and 6th month of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- The sample of the study was consisted of 75 (male= 36, female= 39) children and adolescents in total, including Intervention 1 group (n=25), Intervention 2 (n=25) group and Control (n=25) group determined by double-blind, stratified, random method.
| Arm | Type | Receives |
|---|---|---|
| education-mother and child dyad | Experimental | Other: Medical nutrition therapy and carbohydrate counting educationMother and child dyad have received dietary intervention for 6 months |
| education-only child | Experimental | Other: Medical nutrition therapy and carbohydrate counting educationChildren have received dietary intervention for 6 months. But their mothers didn't receive any dietary intervention |
| control | Experimental | Other: No interventionControl group did't receive any dietary intervention during the study |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 8-18 years old,
- Being diagnosed with T1DM for at least ≥1 year, maximum ≤5 years,
- Latest HbA1c ≥6.5% - <13.5%,
- Receiving intensive insulin therapy (at least 3 times a day bolus and 1 time basal insulin administration or using an insulin pump),
- No communication problems
Key exclusion criteria (5 listed)
- Celiac, cystic fibrosis etc. with gastrointestinal diseases,
- Using any drug that may affect glucose metabolism,
- Switched from an insulin pen to an insulin pump in less than 6 months,
- Involved in any other intervention work in the last 6 months,
- and individuals with communication problems were not included in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical nutrition therapy and carbohydrate counting educationChildren and their mothers have received family-based behavioral medical nutrition therapy and carbohydrate counting education for 6 months by trained dietitian | Other | education-mother and child dyad |
| Medical nutrition therapy and carbohydrate counting educationOnly children have received family-based behavioral medical nutrition therapy and carbohydrate counting education for 6 months by trained dietitian | Other | education-only child |
| No interventionControl group didn't receive any intervention by trained dietitian. Furthermore they continued their routine health controls. | Other | control |
Primary outcome
Change in mean of HbA1c from baseline to 6 months
Time frame: 6 months
All data were analysed by using IBM SPSS Statistics 26 and significance was defined as p< 0.05
2 secondary outcomes
Change in mean of Healthy Eating Index 2015 (HEI-2015) score from baseline to 6 Months
Time frame: 6 months
Change in mean of Mediterranean Diet Quality Index Scale (KIDMED) from baseline to 6 Months
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gulden KOKSAL, Prof. study director
Hasan Kalyoncu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medical nutrition therapy and carbohydrate counting education in people with Type1diabetes, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mean of HbA1c from baseline to 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2022.