UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037268 |
|---|---|
| Receipt number | R000042303 |
| Scientific Title | Individualized dietary advice based on individual dietary assessment compared with conventional advice for Japanese adults with type 2 diabetes: a parallel-group randomized controlled clinical trial |
| Date of disclosure of the study information | 2019/07/04 |
| Last modified on | 2022/02/01 23:51:12 |
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Basic information
Public title
Individualized dietary advice based on individual dietary assessment compared with conventional advice for Japanese adults with type 2 diabetes: a parallel-group randomized controlled clinical trial
Acronym
Individualized dietary advice based on individual dietary assessment compared with conventional advice for Japanese adults with type 2 diabetes: a parallel-group randomized controlled clinical trial
Scientific Title
Individualized dietary advice based on individual dietary assessment compared with conventional advice for Japanese adults with type 2 diabetes: a parallel-group randomized controlled clinical trial
Scientific Title:Acronym
Individualized dietary advice based on individual dietary assessment compared with conventional advice for Japanese adults with type 2 diabetes: a parallel-group randomized controlled clinical trial
Region
| Japan |
Condition
Condition
Type 2 Diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This trial aimed to investigated whether the personalized dietary feedback intervention for patients with type 2 diabetes based on a brief questionnaire is superior in improving glycemic control compared to conventional dietary advice.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The change of HbA1c in six months
Key secondary outcomes
The changes in weight and serum lipid profile (triglyceride, high-density lipoproteins (HDL) -cholesterol, and low-density lipoproteins (LDL) -cholesterol).
Dietary change in 6 months.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Participants with type 2 diabetes answered a brief diet history questionnaire were randomized to the personalized dietary feedback group or the conventional advice group. Both groups received three sessions of 30-minute face-to-face dietary advice in six months by dietitians.
Participants in the personalized feedback group received dietary advice using the revised BDHQ feedback sheet and leaflets corresponding to its contents. The revised feedback sheet included 17 themes (cereals, sugar-sweetened-beverages, confectioneries, meat, dairy, vegetables, fruits, protein, carbohydrates, total fat, saturated fat, dietary fiber, magnesium, salt, glycemic index, having breakfast, and total energy intake corresponding to anthropometric profile. The lower and/or upper limits and traffic lights, which categorize participants' nutrient adequacy into three groups, are displayed on the sheet.
Interventions/Control_2
Conventional dietary advice was provided following ideal energy intake estimated based on participants' height. Dietitians provided a pamphlet on hospital menu of each ideal energy intake, and an explanation of the food substitution table, the Japanese population-based text six food groups of similar nutrients. On the second and third sessions, dietitians questioned the menu contents of their typical three meals and provided interactive advice to reach their ideal energy intake.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who were 20 years or older and diagnosed with type 2 diabetes within 10 years before study entry are recruited.
Key exclusion criteria
Exclusion criteria are severe renal dysfunction (macroalbuminuria or end-stage renal disease), pregnancy, and having received dietary advice from dietitians within three years
Target sample size
118
Research contact person
Name of lead principal investigator
| 1st name | Yuka |
| Middle name | |
| Last name | Omura |
Organization
The Jikei University School of Medicine
Division name
The Division of Diabetes, Metabolism, and Endocrinology
Zip code
105-8471
Address
3-19-18 Nishi-Shimbashi, Minato-ku, Tokyo
TEL
0334331111
yukaomura@jikei.ac.jp
Public contact
Name of contact person
| 1st name | Yuka |
| Middle name | |
| Last name | Omura |
Organization
The Jikei university school of medicine
Division name
The Division of Diabetes, Metabolism, and Endocrinology
Zip code
105-8471
Address
3-19-18 Nishi-Shimbashi, Minato-ku, Tokyo
TEL
0334331111
Homepage URL
yukaomura@jikei.ac.jp
Sponsor or person
Institute
The Jikei university school of medicine
Institute
Department
Personal name
Funding Source
Organization
the Jikei University Fund for Graduate Students
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Department of Social and Preventive Epidemiology, School of Publish Health, University of Tokyo, Tokyo, Japan
Name of secondary funder(s)
The Mishima Kaiun Memorial Foundation academic research incentives
IRB Contact (For public release)
Organization
Jikei university school of medicine
Address
3-19-18 Nishi-Shimbashi, Minato-ku, Tokyo
Tel
0334331111
yukaomura@jikei.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
東京慈恵会医科大学附属病院（東京都）、葛飾医療センター（東京都）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 07 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://authors.elsevier.com/a/1eV%7EU3LdAaoAMU
Number of participants that the trial has enrolled
136
Results
In total, 126 participants were included in the analysis. HbA1c significantly decreased larger in the individualized group [-1.1%, (95% CI: -1.3 to -0.8)] than the conventional group [-0.7% (95% CI: -1.0 to -0.4)] (P = 0.0495). The individualized group decreased weight, serum triglyceride, and LDL-C, and increased HDL-C, without a significant difference to the conventional group. The conventional group decreased alcohol intake and increased total fat and saturated fatty acid intakes.
Results date posted
| 2022 | Year | 02 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 03 | Month | 22 | Day |
Baseline Characteristics
No major differences between the two groups were observed at baseline. All participants were Japanese, 74% of whom were men. The mean age was 57.7 (range 29-87) years. They were characterized by high proportions of obese patients (61.9%). Randomized two groups had no statistical difference in the treated drug category. Through the follow-up measurement period, out of the 126 participants, 8 participants (4 in each group) were transferred into the other drug categories, and another 12 participants (7 in the individualized group, 5 in the conventional group) received minor changes of oral hypoglycemic agent lineages. However, no significant group differences in drug category were observed at baseline and also through the follow-up measurement period.
Participant flow
A total of 136 participants were randomly allocated to an individualized or a conventional group after baseline measurements. During the study period, 3 participants (2 in the intervention, 1 in the conventional group) became unable to eat their usual diet because of gastrointestinal diseases (rupture of esophageal varices, severe vomiting, and mediastinal sarcoma). We considered them unsuitable for receiving dietary advice for diabetes, then excluded them from study participants. Additionally, from April 2020, in the middle of the study period, hospitals had to introduce telemedicine due to the pandemic of coronavirus disease 2019 (COVID-19). Therefore, some participants received only prescriptions without dietary counseling sessions. The fact influenced the attending rate; in total, only 75 participants (38 in the individualized group and 37 in the conventional group) attended all three sessions. Nevertheless, the dropout rate was lower than expected; 7.2% for the individualized group and 7.5% for the conventional group. After 6 months, 126 participants remained in the intention-to-treat analysis as we predefined.
Adverse events
There were no reports of adverse events directly related to this study.
Outcome measures
Irrespective of variables, differences in baseline measurements between the two groups were not statistically significant (p > 0.05). The decrease in HbA1c after six months was more significant in the individualized group [-1.1% (95% CI: -1.3 to -0.8)] compared to the conventional group [-0.7% (95% CI: -1.0% to -0.4)] (p = 0.0495) after adjustment for the baseline HbA1c value, age, sex, BMI, physical activity, and smoking history; an additional analysis showed that the difference was no longer significant after adjustment for weight change between six months (p = 0.07).
Similarly, serum triglyceride and LDL-C were significantly decreased, and HDL-C was increased only in the individualized group; however, the differences compared to the conventional group were not significant (p = 0.15 to 0.16). A significant decrease in weight was shown only in the individualized group, but the group difference was not significant (p = 0.07).
Dietary intake at baseline did not differ between the two groups, apart from the higher intakes of total energy, rice, and confectioneries in the individualized group (p = 0.02, 0.02, and 0.01). After six months, the individualized group significantly decreased total energy intake and intakes of confectioneries, oil and fats, meats, and SSB. On the other hand, alcohol intake decreased, and total fat and saturated fatty acid intakes increased in the conventional group. Significant group differences were observed only for the changes of total fat (p = 0.01) and saturated fatty acid intakes (p = 0.02).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 01 | Month | 06 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 08 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 02 | Month | 08 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 10 | Month | 31 | Day |
Other
Other related information
The results were published on March 22, 2022.
https://authors.elsevier.com/a/1eV%7EU3LdAaoAMU
Management information
Registered date
| 2019 | Year | 07 | Month | 04 | Day |
Last modified on
| 2022 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042303
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